Internet Ambulance Medical portal. Internet Ambulance Medical portal Diane 35 for unwanted hair

Acne (pimples) often occurs against the background of dysfunction that is located in the upper layers.

Usually the appearance of acne indicates diseases of the body, most often this is how problems with the endocrine system manifest themselves.

In cases where external medications to combat acne do not help or their effects are weak, then the dermatologist prescribes a hormonal examination and, based on the tests, prescribes the drug Diane 35.

Indications

The drug is prescribed only to girls and women.

The main reason for prescribing this particular drug is hormonal disbalance, when the content of hormones, in particular the androgynous group, affects the disturbance of fat metabolism in the body. As a result, sebum production increases and sweating increases.

These factors lead to clogging of pores and the proliferation of bacteria, which provoke the appearance of pimples and blackheads, which can be difficult to treat.

Often the problem manifests itself in and persists after puberty, worsening depending on the phase of the menstrual cycle.

Why does Diana 35 help with acne?

The composition of the drug Diane 35 includes cyproterone acetate, which reduces the production of androgens (male sex hormones), they are produced in excess in the female body.

That is why it becomes possible to treat acne and acne that appear against the background of an imbalance of this group of hormones.

While taking the drug, the level of excess hormones decreases, the hyperfunction of the sebaceous glands, which affects the occurrence of pimples, blackheads and seborrhea, weakens.

After a few months (3-4) of taking the drug, the condition improves, while at the same time the oiliness of the hair and its loss decrease, as well less hirsutism.

Many oral contraceptives of the combined group have this effect, but in the case of Diane 35 the effect is more pronounced. In parallel with this, the menstrual cycle is adjusted, and pain during menstruation is reduced.

Most often, this therapeutic effect manifests itself in women from 20 to 40 years old, because Acne is not just a teenage problem, women of childbearing age often encounter it; on average, 40% of the fair sex have a problem with acne, which Diana 35 helps treat.

After completing a course of treatment with this drug, most patients note the complete disappearance of acne. Therefore, if your tests show an increased level of male hormones, then Diane 35 will help solve the problem by restoring the body’s hormonal levels.

Effective fight against acne is possible only with complex treatment. When using preparations for internal use, do not forget about cosmetic skin treatment.

How to take Diana 35 correctly?

Before you start taking the drug, you must undergo a complete gynecological examination in order to identify problems with your health and hormone levels.

When treatment with this particular drug is indicated, only a doctor can prescribe treatment.

When you see your doctor, be sure to tell him if you have any of the following problems:

• systematic smoking;
• diabetes mellitus in you or in your immediate family;
• excess weight;
• problems with blood pressure, heart or circulatory system;
• migraines and epilepsy;
• breast cancer in you and your immediate family;
• diseases of the liver, intestines, skin, blood;
• presence of holoasma (brown pigmentation on the skin).

If at least one of the problems has manifested itself before or appears while taking the drug, then you must inform your doctor about it, because the effectiveness of acne treatment and your health in the future depends on this.

Directions for use and doses

The drug must be taken regularly in order for the full therapeutic effect to be achieved.

The package contains 21 tablets. In the package, the pills are marked according to the day of the cycle (week) when it should be taken.

You need to take the drug in accordance with the marked day at the same time, for simplicity, the direction of reception is also indicated by arrows. After 21 days, you must take a break in order for menstruation to begin, and after the break, the drug is taken again according to the same regimen.

The first package of Diane 35 should be taken on the first day of the monthly cycle, in full accordance with the day labeling; if, for example, bleeding began on Wednesday, then you should take a pill labeled “Wednesday”.

If you combine acne treatment with contraception, then for the first 3-5 days you need to additionally use barrier methods of contraception.

To achieve a therapeutic effect the drug is used for at least 4-6 months. Often, the doctor prescribes a course of treatment in accordance with the test results and may note the intake as you recover; in case of relapse, the drug Diane 35 may again be prescribed, which will be taken according to the previously described regimen.

If you use other oral contraceptives, your doctor will advise you on the procedure for changing the drug to obtain the therapeutic effect of Diane 35.

It is impossible to take two different hormonal contraceptives at the same time, due to the fact that this is dangerous to life and health.

Contraindications for taking this drug

There are the following contraindications for using the drug:

• thrombosis, acute or already treated;
• cardiovascular diseases, heart attacks, angina pectoris, strokes, both acute and already treated;
• diabetes mellitus of both types with vascular disorders;
• diseases of the liver, gall bladder, hepatitis, cancer of the liver;
• oncological diseases of the mammary glands, genital organs, acute or in remission;
• uterine bleeding, the causes of which have not been determined;
• pregnancy, lactation;
• the presence of allergic reactions to the components of the drug.

At the first manifestations of illness or side effects, immediately stop taking the drug and consult a doctor to prescribe other treatment.

Remember that Diana is 35 does not protect against HIV infection or sexually transmitted infections. Never offer the drug to other people if it was prescribed to you.

If you are pregnant, taking the drug may cause a miscarriage or the development of abnormalities in the fetus. During lactation, taking the drug is prohibited due to the fact that loss of the ability to produce milk may occur, and the risk of mastopathy increases. Separately, it should be noted that the drug is not prescribed for children and adolescents, and it is also contraindicated after menopause.

Women with liver disease should not take the drug until clinical liver parameters return to normal. For women with kidney problems, the drug is most often not prescribed due to the fact that the effect of the drug has not been fully studied, and it is not known how the kidneys will react to it. For those women who smoke, the drug is not prescribed, the combination of nicotine and the medicinal components of Diane 35 can lead to the development of serious consequences, such as thrombosis or stroke.

Side effects caused by taking Diane 35

Tell your doctor immediately if you notice changes in your health that you have not previously experienced or that are associated with other diseases.

Side effects include:

• headaches, dizziness;
• engorgement, pain and fluid discharge from the mammary gland;
• libido disturbance;
• mood swings or loss of energy;
• development of intolerance to contact lenses;
• nausea or vomiting;
• changes in vaginal discharge;
• skin rashes that have not previously been observed;
• swelling and retention of urine;
• changes in body weight, both its increase and decrease;
• manifestation of hypersensitivity reactions to odors.

What is the price?

The cost of the drug varies depending on the pharmacy and region. from 770 to 1100 rubles.

Diane 35 for acne: reviews of those taking the drug

Due to the fact that the drug has been used in medical practice against acne for quite a long time, there are many reviews about taking the drug, here are some of them:

Tatiana: Skin problems have been observed since I was 17 years old. She carried out traditional treatment from a dermatologist and cosmetologist, and used external preparations. After 18 years, I turned to a gynecologist, who, after a full examination and treatment of cervical erosion, prescribed me the drug Diane 35. The medicine began to help gradually, acne began to go away, and the wounds from them began to heal. After 5 months, the problems were almost completely gone, all that remained was to carry out a series of procedures to cleanse the facial skin and restore it. The contraceptive drug Diane 35 played a very important role in the treatment, because my hormonal levels improved. Unfortunately, a few months after the cure, due to poor nutrition, rest and hygiene of the facial skin, the rash began to fade again, but now I know for sure that a dermatologist and gynecologist should prescribe treatment for me.

Olga: I’ve been taking the drug for about 4 years, I’m happy with the results. Both from the point of view of contraception and against acne. Although, of course, my skin has not become ideal, but as before, rashes before menstruation with large painful pimples no longer appear. The effect appeared already in the second month and was consolidated after 5 months.

Marina: Acne has been bothering me for several years. The dermatologist I contacted advised me to cleanse my intestines and the entire body of toxins. I was on a terrible diet, lost weight, became haggard, went through a series of reading procedures, but there was no effect. Only after that I turned to a gynecologist-endocrinologist, who sent me to get tested for the androgynous complex, it turned out that I had problems with testosterone (a male hormone), the indicator is not critical, but acne could most likely be caused by it. They prescribed me Diana 35, I had to quit smoking, because you can’t drink the medicine and smoke at the same time. In the first month, the skin began to improve, after 4 months the effect was stunning, however, at the same time as taking Diane 35, I went to a cosmetologist. After taking the medicine, my skin was fine for another 6 months, and then the rashes started again. The gynecologist-endocrinologist explained to me that the level of hormones had increased again and Diana needed to take it again.

The medicinal properties of the drug Diane 35 make it possible to treat acne and various skin diseases that appear due to hormonal imbalance. Treatment can only be prescribed by a doctor and it needs to be carried out for a long period of time, in parallel it is necessary to care for the skin of the face with other means. After completing a course of treatment, the lasting result lasts for a long period of time, but like any hormonal disorder that cannot be completely overcome, the rashes may return, so the drug can and should be taken again. You can continue taking the medicine for an unlimited period of time; it is important to monitor your health during and after taking it, in order to prevent the development of side effects and serious illnesses.

Both active ingredients included in the drug Diane-35 have a positive effect on the state of hyperandrogenism. Cyproterone acetate is a competitive antagonist of androgen receptors; it inhibits the synthesis of androgens and determines a decrease in the concentration of these hormones in the blood due to an antigonadotropic effect. This antigonadotropic effect is enhanced by ethinyl estradiol, which also regulates the synthesis of sex steroid binding globulin (SHBG) in the blood plasma. Taking this into account, the level of unbound biologically available androgen in the blood decreases.
When using the drug Diane-35 (usually after 4 months of therapy), acne is eliminated, excessive oily hair and skin disappears even earlier. Hair loss, which often accompanies seborrhea, is also reduced. When using the drug by persons with mild forms of hirsutism (primarily with mild facial hair), the results of therapy should be expected only after several months from its start.
The contraceptive effect of the drug Diane-35 is based on the interaction of various factors, the most important of which are suppression of ovulation and changes in cervical secretion. In addition to preventing pregnancy, the drug has a number of positive properties. The menstrual cycle becomes more regular, menstruation is less painful, and blood loss decreases. The latter helps reduce the incidence of iron deficiency anemia.
The toxicity profile of ethinyl estradiol has been well studied. There are no preclinical data to supplement the information regarding the safety of ethinyl estradiol indicated in the sections of the instructions for medical use of the drug.
Data from standard preclinical toxicity studies following repeated use of cyproterone acetate do not indicate the existence of any specific risk to the human body.
Available clinical experience does not suggest an increased incidence of liver tumors in humans. Carcinogenicity studies of cyproterone acetate in rodents do not indicate the existence of any specific carcinogenic effect. However, it should be taken into account that sex steroids may promote the growth of certain pre-existing hormone-dependent tumors.
Available data provide no basis to oppose the use of Diane-35 in humans when taken in accordance with the instructions provided and at the recommended dose.
Cyproterone acetate
After oral administration, cyproterone acetate is rapidly and completely absorbed. Its peak serum concentration is 15 ng/ml and is achieved approximately 1.6 hours after a single dose. The bioavailability of cyproterone acetate is approximately 88%.
Cyproterone acetate is almost completely bound to albumin in the blood serum. Only 3.5-4% of the total steroid concentration remains in an unbound state. Ethinyl estradiol-induced increase in SHPS levels does not affect protein binding of cyproterone acetate.
Cyproterone acetate is almost completely metabolized. The main metabolite in blood plasma is 15b-OH-CPA. The clearance rate from serum is approximately 3.6 ml/min/kg.
The concentration of cyproterone acetate in the blood serum decreases biphasically, with half-lives of 0.8 hours and 2.3-3.3 days. Some of the steroid is excreted unchanged. Metabolites are excreted in urine and bile in a 1:2 ratio. The half-life of metabolites is 1.8 days.
Taking into account the long half-life of cyproterone acetate from blood serum, its accumulation in the blood serum can be observed during one cycle of therapy with a coefficient of 2-2.5.
Ethinyl estradiol
Adsorption
When taken orally, ethinyl estradiol is rapidly and completely absorbed. Peak serum concentrations of approximately 71 pg/mL are achieved after 1.6 hours.
Distribution
Ethinyl estradiol binds strongly, but not specifically, to serum albumin (approximately 98%) and induces an increase in serum SHBG concentrations.
Ethinyl estradiol is metabolized mainly by aromatic hydroxylation, resulting in a large number of hydroxylated and methylated metabolites, among which there are both free metabolites and conjugates with glucuronides and sulfates. Clearance is 2.3-7 ml/min/kg.
Serum ethinyl estradiol levels decrease in 2 phases with half-lives of approximately 1 and 10-20 hours, respectively. The substance is not excreted from the body unchanged; ethinyl estradiol metabolites are excreted in urine and bile in a ratio of 4:6. The half-life of metabolites is approximately 1 day.
Equilibrium concentration is achieved in the second half of the administration cycle, when the level of the active substance in the blood serum is 60% higher compared to a single dose.

Indications for use of the drug Diane-35

Treatment of androgen-dependent diseases in women, such as acne, especially severe forms and forms accompanied by seborrhea, inflammation or nodule formation (papular-pustular acne, nodular cystic acne), androgenic alopecia and mild forms of hirsutism.

Use of the drug Diane-35

The drug Diane-35 is intended for regular use in order to achieve a therapeutic effect and the necessary contraceptive protection. The use of other hormonal contraceptives should be discontinued. The method of using Diane-35 does not differ from the usual regimen for taking most combined oral contraceptives. Taking this into account, the same instructions regarding the method of use of the drug should be followed. Irregular use of Diane-35 may cause intermenstrual bleeding and impair therapeutic and contraceptive effectiveness.
If hormonal contraceptives were not used in the previous period (last month)
Taking the pills should start on the 1st day of the menstrual cycle. You can start taking it from the 2-5th day, but in this case, during the first cycle, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the drug.
Switching from another combined oral contraceptive (COC)
It is advisable to start taking Diane-35 the day after taking the last active tablet of the previous COC, at least no later than the next day after a break in taking pills or after taking placebo tablets of the previous COC.
Switching from a progestogen-only method (mini-pills, injections, implants) or a progestogen-containing intrauterine system
You can start taking Diane-35 any day after you stop taking the mini-pill (for an implant or intrauterine system - on the day of their removal; in the case of an injection - instead of the next injection). However, in all cases it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the pill.
After an abortion in the first trimester of pregnancy
You can start using Diane-35 immediately. In this case, she does not need to use additional contraception.
After childbirth or abortion in the second trimester of pregnancy
If breastfeeding, see subsection " During pregnancy and breastfeeding".
It is recommended to start taking the drug Diane-35 from the 21st to 28th day after childbirth or abortion in the second trimester of pregnancy. If you start taking the pill later, you should additionally use a barrier method of contraception during the first 7 days of taking the drug. However, if sexual intercourse has already taken place, then before starting to use the PDA it is necessary to exclude pregnancy or wait until menstruation.
What to do if you miss a pill dose
If the delay in taking the pill does not exceed 12 hours, the contraceptive effect of the drug is not reduced. The missed pill should be taken as soon as possible. The next pill from this package is taken at the usual time.
If the delay in taking the missed pill exceeds 12 hours, contraceptive protection may decrease. In this case, you can follow two basic rules:

• a break in taking pills can never exceed 7 days;
• Adequate suppression of the hypothalamus-pituitary-ovarian system is achieved by continuous intake of the pill for 7 days.

Accordingly, the following recommendations should be followed in daily life:

• 1st week
  You should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. In addition, over the next 7 days you must use a barrier method of contraception, such as a condom. If you had sexual intercourse in the previous 7 days, you need to take into account the likelihood of pregnancy. The more pills you miss and the closer the break in taking the drug, the higher the likelihood of pregnancy.
• 2nd week
  You should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. If you take the tablets correctly for 7 days before the first missed period, there is no need to use additional contraceptives. In another case or if more than 1 pill is missed, it is recommended to additionally use a barrier method of contraception for 7 days.
• 3rd week
  The risk of decreased reliability increases as the break in taking the pill approaches. However, if you follow the regimen for taking pills, you can avoid a decrease in contraceptive protection. If you adhere to one of the following options, then there will be no need to use additional contraceptives, provided you take the tablets correctly for 7 days before the missed period. If this is not the case, you must adhere to the first of the following options and use additional methods of contraception for the next 7 days.

You should take the last missed pill as soon as possible, even if you have to take 2 pills at the same time. After this, continue to take the pills at the usual time. Dragees from the next package must be taken immediately after finishing the previous one, that is, there should be no breaks between packages. It is unlikely that menstrual-like bleeding will begin by the end of the second package, although spotting or breakthrough bleeding is possible while taking the pills.
You may also be advised to stop taking the tablets from the current package. In this case, the break in taking the drug should be up to 7 days, including days of missing pills; You must start taking the pills from the next package.
If a pill is missed and the patient does not have menstrual bleeding during the first regular break from taking the pill, the possibility of pregnancy should be excluded.
Recommendations for gastrointestinal disorders
In case of severe gastrointestinal disorders, incomplete absorption of the drug is possible; in this case, additional contraception should be used.
If vomiting occurs within 3-4 hours after taking the pills, it is advisable to use the recommendations regarding skipping pills. If a woman does not want to change her usual regimen of taking the drug, she needs to take additional pill(s) from a different package.
How to change the timing of your period or how to delay your period
To delay the appearance of menstruation, you should continue to take Diane-35 tablets from a new package and not take a break from taking the drug. If desired, the period of administration can be continued until the end of the second package. In this case, breakthrough bleeding or spotting cannot be ruled out. The usual intake of the drug is restored after a 7-day break from taking the pills.
To shift the onset of menstruation to another day of the week, it is recommended to shorten the break in taking pills by the desired number of days. It should be noted that the shorter the break, the more often the absence of menstrual-like bleeding and breakthrough bleeding or spotting while taking the pills from the second package (as in the case of a delay in the onset of menstruation).

Contraindications to the use of the drug Diane-35

COCs should not be used if you have at least one of the following conditions or diseases. If any of these conditions or diseases occur for the first time while using a COC, the drug should be stopped immediately.
Venous or arterial thrombotic/thromboembolic events (eg deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular disorders, current or in history.
The presence or history of prodromal symptoms of thrombosis (transient cerebrovascular accident, angina pectoris).
History of migraine with focal neurological symptoms.
Diabetes mellitus with vascular damage.
The presence of severe or multiple risk factors for venous or arterial thrombosis may also be a contraindication (see).
Current or history of pancreatitis if associated with severe hypertriglyceridemia.
Current or history of severe liver disease until liver function tests return to normal.
Liver tumors (benign or malignant) - diagnosed or present in history.
Diagnosed or suspected malignant tumors (for example, genitals or mammary glands) that are dependent on sex hormones.
Vaginal bleeding of unknown etiology.
Diagnosed or suspected pregnancy.
Hypersensitivity to the active substances or to any of the components of the drug.
The drug Diane-35 is not prescribed to men.

Side effects of the drug Diane-35

Side effects have been reported when using Diane-35, but their connection with the use of the drug has been neither confirmed nor refuted:

Organs and systems	Frequent (≥1/100)	Uncommon (≥1/1000 and ≤/100)	Single (≤1/1000)
			Contact lens intolerance
	Nausea, abdominal pain	Vomiting, diarrhea
The immune system			Hypersensitivity
Study	Weight gain		Reducing body weight
Metabolism and nutritional disorders		Fluid retention
Mental disorders	Depressed state, mood disturbance	Decreased libido	Increase libido
Reproductive system and mammary glands			Changes in vaginal secretion, the appearance of secretion from the mammary glands
Skin and subcutaneous tissues		Skin rashes, urticaria	Erythema nodosum, exudative erythema multiforme

Special instructions for the use of the drug Diane-35

Clinical data regarding estrogen/progestogen combinations, such as Diane-35, are based on experience with the use of COCs. With this in mind, the following warnings regarding taking COCs also apply to this drug.
If any of the following conditions/risk factors are present, it is necessary to evaluate the benefits of using Diane-35 and the possible risks, taking into account the individual characteristics of each patient and discuss this with her before she decides to take the drug. If any of the following conditions or risk factors become worse, worse, or occur for the first time, it is recommended that you consult your doctor. The doctor must decide whether to stop using Diane-35.
Circulatory disorders
Based on the results of epidemiological studies, there is an association between the use of COCs and an increased risk of venous and arterial thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These conditions occur rarely.
Venous thromboembolism (VTE), manifested as venous thrombosis and/or pulmonary embolism, can occur with the use of any COC. The risk of venous thromboembolism is highest during the 1st year of COC use. The incidence of VTE in patients taking oral contraceptives with a low dose of estrogens (≤0.05 mg ethinyl estradiol) is up to 4 cases per 10,000 women/year compared with 0.5-3 cases per 10,000 women/year in women not using oral contraceptives. The incidence of VTE associated with pregnancy is 6 cases per 10,000 women/year.
Thrombosis of other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, cerebral vessels or retina, has been extremely rarely reported in women using COCs. There is no consensus regarding the connection between these complications and the use of PDAs.
Symptoms of venous or arterial thrombotic/thromboembolic events or stroke may include: unilateral lower extremity pain or swelling; sudden severe chest pain radiating to the left arm; sudden shortness of breath; sudden onset of cough; any unusual, severe, prolonged headache; sudden decrease or complete loss of vision; diplopia; speech impairment or aphasia; vertigo; collapse with or without partial epileptic seizure; weakness or very severe sudden numbness of one side or one part of the body; motor impairment; symptoms of acute abdomen.
Factors that increase the risk of venous or arterial thrombotic/thromboembolic events or stroke:

• age;
• tobacco smoking (in combination with heavy smoking and with age, the risk increases, especially in women over 35 years of age);
• family history (for example, cases of venous or arterial thromboembolism in siblings or parents at a relatively early age). If a hereditary predisposition is suspected, before a decision is made on the use of any COC, the patient should be referred for consultation to an appropriate specialist;
• obesity (body mass index - more than 30 kg/m2);
• dyslipoproteinemia;
• AH (arterial hypertension);
• heart valve pathology;
• atrial fibrillation;
• prolonged immobilization, radical surgical interventions, any surgical operations on the lower extremities, significant injuries. In these cases, it is recommended to stop using the COC (for planned operations at least 4 weeks before they are performed) and not restore it earlier than 2 weeks after complete remobilization.

There is no consensus regarding the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
Other diseases that may be associated with serious circulatory disorders include: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increased incidence of migraine or its exacerbation during the period of use of COCs (which may be a harbinger of cerebrovascular accident) requires urgent cessation of COC use.
Biochemical indicators characteristic of hereditary or acquired susceptibility to venous or arterial thrombosis include: activated protein C (APC) resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies).
When analyzing the risk/benefit ratio, the doctor must take into account that adequate treatment for the conditions mentioned above can reduce the associated risk of thrombosis, and also that the risk of thrombosis associated with pregnancy is higher than with the use of COCs in low doses (≤0.05 mg ethinyl estradiol).
Tumors
The most important risk factor for the development of cervical cancer is the persistence of papillomavirus. Some epidemiological studies suggest an additional increase in this risk with long-term use of COCs, however, this statement is controversial because the extent to which the study results take into account concomitant risk factors, such as cervical smears and sexual behavior, including the use of barrier methods of contraception, is unclear. .
The results of a meta-analysis based on data obtained from 54 epidemiological studies indicate a slight increase in the relative risk (RR = 1.24) of developing breast cancer in women using COCs. This increased risk gradually disappears within 10 years of stopping taking COCs. Because breast cancer is rarely diagnosed in women under 40 years of age, the increase in breast cancer diagnosis among current or recent COC users is small relative to the overall risk of breast cancer. The results of these studies do not provide evidence of a causal relationship. The increased risk may be due to both earlier diagnosis of breast cancer in women using COCs, the biological effects of COCs, or a combination of both factors. There has been a tendency that breast cancer detected in women who have ever taken COCs is clinically less severe than in those who have never taken COCs.
In isolated cases, benign, and even less often, malignant liver tumors were noted in women using COCs, which sometimes led to life-threatening intra-abdominal bleeding. If there are complaints of severe pain in the epigastric region, liver enlargement or signs of intra-abdominal bleeding, the differential diagnosis should take into account the possibility of a liver tumor in women taking COCs.
Other conditions
Women with hypertriglyceridemia or a family history of this disorder are at risk of developing pancreatitis when using COCs.
Although slight increases in blood pressure have been reported in many women taking COCs, clinically significant increases in blood pressure are rare. However, if prolonged clinically significant hypertension (arterial hypertension) occurs while taking a COC, then it is sometimes advisable to discontinue the COC and direct treatment to the hypertension (arterial hypertension).
The occurrence or exacerbation of the following diseases has been reported during pregnancy and with the use of COCs, but their relationship with the use of COCs has not been conclusively established: jaundice and/or pruritus associated with cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea, herpes of pregnancy, hearing loss associated with otosclerosis.
In acute or chronic liver dysfunction, it may be necessary to stop taking COCs until liver function tests return to normal. If cholestatic jaundice relapses, which first occurred during pregnancy or previous use of sex hormones, taking COCs should be discontinued.
Although COCs may affect peripheral insulin resistance and glucose tolerance, there are no data regarding the need to change the therapeutic regimen in women with diabetes mellitus taking low-dose COCs (containing ≤0.05 mg ethinyl estradiol). However, women with diabetes should be closely monitored while taking COCs.
Crohn's disease and ulcerative colitis may be associated with COC use.
Chloasma can sometimes occur, especially in women with a history of chloasma during pregnancy. Women prone to chloasma should avoid exposure to direct sunlight or ultraviolet radiation while taking COCs.
Medical examination
Before starting or resuming taking Diane-35, you should conduct a full medical examination and study the patient’s medical history in detail, taking into account contraindications (see) and warnings (see). When using COCs, periodic examinations are recommended, which is very important, since contraindications (for example, transient circulatory disorders, etc.) or risk factors (for example, a family history of venous or arterial thrombosis) may arise for the first time while taking the drug.
The frequency and nature of these examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each woman, however, special attention is paid to examination of the pelvic organs, including standard analysis of cytology of the cervix, abdominal organs, mammary glands, determination of blood pressure.
It is necessary to warn the woman that Diane-35, like other oral contraceptives, does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Reduced efficiency
The effectiveness of Diane-35 may be reduced if a pill is missed, gastrointestinal dysfunction or other medications are used.
Cycle control
When taking oral contraceptives, intermenstrual bleeding (spotting or breakthrough bleeding) may occur, especially during the first few months of treatment. Taking this into account, examination in the event of any intermenstrual bleeding should be carried out only after a period of adaptation of the body to the drug, which is approximately 3 cycles.
If cycle irregularities continue or recur after several normal cycles, non-hormonal causes of bleeding should be considered and appropriate investigations should be carried out to exclude the presence of a tumor or pregnancy. Diagnostic measures can include curettage.
Some women may not experience menstrual bleeding during a break from taking the drug. Pregnancy is unlikely when you take COCs as directed. However, if the contraceptive is taken irregularly or if menstrual-like bleeding is absent for 2 cycles, pregnancy must be excluded before continuing to take the COC.
During pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy. If pregnancy occurs while using the drug Diane-35, the drug should be discontinued. However, according to the results of embryotoxicity studies when using a combination of two active components of the drug, there was no confirmation of the teratogenic effect of the drug during organogenesis. Although taking cyproterone acetate in high doses during the hormone-sensitive phase of genital differentiation causes the appearance of female sexual characteristics in male fetuses, during the observation of newborn boys whose mothers took cyproterone acetate during pregnancy, no female sexual characteristics were detected.
The use of Diane-35 is contraindicated during breastfeeding. Cyproterone acetate passes into breast milk. About 0.25% of the dose of cyproterone acetate taken by the mother enters the child's body with milk, which corresponds to 1 mcg/kg body weight and 0.2% of the daily dose of ethinyl estradiol.
Impact on the ability to drive vehicles and operate machinery
No effect noted.

Interactions of the drug Diane-35

Interactions between drugs containing a combination of estrogen/progestagen (such as Diane-35) and other drugs may lead to breakthrough bleeding and/or loss of contraceptive effectiveness. The following interactions have been reported in the literature.
Hepatic metabolism: interactions may occur with drugs that induce microsomal enzymes, which can cause an increase in the clearance of sex hormones (for example, phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and drugs containing St. John's wort) .
Interaction with the enterohepatic circulation: The results of some clinical studies suggest that the enterohepatic circulation of estrogens may be reduced when taking certain antibiotics that reduce ethinyl estradiol concentrations (for example, penicillin and tetracycline antibiotics).
When treating any of the above drugs, a woman should temporarily use a barrier method in addition to taking Diane-35 or choose another method of contraception. When treating with drugs that induce microsomal enzymes, the barrier method should be used throughout the entire period of treatment with the corresponding drug and for another 28 days after stopping its use. When treating with antibiotics (excluding rifampicin and griseofulvin), the barrier method should be used for another 7 days after discontinuation of the antibiotic. If the barrier method is still being used, and the tablets in the Diane-35 package have already run out, taking the tablets from the next package should be started without the usual break.
Oral contraceptives containing estrogen/progestogen (such as Diane-35) may affect the metabolism of other drugs. Therefore, the concentrations of active substances in blood plasma and tissues (for example, cyclosporine) may change.
Note. To establish the potential for interaction with drugs that are prescribed concomitantly with Diane-35, it is recommended that you read the instructions for the medical use of these drugs.
Impact on laboratory results
Taking contraceptives such as Diane-35 may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, and plasma levels of proteins (carriers) such as sex-binding globulin hormones and lipid/lipoprotein fractions, carbohydrate metabolism parameters, as well as coagulation and fibrinolysis parameters.

Overdose of the drug Diane-35, symptoms and treatment

No serious adverse effects due to overdose have been reported. The following symptoms of overdose are possible: nausea, vomiting, and in young girls - slight bleeding from the vagina. There are no specific antidotes treatment must be symptomatic.

Storage conditions for the drug Diane-35

At a temperature not exceeding 30 °C.

List of pharmacies where you can buy Diane-35:

• Saint Petersburg

Registration number P N°012240/01

Tradename
Diane-35®

Dosage form
Dragee.

Compound
Each dragee contains:

Excipients: lactose monohydrate, corn starch, povidone, magnesium stearate, sucrose, povidone 700000, polyethylene glycol (macrogol 6000), calcium carbonate, talc, titanium dioxide, iron (II) oxide, glycerol, mountain glycol wax.

Description
Round, biconvex pellets of light yellow color.

Pharmacotherapeutic group
Contraceptive (estrogen + antiandrogen).

ATX code G03НВ01

Pharmacological properties

Diane-35 is a low-dose monophasic oral combined estrogen-antiandrogen contraceptive drug.
The contraceptive effect of Diane-35 is carried out through complementary mechanisms, the most important of which include suppression of ovulation and changes in the properties of cervical secretion, as a result of which it becomes impenetrable to sperm.
The composition and properties of the active components of Diane-35 make it possible to treat diseases that are caused by either increased production of androgens or special sensitivity to these hormones.
Treatment with Diane-35 leads - usually after 3-4 months of therapy - to the healing of existing acne lesions. Excessive oiliness in hair and skin usually disappears earlier. Hair loss, which often accompanies seborrhea, is also reduced. However, in women suffering from mild forms of hirsutism and, in particular, a slight increase in facial hair growth, results become visible only after several months of use.
Thanks to the combination of two active components in Diana-35, the drug has the properties of a combined contraceptive (“birth control pill”). If you take Diane-35 correctly (without missing pills), the chance of getting pregnant is very low. For this reason, there is no need for the concomitant use of hormonal or other contraceptives. Previously taken hormonal contraceptives should be discontinued.
Taking Diane-35 can also have the following positive health effects that are inherent in birth control pills: the menstrual cycle becomes more regular, painful menstruation is less common, the intensity of bleeding decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence that the risk of developing endometrial and ovarian cancer is reduced.

Indications

Contraception (prevention of unwanted pregnancy).
Treatment of androgen-dependent diseases in women, such as acne, especially common forms and forms accompanied by seborrhea, inflammation or nodule formation (papular-pustular acne, nodular-cystic acne); androgenetic alopecia and mild forms of hirsutism.

Contraindications

Diane-35 should not be used if you have any of the conditions listed below.
Thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders, such as stroke).
Conditions preceding thrombosis (including transient ischemic attacks, angina) currently or in history.
History of migraine with focal neurological symptoms
Diabetes mellitus with vascular complications.
Multiple or severe risk factors for venous or arterial thrombosis, including heart valve disease, heart rhythm disturbances, cerebrovascular disease or coronary artery disease; uncontrolled arterial hypertension.
Pancreatitis with severe hypertriglyceridemia, currently or in history.
Severe liver disease (until liver function tests return to normal).
Liver tumors (benign or malignant) currently or in history.
Identified hormone-dependent malignant diseases (including genital organs or mammary glands) or suspicion of them.
Vaginal bleeding of unknown origin.
Pregnancy or suspicion of it.
Breastfeeding period.
Hypersensitivity to any of the components of the drug Diane-35.

If any of these conditions appear for the first time while taking Diane-35, stop taking this drug immediately and consult your doctor. In the meantime, use non-hormonal remedies. See also “Special Instructions”.

Carefully

If you are using combined oral contraceptives if you have any of the conditions listed below, you may need to be monitored closely as your doctor explains why. Before you start taking Diane-35, tell your doctor about whether you have any of the conditions or diseases listed below.
Risk factors for the development of thrombosis and thromboembolism: smoking; thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family; obesity; dyslipoproteinemia; arterial hypertension; migraine; heart valve diseases; heart rhythm disturbances, prolonged immobilization, major surgical interventions, major trauma
Other diseases in which peripheral circulatory disorders may occur: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; as well as phlebitis of superficial veins
Hypertriglyceridemia
Liver diseases
Diseases that first appeared or worsened during pregnancy or during previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes of pregnancy, Sydenham's chorea)

Pregnancy and lactation

Diane-35 is not prescribed during pregnancy and breastfeeding. If pregnancy is detected while taking Diane-35, the drug should be discontinued immediately and consult a doctor. However, extensive epidemiological studies have not found any increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or when sex hormones were inadvertently taken during early pregnancy.

Directions for use and doses

When and how to take pills
The calendar pack contains 21 tablets. In the package, each pill is marked with the day of the week on which it should be taken. Take the tablets at the same time every day with a small amount of water. Follow the direction of the arrow until all 21 tablets have been taken. You do not take the drug for the next 7 days. Menstruation (withdrawal bleeding) should begin within these 7 days. It usually begins 2-3 days after taking the last Diane-35 tablet. After a 7-day break, start taking the next pack, even if the bleeding has not stopped yet. This means that you will always start a new pack on the same day of the week, and that your withdrawal bleed will occur on approximately the same day of the week each month.

Reception of the first package of Diane-35
When no hormonal contraceptive was used in the previous month.
Start taking Diane-35 on the first day of the cycle, that is, on the first day of menstrual bleeding. Take the pill that is marked with the corresponding day of the week. Then take the pills in order. You can also start taking it on days 2-5 of the menstrual cycle, but in this case you must use an additional barrier method of contraception during the first 7 days of taking the tablets from the first package.

When switching from other combined oral contraceptives.
You can start taking Diane-35 the day after you take the last tablet of the current package of the oral combination drug (i.e., without stopping taking the tablet). You can also start taking it later, but in this case no later than the next day after the usual break in taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package).

When switching from oral contraceptives containing only gestagen (“mini-pills”).
You can stop taking the mini-pill any day and start taking Diane-35 the next day at the same time. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.

When switching from an injectable contraceptive or implant.
Start taking Diane-35 on the day the next injection is due or on the day the implant is removed. During the first 7 days of taking the pills, you must also use an additional barrier method of contraception.

After childbirth.
If you have just given birth, your doctor may recommend that you wait until the end of your first normal menstrual cycle before starting Diane-35. Sometimes, on the recommendation of a doctor, it is possible to start taking the drug earlier.

After spontaneous miscarriage or abortion.
Check with your doctor.

Taking missed pills
If you are late in taking the next pill less than 12 hours, the contraceptive effect of Diane-35 remains. Take the pill as soon as you remember. Take your next pill at the usual time.
If the delay in taking the pills was more than 12 hours, contraceptive protection may be reduced. The more pills in a row you miss, and the closer this skip is to the start or end of the dose, the higher the risk of pregnancy.

In this case, you can be guided by the following rules:

More than one pill from the package was forgotten
Consult your doctor.

One tablet was missed in the first week of taking the drug
Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take your next pill at the usual time. Additionally, use a barrier method of contraception for the next 7 days. If sexual intercourse took place within a week before missing the pills, the possibility of pregnancy must be taken into account. Consult your doctor immediately.

One tablet was missed in the second week of taking the drug
Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take your next pill at the usual time. The contraceptive effect of Diane-35 remains, and you do not need to use additional contraceptive measures.

One tablet was missed during the third week of taking the drug
You can stick to either of the following two choices without having to use additional contraceptive precautions.

1. Take the missed pill as soon as you remember (even if this means taking two pills at the same time). Take your next pill at the usual time. Start the next pack immediately after finishing the current pack, so there is no break between packs. Withdrawal bleeding is unlikely until the second pack of pills is finished, but spotting or breakthrough bleeding may occur on the days you take the pills.

2. Stop taking pills from the current package, take a break for 7 days or less ( including the day of missing pills) and then start taking a new package.

Using this regimen, you can always start taking the next pack on the day of the week when you usually do it.

If after a break in taking the tablets you do not get your expected menstruation, you may be pregnant.
Consult your doctor before starting a new pack.

If you have had vomiting or diarrhea within 3 to 4 hours after taking Diane-35 tablets, the active ingredients may not have been completely absorbed. This situation is similar to skipping a drug dose. Therefore, follow the instructions for missed pills.

Delaying the onset of menstruation

You can delay the onset of menstruation if you start taking the next package of Diane-35 immediately after finishing the current package. You can continue taking the tablets from this pack for as long as you wish, or until the pack runs out. If you want your period to start, stop taking the pills. While taking Diane-35 from the second package, spotting or breakthrough bleeding may occur on the days of taking the pill. Start the next pack after the usual 7-day break.

Changing the day your period starts
If you take the pills as recommended, you will have your period on approximately the same day every 4 weeks. If you want to change it, shorten (but do not lengthen) the period of time free from taking pills. For example, if your menstrual cycle usually starts on Friday, but in the future you want it to start on Tuesday (3 days earlier), the next pack should start 3 days earlier than usual. If the break from taking pills is very short (for example, 3 days or less), menstruation may not occur during the break. In this case, breakthrough bleeding or spotting may occur while taking the pill from the next package.

Side effect

When taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.

Other undesirable effects have been observed in women while taking combined oral contraceptives.

Organ system	Often (≥1/100)	Uncommon (≥1/1000 and<1/100)	Rarely (<1/1000)
Organ of vision			intolerance to contact lenses
Gastrointestinal tract	nausea, abdominal pain	vomiting, diarrhea
The immune system			hypersensitivity reactions
General symptoms	weight gain		Weight loss
Metabolism		fluid retention
Nervous system	headache	migraine
Psychiatric disorders	decreased mood, mood swings	decreased libido	increased libido
Reproductive system and mammary glands	pain in the mammary glands, engorgement of the mammary glands	mammary hypertrophy	vaginal discharge, breast discharge
Skin and subcutaneous tissues		rash, hives	Erythema nodosum, erythema multiforme

As with other combined oral contraceptives, in rare cases the development of thrombosis and thromboembolism is possible (see also “Special Instructions”).

Overdose

Symptoms that may occur in case of overdose: nausea, vomiting, bleeding from the genital tract.

In case of overdose, consult a doctor.

Interaction with other drugs

Some medications may reduce the effectiveness of Diane-35. These include drugs used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (eg, rifampicin, rifabutin), and HIV infection (ritonavir); antibiotics for the treatment of certain other infectious diseases (for example, ampicillin, tetracyclines, griseofulvin), as well as medicines based on St. John's wort (used mainly in the treatment of depressive conditions).

Always tell the doctor who prescribes Ditane-35 what medications you are already taking. Also tell any doctor or dentist who prescribes other drugs, or the pharmacist who sells drugs at your pharmacy, that you are taking Diane-35.

special instructions

If you suffer from hirsutism, and this disease has recently appeared or has recently become significantly worse, you should definitely inform your doctor about this, since it is necessary to find out the cause of this phenomenon.

Data on estrogen/progestin combinations, such as Diane-35, are based primarily on experience with combined oral contraceptives (birth control pills). Therefore, the following warnings regarding the use of birth control pills also apply to Diana-35.

Thrombosis

Thrombosis is the formation of a blood clot that can block a blood vessel.

The risk of thrombosis in women taking combined oral contraceptives is higher than in those who do not use them, but not as high as during pregnancy.

The risk of developing myocardial infarction or cerebrovascular accident increases with age. The risk also increases with the number of cigarettes smoked.

When using Diane-35, you should stop smoking, especially if you are over 35 years old.

The risk of deep vein thrombosis increases temporarily with surgery or prolonged immobility.

Tumors

The connection between taking combined oral contraceptives and breast cancer has not been proven, although it is detected slightly more often in women taking combined oral contraceptives than in women of the same age who are not using them. This difference may be due to the fact that women are screened more often when taking the drug and therefore breast cancer is detected at an early stage.

In rare cases, the development of liver tumors has been observed during the use of sex steroids, which can lead to life-threatening intra-abdominal bleeding. The connection with the use of the drug has not been proven. If you suddenly experience severe abdominal pain, consult your doctor immediately.

Cervical cancer was detected slightly more often in women using combined oral contraceptives for a long period of time. The connection with the use of combined oral contraceptives has not been proven. This may be due to more frequent gynecological examinations to detect cervical diseases or to characteristics of sexual behavior (less frequent use of barrier methods of contraception). The most significant risk factor for developing cervical cancer is persistent papilloma viral infection.

Women prone to chloasma should avoid prolonged exposure to the sun and ultraviolet radiation while taking combined oral contraceptives.

Intermenstrual bleeding

As with other combined oral contraceptives, when taking Diane-35 during the first few months, irregular vaginal bleeding (spotting or breakthrough bleeding) may be observed between menstrual periods. Use hygiene products and continue taking the tablets as usual. Irregular vaginal bleeding usually stops as your body adapts to Diana-35 (usually after 3 cycles of taking the tablets). If these problems continue, become severe, or return after stopping, consult your doctor.

Lack of regular menstruation

If you took all the pills correctly and did not vomit while taking the pills or taking other medications at the same time, then the likelihood of pregnancy is low. Continue taking Diane-35 as usual.

If you miss two periods in a row, consult your doctor immediately. Do not start taking the next pack until your doctor has ruled out pregnancy.

When to consult a doctor

Regular checkups
If you are taking Diane-35, your doctor will tell you about regular checkups, which a woman should usually undergo at least once a year.

Consult your doctor as soon as possible:
if you experience any changes in health, especially any of the conditions listed in this leaflet (see also Contraindications and Precautions);
with local compaction in the mammary gland; if you are going to use other medications (see also “Interactions with other medications”);
if prolonged immobility is expected (for example, a leg is in a cast), hospitalization or surgery is planned (consult your doctor at least 4-6 weeks in advance);
if you experience unusual heavy vaginal bleeding;
if you forgot to take a pill in the first week of taking the package and had sexual intercourse 7 days before;
you have missed your next period twice in a row or you suspect that you are pregnant (do not start taking the next pack until you have consulted your doctor).

Stop taking the pills and consult your doctor immediately if you notice signs of thrombosis: new: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath; unusual, severe or prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe leg pain or sudden swelling of either leg.

Diane-35 does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Impact on the ability to drive a car and operate machinery

Not found.

Release form

Dragee. 21 tablets per blister made of PVC and aluminum foil. The blister along with instructions for use is placed in a cardboard box

Storage conditions
At a temperature not higher than 30°C.
Keep out of the reach of children.

Best before date
5 years. Do not use after expiration date!

Conditions for dispensing from pharmacies
On prescription.

Manufacturer
Bayer Schering Pharma AG, produced by Schering GmbH & Co. Productions KG, Germany
Bayer Schering Pharma AG, manufactured by Schering GmbH & Co. Products KG, Germany
Dobereinerstr. 20
D-99427 Weimar, Germany
Debereinerstrasse 20
D-99427 Weimar, Germany

Diane-35 birth control pills are produced in the form of pills, which are contained in a blister - a special calendar package of 21 pieces. Packaged in a cardboard box.

The dragees are light yellow in color, round, biconvex.

pharmachologic effect

Diane-35 is a monophasic combined oral contraceptive that has antiandrogenic, estrogenic, contraceptive, and gestagenic effects. This is a combination product that contains – ethinyl estradiol, as well as the antiandrogen substance cyproterone acetate, which demonstrates gestagenic properties.

Under the influence of the drug, the increased viscosity of the cervical mucus remains, which makes it difficult for sperm to enter the uterine cavity. As a result, a contraceptive effect is noted. The substance cyproterone acetate blocks androgen receptors and reduces the phenomenon of androgenization in women, reducing the severity of sebum production, hair loss, and the growth of unwanted hair. Also provides treatment for diseases associated with excess production or high sensitivity to them.

In the process of taking Diane-35 in women, the severity of acne , the number of new acne decreases. The substance also exhibits gestagenic activity, inhibiting the ovulation process.

The contraceptive effect of the drug is observed by the 14th day from the start of its use and remains during a seven-day pause in use. When using a contraceptive, the menstrual cycle is normalized, menstruation becomes less painful, the intensity of bleeding decreases and, as a result, the likelihood of iron deficiency anemia .

Pharmacokinetics and pharmacodynamics

Highest concentration cyproterone acetate observed 1.6 hours after taking the pills. Its bioavailability is 88%. In the first and second phases of elimination, the half-life of the substance cyproterone acetate is 3-4 hours and 2 days.

Ethinyl estradiol After oral administration, it is rapidly absorbed, the highest concentration in the blood is observed after 1.6 hours. The bioavailability of the substance is 45%. Almost completely nonspecifically binds to albumin. The half-life of the substance ethinyl estradiol occurs in two phases - 1-3 hours and 1 day.

In breast milk, approximately 0.2% of the dose of cyproterone acetate and approximately 0.02% of ethinyl estradiol are determined.

Indications for use

The drug is used to prevent pregnancy in women who are diagnosed with androgenization (that is, the manifestation of male traits provoked by the action of male sex hormones).

The drug is also indicated for manifestations androgenization : seborrhea, acne, mild forms , .

Contraindications

The following indications for the use of the drug Diane-35 are determined:

• period of pregnancy and breastfeeding, suspicion of pregnancy;
• liver damage;
• manifestation of skin itching or idiopathic jaundice history of pregnancy;
• And thromboembolism ;
• angina pectoris , ischemic transient attacks;
• Dubin-Johnson syndromes And Rotor (hereditary liver diseases);
• endometrial cancer and mammary gland;
• disorders of fat metabolism;
• blistering dermatosis with a history of pregnancy;
• otosclerosis worsening during previous pregnancies;
• accompanied by vascular complications;
• hormone-dependent malignant diseases;
• vaginal bleeding .

Side effects of Diane-35

During administration, the following side effects of Diane-35 may occur:

• endocrine system: soreness of the mammary glands, the appearance of discharge from them, weight changes;
• reproductive system: the appearance of bleeding between menstruation, changes in libido, changes in vaginal secretion;
• nervous system: , headaches, unstable mood;
• digestive system: vomiting, nausea;
• other manifestations: allergic manifestations, poor tolerance to contact lenses, chloasma.

These side effects rarely develop when taking the drug. As a rule, negative manifestations occur in the first months of taking Diane-35; over time, their severity decreases.

Many women are concerned about the connection between taking Diane-35 and weight gain. As a rule, weight gain when using a contraceptive occurs only in some cases. If such a side effect develops, a woman needs to adjust her diet and lifestyle, and also consult a doctor.

Diane-35 tablets, instructions for use (Method and dosage)

The provided instructions for use of Diane-35 provide for oral administration of the pill. To ensure the necessary contraception of active substances in the body, you need to take the drug regularly.

If a woman has used any other hormonal contraceptives, stop using Diane-35 before taking it.

The dosage regimen of this contraceptive is the same as that of other oral contraceptives. If you do not take this medication regularly, acyclic bleeding may occur and the therapeutic and contraceptive effect may decrease.

Diana-35 calendar pack contains 21 tablets. For ease of use, each pill is marked with the day of the week on which it should be taken. You need to swallow the pills at the same time, washing down the drug with liquid. You need to take the pills in the direction of the arrow until all the pills have been taken. After completing the dose, you do not need to drink the drug for 7 days. During these days – usually on days 2-3 – withdrawal bleeding begins. After a seven-day break, you need to start the next package, adhering to this regimen, even if the bleeding has not stopped. That is, a woman always starts a new package of Diana-35 on the same day of the week.

You should start taking the pills on the first day of your monthly bleeding. For convenience, you should use the first tablet marked with the day of the week on which you begin taking it. Next, the pills are taken in order.

The contraceptive effect is observed from the first day of administration, therefore, there is no need to use others.

You can start drinking Diane-35 on days 2-5 of your cycle. But at the same time, barrier contraception should be used additionally during the first 7 days of admission.

If a woman switches to Diane-35 after using any other methods of contraception, she should additionally consult a gynecologist.

After an early abortion, a woman can start taking pills immediately. In this case, no additional protection is required.

After a miscarriage or spontaneous abortion, you should consult a doctor who will tell you how to take contraceptives.

If you missed taking the pill, you need to take it as quickly as possible and take the next pill at the usual time. It should be taken into account that if you are less than 12 hours late, the contraceptive effect does not decrease.

The likelihood of conception increases the more pills a woman misses and the closer the skips are to the seven-day break. If you miss taking the drug for many days, you should consult your doctor.

If a woman vomits or diarrhea It is advisable to use additional contraceptive methods within 3-4 hours after taking the pill.

When used for treatment, its duration depends on the severity of symptoms. As a rule, taking the medicine lasts several months. When using an anti-acne product, the period of use may be shorter, as evidenced by reviews.

Overdose

There is no evidence of a serious overdose of the drug. When taking large doses of Diane-35, nausea and vomiting may occur, as well as slight bleeding from the vagina, which occurs mainly in young women and girls. Symptomatic therapy is practiced.

Interaction

Before starting to take Diane-35, a woman must inform her doctor about all the drugs she is taking.

Terms of sale

You can buy Diane-35 with a prescription.

Storage conditions

Keep away from children, store at a temperature not exceeding 30 °C.

Best before date

The product can be stored for 5 years.

special instructions

If any of the risk factors are present, before starting to take the drug, you must carefully determine the likely risk and expected benefit. There is evidence of an increase in the incidence of thrombosis and thromboembolism when using oral contraceptives. The severity and frequency of migraines are likely to increase when using this method of contraception. There is evidence of a possible increase in the likelihood of developing cervical cancer, but this connection has not been clearly proven.

Women who are prone to developing chloasma should not spend long periods of time in the sun while taking oral contraceptives.

Women with diabetes need constant supervision by a specialist during the period of use of Diane-35.

It should be taken into account that the use of Diane-35 may affect the results of laboratory tests.

In the first months of use, menstrual bleeding may be irregular. Sometimes during a break in taking pills there may be no withdrawal bleeding.

With prolonged use of the Diane-35 contraceptive, a woman should be examined by a gynecologist every 6 months.

It should be borne in mind that pregnancy can occur almost immediately after discontinuation of the drug. If a woman suspects that she became pregnant while discontinuing a contraceptive, she needs to consult a specialist.

During pregnancy and lactation

Diana-35 is contraindicated during pregnancy and breastfeeding.

Diane-35: instructions for use and reviews

Latin name: Diane-35

ATX code: G03HB01

Active substance: Cyproterone + Ethinylestradiol

Manufacturer: Bayer Weimer GmbH & Co, KG (Germany)

Updating the description and photo: 26.07.2018

Diane-35 is a combined monophasic contraceptive with antiandrogenic properties.

Release form and composition

Dosage form – dragees (21 pieces in blisters, 1 blister in a cardboard pack).

• Cyproterone acetate – 2 mg;
• Ethinyl estradiol – 0.035 mg.

Excipients: corn starch, lactose monohydrate, povidone, magnesium stearate, talc (magnesium hydrosilicate).

Shell composition: povidone 700,000, sucrose, macrogol 6000, titanium dioxide, calcium carbonate, mountain glycol wax, glycerol, iron (II) oxide, talc (magnesium hydrosilicate).

Pharmacological properties

Pharmacodynamics

Diane-35 is a low-dose monophasic oral estrogen-antiandrogen contraceptive drug of the combined type. It prevents conception by suppressing ovulation and changing the characteristics of cervical secretions, making them impermeable to sperm.

In women taking Diane-35, the menstrual cycle is normalized, the pain of menstruation and the intensity of bleeding are reduced, which minimizes the risk of developing iron deficiency anemia. It has been suggested that the use of the drug is justified for the prevention of ovarian and endometrial cancer.

While taking a contraceptive, the activity of the sebaceous glands, which plays an important role in the occurrence of seborrhea and acne, decreases. A course of therapy lasting 3–4 months leads to the almost complete disappearance of acne and excessive oiliness of the scalp. Hair loss, which is often a symptom of seborrhea, also slows down. Taking Diane-35 by women of reproductive age weakens the clinical manifestations of mild hirsutism (for example, increased growth of facial hair), but the result of treatment becomes noticeable only after several months of therapy.

Cyproterone acetate, in addition to its antiandrogenic properties, is also characterized by a pronounced gestagenic effect.

Pharmacokinetics of cyproterone acetate

When administered orally, cyproterone acetate is completely absorbed, almost regardless of dose. After oral administration of Diane-35, the maximum serum level of 15 ng/ml is achieved after 1.6 hours. The absolute bioavailability of cyproterone acetate is approximately 88% of the dose.

This active component of the contraceptive binds only to serum albumin. Approximately 3.5-4% of cyproterone acetate remains in free form in the blood serum. The increase in SHPS caused by ethinyl estradiol is not reflected in the binding of the compound to serum proteins. The average apparent volume of distribution is 986±437 l.

Cyproterone acetate is metabolized by conjugation or hydroxylation. The main metabolite in human plasma is the 15β-hydroxyl derivative.

A certain portion of the dose of Diane-35 is excreted unchanged in the bile. Most of the cyproterone acetate contained in it is excreted in the form of metabolites in urine or bile in a 1:2 ratio. The half-life of eliminated metabolites from plasma is 1.8 days.

Since there is no specific protein binding, changes in the concentration of sex steroid binding globulin (SGBS) do not affect the pharmacokinetics of cyproterone acetate. During the menstrual cycle, the highest equilibrium concentration of this substance in the blood serum is observed in the second half of the cycle.

Pharmacokinetics of ethinyl estradiol

After oral administration, ethinyl estradiol is completely absorbed within a minimal period of time. Its maximum serum concentration of 71 pg/ml is achieved in 1.6 hours. During absorption and “first passage” through the liver, ethinyl estradiol forms metabolites, and its bioavailability averages about 45%.

The compound binds almost completely (98%) to albumin, but not in a specific manner. It promotes the synthesis of GSPC. The apparent volume of distribution of ethinyl estradiol is 2.8–8.6 l/kg.

Ethinyl estradiol is subject to presystemic conjugation in the liver and in the mucosa of the small intestine. The main route of its metabolism is aromatic hydroxylation. The plasma clearance rate is 2.3–7 ml/min/kg.

The equilibrium concentration of ethinyl estradiol is achieved during the second half of the course of treatment.

Indications for use

The use of the drug is indicated for women with androgenization phenomena as oral contraception.

In addition, Diane-35 is prescribed for the treatment of androgen-dependent diseases in women: severe forms of acne, accompanied by seborrhea, the formation of inflammatory nodes, including nodular cystic acne, papular pustular acne; mild forms of hirsutism; androgenetic alopecia.

Contraindications

• Thromboembolism and thrombosis, including a history (cerebrovascular disorders, deep vein thrombosis, myocardial infarction, pulmonary embolism);
• The presence of multiple or severe signs of risk of arterial or venous thrombosis;
• Angina pectoris, transient ischemic attacks and other conditions preceding thrombosis;
• Liver tumors, including a history of;
• Liver disease or severe functional impairment;
• Pancreatitis, including a history, if it was accompanied by severe hypertriglyceridemia;
• Diabetes mellitus complicated by microangiopathies;
• A history of migraine, which occurred with focal neurological symptoms;
• Uterine bleeding of unknown origin;
• Hormone-dependent malignant neoplasms, including tumors of the genital organs or breast (including a history);
• Hypersensitivity to the components of the drug.

The drug must be discontinued immediately if any of these pathologies develop for the first time while using Diane-35.

The drug is also contraindicated in cases of suspected pregnancy, during pregnancy and breastfeeding.

Instructions for use of Diane-35: method and dosage

Dragees are taken orally, without chewing, with a small amount of liquid, preferably immediately after breakfast or dinner.

Dosage of the drug – 1 tablet per day.

Reception begins on the first day of the cycle, using tablets from the calendar package of the corresponding day of the week, at a time convenient for the patient, with the condition that subsequent doses will necessarily be carried out at this specific hour of the day.

For each subsequent method, use a dragee from the cell, which is indicated by an arrow from the previous one on the foil. Following the directions on the calendar package, the woman takes all 21 tablets and takes a break of 7 days, during which bleeding similar to menstrual bleeding occurs. One course of therapy lasts 28 days, of which 21 days are taking pills and 7 days are a break. It must be remembered that use should not be interrupted for more than 7 days and the first 7 days of taking the pills are required to achieve appropriate suppression of the function of the hypothalamic-pituitary-ovarian system.

The day of taking the drug from the next package must coincide with the day of the week on the calendar package of the previous course and begin on the 8th day after the start of the break at a strictly prescribed time.

To switch from combined oral contraceptives to the use of Diane-35, use must begin the day after the last pill from the package with active substances of the previous drug, for a calendar pack of 28 pills and no later than 1 day after a 7-day break, for contraceptives with 21 dragee.

To switch from drugs consisting only of gestagens (“mini-pills”), taking Diane-35 can be started without interruption, with injectable forms of contraception - from the day of the next injection, from an implant - on the day of its removal. For each of these transitions, it is additionally necessary to use a barrier method of contraception for the first 7 days.

If an abortion is performed in the 1st trimester of pregnancy, oral contraception is started immediately; in this case, additional methods of contraception are not required.

In the absence of sexual intercourse after an abortion in the second trimester of pregnancy or childbirth, it is recommended to start using the drug on the 21-28th day. If a woman starts taking it later, then during the first 7 days a barrier method of contraception should be used in parallel. Patients who were sexually active between abortion or childbirth and starting to use the drug should wait until their first menstruation or exclude pregnancy.

If a woman misses taking a pill at the prescribed time, it should be taken as soon as possible, and the next pill at the usual time. The reliability of contraception is not impaired if the delay is less than 12 hours.

If more than 36 hours have passed since the last dose (more than 12 hours late), the missed pill should be taken as soon as remembered, even if it is taking two pills at the same time, with the next dose taken at the usual time. If the violation occurred in the first or second week of use, it is necessary to use a barrier method of contraception for the next 7 days. If you are more than 12 hours late during the third week of administration, there is no need to take a break in administration after the end of the calendar pack; you must continue taking it from the next blister. While taking the second package, a woman may experience spotting or breakthrough uterine bleeding.

If the patient has vomited after taking the pills (in the first 3-4 hours), the absorption of the active substances may be impaired and incomplete, so you should use the recommendations for the case of skipping a dose.

To delay the onset of menstruation, you must continue taking the tablets from the new calendar pack without taking a 7-day break. You can take the pills from the second package until it runs out. You should be aware that during this period the patient may experience spotting or breakthrough bleeding. After a 7-day break, you should continue using Diane-35 from a new package.

To change the start day of the menstrual cycle to another, the next break should be shortened by the required number of days. The fewer days of break, the greater the likelihood of no withdrawal bleeding and the presence of spotting during the period of taking the pills.

The duration of taking the drug in the treatment of hyperandrogenic pathologies depends on the severity of the condition; after the signs of the disease disappear, it is recommended to continue taking the pills for 3-4 months. If a relapse occurs, the course of therapy can be repeated.

Side effects

The use of the drug may cause side effects:

• From the reproductive system: rarely - intermenstrual bleeding, changes in libido, disturbances in vaginal secretion;
• From the digestive system: rarely – nausea and vomiting;
• From the nervous system: rarely - migraine, decreased mood, headache;
• From the endocrine system: rarely - changes in body weight, engorgement, enlargement, tenderness of the mammary glands and discharge from them;
• Other: very rarely - allergic reactions, poor tolerance to contact lenses, the appearance of age spots on the face (chloasma).

These side effects may appear in the first months of taking the drug and, as a rule, gradually decrease.

Overdose

Symptoms of an overdose of Diane-35 are slight bleeding from the vagina (in girls), nausea, and vomiting. There is no specific antidote. If necessary, symptomatic therapy is prescribed.

special instructions

The use of Diane-35 can be started only after a general medical examination, including a cytological examination of cervical mucus and mammary glands, to exclude disorders of the blood coagulation system and the presence of pregnancy. Control examinations for long-term use of the drug are recommended to be carried out once every six months.

If there are risk factors, a woman should make a decision about future therapy, carefully assessing the potential risk and expected benefits of taking the drug.

The woman should be informed about the possible development of arterial or venous thrombosis, and about the need to immediately consult a doctor if the first symptoms appear. They include: movement disorders; swelling and/or unilateral leg pain; sharp chest pain radiating to the left arm or without radiating; sudden shortness of breath and/or coughing fit; severe and prolonged headache; increased severity and frequency of migraines; sudden loss of vision (partial or complete); diplopia; dizziness; slurred speech or aphasia; and others.

If persistent arterial hypertension occurs, the drug should be discontinued; after appropriate antihypertensive therapy and blood pressure normalization, the contraceptive can be continued.

The occurrence of functional liver disorders may require temporary discontinuation of Diane-35 until laboratory parameters normalize. If cholestatic jaundice recurs, you should stop taking combined oral contraceptives.

In patients with diabetes mellitus, there is no need to adjust the dose of glucose-lowering drugs, but women in this category should be under special medical supervision.

An assessment of irregular bleeding (spotting or breakthrough bleeding) that occurs during the use of Diane-35 in the first months of therapy should be carried out after an adaptation period that lasts three cycles.

The development of irregular bleeding after previous systematic cycles should involve consideration of non-hormonal causes, diagnostic measures to exclude pregnancy or malignant neoplasms, including curettage.

When making a differential diagnosis in women with hirsutism, the causes of the appearance or significant increase in symptoms of the disease should include an androgen-producing tumor and congenital dysfunction of the adrenal cortex.

If there is no withdrawal bleeding during the 7-day break after taking two calendar packs of the drug in a row, it is recommended to rule out pregnancy before continuing use.

Impact on the ability to drive vehicles and complex mechanisms

According to available data, Diane-35 does not have a significant effect on the ability to drive vehicles or mechanisms with complex operating principles.

Use in childhood

According to the instructions, Diane-35 is prescribed to adolescents only after the onset of menarche.

For liver dysfunction

If liver dysfunction occurs, it is advisable to temporarily discontinue the drug until laboratory parameters improve. Recurrent cholestatic jaundice, first diagnosed during pregnancy or a previous course of sex hormone therapy, is an indication to stop taking Diane-35.

Drug interactions

The contraceptive reliability of Diane-35 is reduced when taken simultaneously with tetracyclines and ampicillins.

When combined with inducers of microsomal liver enzymes, including barbiturates, hydantoins, primidone, rifampicin, carbamazepine, and possibly with topiramate, oxcarbazepine, felbamate and griseofulvin, the clearance of active substances increases, this can cause breakthrough uterine bleeding and reduce the reliability of contraception.

Analogues

Analogues of Diana-35 are: Bellune-35, Erica-35, Chloe.

Terms and conditions of storage

Store at room temperature. Keep away from children.

Shelf life – 5 years.