Diane 2/35 Mg.
Diane 2/35 Mg.

Diane 2/35 Mg.

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$20.00
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Pack & Dosage: 21 tabs (2-35mg/tab)
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Product Description

Manufacturer: Bayer
Substance: Cyproterone Acetate + Ethynylestradiol
Pack: 21 tabs (2-35mg/tab)




Formula 
A dragee contains 2 mg of Ciproteron acetate and 0.035 mg of Ethinylestradiol. 
Excipients 
Sugar 
Iron oxide pigment, yellow 
Titanium dioxide 
Pharmacological properties 
Pharmacodynamic properties 
Siproteron acetate in Diane-35 
prevents the effects of androgens produced by the female organism . Thus, it is possible to 
treat diseases caused by excessive androgen production or hypersensitivity to normal androgens 
. In 
Diane-35 application, sebaceous which plays an important role in acne and seborrhea formation
Excessive function of the glands is prevented and existing acne foci usually 
heal after 3-4 months of treatment. Lubrication problems of skin and hair typically 
disappear more quickly . Seborrhea is often avoided with hair loss. Diane-35 is useful 
in women of sexual maturity , especially in 
cases of mild hirsutismus presenting as facial hair , but the success of treatment 
should be expected after several months of treatment . 
In addition to the antiandrogen effect of ciproterone acetate, it has obvious gestagen effect. 
Cyclical disorders that may occur when ciproterone acetate is administered alone 
are prevented by the combination of ethinylestradiol in Diane-35. This product is
as long as it is used properly. 
The contraceptive effect of Diane-35 
is based on the interaction of several factors , most notably ovulation inhibition and cervical secretion changes. Combined oral 
contraceptives 
may 
offer additional benefits that may be helpful in choosing contraceptive methods besides their contraceptives, as well as some negative features (see Warnings / Precautions) . Cycles are more regular, bleeding is often less painful and 
lighter. Lighter bleeding reduces the likelihood of iron failure. In 
addition, a reduction in endometrial and ovarian cancers has been demonstrated. In addition, more
high-dose combined oral contraceptives (0.05 mg ethinylestradiol) have been shown to reduce the incidence of fibrocystic 
tumors of the breast , ovarian cysts, pelvic inflammatory disease and ectopic pregnancy 
. These 
have not yet been shown to be valid for low-dose combined oral contraceptives. 
Diane-35 
alleviates androgenization symptoms in women with polycystic ovary syndrome , improves endocrine parameters, 
reduces cyst formation and ovarian volume , and helps regenerate regular menstruation. 
Pharmacokinetic properties 
Siproteron acetate 
Oral ciproteron acetate is rapidly and completely absorbed. Single dose of Diane-35
followed by 1.6 hours, the maximum active substance level of about 15 ng / ml is reached. 
Bioavailability is about 88%. 
Ciproteron acetate binds almost exclusively to serum albumin. 
Only 3.5-4.0% of total serum drug concentrations are found as free steroids. The increase 
in SHBG (sex hormone binding globulin) caused by ethinylestradiol does 
not affect serum protein binding of cyproterone acetate . The dispersion volume of ciproterone acetate is about 986 ± 437 l. 
Ciproteron acetate is almost fully metabolized. The clearance rate from plasma is 
about 3.6 ml / min / kg. 
Ciproterone acetate is discarded partially unchanged. Half-life of approximately 1.8 days
excreted in the form of metabolites from the kidney and bile in a ratio of about 1: 2. 
Ethinylestradiol 
Oral ethinylestradiol is rapidly and completely absorbed. Maximum plasma levels 
of 71 pg / ml are reached after 1.6 hours. During absorption and first pass through the liver, 
ethinylestradiol undergoes intensive metabolization 
and results in an average oral bioavailability of about 45% with a significant individual variability of about 20-65 %. 
Ethinylestradiol binds highly but non-specifically (approximately 98%) 
to serum albumin and causes an increase in SHBG serum concentrations. The dispersion volume 
is reported to be about 2.8-8.6 l / kg.
Ethinylestradiol is metabolized mainly by aromatic hydroxylation. The clearance rate 
was reported as 2.3-7 ml / min / kg. 
Ethinylestradiol is not discarded unchanged. It is 
excreted in the ratio of 4: 6 from the kidney and bile as metabolites with a half-life of approximately 1 day . 
Indications In 
androgen-related diseases in women, e.g. in obvious forms of acne, especially in 
cases of seborrhea, inflammation or scarring (Acne papulopustulosa, Acne 
nodulocystica); androgenetic alopecia and mild hirsutismus cases. Contraindications to 
polycystic ovary syndrome in women who do not wish to have children Preparations containing estrogen / progestogen combinations


should not be used. When using combined oral contraceptives for the first time 
, use should be stopped immediately if any of the following conditions occur. 
• venous or arterial thrombotic / thromboembolic events (e.g. deep vein thrombosis, 
pulmonary embolism, myocardial infarction) or cerebrovascular presence or an event 
history, 
• a thrombosis or history of prodrome (e.g., transient ischemic attack, angina 
pectoris) 
• focal neurological symptoms history of migraine 
• Diabetes mellitus with vascular involvement 
• The 
presence of severe or multiple factors posing a risk for venous or arterial thrombosis may be a contraindication (see Warnings / Precautions).
• pancreatitis or severe hypertriglyceridemia associated with a history of pancreatitis 
• severe liver disease presence or (liver function values normalize 
not returned by) history 
• benign or malignant liver tumor, presence or history 
• If affected by sex steroid known or breast genitals or 
uncertain malignant diseases 
• Diagnosis vaginal bleeding 
• Presence or suspicion of pregnancy 
• Lactation 
• Hypersensitivity to any of the active or excipients 
Diane-35 is not used in men. 
Warnings / Precautions 
Clinical and epidemiological information on estrogen / progestogen combinations such as Diane-35
experience is largely based on combined oral contraceptives. Therefore, the 
following warnings regarding the use of combined oral contraceptives also 
apply to Diane-35 . 
If any of the conditions or risk factors described below are present 
, the benefit and potential risks of using Diane- 35 should be compared separately for each woman and 
discussed before starting use . If any 
of the following conditions or risk factors develop, exacerbate, or occur for the first time, the user 
should consult his / her physician. The physician should decide whether to continue or discontinue use. 
• Circulatory disorders
Epidemiological studies have suggested an association between the use of combined oral contraceptives 
and 
increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism . However, 
these conditions are rarely encountered. 
Deep venous thrombosis and / or pulmonary embolism may result in venous thromboembolism 
during the use of all combined oral contraceptives. Oral 
about the incidence of venous thromboembolism among non-contraceptive 10,000 women 
years compared to 0.5-3, with a low estrogen dose (<0.05 mg ethinylestradiol) oral 
4. 10 000 woman years, the ratio of contraceptive users. Pregnancy-related venous
The incidence of thromboembolism is 6 per 10,000 pregnant women. 
Thrombosis 
has rarely been reported to occur in other blood vessels such as hepatic, mesenteric, renal, cerebral or retinal veins and arteries . There 
is 
no consensus on whether these events can be associated with the use of combined oral contraceptives . 
Venous or arterial thrombotic / thromboembolic events or a cerebrovascular event 
may be accompanied by the following symptoms: unilateral pain and swelling of the leg; 
sudden severe pain in the chest, although it does not spread to the left arm ; sudden difficulty in breathing; onset of sudden cough; unusual, severe, 
prolonged headache; sudden partial or complete loss of vision; diplopia; impaired speech or
aphasia; vertigo; coma, with or without focal seizures, 
weakness or very pronounced drowsiness that suddenly affects part or part of the body ; motor disorders; 
acute abdomen. 
The risk of venous or arterial thrombotic / thromboembolic conditions or cerebrovascular event increases with the 
following factors: 
- Age 
- Smoking (smoking 
increases with more age and older age, especially in women over 35 years ) 
- Positive family history (in a sibling or parent) venous or 
arterial thromboembolism at an earlier age ). If a hereditary predisposition is suspected, 
a specialist should be consulted before deciding on the use of combined oral contraceptives.
Obesity (body weight index above 30 kg / m2) 
- 
- Dyslipoproteinemia 
- Hypertension 
- Migraine 
- Heart valve disease 
- Atrial fibrillation 
- Long-term immobilization, major surgical intervention, any surgical intervention to the legs 
, major trauma. In these cases, the use of combined oral contraceptives ( 
4 weeks before elective surgery) should be discontinued and complete 
remobilization should not start before 2 weeks. There is no consensus 
on the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism 
.
The risk of thromboembolism during puerperium should be considered 
(see section for pregnancy and lactation). 
Other conditions that may be associated with adverse events of the circulatory system include diabetes 
mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory 
bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia. An increase in the 
frequency or severity 
of migraine (which may be the precursor of a cerebrovascular event) during combined oral contraceptive use 
may be a reason to immediately discontinue use . 
Indicator of inherited or acquired predisposition of venous or arterial thrombosis
biochemical factors may include activated protein C (APC) resistance, 
hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency 
and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant). 
When making a risk / benefit comparison, the physician should consider that appropriate treatment of any condition 
reduces the risk of thrombosis and that the risk of thrombosis during pregnancy 
is higher than combined with combined oral contraceptives. 
• Tumors 
Some epidemiological studies have 
reported an increased risk of cervical cancer in long-term combined oral contraceptives . However, these findings suggest that sexual behavior and human
the extent to which it can be 
associated with the misleading effects of other factors such as papilloma virus (HPV) is still under discussion. 
A meta-analysis of 54 epidemiological studies 
found a slight increase in the relative risk of breast cancer diagnosed in women who are currently using combined oral contraceptives (RR = 1.24).

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