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  • Diane 35
    / Bayer

    Active Ingredient *

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    Coated Tablets


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    Dosage regimen: Diane-35 inhibits ovulation and thereby prevents conception. Patients who are using Diane-35 should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive
    dose of hormones and is not necessary for effective contraception.
    First treatment course: One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1).
    Subsequent courses: Each subsequent course is started after 7 tablet-free days have followed the preceding course.
    When the contraceptive action of Diane-35 is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started.
    When changing from an oral contraceptive and relying on the contraceptive action of Diane-35, follow the instructions given below:
    Changing from 21-day combined oral contraceptives: The first tablet of Diane-35 should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required.
    Changing from a combined Every Day pill (28 day tablets): Diane-35 should be started after taking the last hormone containing tablet from the Every Day Pill pack. The first Diane-35 tablet is taken the next day. Additional contraceptive precautions are not then required.
    Changing from a progestogen-only pill (POP): The first tablet of Diane-35 should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required. The remaining progestogen-only pills should be discarded.
    Post-partum and post-abortum use: After pregnancy, Diane-35 can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of pill taking. Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. Lactation is contra-indicated with Diane-35. After a first-trimester abortion,
    Diane-35 may be started immediately in which case no additional contraceptive precautions are required.
    Children and adolescents:only indicated after menarche.
    Geriatric patients: Not applicable, not indicated after menopause.
    Patients with hepatic impairment: contraindicated in women with severe hepatic disease as long as liver function values have not returned to normal.
    Patients with renal impairment:  the drug  has not been specifically studied in renally impaired patients. Available data do not suggest a change in treatment in this patient population.
    See prescribing information for full details.


    Signs of androgenization in women (pronounced forms of acne, androgenetic alopecia, and mild forms of hirsutism).


    Hypersensitivity to the active substances.
    Concomitant use with another hormonal contraceptive.
    Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)
    Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g.angina pectoris and transient ischaemic attack).
    Presence or history of cerebrovascular accident
    The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis such as: diabetes mellitus with vascular symptoms, severe hypertension, severe dyslipoproteinaemia.
    Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C.
    (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus
    History of migraine with focal neurological symptoms.
    Presence or history of severe hepatic disease e.g. active viral hepatitis and severe cirrhosis, as long as liver function values have not returned to normal.
    Presence or history of liver tumours (benign or malignant).|
    Current or history of breast cancer.
    Meningioma or history of meningioma.
    Known or suspected pregnancy.
    See prescribing information for full details.

    Special Precautions

    Liver function tests should be performed pre-treatment and whenever any symptoms or signs suggestive of hepatoxicity occur. Combined oral contraceptives must not be taken during treatment. The following conditions require strict medicdbal supervision: Diabetes mellitus, tendency towards diabetes mellitus, hypertension, varicose veins, a history of phlebitis, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal hemorrhage occur, a liver tumor should be included in the differential-diagnostic considerations. Reasons for stopping medicdbation immediately: Occurrence of migraine. Frequent or unusually severe headaches. Acute disturbances of vision, suspicion of thrombosis or infarction. Jaundice. Six weeks before elective operations and during immobilization. Significant rise in blood pressure. Pregnancy. Examination of the pelvic organs, breasts and blood pressure should proceed the prescribing of Diane-35, and should be repeated regularly. History of severe depressive states, varicose veins, diabetes, hypertension, epilepsy, otosclerosis, multiple sclerosis, porphyria, tetany, disturbed liver function, gallstones, cardiovascular diseases, renal diseases, chloasma, uterine fibroids, asthma, wearing of contact lenses or any disease that is prone to worsen during pregnancy. Blood estimations are recommended regularly during treatment. Chronic alcoholics. Adrenal function should be monitored during treatment.
    See prescribing information for full details.

    Side Effects

    Nausea, abdominal pain, weight increased, headache, depressed mood, mood altered, breast pain, breast tenderness.
    See prescribing information for full details.

    Drug interactions

    Alcohol. Rifampicin, griseofulvin, barbiturates, phenytoin, primidone, carbamazepine. Tetracyclines, ampillicin, coumarin anticoagulants. Bile acids, danazol, oral hypoglycemics, insulin. Theophylline, cyclosporin.
    See prescribing information for full details.

    Bayer Weimar und co. KG GmbH, Weimar, Germany
    Licence holder