Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
CYPROTERONE ACETATE; ETHINYLESTRADIOL
BAYER ISRAEL LTD
G03HB01
TABLETS
ETHINYLESTRADIOL 35 MCG; CYPROTERONE ACETATE 2 MG
PER OS
Required
BAYER AG, GERMANY
CYPROTERONE AND ESTROGEN
CYPROTERONE AND ESTROGEN
Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Diane-35 should only be used after topical therapy or systemic antibiotic treatments have failed.
2023-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only Diane 35 Tablets Each tablet contains: ethinylestradiol 35 mcg cyproterone acetate 2 mg Inactive ingredients and allergens: see section 6 “Further Information” and section 2 “Important information regarding some of the ingredients of the medicine”. Read this leaflet carefully in its entirety before using this medicine. This leaflet contains concise information about the medicine. If you have further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1) WHAT IS THE MEDICINE INTENDED FOR? Diane 35 is a medicine with hormonal activity (estrogenic and anti-androgenic) and is intended to treat skin problems such as acne, very oily skin and excessive hair growth in women of reproductive age. Diane 35 is not intended for use in adolescent girls who have not yet begun menstruating. Only take Diane 35 to treat acne if topical treatment or antibiotics have not worked. Therapeutic group: Diane 35 belongs to a group of medicines called estrogens and antiandrogens. Androgens are hormones that stimulate hair growth and activity of the sebaceous glands in your skin. If your body produces too much androgen, or if you are sensitive to the effect of androgens, the sebaceous glands may produce too much sebum. As a result, the sebaceous glands may become blocked, infected and inflamed, causing acne spots. Diane 35 stops the androgens affecting your skin and reduces the amount of androgens produced. Although Diane 35 also acts as a contraceptive, it is not intended only as a contraceptive, unless your doctor has instructed you to use the medicine to treat skin problems such as acne, very oily skin and excessive hair growth in women of reproductive age. If you are taking Diane 35 to treat your skin, do not use another ho Læs hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Diane ® 35 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Actives: Cyproterone acetate 2.00 mg Ethinylestradiol 35 micrograms Excipients: Lactose monohydrate 30.965mg Sucrose 19.371 mg For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Sugar-coated tablets. Beige, round tablet, with convex faces. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Diane 35 should only be used after topical therapy or systemic antibiotic treatments have failed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION _ Oral use _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. 2 2 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 Læs hele dokumentet