Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Cyproterone acetate 2mg; ; ; Ethinylestradiol 0.035mg;
REX Medical Ltd
Cyproterone acetate 2 mg
Film coated tablet
Active: Cyproterone acetate 2mg Ethinylestradiol 0.035mg Excipient: Hypromellose Lactose monohydrate Magnesium stearate Povidone Propylene glycol Purified talc Quinoline yellow Starch Titanium dioxide Colloidal silicon dioxide Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Propylene glycol Purified talc Starch Titanium dioxide
Blister pack, uPVC/aluminium with VMCH seal. 3 x 21 active and 3 x 7 placebo (total, 84) tablets per carton, 84 tablets
Prescription
Prescription
Cipla Ltd
Androgen-dependent diseases in women are an indication for treatment with GINET. These diseases may include: acne (where local treatment or oral antibiotics alone have not been successful), especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), seborrhea, mild forms of hirsutism and/or androgenic alopecia. Oral contraception in women requiring treatment for these androgen-dependent diseases is an indication for treatment with GINET. However GINET is not recommended in women solely for contraception. It should not be used in combination with other hormonal contraceptives. GINET is indicated for the relief of symptoms of polycystic ovary syndrome.
Package - Contents - Shelf Life: Blister pack, uPVC/aluminium with VMCH seal. 3 x 21 active and 3 x 7 placebo tablets per carton - 84 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, uPVC/aluminium with VMCH seal. 6 x 21 active and 6 x 7 placebo tablets per carton - 168 tablets - 36 months from date of manufacture stored at or below 25°C
2002-05-03
CONSUMER MEDICINE INFORMATION GINET _Cyproterone acetate 2mg and Ethinylestradiol 35mcg tablets _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GINET. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of your taking GINET against the benefits this medicine is expected to have for you. If you have any concerns about taking this medicine, ask your doctor, professional health care provider or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT IS GINET USED FOR GINET is used to treat women with acne, hair loss or increased growth of facial and body hair if these conditions are the result of over-production of male-type hormones called androgens. GINET contains two substances that act against the androgens, cyproterone acetate and ethinylestradiol. As well as being an antiandrogen, cyproterone acetate acts like the female sex-hormone progestogen, and when combined with an estrogen (as in GINET, with ethinylestradiol), is an oral contraceptive for women being treated for androgen- dependent symptoms; however, GINET is not recommended in women solely for contraception. GINET can also be used to treat polycystic ovary syndrome, a hormone imbalance that can cause irregular or absent periods, acne, excessive hair growth, infertility, recurrent miscarriage and obesity. Your doctor may have prescribed GINET for another purpose. Ask your doctor if you have any questions why GINET has been prescribed for you. GINET is not addictive. This medicine is available only with a prescription. BEFORE YOU USE GINET _ _ _WHEN YOU MUST NOT TAKE IT _ Do not take GINET if: 1. you are pregnant or think you might be pregnant, GINET must not be used by women who are pregnant or who think they might be pregnant. 2. you are breast-feeding, GINET must not be used by women who are breast-feeding. 3. you have, or have ever had, a condition involvin Lugege kogu dokumenti
NEW ZEALAND DATASHEET 1 PRODUCT NAME GINET 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Cyproterone Acetate 2.00 mg and Ethinylestradiol Tablets 35 mcg. 3 PHARMACEUTICAL FORM Each blister tray contains 21 yellow active tablets and 7 larger white inactive tablets. Each active tablet is a yellow, biconvex, film-coated tablet, containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms (0.035 mg) with a diameter of 5.7 mm. Each inactive tablet is a white, round, biconvex, tablet, plain on both sides with a diameter of 7.1 mm. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Androgen-dependent diseases in women are an indication for treatment with GINET. These diseases may include: acne (where local treatment or oral antibiotics alone have not been successful), especially pronounced forms of acne that may be accompanied by inflammation or formation of nodes (acne nodulocystica, acne papulopustulosa), seborrhea, mild forms of hirsutism and/or androgenic alopecia. Oral contraception in women requiring treatment for these androgen-dependent diseases is an indication for treatment with GINET. However, GINET is not recommended in women solely for contraception. It should not be used in combination with other hormonal contraceptives. GINET is indicated for the relief of symptoms of polycystic ovary syndrome. 4.2 Dose and method of administration Any previously used hormonal contraception should be discontinued. To achieve therapeutic efficacy and the required contraceptive protection, GINET needs to be taken regularly. The dose regimen of GINET is similar to the usual regimen for most combined oral contraceptives. Thus, the same administration rules for most combined oral contraceptives (COC’s) must be considered. Intermenstrual bleeding and eventual deterioration of the therapeutic and contraceptive reliability may be caused by not taking GINET regularly at about the same time each day. HOW TO TAKE GINET Tablets must be taken in the order directed on the blister each day at about the same Lugege kogu dokumenti