País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Cyproterone acetate 50mg; ;
Douglas Pharmaceuticals Limited
Cyproterone acetate 50 mg
50 mg
Tablet
Active: Cyproterone acetate 50mg Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Povidone
Blister pack, PVC/PVDC/Al, 20 tablets
Prescription
Prescription
Hubei Gedian Humanwell Pharmaceuticals Co., Ltd.
In Men · Antiandrogen treatment in inoperable carcinoma of the prostate
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 20 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al - 50 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, White HDPE/PP screw cap - 20 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, White HDPE/PP screw cap - 50 tablets - 36 months from date of manufacture stored at or below 30°C
2006-01-24
CONSUMER MEDICINE INFORMATION 1 PROCUR _Cyproterone acetate _ 50 mg and 100 mg tablets WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PROCUR This leaflet answers some common questions about Procur. 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 you taking Procur against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT PROCUR IS USED FOR Procur tablets contain the active ingredient cyproterone acetate. Cyproterone acetate is an antiandrogen. It works by blocking the actions of sex hormones (androgens) that are produced mainly in men but also, to a lesser extent in women. In men, Procur is used: • to treat prostate cancer • to control sexual desire in men who have an increased sex drive (hypersexuality) and/or sexual abnormalities. In women, Procur is used: • to treat severe signs of androgenisation such as excessive hair growth. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PROCUR HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE PROCUR _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PROCUR IF YOU HAVE AN ALLERGY TO: • any medicine containing cyproterone acetate • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • difficulty in breathing or wheezing • shortness of breath • swelling of the face, tongue, lips, or other parts of the body • hives on the skin, rash, or itching DO NOT TAKE PROCUR IF: • you are allergic to cyproterone acetate or any other ingredient listed at the end of this leaflet • you are pregnant • you are breastfeeding • you suffer from liver diseases (including previous or existing liver tumours, Dubin- Johnson syndrome Llegiu el document complet
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME PROCUR® 50 mg and 100 mg tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each PROCUR 50 mg tablet contains 50 mg of cyproterone acetate. Each PROCUR 100 mg tablet contain 100 mg of cyproterone acetate. EXCIPIENT(S) WITH KNOWN EFFECT PROCUR tablet contains lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM PROCUR 50 mg Tablets are white to off-white, round, flat, tablets having a score and embossed 50 on one side and plain on the other. PROCUR 100 mg Tablets are white to off white, capsule shaped tablets having a score on one face and embossed 100 on the other. PROCUR (Cyproterone acetate) is an antiandrogenic hormone preparation. Cyproterone acetate is a white or almost white crystalline powder, practically insoluble in water, very soluble in methylene chloride, freely soluble in acetone, soluble in methanol, sparingly soluble in ethanol. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS MEN • Antiandrogen treatment in inoperable carcinoma of the prostate • Reduction of drive in sexual deviations WOMEN • Severe signs of androgenization, e.g. very severe hirsutism in the female, severe androgenetic alopecia, often attended by severe forms of acne and/or seborrhoea. 2 | P a g e 4.2. DOSE AND METHOD OF ADMINISTRATION DOSE _ADULT MEN _ Antiandrogen treatment in inoperable carcinoma of the prostate To eliminate the effect of adrenocortical androgens after orchiectomy: two 50 mg tablets once or twice daily (= 100-200 mg total daily dose). Without orchiectomy: two 50 mg tablets twice to three times daily (= 200-300 mg total daily dose). Treatment should not be interrupted, nor the dosage reduced after improvement or remissions have occurred. To reduce the initial increase of male sex hormones in treatment with LH-RH agonists: Initially two 50 mg tablets PROCUR twice daily (= 200 mg total daily dose) alone for 5 - 7 days followed by two 50 mg tablets PROCUR twice daily (= 200 mg total daily dose) for 3 - 4 weeks tog Llegiu el document complet