Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 100 mg
Bayer Australia Ltd
Tablet, uncoated
Excipient Ingredients: magnesium stearate; povidone; lactose monohydrate; maize starch
Oral
50, 100 tablets, 30, 60, 90, 120 tablets
(S4) Prescription Only Medicine
Inoperable prostatic carcinoma. Because of its anti-androgenic effect Cyprostat is indicated for the treatment of inoperable prostatic carcinoma in patients who have failed primary hormonal manipulation or who are at risk from cardiovascular disease and/or intolerant of oestrogen therapy. INDICATIONS AS AT 18 MAY 2005 : Inoperable prostatic carcinoma. * To suppress flare with initial LHRH analogues therapy. * In long term palliative treatment where LHRH analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred. * In the treatment of hot flushes in pateinets treated with LHRH analogues or who have had orchiectomy.
Visual Identification: White to slightly yellowish capsule-shaped scored tablets; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1995-06-20
CYPROSTAT ® -100 CMI vx1.0 Page 1 of 4 CYPROSTAT ® -100 (SIGH·PRO·STAT) _cyproterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cyprostat-100. 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 Cyprostat-100 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 CYPROSTAT- 100 IS USED FOR Cyprostat-100 is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens may help the cancer cells to grow. By blocking these hormones, Cyprostat-100 may slow or stop the growth of cancer. Cyprostat-100 may be used in combination with other medicines or following surgical removal of the testes to treat side effects such as “hot flushes” or “sweats” and to prevent any initial worsening of the disease. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE CYPROSTAT-100 _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CYPROSTAT-100 IF YOU HAVE AN ALLERGY TO: • cyproterone acetate, the active ingredient in Cyprostat-100 • any of the ingredients listed at the end of this leaflet _ _ Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE CYPROSTAT-100 IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: • liver disease, previous or existing liver tumours unless they are caused by metastases from prostate cancer (your doctor Прочитать полный документ
Cyprostat 100 PI VX1.0, CCDS 11 Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION - CYPROSTAT ® 100 MG (CYPROTERONE ACETATE) TABLET 1 NAME OF THE MEDICINE Cyproterone acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cyprostat 100 mg tablets Each tablet contains 100 mg cyproterone acetate. Excipients with known effect: sugars as lactose monohydrate. For a full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Cyprostat 100 mg tablets Capsule-shaped, white to slightly yellowish, scored tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INOPERABLE PROSTATIC CARCINOMA • to suppress “flare” with initial LHRH analogue therapy • in long term palliative treatment where LHRH analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred • in the treatment of hot flushes in patients treated with LHRH analogues or who have had orchidectomy. 4.2 DOSE AND METHOD OF ADMINISTRATION The maximum daily dose is 300 mg. INOPERABLE PROSTATIC CARCINOMA Cyprostat tablets should be taken with some liquid after a meal. TO REDUCE THE INITIAL INCREASE OF MALE SEX HORMONES (‘FLARE’) IN TREATMENT WITH LHRH AGONISTS Initially 1 tablet Cyprostat twice daily (i.e. 200 mg a day) alone for 5-7 days, followed by 1 tablet Cyprostat twice daily (i.e. 200 mg a day) for 3-4 weeks together with an LHRH agonist in the dosage recommended by the manufacturer. IN LONG TERM PALLIATIVE TREATMENT OF ADVANCED PROSTATE CANCER IN PATIENTS WHO HAVE NOT HAD AN ORCHIECTOMY 100 mg (1 tablet Cyprostat) two to three times daily. Treatment should not be interrupted nor the dosage reduced after improvement or remissions have occurred. Cyprostat 100 PI VX1.0, CCDS 11 Page 2 of 10 TO TREAT HOT FLUSHES IN PATIENTS UNDER TREATMENT WITH LH-RH ANALOGUES OR WHO HAVE HAD ORCHIECTOMY 50 mg-150 mg (half to one and a half tablets) per day with upward titration up to 1 tablet three times daily (300 mg) if necessary. PEDIATRIC USE Cyprostat is not recommended for use in male children and adolesc Прочитать полный документ