Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 100 mg
Sandoz Pty Ltd
cyproterone acetate
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate
Oral
50 tablets
(S4) Prescription Only Medicine
Inoperable prostatic carcinoma. To suppress flare with initial luteinising hormone releasing hormone (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.
Visual Identification: White to off white, capsule shaped tablet with '100' engraved on one face, and a break line on the other face.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2004-11-15
CYPROTERONE SANDOZ ® 1 CYPROTERONE SANDOZ ® _cyproterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cyproterone Sandoz. 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 this medicine 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 CYPROTERONE SANDOZ IS USED FOR Cyproterone Sandoz is an anti- androgen medicine. Androgens such as testosterone are natural male sex hormones which are also produced, to a slight extent, in females. MEN: In men, androgens may help cancer cells to grow in some types of prostate cancer. By blocking these hormones, Cyproterone Sandoz may slow or stop the growth of cancer. It can also 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. Cyproterone Sandoz is also used to reduce abnormal sex drive in men. WOMEN: In women, androgens may increase hair growth, loss of scalp hair and secretion of oil from the sweat glands. By blocking these hormones, Cyproterone Sandoz may slow or stop excessive hairiness, loss of scalp hair, acne, oily skin and dandruff. 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 CYPROTERONE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • cyproterone acetate, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description. Some of the symptoms of an allergic reac Přečtěte si celý dokument
210303-cyproterone-sandoz-pi Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION CYPROTERONE SANDOZ ® (CYPROTERONE ACETATE) 100 MG TABLETS 1 NAME OF THE MEDICINE Cyproterone acetate _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cyproterone Sandoz 100 mg tablet contains 100 mg cyproterone acetate. _Excipient with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Cyproterone Sandoz 100 mg tablets are white to off white, capsule shaped tablet with '100' engraved on one face, and a break line on the other face. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS _INOPERABLE PROSTATIC CARCINOMA_ • to suppress “flare” with initial luteinising hormone releasing hormone (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 D OSE AND METHOD OF ADMINISTRATION DOSAGE Cyproterone Sandoz 100 mg tablets are to be taken with some liquid after meals. _INOPERABLE PROSTATIC CARCINOMA _ _Suppression of “flare” with initial LHRH analogue therapy _ Initially 100 mg twice daily alone for 5-7 days, then 100 mg twice daily for 3-4 weeks together with an LHRH agonist at the dosage recommended by the manufacturer. _Long-term palliative treatment without orchidectomy _ 100 mg two or three times daily. Treatment should not be interrupted, nor the dosage reduced, after improvement or remissions have occurred. _Treatment of hot flushes (in patients treated with LHRH analogues or post-orchidectomy) _ Low initial dose of 50 mg once to three times daily, with upward titration to 100 mg three times daily if necessary. 210303-cyproterone-sandoz-pi Page 2 of 11 See Sections 4.4 Special warnings and precautions for use, 4.8 Adverse effects (Undesirable effects) and 4.9 Overdose. DOSAGE ADJUSTMENT IN: renal impairment There are no da Přečtěte si celý dokument