Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Zydus Healthcare (Pty) Ltd
See ingredients
CAPSULES
EACH CAPSULE CONTAINS DUTASTERIDE 0,5 mg
Registered
Zydus Healthcare SA (Pty) Ltd ZEDRAST 0,5 mg soft capsules Page 1 of 10 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 ZEDRAST 0,5 MG SOFT CAPSULES DUTASTERIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ZEDRAST. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or pharmacist. • ZEDRAST has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. WHAT ZEDRAST IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEDRAST 3. HOW TO TAKE ZEDRAST 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ZEDRAST 6. CONTENTS OF THE PACK AND OTHER INFORMATION Zydus Healthcare SA (Pty) Ltd ZEDRAST 0,5 mg soft capsules Page 2 of 10 1. WHAT ZEDRAST IS AND WHAT IT IS USED FOR ZEDRAST contains the active substance dutasteride that belongs to a group of medicines called 5 alpha-reductase inhibitors. ZEDRAST is used in men to treat prostate enlargement, also referred to as benign prostatic hyperplasia (BPH). BPH is an increased growth of the prostate gland and is caused by your body producing too much of a hormone called dihydrotestosterone. ZEDRAST decreases your body’s production of dihydrotestosterone, thereby reducing the size of your enlarged prostate and relieving accompanying symptoms, such as difficulty passing urine and an urge to urinate more often than usual. By doing this, ZEDRAST lowers the need for surgery in men with enlarged prostates. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEDRAST DO NOT TAKE ZEDRAST • If you are hypersensitive (allergic) to dutasteride or any of the other ingredients of ZEDRAST listed in section 6 of this leaflet. • If you are a women. • If you are a child or adolescent younger than 18 years old. • If you have severe liver disease. WARNINGS AND PRECAUTIONS _TAKE SPECIAL CARE WITH ZEDRAST: _ • Before you start and while you are taking ZEDRAST, your doctor may examine and eva Прочитать полный документ
Zydus Healthcare SA (Pty) Ltd ZEDRAST 0,5 mg soft capsules Page 1 of 18 PROFESSIONAL INFORMATION FOR ZEDRAST SCHEDULING STATUS S4 1. NAME OF THE MEDICINE ZEDRAST 0,5 mg soft capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0,5 mg dutasteride. Preservatives: 0,2 % _m/m_ methyl hydroxybenzoate and 0,03 % _m/m_ propyl hydroxybenzoate. Sugar free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, soft. Opaque, yellow, oblong shaped soft gelatine capsules containing a clear, colourless to slightly yellowish oily liquid. Zydus Healthcare SA (Pty) Ltd ZEDRAST 0,5 mg soft capsules Page 2 of 18 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZEDRAST is indicated for the treatment of benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULT MALES (INCLUDING ELDERLY) _ The recommended dose of ZEDRAST_ _is one capsule (0,5 mg) taken orally once a day. The capsules should be swallowed whole. ZEDRAST may be taken with or without food. Although an improvement may be observed at an early stage, treatment for at least six months may be necessary in order to assess objectively whether a satisfactory response to the treatment can be achieved. _RENAL IMPAIRMENT _ The effect of renal impairment on dutasteride pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment (see section 5.2). _HEPATIC IMPAIRMENT _ The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied (see sections 4.4 and 5.2). Zydus Healthcare SA (Pty) Ltd ZEDRAST 0,5 mg soft capsules Page 3 of 18 4.3 CONTRAINDICATIONS ZEDRAST is contraindicated in: • Patients with hypersensitivity to dutasteride, other 5α-reductase inhibitors or to any of the excipients of ZEDRAST. • Women (see section 4.6). • Children and adolescents younger than 18 years (see section 4.4). • Patients with severe hepatic impairment. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Careful benefit risk assessment is r Прочитать полный документ