מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SOLIFENACIN SUCCINATE
NOVUGEN PHARMA SDN. BHD.
SOLIFENACIN SUCCINATE
10 Tablets; 30 Tablets; 60 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets; 14 Tablets; 28 Tablets; 56 Tablets; 84 Tablets; 112 Tablets; 168 Tablets
NOVUGEN PHARMA SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ RENAXIN FILM COATED TABLETS Solifenacin Succinate 5mg, 10mg 1 WHAT IS IN THIS LEAFLET 1. What Renaxin is used for 2. How Renaxin works 3. Before you use Renaxin 4. How to use Renaxin 5. While you are using Renaxin 6. Side effects 7. Storage and Disposal of Renaxin 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT RENAXIN IS USED FOR Renaxin is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time. HOW RENAXIN WORKS Renaxin contains an active ingredient, Solifenacin Succinate which belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. By relaxing the muscles in the bladder, it improves your ability to control your urination. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder. BEFORE YOU USE RENAXIN − _When you must not use it _ _ _ DO NOT TAKE RENAXIN: − if you are allergic to active substance or any of the other ingredients of this medicine, − if you have an inability to pass water or to empty your bladder completely (urinary retention), − if you have a severe stomach or bowel condition (including an acute form of colonic distension (toxic megacolon); a complication associated with an inflammatory bowel disease that causes long lasting inflammation and ulcers (sores) in your digestive tract (ulcerative colitis), − if you suffer from the muscle disease, which can cause an extreme weakness of certain muscles (myasthenia gravis), − if you suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma), − if you are undergoing kidney dialysis, − if you have severe liver disease, − if you suffer from severe kidney disease or קרא את המסמך השלם
1. NAME OF THE MEDICINAL PRODUCT Renaxin 5mg Film Coated Tablets Renaxin 10mg Film Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RENAXIN 5MG FILM COATED TABLETS: Each tablet contains 5mg of Solifenacin Succinate. RENAXIN 10MG FILM COATED TABLETS: Each tablet contains 10mg of Solifenacin Succinate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film Coated Tablets. RENAXIN 5MG FILM COATED TABLETS: Light yellow, round shaped film coated tablets debossed with “N” on one side and “25” other side. RENAXIN 10MG FILM COATED TABLETS: Light pink, round shaped film coated tablets debossed with “N” on one side and “24” other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS, INCLUDING THE ELDERLY The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily. PAEDIATRIC POPULATION The safety and efficacy of solifenacin in children have not yet been established. Therefore, Solifenacin should not be used in children. PATIENTS WITH RENAL IMPAIRMENT No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg once daily (see section 5.2). PATIENTS WITH HEPATIC IMPAIRMENT No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily (see section 5.2). POTENT INHIBITORS OF CYTOCHROME P450 3A4 The maximum dose of solifenacin should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors e.g קרא את המסמך השלם