País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Solifenacin succinate
Zentiva Pharma UK Ltd
G04BD08
Solifenacin succinate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 8594739231092
PACKAGE LEAFLET: INFORMATION FOR THE USER SOLIFENACIN SUCCINATE 5 MG FILM-COATED TABLETS SOLIFENACIN SUCCINATE 10 MG FILM-COATED TABLETS SOLIFENACIN SUCCINATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Solefenacin is and what it is used for 2. What you need to know before you take Solifenacin 3. How to take Solifenacin 4. Possible side effects 5. How to store Solifenacin 6. Contents of the pack and other information 1. WHAT SOLIFENACIN IS AND WHAT IT IS USED FOR The active substance of Solifenacin belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. 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. Solifenacin 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLIFENACIN DO NOT TAKE SOLIFENACIN IF YOU: • are allergic to solifenacin or any of the other ingredients of this medicine (listed in section 6). • have an inability to pass water or to empty your bladder completely (urinary retention). • have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis). • suffer from the muscle disease called myasthenia gravis, which can ca Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solifenacin succinate 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Solifenacin succinate 10 mg film-coated tablets Each tablet contains 10 mg solifenacin succinate. Excipient(s) with known effect: lactose monohydrate 102.5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets Solifenacin succinate 10 mg Film-coated Tablets: Light pink, round shaped, film coated tablets debossed with "S10" on one side and plain on other side. Approximate tablet diameter: 7. 60 mm ± 0.3 mm 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 Posology _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 succinate tablets in children have not yet been established. Therefore, solifenacin succinate 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 succinate tablets should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4-inhibitors e Leer el documento completo