Страна: Нидерланды
Язык: голландский
Источник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SOLIFENACINESUCCINAAT SAMENSTELLING overeenkomend met ; SOLIFENACINE
Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)
G04BD08
SOLIFENACINESUCCINAAT COMPOSITION corresponding to ; SOLIFENACIN
Filmomhulde tablet
HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; PROPYLGALLAAT (E 310) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Solifenacin
Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; PROPYLGALLAAT (E 310); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-11-22
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SOLIFENACINESUCCINAAT AET 5 mg filmomhulde tabletten SOLIFENACINESUCCINAAT AET 10 mg filmomhulde tabletten 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 Solifenacinesuccinaat AET is and what it is used for 2. What you need to know before you take Solifenacinesuccinaat AET 3. How to take Solifenacinesuccinaat AET 4. Possible side effects 5. How to store Solifenacinesuccinaat AET 6. Contents of the pack and other information 1. WHAT SOLIFENACINESUCCINAAT AET IS AND WHAT IT IS USED FOR The active substance 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. Solifenacinesuccinaat AET 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 SOLIFENACINESUCCINAAT AET DO NOT TAKE SOLIFENACINESUCCINAAT AET - 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 toxic megacolon, a complication associated with ulcerative colitis) - if you suffer from the muscle disease called myasthenia gr Прочитать полный документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Solifenacinesuccinaat AET 5 mg filmomhulde tabletten Solifenacinesuccinaat AET 10 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Solifenacinesuccinaat AET 5 mg filmomhulde tabletten: Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin. Excipient(s) with known effect: lactose monohydrate (128.7 mg) Solifenacinesuccinaat AET 10 mg filmomhulde tabletten: Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin. Excipient(s) with known effect: lactose monohydrate (123.7 mg) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Solifenacinesuccinaat AET 5 mg filmomhulde tabletten: Each 5 mg tablet is a pink coloured, round (8 mm diameter), biconvex film-coated tablets embossed with ‘5’ on one side. Solifenacinesuccinaat AET 10 mg filmomhulde tabletten: Each 10 mg tablet is a red-brown coloured, round (8 mm diameter), biconvex film-coated tablets embossed with ‘10’ on one 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 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 in children have not yet been established. Therefore, solifenacin should not be used in children. _ _ 2 _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 Прочитать полный документ