国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tolterodine tartrate
CST Pharma Ltd
G04BD07
Tolterodine tartrate
4mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5055946807232
DETRUSITOL ® XL 4MG CAPSULES (tolterodine L-tartrate) The name of your medicine is Detrusitol XL 4mg Capsules but will be referred to as Detrusitol XL throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Detrusitol XL is and what it is used for 2. Before you take Detrusitol XL 3. How to take Detrusitol XL 4. Possible side effects 5. How to store Detrusitol XL 6. Further information 1. WHAT DETRUSITOL XL IS AND WHAT IT IS USED FOR The active substance in Detrusitol XL is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics. Detrusitol XL is used for the treatment of the symptoms of overactive bladder syndrome. If you have overactive bladder syndrome, you may find that: - you are unable to control urination, - you need to rush to the toilet with no advance warning and/or go to the toilet frequently. 2. BEFORE YOU TAKE DETRUSITOL XL DO NOT TAKE DETRUSITOL XL IF YOU: - are allergic (hypersensitive) to tolterodine or any of the other ingredients in Detrusitol XL - are unable to pass urine from the bladder (urinary retention) - have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated) - suffer from myasthenia gravis (excessive weakness of the muscles) - suffer from severe ulcerative colitis (ulceration and inflammation of the colon) - suffer from a toxic megacolon (acute dilatation of the colon). TAKE SPECIAL CARE WITH DETRUSITOL XL - If you have difficulties in passing urine and/or a poor stream of urine - If you have a gastro-intestinal disease tha 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrusitol XL 4 mg, prolonged-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74 mg tolterodine. Each 4 mg prolonged-release capsule contains a maximum of 123.07 mg of sucrose. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard The 4 mg prolonged-release capsule is blue with white printing (symbol and 4). 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 4 mg once daily except in patients with impaired liver function or severely impaired renal function (GFR ≤ 30 ml/min) for whom the recommended dose is 2 mg once daily (see sections 4.4 and 5.2). In case of troublesome_ _side-effects the dose may be reduced from 4 mg to 2 mg once daily. The prolonged-release capsules can be taken with or without food and must be swallowed whole. The effect of treatment should be re-evaluated after 2-3 months (see section 5.1). _ _ _Paediatric patients: _ Efficacy of Detrusitol XL has not been demonstrated in children (See section 5.1). Therefore, Detrusitol XL is not recommended for children. 4.3 CONTRAINDICATIONS Tolterodine is contraindicated in patients with - Urinary retention - Uncontrolled narrow angle glaucoma - Myasthenia gravis - Known hypersensitivity to tolterodine or excipients - Severe ulcerative colitis - Toxic megacolon 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Tolterodine shall be used with caution in patients with - Significant bladder outlet obstruction at risk of_ _urinary retention - Gastrointestinal obstructive disorders, e.g. pyloric stenosis - Renal impairment (see sections 4.2 and 5.2) - Hepatic disease (see sections 4.2 and 5.2) - Autonomic 阅读完整的文件