Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
TOLTERODINE TARTRATE
McDowell Pharmaceuticals
4 Milligram
Prolonged Release Capsules
2009-10-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrusitol SR 4mg, prolonged-release capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release capsule contains tolterodine tartrate 4mg corresponding to 2.74mg tolterodine. Excipients – Contains sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard. _Product imported from _the UK: The 4mg 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 SR has not been demonstrated in children (See section 5.1). Therefore, Detrusitol SR 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 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/02 Baca dokumen lengkap