Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PCO Manufacturing
2 Milligram
Tablets
2001-10-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrusitol 2 mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg tolterodine tartrate equivalent to 1.37 mg tolterodine. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, white tablets with ‘DT’ and arcs above and below the lettering on one side and plain on the 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 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR ≤ 30ml/min) for whom the recommended dose is 1mg twice daily (see section 4.4) . In case of troublesome side-effects the dose may be reduced from 2 mg to 1 mg twice daily. The effect of treatment should be re-evaluated after 2-3 months (see section 5.1). _Paediatric Patients:_ Efficacy of Detrusitol has not been demonstrated in children (See section 5.1). Therefore, Detrusitol is not recommended for children. 4.3 CONTRAINDICATIONS Tolterodine is contra-indicated in patients with: o urinary retention, o uncontrolled narrow angle glaucoma, o myasthenia gravis, o known hypersensitivity to tolterodine or excipients, o severe ulcerative colitis, o toxic megacolon. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Tolterodine should 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 section 4.2) hepatic disease (see section 4.2 and 5.2) IRISH Read the complete document