Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
TOLTERODINE TARTRATE
Specifar S.A.
TOLTERODINE TARTRATE
2 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-07-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tolterodine Tartrate Specifar 2 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tolterodine Tartrate Specifar 2 mg film-coated tablets contains 2 mg tolterodine tartrate equivelant to 1.37 mg tolterodine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Tolterodine Tartrate Specifar 2mg film-coated tablets are white, round, biconvex, film-coated tablets, bearing a breakline on one side, having a diameter of 6.0mm approximately. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tolterodine Tartrate Specifar 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 elderly):_ The recommended dose is 2 mg twice daily except in patients with impaired liver function or severely impaired renal function (GFR<30 ml/min) for whom the recommended dose is 1 mg 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 Tolterodine Tartrate Specifar has not been demonstrated in children (See section 5.1). Therefore, Tolterodine Tartrate Specifar is not recommended for children. 4.3 CONTRAINDICATIONS Tolterodine is contraindicated in patients with - Urinary retention - Uncontrolled narrow angle glaucoma - Myasthenia gravis IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/08/2011_ _CRN 2082011_ _page number: 1_ - Known hy Lees het volledige document