Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
TOLTERODINE TARTRATE
Specifar S.A.
1 Milligram
Film Coated Tablet
2011-08-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tolterodine Tartrate Specifar 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tolterodine Tartrate Specifar 1 mg film-coated tablets contains 1 mg tolterodine tartrate equivelant to 0.68 mg tolterodine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets White, round, biconvex, film-coated Tablets, having a diameter of 6.0mm approximately. 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 Specifaris 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 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/08/2011_ _CRN 2082011_ _page number: 1_ - Severe ulcerative colitis - Toxic megacolon 4.4 SPECIAL WARNINGS AND PRECAUTIONS Belgenin tamamını okuyun