Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tolterodine tartrate
Actavis UK Ltd
G04BD07
Tolterodine tartrate
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5012617022387
AAAF6278 _Continued top of next column_ TOLTERODINE TARTRATE 2MG FILM-COATED TABLETS Tolterodine tartrate _Continued over page_ PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 TOLTERODINE TARTRATE IS AND WHAT IT IS USED FOR 2 BEFORE YOU TAKE TOLTERODINE TARTRATE 3 HOW TO TAKE TOLTERODINE TARTRATE 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE TOLTERODINE TARTRATE 6 FURTHER INFORMATION 1 WHAT TOLTERODINE TARTRATE IS AND WHAT IT IS USED FOR The active substance in Tolterodine Tartrate is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics. Tolterodine Tartrate 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 TOLTERODINE TARTRATE DO NOT TAKE TOLTERODINE TARTRATE IF YOU: • are allergic (hypersensitive) to tolterodine or any of the other ingredients in Tolterodine Tartrate • 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 TOLTERODINE TARTRATE • If you have difficulties in p Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tolterodine 2 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains tolterodine tartrate 2 mg corresponding to 1.37 mg tolterodine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Tolterodine 2 mg: White, round, biconvex, 5.5 mm film-coated tablets marked with “T2” on one 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 Posology _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 has not been demonstrated in children (See section 5.1). Therefore, Tolterodine is not recommended for children. Method of administration Oral. 4.3 CONTRAINDICATIONS Tolterodine is contraindicated in patients with - Urinary retention - Uncontrolled narrow angle glaucoma - Myasthenia gravis - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - 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 section 4.2) - Hepatic disease (see section 4.2 and 5.2) - Autonomic neuropathy - Hiatus hernia - Risk for decreased gastrointestinal motility Multiple oral total daily doses of immediate releas Read the complete document