Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tolterodine tartrate
Upjohn EESV
G04BD; G04BD07
Tolterodine tartrate
2 milligram(s)
Prolonged-release capsule, hard
Drugs for urinary frequency and incontinence; tolterodine
Marketed
2001-07-27
Page 1 of 7 2022-0076539 PACKAGE LEAFLET: INFORMATION FOR THE USER DETRUSITOL SR 2 MG & 4 MG PROLONGED RELEASE CAPSULES, HARD TOLTERODINE TARTRATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Detrusitol SR is and what it is used for 2. What you need to know before you take Detrusitol SR 3. How to take Detrusitol SR 4. Possible side effects 5. How to store Detrusitol SR 6. Contents of the pack and other information 1. WHAT DETRUSITOL SR IS AND WHAT IT IS USED FOR The active substance in Detrusitol SR is tolterodine. Tolterodine belongs to a class of medicinal products called antimuscarinics. Detrusitol SR 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUSITOL SR DO NOT TAKE DETRUSITOL SR IF YOU • are allergic (hypersensitive) to tolterodine or any of the other ingredients in Detrusitol SR (listed in section 6) • 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). Soma hati kamili
Health Products Regulatory Authority 22 December 2022 CRN00CYR8 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrusitol SR 2 mg, prolonged-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release capsule contains tolterodine tartrate 2 mg corresponding to 1.37 mg tolterodine. Excipient(s) with known effect Each 2 mg prolonged-release capsule contains a maximum of 61.52 mg of sucrose. For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard The 2 mg prolonged-release capsule is blue-green with white printing (symbol and 2). 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 troublesomeside-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 POPULATION_ 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 (see section 6) Severe ulcerative colitis Toxic megacolon 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Tolterodine shall be used with caution in patients with: Health Products Regulatory Authority 22 December 2022 CRN00CYR8 Page 2 of 8 Significant bladder outl Soma hati kamili