Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TOLTERODINE L-TARTRATE
UPJOHN (MALAYSIA) SDN. BHD.
TOLTERODINE L-TARTRATE
30 Capsule Capsules
Catalent Pharma Solutions, LLC
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DETRUSITOL ® SR CAPSULES Tolterodine tartrate (2 mg, 4 mg) 1 WHAT IS IN THIS LEAFLET 1. What Detrusitol SR is used for 2. How Detrusitol SR works 3. Before you use Detrusitol SR 4. How to use Detrusitol SR 5. While you are using it 6. Side effects 7. Storage and Disposal of Detrusitol SR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT DETRUSITOL SR IS USED FOR 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. HOW DETRUSITOL SR WORKS Detrusitol SR belongs to a class of medicines called antimuscarinics. It works by reducing spasm and relaxing the bladder muscles. BEFORE YOU USE DETRUSITOL SR - _When you must not use it_ Do not take Detrusitol SR if you: - are allergic (hypersensitive) to Detrusitol SR or any of the other ingredients in Detrusitol SR or to fesoterodine fumarate extended- release tablets; - are unable to pass urine from the bladder (urinary retention); - suffer from a condition in which the stomach's ability to empty its contents is impaired (gastric retention); - have uncontrolled narrow-angle glaucoma (uncontrolled high pressure in the eyes). _Pregnancy and lactation_ The safety of Detrusitol SR during pregnancy has not yet been proven. It is not known if Detrusitol SR is excreted in the mother’s breast milk. You must discuss with your doctor about the health benefits of breast feeding, underlying maternal condition, and the side effects of Detrusitol SR, on your breastfed baby before taking Detrusitol SR. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Check with your doctor before you use this medicine: - if you have serious allergic reaction which causes difficulty in breathing or Läs hela dokumentet
Pfizer Confidential 1 PFIZER DETRUSITOL ® SR Tolterodine Tartrate 1. NAME OF THE MEDICINAL PRODUCT DETRUSITOL ® SR 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DETRUSITOL ® SR Capsules 2 mg are blue-green with symbol and 2 printed in white ink. Each extended release capsule contains tolterodine tartrate 2 mg equivalent to 1.37 mg tolterodine. DETRUSITOL ® SR Capsules 4 mg are blue with symbol and 4 printed in white ink. Each extended release capsule contains tolterodine tartrate 4 mg equivalent to 2.74 mg tolterodine. 3. PHARMACEUTICAL FORM Extended release capsules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION DETRUSITOL ® SR Capsules are once-daily extended release capsules indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dose of DETRUSITOL ® SR Capsules is 4 mg once daily with water and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for DETRUSITOL ® SR 2 mg _[see CLINICAL STUDIES]_ . 4.2.1 DOSAGE ADJUSTMENT IN SPECIFIC POPULATIONS HEPATIC AND RENAL IMPAIRMENT For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) or severe renal impairment (CCr 10 - 30 mL/min), the recommended dose of DETRUSITOL ® SR is 2 mg once daily. DETRUSITOL ® SR is not recommended for use in patients with severe hepatic impairment (Child- Pugh Class C). Patients with CCr<10 mL/min have not been studied and use of DETRUSITOL ® SR in this population is not recommended _[see WARNINGS AND PRECAUTIONS and PHARMACOKINETICS _ _IN SPECIAL POPULATIONS]. _ _ _ PEDIATRIC USE Efficacy in the pediatric population has not been demonstrated. GERIATRIC USE No overall differences in safety were observed between the older and younger patients treated with tolterodine. Pfizer Confidential 2 4.2.2 DOSAGE ADJUSTMENT IN PRESENCE OF CONCOMITANT DRUGS For patients who are taking drugs that are poten Läs hela dokumentet