Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TOLTERODINE L-TARTRATE
VIATRIS SDN. BHD.
TOLTERODINE L-TARTRATE
56 Tablets; 28 Tablets; 14 Tablets
PFIZER ITALIA S.R.L.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DETRUSITOL ® TABLET Tolterodine tartrate (2 mg) 1 WHAT IS IN THIS LEAFLET 1. What Detrusitol is used for 2. How Detrusitol works 3. Before you use Detrusitol 4. How to use Detrusitol 5. While you are using it 6. Side Effects 7. Storage and Disposal of Detrusitol 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT DETRUSITOL IS USED FOR Detrusitol is used for the treatment of overactive bladder. 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 WORKS Detrusitol belongs to a class of medicines called antimuscarinics. It works by reducing spasm and relaxing the bladder muscles. BEFORE YOU USE DETRUSITOL _-_ _When you must not use it_ Do not take Detrusitol if you: - are allergic (hypersensitive) to tolterodine or any of the other ingredients in Detrusitol; - are unable to pass urine (urinary retention); - have an uncontrolled narrow-angle glaucoma (uncontrolled 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 expansion of the colon). _Pregnancy and lactation_ The safety of Detrusitol during pregnancy has not yet been proven. Detrusitol is not recommended during pregnancy. You should use Detrusitol only after discussing the potential benefits and the potential risks to your unborn child with your doctor. It is not known if Detrusitol is excreted in the mother’s breast milk. Detrusitol should be avoided during breast feeding. 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 difficulties in passing urine and/ Perskaitykite visą dokumentą
Pfizer Confidential CLD Title : Tolterodine tartrate (Detrusitol) CLD Date : 2147 May January 20212022 Country : Malaysia Reference Document : EU SPC dated 17 February 2021 Reason for change : Minor administrative changes to remove Pfizer reference PfLEET 2020-0061583 (S2): Update 4.4 “warnings and precautions for use” for information on the excipient "sodium". Pfizer Confidential 1 DETRUSITOL ® Tolterodine Tartrate 1. NAME OF THE MEDICINAL PRODUCT Detrusitol 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. The film-coated tablets are white, round and biconvex. The 2 mg tablet is engraved with arcs above and below the letters DT. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, or urge incontinence. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the Elderly) The recommended total daily dose is 4 mg. Dosage with tolterodine tablets is 2 mg twice daily. The total daily dose may be reduced to 2 mg, based on individual tolerability. Use in Children Safety and effectiveness in children have not been established. Use in Impaired Renal Function The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired renal function (see Section 4.4). Use in Impaired Hepatic Function The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired hepatic function (see Section 4.4). COMMENTED [PC1]: As per registered with NPRA Pfizer Confidential 2 Use with Potent CYP3A4 Inhibitors The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients receiving concomitant ketoconazole or other potent CYP3A4 inhibitors (see Sections 4.4 and 4.5). 4.3 CONTRAINDICATIONS Tolterodine is contraindicate Perskaitykite visą dokumentą