Страна: Швеция
Език: шведски
Източник: Läkemedelsverket (Medical Products Agency)
tolterodintartrat
2care4 ApS
G04BD07
tolterodine tartrate
4 mg
Depotkapsel, hård
tolterodintartrat 4 mg Aktiv substans; natriumlaurilsulfat Hjälpämne; laktosmonohydrat Hjälpämne; propylenglykol Hjälpämne
Receptbelagt
Förpacknings: Blister, 30 kapslar; Blister, 60 kapslar; Blister, 100 kapslar
Avregistrerad
2019-05-22
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TOLTERODIN RIVOPHARM 2 MG PROLONGED-RELEASE CAPSULES, HARD TOLTERODIN RIVOPHARM 4 MG PROLONGED-RELEASE CAPSULES, HARD tolterodine tartrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Tolterodin Rivopharm is and what it is used for 2. What you need to know before you take Tolterodin Rivopharm 3. How to take Tolterodin Rivopharm 4. Possible side effects 5. How to store Tolterodin Rivopharm 6. Contents of the pack and other information 1. WHAT TOLTERODIN RIVOPHARM IS AND WHAT IT IS USED FOR The active substance in Tolterodin Rivopharm is tolterodine. Tolterodine belongs to a class of medicines called antimuscarinics. Tolterodin Rivopharm 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 TOLTERODIN RIVOPHARM DO NOT TAKE TOLTERODIN RIVOPHARM • if you are allergic to tolterodine or any of the other ingredients of this medicine (listed in section 6). • if you are unable to pass urine from the bladder (urinary retention). • if you have an uncontrolled narrow-angle glaucoma (high pressure in the eyes with loss of eyesight that is not being adequately treated). • if you suffer from myasthenia gravis (excessive weakness of the muscles). • if you suffer from severe ulcerative colitis (ulcerat Прочетете целия документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tolterodin Rivopharm 2 mg, prolonged-release capsules, hard Tolterodin Rivopharm 4 mg, prolonged-release capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release capsule, hard contains 2 mg tolterodine tartrate, which is equivalent to 1.37 mg of tolterodine. One prolonged-release capsule, hard contains 4 mg tolterodine tartrate, which is equivalent to 2.74 mg of tolterodine. Excipient with known effect Each 2 mg prolonged release capsule, hard contains 32.70-34.50 mg lactose monohydrate. Each 4 mg prolonged release capsule, hard contains 65.41-68.99 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule, hard The 2 mg prolonged release capsule, hard is opaque green-opaque green size 1 hard gelatin capsule containing two white, round, biconvex coated tablets. The 4 mg prolonged release capsule, hard is light blue opaque-light blue opaque size 1 hard gelatin capsule containing four white, round, biconvex coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tolterodin Rivopharm is indicated in 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 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 troublesome side-effects the dose may be reduced from 4 mg to 2 mg once daily. The effect of treatment should be re-evaluated after 2-3 months (see section 5.1). _Paediatric population_ The safety and efficacy of tolterodine has not been demonstrated in children (see section 5.1). Therefore, tolterodine is not recommended for children. 2 Method of administration The prolonged-release capsules, hard ca Прочетете целия документ