Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Solifenacin succinate
Astellas Pharma Australia Pty Ltd
Medicine Registered
1 5 MG AND 10 MG FILM-COATED TABLETS contains the active ingredient _solifenacin succinate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet answers some common questions about VESICARE. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking VESICARE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT VESICARE IS USED FOR VESICARE is used to treat the symptoms of overactive bladder. These symptoms include needing to rush to the toilet to urinate without warning, needing to urinate frequently, or wetting yourself because you did not get to the toilet in time. VESICARE belongs to a group of medicines called anticholinergic medicines. It works by acting on specialised cells to reduce the activity of your bladder and help you control your bladder. Your doctor may have prescribed VESICARE for another reason. Ask your doctor if you have any questions about why VESICARE has been prescribed for you. VESICARE is available only with a doctor's prescription. There is no evidence that VESICARE is addictive. BEFORE YOU TAKE VESICARE WHEN YOU MUST NOT TAKE IT DO NOT TAKE VESICARE IF YOU ARE ALLERGIC TO MEDICINES CONTAINING SOLIFENACIN OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shor Διαβάστε το πλήρες έγγραφο
PRODUCT INFORMATION VESICARE (SOLIFENACIN 5MG, 10MG FILM-COATED TABLETS) NAME OF THE MEDICINE Vesicare® 5 mg Tablet Vesicare® 10 mg Tablet DESCRIPTION Vesicare 5 mg film-coated tablet: Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin. Vesicare 10 mg film-coated tablet: Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin. Solifenacin (3R)-1-azabicyclo[2.2.2]oct-3-yl(1S)-1-phenyl-3,4-dihydroisoquinoline- 2(1H)-carboxylate monosuccinate The empirical formula is C 23 H 26 N 2 O 2 .C 4 H 6 O 4 The molecular weight is 480.55 The CAS number is 242478-38-2 Molecular structure: N O O N O O O H OH • PHARMACOLOGY Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04B D08. Mechanism of Action Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergic mediated functions, including contractions of urinary bladder smooth muscle and stimulation of the salivary secretion. Vesicare (solifenacin 5mg, 10mg): Product Information 1 Pharmacokinetics _Absorption _ After intake of Vesicare tablets, maximum solifenacin plasma concentrations (C max ) are reached after 3 to 8 hours and at steady state ranged from 32.3 to 69.9 ng/ml for the 5 and 10 mg Vesicare tablets, respectively. The t max is independent of the dose. The C max and area under the curve (AUC) increase in proportion to the dose between 5 to 40 mg. Absolute bioavailability is approximately 90%. Food intake does not affect the C max and AUC of solifenacin. _Distribution _ The apparent volume of distribution of solifenacin following intravenous administration is about 600 L. Solifenacin is to a great extent (approximately 98%) bound to plasma Διαβάστε το πλήρες έγγραφο