Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SOLIFENACIN SUCCINATE
MEDISPEC (M) SDN.BHD
SOLIFENACIN SUCCINATE
10 x 3 Tablets
Unison Laboratories Co. Ltd.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SOFCARE 5MG/10MG TABLET Solifenacin succinate (5 mg and 10 mg) 1 WHAT IS IN THIS LEAFLET 1. What Sofcare is used for 2. How Sofcare works 3. Before you use Sofcare 4. How to use Sofcare 5. While you are using it 6. Side effects 7. Storage and Disposal of Sofcare 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SOFCARE IS USED FOR Sofcare is used to treat the symptoms of a condition called overactive bladder. These symptoms include: having a strong, sudden urge to urinate without prior warning, having to urinate frequently or wetting yourself because you could not get to the bathroom in time. HOW SOFCARE WORKS The active substance of Sofcare belongs to the group of anticholinergics which is Solifenacin succinate. These medicines are used to reduce the activity of an overactive bladder. This enables you to wait longer before having to go to the bathroom and increases the amount of urine that can be held by your bladder. BEFORE YOU USE SOFCARE _- When you must not use it _ Do not take Sofcare: • if you have an inability to pass water or to empty your bladder completely (urinary retention) • if you have a severe stomach or bowel condition (including toxic megacolon, a complication associated with ulcerative colitis) • if you suffer from the muscle disease called myasthenia gravis, which can cause an extreme weakness of certain muscles • if you suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma) • if you are allergic to Solifenacin or any of the other ingredients of this medicine • if you are undergoing kidney dialysis • if you have severe liver disease • if you suffer from severe kidney disease or moderate liver disease and at the same time are being treated with medicines that may decrease the removal of Sofcare from the body (for example, Ketoconazole). Your doctor or pharmacist will have informed you if this is the case. Inform your Citiți documentul complet
1 of 5 SOFCARE 5 MG TABLET SOFCARE 10 MG TABLET Each film coated tablet contains: SOLIFENACIN SUCCINATE 5 MG SOLIFENACIN SUCCINATE 10 MG PRODUCT DESCRIPTION: _5 MG: _Light yellow, round, biconvex, film coated tablet with engraved 5 on one side and plain on the other side_ _ _10 MG: _Light pink, oblong, biconvex, film coated tablet with engraved 10 on one side and plain on the other side _ _ MECHANISM OF ACTION: _PHARMACOLOGY _ Solifenacin is a competitive, specific cholinergic-receptor antagonist. The urinary bladder is innervated by parasympathetic cholinergic nerves. Acetylcholine contracts the detrusor smooth muscle through muscarinic receptors of which the M3 subtype is predominantly involved. Solifenacin is a competitive inhibitor of the muscarinic M3 subtype receptor. In addition, Solifenacin showed to be a specific antagonist for muscarinic receptors by displaying low or no affinity for various other receptors and ion channels tested. _PHARMACOKINETICS _ Absorption After intake of Solifenacin, maximum Solifenacin plasma concentrations (C max ) are reached after 3 to 8 hours. 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 proteins, primarily α 1 -acid glycoprotein. Biotransformation Solifenacin is extensively metabolized by the liver, primarily by cytochrome P450 3A4 (CYP3A4). However, alternative metabolic pathways exist, that can contribute to the metabolism of Solifenacin. The systemic clearance of Solifenacin is about 9.5 L/h and the terminal half life of Solifenacin is 45-68 hours. After oral dosing, one pharmacologically active (4_R_-hydroxy Solifenacin) and three inactive metabolites (_N_-glucuronide, _N_-oxide and 4_R_- hyd Citiți documentul complet