Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SOLIFENACIN SUCCINATE
MEDISPEC (M) SDN.BHD
SOLIFENACIN SUCCINATE
3x10 Tablets
GETZ PHARMA (PVT) LIMITED
SOLIFEN FILM COATED TABLETS 5MG Solifenacin Succinate (5mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Solifen_ is used for 2. How _Solifen_ works 3. Before you use _Solifen_ 4. How to use _Solifen_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Solifen_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _SOLIFEN_ IS USED FOR Solifen 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. HOW _SOLIFEN_ WORKS Solifen 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. BEFORE YOU USE _SOLIFEN _ - _When you must not use it _ • 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 Solifen from the body (for example, ketoconazole). Your doctor or pharmacist will have informed you if this is the case. Inform your doctor if you have or ever had any of the above mentioned conditions before treatment with Solifen starts. _ _ _Pregnancy and lactation _ You should not use Solifen if you are pregnant unless clear Izlasiet visu dokumentu
SOLIFEN FILM COATED TABLETS 5MG (Solifenacin succinate) 5mg Film-Coated Tablets DESCRIPTION Solifen Tablet 5mg is available as white oblong, biconvex shaped film coated tablet plain on both sides. QUALITATIVE & QUANTITATIVE COMPOSITIONS SOLIFEN (Solifenacin succinate) is available for oral administration as: SOLIFEN Tablets 5mg Each film-coated tablet contains: Solifenacin succinate ... 5mg CLINICAL PHARMACOLOGY MECHANISM OF ACTION 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. Reported in vitro and in vivo pharmacological studies indicate that 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 After oral administration of solifenacin succinate, it is absorbed from the gastrointestinal tract, with the peak plasma concentrations reaching after 3 to 8 hours and a bioavailability of about 90%. There is no effect of food on the pharmacokinetics of solifenacin. Solifenacin succinate is about 98% bound to plasma proteins principally to (alpha1)-acid glycoprotein. It is highly distributed to non-CNS tissues, having a mean steady-state volume of distribution of 600L. Solifenacin succinate is extensively metabolised in the liver mainly by the cytochrome P450 isoenzyme CYP3A4, and has a terminal half-life of 45-68hours. Solifenacin succinate is excreted mainly as metabolites in urine and feces. THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. DOSAGE AND ADMINISTRATION _Adults, including the elderly _ The recommended dose is 5 mg solifenacin succinate once daily. If Izlasiet visu dokumentu