Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SOLIFENACIN SUCCINATE
PHARMENG TECHNOLOGY SDN. BHD.
SOLIFENACIN SUCCINATE
100 Tablets; 30 Tablets
PRO.MED.CS Praha a.s.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ QUEMED 5 MG TABLETS QUEMED 10 MG TABLETS Solifenacin succinate (5mg / 10mg) 1 WHAT IS IN THIS LEAFLET 1. What Quemed is used for 2. How Quemed works _3._ _ _ Before you use Quemed _ _ 4. How to use Quemed 5. While you are using Quemed 6. Side effects _7._ _ _ Storage and Disposal of Quemed _ _ 8. Product Description 9. Manufacturer 10. Product Registration Holder and Distributor 11. Date of revision 12. Serial Number WHAT QUEMED IS USED FOR Quemed 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 QUEMED WORKS The active substance of Quemed belongs to the group of anticholinergics. These medicines are used to reduce the activity of an overactive bladder. By relaxing the muscles in the bladder, it improves your ability to control your urination. 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 QUEMED_ _ - _When you must not use it _ DO NOT TAKE QUEMED - if you are allergic to active substance or any of the other ingredients of this medicine, - 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 an acute form of colonic distension (toxic megacolon); a complication associated with an inflammatory bowel disease that causes long- lasting inflammation and ulcers (sores) in your digestive tract (ulcerative colitis)), - if you suffer from the muscle disease, which can cause an extreme weakness of certain muscles (myasthenia gravis), - if you suffer from increased pressure in the eyes, with gradual loss of eye sight (glaucoma), - if you are undergoing kidney dialysis, - if you have severe liver disease, - if you suffer from severe kidney disease or moderate live Baca dokumen lengkapnya
QUEMED 5 MG TABLETS QUEMED 10 MG TABLETS Solifenacin succinate DESCRIPTION Film-coated tablet. Quemed 5 mg: yellow round biconvex film-coated tablets, plain on both sides, diameter 6 mm, without break line. Quemed 10 mg: pink round biconvex film-coated tablets, plain on both sides, diameter 7 mm, without break-line. COMPOSITION Quemed 5 mg: each film-coated tablet contains 5 mg of solifenacin succinate. Quemed 10 mg: each film-coated tablet contains 10 mg of solifenacin succinate. List of excipients: Tablet core: Lactose monohydrate, Maize starch, Talc, Magnesium stearate. Tablet coating: Quemed 5 mg: Opadry yellow OY 32823 (Hypromellose 6cP, Titanium dioxide, Macrogol 400, Ferric oxide Yellow, Ferric oxide Red) Quemed 10 mg: Opadry white 03B28796 (Hypromellose 6cP, Titanium dioxide, Macrogol 400), Opadry brown 02F23883 (Hypromellose 5cP, Titanium dioxide, Macrogol 6000, Ferric oxide Yellow, Ferric oxide Red) PHARMACODYNAMICS Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04BD08. 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 M 3 subtype is predominantly involved. Solifenacin is a competitive inhibitor of the muscarinic M 3 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. PHARMACOKINETICS Absorption After intake of solifenacin tablets, 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 abo Baca dokumen lengkapnya