देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESOMEPRAZOLE MAGNESIUM
RANBAXY (MALAYSIA) SDN. BHD.
ESOMEPRAZOLE MAGNESIUM
3 x 10 Tablets
Sun Pharmaceutical Industries Limited
ESOZ 40 MG Page 1 ESOZ _ _ (Esomeprazole Magnesium Gastro Resistant Tablets 40 mg) _Consumer Medication Information Leafleat (RiMUP)_ _ _ WHAT IS IN THIS LEAFLET 1. What ESOZ is used for 2. How ESOZ works 3. Before you use ESOZ 4. How to use ESOZ 5. While you are using ESOZ 6. Side Effects 7. Storage and Disposal of ESOZ 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of Revision This leaflet answers some common questions about ESOZ . All medicines have risks and benefits. Your doctor has weighed the risks of you taking ESOZ against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ESOZ IS USED FOR ESOZ is used to treat the following conditions: ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. It also helps to stop reflux oesophagitis from coming back or relapsing. A rare condition where the stomach produces large amounts of acid, much more than in ulcers or reflux disease (Zollinger-Ellison syndrome). Prevention of rebleeding of ulcers following treatment with esomeprazole IV solution by intravenous infusion. HOW ESOZ WORKS ESOZ contains a medicine called esomeprazole. Esomeprazole is a type of medicine called a proton-pump inhibitor. It works by decreasing the amount of acid made by the stomach to relieve symptoms and allow healing to take place. This does not stop food being digested in the normal way. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ESOZ HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This product is available in 40 mg strength. BEFORE YOU USE ESOZ _WHEN YOU MUST NOT USE IT _ IF YOU HAVE AN ALLERGY TO: Esomeprazole or any ingredient of ESOZ listed at the end of this leaflet (see PRODUCT DESCRIPTION ) Any पूरा दस्तावेज़ पढ़ें
2+ _For the use of a Registered Medical Practitioner only_ PRESCRIBING INFORMATION ESOZ TABLETS (Esomeprazole Magnesium Gastro Resistant 40 mg) COMPOSITION ESOZ 40 MG Each gastro-resistant tablet contains: Esomeprazole Magnesium Amorphous equivalent to Esomeprazole……..………40 mg _Inactive components:_ Sugar spheres , Hydroxyl propyl cellulose (HPC-L), Crospovidone PPXL-10, Povidone (PVP K- 30), Macrogol 400, Purified talc, Isopropyl alcohol, Hypromellose phthalate(HP-55S), Hypromellose phthalate(HP-50), Diethylphalate, Acetone, Macrogol 6000, Methylene chloride, Microcrystalline cellulose PH101, Microcrystalline cellulose PH112, Sodium stearyl fumerate Macrogol 4000, and Opadry 03B86651 brown(HPMC 2910/Hypromellose 6cP,Tiatanium dioxide,Macrogol/PEG 400,Talc, Iron oxide red) PRODUCT DESCRIPTION ESOZ 40 MG: Light brick red to brown colored, oval, biconvex, film coated tablets with ‘E6’ debossed on one side and plain on other side. DESCRIPTION ESOZ TABLETS contain esomeprazole magnesium. Chemically it is, (T-4)-Bis[5-methoxy-2-[(S)- [(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazolato]magnesium , a compound that inhibits gastric acid secretion. Esomeprazole is the S-isomer of omeprazole. Its molecular formula is C 34 H 36 Mg N 6 O 6 S 2 with molecular weight of 713.12. The structural formula is: H 3 CO N - CH 3 N S O N OCH 3 Mg CH 3 2 ESOMEPRAZOLE MAGNESIUM PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES PHARMACODYNAMICS Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Both the R- and S-isomer of omeprazole have similar pharmacodynamic activity. _Site and mechanism of action_ Esomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H + K + - ATPase – the acid pump and inhibits both basal and stimulated acid पूरा दस्तावेज़ पढ़ें