Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
CIPLA MALAYSIA SDN BHD
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
3x10 Tablets
CIPLA LTD
ESOMAC GASTRO RESISTANT TABLETS CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) ESOMEPRAZOLE (20MG, 40MG) ___________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What ESOMAC is used for 2. How ESOMAC works 3. Before you use ESOMAC 4. How to use ESOMAC 5. While you are using it 6. Side effects 7. Storage and disposal of ESOMAC 8. Product description 9. Manufacturer and product holder 10. Date revision 11. Serial number WHAT ESOMAC IS USED FOR • ‘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. • Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called ‘ _Helicobacter pylori’_ . If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. • Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti- Inflammatory Drugs). Esomeprazole can also be used to stop stomach ulcers from forming if you are taking NSAIDs. • Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole. • Too much acid in the stomach caused by a growth in the pancreas (Zollinger- Ellison syndrome). HOW ESOMAC WORKS ESOMAC contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. BEFORE YOU USE ESOMAC _-When you must not use it _ • If you are allergic to esomeprazole or any of the other ingredients of this medicine. • If you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole). • If you are taking a medicine containing nelfinavir (used to treat HIV). _ _ _-Before you start to use it _ Talk to your doctor or pharmacist before taking esomeprazole tablets: • If you have severe liver problems. • If Izlasiet visu dokumentu
FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY ONLY OR FOR SPECIALIST USE ONLY ESOMAC-20 GASTRO RESISTANT TABLETS 20MG ESOMAC-40 GASTRO RESISTANT TABLETS 40MG COMPOSITION ESOMAC-20 Each film coated tablets contains: Esomeprazole Magnesium Dihydrate equivalent to Esomeprazole …………….20 mg (As enteric coated pellets) Colour: Iron oxide red and Titanium dioxide ESOMAC-40 Each film coated tablets contains: Esomeprazole Magnesium Dihydrate equivalent to Esomeprazole ……………. 40 mg (As enteric coated pellets) Colour: Iron oxide red, Iron oxide black, Titanium dioxide & Erythrosine DOSAGE FORM Gastro resistant Tablets PRODUCT DESCRIPTION 20 mg: Pink, coloured capsule shaped, Biconvex, Film coated tablets, debossed “20” on one side and plain on other side. 40 mg: Pink, coloured capsule shaped, Biconvex, Film coated tablets, debossed “40” on one side and plain on other side PHARMACOLOGY _PHARMACODYNAMICS_ PHARMACOTHERAPEUTIC GROUP: Drugs for acid-related disorders proton pump inhibitors. ATC CODE: A02B C05 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. 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 secretion. PHARMACODYNAMIC EFFECTS After oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one hour. After repeated administration with 20 mg esomeprazole once daily for five days, mean peak acid output after pentagastrin stimulation is decreased 90% when measured 6–7 hours after dosing on day five. After five days of oral dosing with 20 mg and 40 mg of esomeprazole, intragas Izlasiet visu dokumentu