Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
PAHANG PHARMACY SDN. BHD.
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
14capsule Capsules; 28capsule Capsules
KRKA, d.d., Novo mesto
EMANERA Esomeprazole gastro-resistant capsules, hard (20 mg and 40 mg) _ _ 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Emanera _is used for 2. How _Emanera_ works 3. Before you use _Emanera_ 4. How to use _Emanera_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Emanera_ Product Description 8. Manufacturer and Product Registration Holder 9. Date of revision WHAT _EMANERA_ IS USED FOR _Emanera_ is used to treat the following conditions: - "Gastro-oesophageal reflux disease" (GORD). 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 (acid indigestion with a burning sensation in the chest). - 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). Emanera 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 _EMANERA_ WORKS _Emanera_ 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 _EMANERA _ - _When you must not use it _ If you are allergic (hypersensitive) to esomeprazol or any of the other ingredients of _Emanera_. If you are allergic to other proton pump inhibitor medicines. If you are taking atazanavir (a medicine used to treat HIV). Do not take _Emanera_ if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking _Emanera_. _ _ - _Before you start use it _ Izlasiet visu dokumentu
1.3.1 Esomeprazole SPC, Labeling and Package Leaflet MY SmPCPIL163312_1 16.02.2021 – Updated: 16.02.2021 Page 1 of 12 EMANERA 20 MG GASTRO-RESISTANT CAPSULES, HARD EMANERA 40 MG GASTRO-RESISTANT CAPSULES, HARD COMPOSITION Each gastro-resistant capsule, hard, contains 20 mg esomeprazole (as esomeprazole magnesium dihydrate). Each gastro-resistant capsule, hard, contains 40 mg esomeprazole (as esomeprazole magnesium dihydrate). Excipient with known effect: 20 mg gastro-resistant capsule, hard 40 mg gastro-resistant capsule, hard sucrose 28.46–32.56 mg 56.93–65.11 mg PRODUCT DESCRIPTION 20 mg: the body and the cap are slightly pink; the capsules are filled with white to almost white pellets. Capsule size no. 3. 40 mg: the body and the cap are off-pink; the capsules are filled with white to almost white pellets. Capsule size no. 1. THERAPEUTIC INDICATIONS Emanera capsules are indicated for: GASTROESOPHAGEAL REFLUX DISEASE (GERD) - treatment of erosive reflux esophagitis - long-term management of patients with healed esophagitis to prevent relapse - symptomatic treatment of gastroesophageal reflux disease (GERD) IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMENS FOR THE ERADICATION OF _HELICOBACTER PYLORI _AND - healing of _Helicobacter pylori _associated duodenal ulcer and - prevention of relapse of peptic ulcers in patients with _Helicobacter pylori _associated ulcers PATIENTS REQUIRING CONTINUED NSAID THERAPY - Healing of gastric ulcers associated with NSAID therapy. - Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk. PROLONGED TREATMENT AFTER IV INDUCED PREVENTION OF REBLEEDING OF PEPTIC ULCERS. TREATMENT OF ZOLLINGER ELLISON SYNDROME POSOLOGY AND METHOD OF ADMINISTRATION The capsules should be swallowed whole with some water. The capsules should not be chewed or crushed. For patients who have difficulty in swallowing, the capsules can also be opened and the pellets mixed in half a glass of non-carbonated water. No other liquids should be used as th Izlasiet visu dokumentu