国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium dihydrate
Medis Pharma Pty Ltd
esomeprazole magnesium dihydrate
Registered
Version 01 1 ESOMEPRAZOLE AMNEAL_ _ ESOMEPRAZOLE MAGNESIUM DIHYDRATE_ _ (ES-oh-MEP-ra-zole) enteric capsules _ _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about ESOMEPRAZOLE AMNEAL. It does not contain all the information that is known about ESOMEPRAZOLE AMNEAL. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking ESOMEPRAZOLE AMNEAL against the benefits they expect it will 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 ESOMEPRAZOLE AMNEAL IS USED FOR _REFLUX OESOPHAGITIS _ _ _ ESOMEPRAZOLE AMNEAL is taken to treat reflux oesophagitis. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe (oesophagus). Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. ESOMEPRAZOLE AMNEAL is also taken to help stop reflux oesophagitis coming back or relapsing. _ _ _UPPER GASTROINTESTINAL SYMPTOMS _ _ASSOCIATED WITH NON-STEROIDAL ANTI-_ _INFLAMMATORY DRUGS (NSAIDS) _ _THERAPY _ _ _ ESOMEPRAZOLE AMNEAL is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation. ESOMEPRAZOLE AMNEAL is also taken to help heal and prevent ulcers caused by NSAIDs. _PEPTIC ULCERS ASSOCIATED _ _WITH HELICOBACTER PYLORI _ _INFECTION _ _ _ Most people who have a peptic (gastric and duodenal) ulcer also have a bacterium called Helicobacter pylori in their stomach. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out from the stomach. If you have a peptic ulcer, your doctor will prescribe ESOMEPRAZOLE AMNEAL with antibiotics. When ESOMEPRAZOLE AMNEAL and an 阅读完整的文件
AUSTRALIAN PRODUCT INFORMATION - ESOMEPRAZOLE AMNEAL (ESOMEPRAZOLE (AS MAGNESIUM DIHYDRATE)) 20MG AND 40MG ENTERIC CAPSULES 1. NAME OF THE MEDICINE Esomeprazole (as magnesium dihydrate) 2. QUANTITATIVE AND QUALITATIVE COMPOSITION ESOMEPRAZOLE AMNEAL 20 mg and 40 mg capsules contain enteric coated granules which contain esomeprazole (as magnesium dihydrate). Excipients of known effect: propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218) and sodium benzoate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM ESOMEPRAZOLE AMNEAL 20 mg gastro-resistant hard capsules, are size 4 capsules containing off-white to greyish spherical microgranules. The capsules have opaque yellow cap and opaque white body printed with a black inscription “20 mg” on the cap and on the body. ESOMEPRAZOLE AMNEAL 40 mg gastro-resistant hard capsules, are size 3 capsules containing off-white to greyish spherical microgranules. The capsules have opaque yellow cap and body printed with a black inscription “40 mg” on the cap and on the body. 4. CLINICAL PARTICULARS 4.1 INDICATIONS ESOMEPRAZOLE AMNEAL is indicated for: GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) treatment of erosive reflux oesophagitis long-term management of patients with healed oesophagitis to prevent relapse symptomatic treatment of gastro-oesophageal reflux disease (GORD) PATIENTS REQUIRING NSAID THERAPY short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti- inflammatory drug NSAID (non-selective and COX-2 selective) therapy. healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non- selective and COX-2 selective) therapy prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk. PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING TREATMENT WITH IV ESOMEPRAZOLE SOLUTION BY INTRAVENOUS INFUSION. PATHOLOGICAL HYP 阅读完整的文件