Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium dihydrate
Medis Pharma Pty Ltd
esomeprazole magnesium dihydrate
Registered
Pharmacor Pty. Ltd. Version 01 1 PHARMACOR ESOMEPRAZOLE ESOMEPRAZOLE MAGNESIUM DIHYDRATE_ _ (ES-oh-MEP-ra-zole) - enteric coated tablets _ _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about PHARMACOR ESOMEPRAZOLE. It does not contain all the information that is known about PHARMACOR ESOMEPRAZOLE. 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 PHARMACOR ESOMEPRAZOLE 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 PHARMACOR ESOMEPRAZOLE IS USED FOR _REFLUX OESOPHAGITIS _ _ _ PHARMACOR ESOMEPRAZOLE 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. PHARMACOR ESOMEPRAZOLE is also taken to help stop reflux oesophagitis coming back or relapsing. _ _ _ _ _UPPER GASTROINTESTINAL SYMPTOMS _ _ASSOCIATED WITH NON-STEROIDAL ANTI-_ _INFLAMMATORY DRUGS (NSAIDS) _ _THERAPY _ _ _ PHARMACOR ESOMEPRAZOLE is taken to treat the symptoms of pain or discomfort, in the stomach caused by NSAIDs, a type of medicine for pain or inflammation. PHARMACOR ESOMEPRAZOLE 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 PHARMACO Aqra d-dokument sħiħ
PHARMACOR ESOMEPRAZOLE PI V3 JULY 2021 Page 1 of 30 AUSTRALIAN PRODUCT INFORMATION- PHARMACOR ESOMEPRAZOLE (ESOMEPRAZOLE (AS MAGNESIUM DIHYDRATE)) ENTERIC-COATED TABLET 1. NAME OF THE MEDICINE Esomeprazole (as magnesium dihydrate) 2. QUANTITATIVE AND QUALITATIVE COMPOSITION The PHARMACOR ESOMEPRAZOLE 20 mg and 40 mg tablet are enteric coated and contain esomeprazole (as magnesium dihydrate). PHARMACOR ESOMEPRAZOLE 20 mg tablet: Each enteric-coated tablet contains esomeprazole magnesium dihydrate 21.75 mg (equal to 20 mg esomeprazole). PHARMACOR ESOMEPRAZOLE 40 mg tablet: Each enteric-coated tablet contains esomeprazole magnesium dihydrate 43.50 mg (equal to 40 mg esomeprazole). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM PHARMACOR ESOMEPRAZOLE 20 mg tablet: light pink, elliptically shaped, biconvex, enteric coated tablet. Each enteric-coated tablet contains esomeprazole magnesium dihydrate 21.75 mg (equal to 20 mg esomeprazole). PHARMACOR ESOMEPRAZOLE 40 mg tablet: pink, elliptically shaped, biconvex, enteric-coated tablet. Each enteric-coated tablet contains esomeprazole magnesium dihydrate 43.50 mg (equal to 40 mg esomeprazole). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PHARMACOR ESOMEPRAZOLE 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. PHARMACOR ESOMEPRAZOLE PI V3 JULY 2021 Page 2 of 30 • 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 selectiv Aqra d-dokument sħiħ