Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium
Lupin Australia Pty Limited
Esomeprazole magnesium
Registered
Esomeprazole GH CMI v2 Sep2017 Page 1 of 5 CONSUMER MEDICINE INFORMATION ESOMEPRAZOLE GH esomeprazole What is in this leaflet This leaflet answers some of the common questions people ask about Esomeprazole GH enteric- coated tablet. It does not contain all the information that is known about Esomeprazole GH enteric- coated tablet. 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 GH enteric-coated tablet 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 GH is used for Reflux Oesophagitis Esomeprazole GH enteric- coated tablet 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 GH enteric- coated tablet 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 GH enteric- coated tablet 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 GH enteric- coated tablet 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 GH enteric- c Прочитајте комплетан документ
AUSTRALIAN PI - ESOMEPRAZOLE GH (ESOMEPRAZOLE MAGNESIUM) ENTERIC-COATED TABLETS 1 NAME OF THE MEDICINE Esomeprazole magnesium. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Esomeprazole GH (esomeprazole enteric-coated 20 mg and 40 mg tablets) is comprised of enteric- coated pellets containing esomeprazole (as magnesium amorphous). The tablets contain the following inactive ingredients: Sugar Spheres (non-pareil seeds 40-50), hydroxypropylcellulose, crospovidone, sucrose, maize starch, magnesium oxide-light, purified talc, macrogol 6000, Methacrylic acid- ethyl acrylate copolymer (1:1), glycerol monostearate (40-55), macrogol 400, polysorbate 80, hypromellose phthalate, microcrystalline cellulose, povidone, pregelatinised maize starch, silicon dioxide. The 20 mg and 40 mg tablets are coloured with titanium dioxide, iron oxide red, and 20mg tablet also contain iron oxide yellow. 3 PHARMACEUTICAL FORM ESOMEPRAZOLE GH 20 MG: Light pink coloured, oblong, biconvex, coated tablets debossed with '20' on one side and ‘CE’ on the other. ESOMEPRAZOLE GH 40 MG: Pink coloured, oblong, biconvex, coated tablets debossed with '40' on one side and ‘CE’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Esomeprazole GH (esomeprazole enteric-coated 20 mg and 40 mg tablet) is indicated for: • GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD): o treatment of erosive reflux oesophagitis. o long-term management of patients with healed oesophagitis to prevent relapse. o symptomatic treatment of gastro-oesophageal reflux disease (GORD). • PATIENTS REQUIRING NSAID THERAPY: o short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy. o healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non- Esomeprazole GH PI v3 Page 2 of 32 selective and COX-2 selective) therapy. o prevention of gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug NSAID (non-selective and COX Прочитајте комплетан документ