País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium dihydrate, Quantity: 43.37 mg
Medis Pharma Pty Ltd
esomeprazole magnesium dihydrate
Capsule, enteric
Excipient Ingredients: maize starch; dimeticone 350; Gelatin; purified water; hypromellose; sucrose; methacrylic acid - ethyl acrylate copolymer (1:1); titanium dioxide; polysorbate 80; triethyl citrate; purified talc; iron oxide yellow; diacetylated monoglycerides; mannitol; stearoyl macrogolglycerides; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
30 or 98 capsules
(S4) Prescription Only Medicine
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 hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion,In combination with appropriate antibiotics for:,? healing of duodenal ulcer associated with Helicobacter pylori,? eradication of Helicobacter pylori in patients with active or healed peptic ulcer
Visual Identification: 40 mg capsule, hard, size 3 capsules, opaque yellow cap and body printed with a black inscription '40 mg' on the cap and body.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-03-21
Version 01 1 ESOMEPRAZOLE ACTAVIS_ _ 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 ACTAVIS. It does not contain all the information that is known about ESOMEPRAZOLE ACTAVIS. 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 ACTAVIS 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 ACTAVIS IS USED FOR _REFLUX OESOPHAGITIS _ _ _ ESOMEPRAZOLE ACTAVIS 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 ACTAVIS 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 ACTAVIS 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 ACTAVIS 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 ACTAVIS with antibiotics. When ESOMEPRAZOLE ACT Llegiu el document complet
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 Llegiu el document complet