Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
esomeprazole magnesium, Quantity: 20.7 mg (Equivalent: esomeprazole, Qty 20 mg)
Sun Pharma ANZ Pty Ltd
Esomeprazole magnesium
Tablet, enteric coated
Excipient Ingredients: hyprolose; sodium stearylfumarate; hypromellose phthalate; macrogol 6000; diethyl phthalate; crospovidone; macrogol 400; microcrystalline cellulose; povidone; macrogol 4000; purified talc; titanium dioxide; hypromellose; iron oxide red; maize starch; sucrose
Oral
10, 30, 28, 7
(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 esomeprazole solution administered 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: Light brick red to brown, oval, biconvex, film-coated tablets with 'E5' debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-02-09
ESOMEPRAZOLE RBX TABLETS ESOMEPRAZOLE MAGNESIUM _CONSUMER MEDICINE _ _INFORMATION _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ESOMEPRAZOLE RBX. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ESOMEPRAZOLE RBX against the benefits it is expected to 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 RBX IS USED FOR _ _ _REFLUX OESOPHAGITIS _ ESOMEPRAZOLE RBX 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 RBX 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 RBX 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 RBX 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 RBX with antibiotics. When ESOMEPRAZOLE RBX and antibiotics are taken together, they work to kill the bacterium and let your ulcer heal. You may need further treatment with antibiotics. _ZOLLINGER-ELLISON SYN Soma hati kamili
Page 3 of 28 AUSTRALIAN PRODUCT INFORMATION ESOMEPRAZOLE RBX ESOMEPRAZOLE (AS MAGNESIUM) ENTERIC-COATED TABLETS 1 NAME OF THE MEDICINE Esomeprazole magnesium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Esomeprazole is a proton pump inhibitor. The active ingredient in ESOMEPRAZOLE RBX is esomeprazole magnesium, a substituted benzimidazole. Each enteric-coated tablet of ESOMEPRAZOLE RBX comprises enteric-coated pellets with esomeprazole magnesium equivalent to esomeprazole 20 mg or 40 mg. Contains excipient of known effect: sucrose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM ESOMEPRAZOLE RBX esomeprazole (as magnesium) 20 mg tablets are light brick red to brown, oval, biconvex, enteric-coated tablets with ‘E5’ debossed on one side and plain on other side. ESOMEPRAZOLE RBX esomeprazole (as magnesium) 40 mg tablets are light brick red to brown, oval, biconvex, enteric-coated tablets with ‘E6’ debossed on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ESOMEPRAZOLE RBX 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. Page 3 of 28 PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING TREATMENT WITH ESOMEPRAZOLE SOLUTION ADMINISTERED BY INTRAVENOUS INFUSION. PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISO Soma hati kamili