TERRY WHITE CHEMISTS ESOMEPRAZOLE esomeprazole (as magnesium dihydrate) 40mg tablet enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

esomeprazole magnesium dihydrate, Quantity: 43.5 mg (Equivalent: esomeprazole, Qty 40 mg)

Available from:

Medis Pharma Pty Ltd

INN (International Name):

esomeprazole magnesium dihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: triethyl citrate; hypromellose; microcrystalline cellulose; purified talc; sodium stearylfumarate; glyceryl monostearate; polysorbate 80; hyprolose; crospovidone; magnesium stearate; methacrylic acid - ethyl acrylate copolymer (1:1); povidone; macrogol 6000; titanium dioxide; macrogol 400; iron oxide red; iron oxide yellow; maize starch; sucrose

Administration route:

Oral

Units in package:

30, 100, 14, 7

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

It is indicated for:,Gastro-Oesophageal Reflux Disease (GORD): treatment of erosive reflux oesophagitis, long-term management of patients with healed oesophagitis to prevent relapse and 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 and 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 (intravenous dosage form can be available from other brands).,Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion, in combination with appropriate antibiotics for: healing of duodenal ulcer associated with Helicobacter pylori and eradication of Helicobacter pylori in patients with active or healed peptic ulcer.

Product summary:

Visual Identification: elliptically shaped, biconvex, pink enteric coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-07-30