ACEOMEZ esomeprazole (as magnesium) 40 mg enteric coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

esomeprazole magnesium trihydrate, Quantity: 44.528 mg

Available from:

Jubilant Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: microcrystalline cellulose; hyprolose; polysorbate 80; light magnesium oxide; macrogol 6000; macrogol 400; silicon dioxide; crospovidone; pregelatinised maize starch; iron oxide red; hypromellose phthalate; glyceryl monostearate; methacrylic acid - ethyl acrylate copolymer (1:1); povidone; purified talc; titanium dioxide; hypromellose; maize starch; sucrose

Administration route:

Oral

Units in package:

30, 7, 56, 100, 15

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ACEOMEZ 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 esomeprazole IV (available in other brands) 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

Product summary:

Visual Identification: Pink coloured, oblong, biconvex, coated tablets debossed with 40 on one side and CE on the other.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-09-22