REFEXXIN esomeprazole (as magnesium trihydrate) 20 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esomeprazole magnesium trihydrate, Quantity: 22.3 mg (Equivalent: esomeprazole, Qty 20 mg)

Available from:

AstraZeneca Pty Ltd

INN (International Name):

esomeprazole magnesium trihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: purified talc; glyceryl monostearate; iron oxide yellow; hypromellose; microcrystalline cellulose; methacrylic acid copolymer; synthetic paraffin; iron oxide red; triethyl citrate; macrogol 6000; polysorbate 80; crospovidone; titanium dioxide; magnesium stearate; hyprolose; sodium stearylfumarate; maize starch; sucrose

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

REFEXXIN 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 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: A light pink, oblong, biconvex, film-coated tablet with '20mg' on one side and 'A/EH' on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-06-20