PANTOPRAZOLE MYLAN pantoprazole 20mg (as sodium sesquihydrate) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate, Quantity: 22.55 mg (Equivalent: pantoprazole, Qty 20 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: triethyl citrate; microcrystalline cellulose; magnesium stearate; lactose monohydrate; purified talc; colloidal anhydrous silica; croscarmellose sodium; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; iron oxide yellow; polyvinyl alcohol; quinoline yellow aluminium lake; macrogol 3350

Administration route:

Oral

Units in package:

30 tablets, 5 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. Symptomatic improvement and healing of the following gastrointestinal diseases which require a reduction in acid secretion: Duodenal ulcer; Gastric ulcer; Gastroesophageal reflux disease (GORD): - Symptomatic GORD.The treatment of heartburn and other symptoms associated with GORD; - Reflux oesophagitis; Gastrointestinal lesions refractory to H2-blockers; Zollinger-Ellison syndrome; Patients whose gastric or duodenal ulceration is not associated with ingestion of NSAIDs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with nonselective NSAIDs in increased risk patients with a need for continuous nonselective NSAID treatment.

Product summary:

Visual Identification: Yellow to ocher, elongated coated tablet; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2009-06-30