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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lansoprazole TEVA 15 mg Gastro-resistant Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gastro-resistant capsule, hard contains 15 mg of lansoprazole.
_Excipients:_
One gastro-resistant capsule, hard contains 83 mg of sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
A hard gelatin size 3 capsule with a light blue opaque cap and flesh opaque body, filled with granules.
Body and cap imprinting:
93
7350
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Long-term prophylaxis of reflux oesophagitis
- Prophylaxis of NSAID-associated gastric and duodenal ulcer in patients at risk requiring continuous NSAID
treatment
The 15 mg strength should be used for the above indications
- Treatment of reflux oesophagitis
- Treatment of duodenal and gastric ulcer
- Eradication of _Helicobacter pylori _concurrently given with appropriate antibiotic therapy and prevention of relapse
of peptic ulcers in patients with _H. pylori_-associated ulcers
- Zollinger-Ellison syndrome
-
Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continuous NSAID
treatment
The 30 mg strength should be used for the above indications with few exceptions (see 4.2 and impaired hepatic
function)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prophylaxis of reflux oesophagitis:
15 mg once daily. The dose may be increased up to 30 mg daily as necessary.
Prophylaxis of NSAID-associated gastric and duodenal ulcers in patients requiring continuous NSAID treatment:
15 mg once daily. If the treatment fails the dose 30 mg once daily should be used.
Symptomatic gastro-oesophageal reflux disease:
The recommended dose is 15 mg or 30 mg once daily. Relief of symptoms is obtai
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