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Lanzul

COMPOSITION
Each gastro-resistant capsule contains 30 mg of lansoprazole.

DESCRIPTION
Capsules, filled with a white to light brown or slightly pink coloured pellets. The body and the cap of the capsules are white. The pellets are covered with a gastro-resistant coating.

CLINICAL PARTICULARS
Therapeutic indications
Treatment of duodenal or gastric ulcers, verified by endoscopy or radiography.
Treatment of reflux oesophagitis.
Zollinger-Ellison syndrome.

Posology and method of administration
The capsules are swallowed whole with liquid. The capsules may be emptied, but the contents may not be chewed or ground.

Concomitant intake food slows down and reduces the absorption of lansoprazole. This medicine has the best effect when taken on an empty stomach. To achieve the optimal acid inhibitory effect, and hence most rapid healing and symptom relief, lansoprazole should be administered in the morning before food intake. When twice-daily dosage is needed the second dose should be administered in the evening before food intake.

Duodenal ulcer:
The recommended dose is 30 mg once daily for 2 weeks. In patients not fully healed within this time, the medication should be continued at the same dose for another 2 weeks.

Gastric ulcer:
The recommended dose is 30 mg once daily for 4 weeks. The ulcer usually heals within 4 weeks. In patients not fully healed within this time, the medication should be continued at the same dose for another 4 weeks.

Treatment of reflux oesophagitis:
The recommended dose is 30 mg once daily for 4 weeks. In patients not fully healed within this time, the treatment may be continued at the same dose for another 4 weeks.

Zollinger-Ellison syndrome:
The recommended initial dose is 60 mg once daily. The dose should be individually adjusted and treatment should be continued for as long as necessary. Daily doses for up to 180 mg have been used. If the required daily dose exceeds 120 mg, it should be given in two divided doses.

Hepatic and renal insufficiency:
There is no need to change the dose in patients with impaired renal function. However, the normal daily dose of 30 mg should not be exceeded in these patients. Care should be exercised in the administration of lansoprazole in patients with mildly to moderately impaired hepatic function. In mildly impaired patients, the dose should not exceed 30 mg. In patients with moderately impaired hepatic function, the dose should be restricted to 15 mg daily. Due to the lack of data in patients with severely impaired hepatic function, lansoprazole is not recommended in these patients.

Children:
Lansoprazole in not recommended in children as safety and efficacy have not been established in this population.

Elderly:
Due to delayed elimination of lansoprazole in the elderly it may be necessary to administer the treatment in doses of 15-30 mg adjusted to individual requirements. However, the daily dose in the elderly should not exceed 30 mg.

Contraindications
Hypersensitivity to lansoprazole or to any of the excipients.

Special warnings and special precautions for use
The diagnosis of gastroduodenal ulcers and reflux oesophagitis should be confirmed by endoscopy or other appropriate diagnostic means. Reflux oesophagitis may not present as ulceration and/or visual damage, therefore in certain cases endoscopy alone may not be sufficient.

The possibility of malign gastric tumour should be excluded before initiating treatment of gastric ulcers with lansoprazole because lansoprazole can mask the symptoms and delay the diagnosis. Capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Lansoprazole should be used with caution in patients with hepatic dysfunction (see Posology and Method of Administration).

Lansoprazole has a similar mechanism of action to omeprazole and both increase gastric pH. The following statement is made by analogy to omeprazole. Decreased gastric acidity due to lansoprazole might be expected to increase gastric counts of bacteria normally present in the gastrointestinal tract.

Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

In patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.

If lansoprazole, in combination with antibiotics, is used for eradication therapy of H. pylori, then also instructions for the use of these antibiotics should also be followed.

Because of limited safety data for patients on maintenance treatment for longer than one year, regular review of the treatment and a thorough benefit-risk assessment should regularly be performed in these patients.

If visual disturbances occur during long-term use (>1 year), an ophthalmologist should be consulted.

Lansoprazole is not recommended in children as safety and efficacy have not been established in this population.

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