Each gastro-resistant capsule contains 30 mg of lansoprazole.
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.
• Treatment of duodenal or gastric ulcers, verified by endoscopy or
• 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.
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.
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.
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
Lansoprazole in not recommended in children as safety and efficacy have not
been established in this population.
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.
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
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.