Omeprazole ................................................. ................ 20 mg
- In combination with an antibiotic combination therapy, eradication of Helicobacter pylori in cases of peptic ulcer disease,
- Duodenal ulceration,
- Active gastric ulcer,
- Erosive esophagitis or ulcerative symptomatic gastroesophageal reflux disease
- Symptomatic treatment of gastroesophageal reflux with or without esophagitis, in case of resistance at a dose of 10mg per day Omépral,
- Maintenance treatment of duodenal ulcers in patients not infected with Helicobacter pylori eradication or who has not been possible,
- Maintenance treatment of reflux esophagitis, esophageal,
- Treatment of gastroduodenal lesions induced by nonsteroidal anti-inflammatory when continued anti-inflammatory is essential
- Preventive treatment of gastroduodenal injury by non-steroidal anti-inflammatory drugs in patients at risk (particularly older than 65 years, history of peptic ulcer) for which an anti-inflammatory treatment is essential.
● Children from a year: erosive esophagitis or ulcerative symptomatic gastroesophageal reflux.
- Pregnancy and lactation
- Ketoconazole, itraconazole.
WARNINGS AND PRECAUTIONS
- In gastric ulcer cases it is advisable to check the benignity of the lesion before treatment.
- In elderly patients, renal or hepatic impairment.
- Cases of diarrhea, constipation, abdominal pain, nausea / vomiting, headache and dizziness, and rash, hives or itching.
DOSAGE AND ADMINISTRATION
The capsules can be taken with food or on an empty stomach.
* Eradication of Helicobacter pylori in cases of peptic ulcer disease: are recommended the following schedules:
- Let 1 capsule of Omépral 20mg morning and evening combined with clarithromycin 500mg morning and evening and amoxicillin 1000mg morning and night, for 7 days;
- Let 1 capsule of Omépral clarithromycin 500mg 20mg associated with morning and evening or tinidazole and metronidazole 500mg morning and night, for 7 days.
This triple therapy followed by 20 mg per day of Omépral for another 3 weeks for evolutionary duodenal ulcer or an additional 3 to 5 weeks in case of active gastric ulcer.
The effectiveness of treatment depends on respecting the regimen, including taking HAART for 7 days.
- Duodenal ulceration: 1 capsule of Omépral 20mg daily for 4 weeks.
- Active gastric ulcer: 1 capsule of Omépral 20mg daily for 4-6 weeks
- Esophagitis gastroesophageal reflux disease: 1 capsule of Omépral 20mg daily for 4 weeks, with a possible second period of 4 weeks at the same dose.
* In patients with severe esophagitis, switching to 40mg Omépral in 2 doses may be offered in the absence of symptoms at a dose of 20mg per day.
- Symptomatic gastroesophageal reflux disease treatment:
The dosage is 1 capsule dosed at 10mg per day. The dosage may be increased to 20mg failure response.
The initial duration of treatment is 4 to 6 weeks. Thereafter, intermittent treatment may be administered at the time of symptomatic periods.
- Maintenance treatment of duodenal ulcer: 1 capsule of Omépral 10mg per day. The dosage should be increased to 20mg in case of inefficiency or if resistance to a maintenance treatment with H2 blockers.
- Maintenance treatment esophagitis gastroesophageal reflux:
The maximum effective dose should be sought. The dose is 10 to 20mg per day, depending on the adapted response symptomatic and / or endoscopy.
In severe esophagitis, a starting dose of 20mg is recommended.
- Zollinger-Ellison syndrome: The recommended starting dose is 60mg of Omépral once a day. It should be individually adjusted and treatment continued as long as clinically indicated.
For higher than 80mg per day dosage, the daily dose should be divided and given in 2 doses.
- Treatment of gastroduodenal lesion induced by nonsteroidal anti-inflammatory drugs: 1 capsule Omépral of 20mg per day for 4-8 weeks.
- Preventive treatment of gastroduodenal lesions induced by nonsteroidal anti-inflammatory:
1 capsule of 20mg per day Omépral
Child: esophagitis gastroesophageal reflux: 1 mg / kg / day for 4-8 weeks, which is:
- Children from 10 to 20kg: 1 capsule of Omépral 10mg per day. If necessary, this dose may be increased up to 20mg per day;
- Children over 20kg: 1 capsule of Omépral 20mg per day.
In children under 6 years and children who can not swallow capsules, they must be opened and mixed with a slightly acidic food such as yoghurt, Orange juice, applesauce.
Store at a temperature below 30 ° C
Registration no.: 08L-418