OMEPRAL®

(Omeprazole 20 mg)

 

What you should know about OMEPRAL®

Each capsule of OMEPRAL® contains pellets of omeprazole 20 mg.

OMEPRAL® belongs to the anti ulcer drugs / the Proton Pump inhibtors. It reduces gastric acid secretion by inhibiting the enzyme H+/K+ ATP ase, the proton pump.

After oral once daily administration, OMEPRAL® provides rapid and effective inhibition of daytime and nighttime gastric acid secretion with maximum effect being achieved within 4 days of treatment.

When to use OMEPRAL®

OMEPRAL® is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat gastric and duodenal ulcers and gastroesophageal reflux disease, a condition in which the acid in the stomach washes back up into the esophagus.

OMEPRAL® is indicated in combination use with two-drug antibiotic therapy for eradication of Helicobacter pylori bacteria in case of gastroduodenal ulcer disease.

OMEPRAL® is also used to treat Zollinger-Ellison disease, a condition in which the stomach produces too much acid.

How to take OMEPRAL®

Take OMEPRAL® exactly as prescribed by your doctor.

The daily dose is usually taken in the morning.

 

Indication	Recommended dose	Duration of treatment
Duodenal ulcer	1 capsule once daily	4 weeks
Gastric ulcer	1 capsule once daily	4 to 6 weeks
Gastroesophageal reflux disease	1 capsule once daily	4 to 8 weeks
Eradication of Helicobacter pylori in the case of gastroduodenal ulcer disease	1 capsule morning and 1 capsule in the evening, + Clarithromycin 500 mg morning and evening + Amoxicillin 1000 mg or Metronidazole 500 mg morning and evening	7 days this 3- drug therapy will be followed by 1 capsule of OMEPRAL® for 3 additional weeks in case of active duodenal ulcer and 3 to 5 weeks in case of gastric ulcer
NSAID associated gastric ulcers, duodenal ulcers, gastroduodenal erosions	1 capsule once daily	4 to 8 weeks
Zollinger Ellison disease	3 capsules once daily	Duration decided by your doctor.

 

No dosage adjustment is necessary for patients with renal impairment, hepatic dysfunction or for elderly.

What to do in case of missed dose

Take the missed dose as soon as you remember, unless the next intake is near.

Go on taking OMEPRAL® in the dose your doctor recommended.

What to do in case of overdose

In case of intake of high doses of this medication, inform your doctor.

General measures should be adopted.

When not to use this medication

Do not use this medication in case of hypersensitivity to any component of this medication.

Precautions when taking this medication

-          Tell your doctor if you have ever had any unusual or allergic reaction to omeprazole.

-          This medication should be used only if clearly needed during pregnancy, discuss the risks and the benefits with your doctor.

-          Because of the potential for adverse effects for the infant, breast-feeding is not recommended while taking omeprazole.

-          Do not use for children since safety and effectiveness have not been established.

What kind of side effects may occur

This drug is usually well tolerated.

Rarely were reported the following side effects: abdominal pain, flatulence, constipation, diarrhea, vomiting and headache. If these effects persist or become bothersome, inform your doctor. Very rare cases of rash, urticaria, pruritis, reversible mental confusion, agitation, depression and hallucination in elderly or in patients with severe hepatic impairment were reported. Isolated cases of thrombocytopenia, pancytopenia, neutropenia and reversible changes in liver enzymes were mentioned.

What to do if OMEPRAL® is taken with other medications

Please notify your doctor at all events if other medicines, beside OMEPRAL®, are being taken or have been taken recently.

Omeprazole may interfere with warfarin, phenitoin, diazepam, ketoconazole and digoxin.

No interaction with propranolol, theophylline, metoprolol, lidocaine, quinidine or cyclosporin was found. When taken with clarithromycin, both plasmatic concentrations are increased.

How to store OMEPRAL®

Store in a cool dry place (25°C) protected from sunlight and excessive heat, beyond the reach of children.

The expiry date is printed on the pack, don’t use this medicine after this date.

Pack presentation

OMEPRAL® Omeprazole 20 mg, pack of 14 capsules.

N.B: OMEPRAL® capsules contains Omeprazole pellets supplied by Ethypharm – France, a leading and innovative company in drug delivery systems.

OMEPRAL® is manufactured under technical assistance from Ethypharm.

OMEPRAL® (Omeprazole pellets) has the United States patent for the stable composition of gastroprotected Omeprazole microgranules and for the production process.

Leaflet revised in May 2002.