Omeprex

Omeprex®

Omeprazole 20 mg

Capsules for oral use

Product leaflet summary

Therapeutic Indications

Adults

  • Treatment of duodenal ulcers
  • Prevention of relapse of duodenal ulcers
  • Treatment of gastric ulcers
  • Prevention of relapse of gastric ulcers
  • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication of peptic ulcer disease
  • Treatment of NSAID-associated gastric and duodenal ulcers
  • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
  • Treatment of reflux esophagitis
  • Long-term management of patients with healed reflux esophagitis
  • Treatment of symptomatic gastro-esophageal reflux disease
  • Treatment of Zollinger-Ellison syndrome

Pediatric

Children over 1 year of age and 10 kg

  • Treatment of reflux esophagitis.
  • Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease

Children and adolescents over 4 years of age

  • In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori

 

Dosage and Administration

The recommended dose in patients with an active duodenal ulcer is Omeprex 20 mg once daily.

In patients with poorly responsive duodenal ulcer Omeprex 40 mg once daily is recommended and healing is usually achieved within four weeks.

 

Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients.

Omeprazole like other proton pump inhibitors (PPIs) must not be used concomitantly with nelfinavir.

 

Pregnancy and Lactation

Pregnancy:

Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse effects of omeprazole during pregnancy or on the health of the fetus/newborn child. Omeprazole is class c product in pregnancy

Lactation:

Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.

 

Ability to drive and use machinery

Omeprex is not likely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machinery.

 

Package Presentation:

1- A box of 14 capsules each contains 20 mg omeprazole.

2- A box of 28 capsules each contains 20 mg omeprazole.