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Normon S.A. - Sapin

ANASTROZOLE NORMON
BISOPROLOL NORMON
DESLORATIDINE NORMON
ESCITALOPRAM NORMON
ESOMEPRAZOLE NORMON
ESTECINA Inj.
ESTECINA Tablets
FIXIM
GASTRIMUT
LAMOTRIGINE NORMON
LETROZOLE NORMON
LEVOFLOXACIN NORMON
LIDOCAINE 2% EPINEPHRINE NORMON
NORMOCEF
NORMOPRIL
PARACETAMOL NORMON
SIMVASTATIN NORMON
TOPAGAN

Forms and presentation
Capsules: Box of 14.

Composition
Each capsule contains: Omeprazole: 20 mg.

Properties
Omeprazole is a specific proton pump inhibitor of the gastric parietal cell. This mechanism of action prevents secretion of gastric acid. Its action is rapid and produces a reversibly blockage in the acid secretion at once daily dose.

Indications
Duodenal ulcer. Gastric ulcer. Gastro-oesophagitis reflux. Zollinge-Ellison syndrome.

Contraindications
Lactation: Since no studies of secretion in human milk.

Drug interactions
Diazepam, phenytoin and warfarin (drug metabolised by the hepatic oxidation): Omeprazole may decrease their excretion. It is recommended to decrease the dosage of Omeprazole in patients treated with these products.
Theophylline: There is no interaction with theophylline.

Pregnancy and lactation
Pregnancy: In pregnant women, safety of Omeprazole was not established, therefore studies in animals reported no tetatogenicity or foetal toxicity.

Side effects
Omeprazole is generally well-tolerated. Adverse events like nausea, headache, diarrhea, constipation and flatulence are remotely related. Some patients reported rash. These adverse events were mild, temporary and no related with the treatment.

Dosage and administration
Initial treatment:
Duodenal ulcer: 1 capsule daily for 4 weeks.
Gastric ulcer: 1 capsule daily for 4-6 weeks.
Zollinger-Ellison syndrome: The initial recommended dosage is 60 mg Omeprazole, once daily. The dosage should be adjusted individually. and treatment must be continued as long as necessary. Doses above 80 mg daily, the daily dosage should be divided and administered in 2 intakes.
Gastro-oesophagitis reflux: 1 capsule daily for 4 weeks. Patients that reported no improvement needed an additional treatment of 4 weeks of treatment with the same dosage.
Maintenance treatment: 1 capsule daily is recommended in patients with severe gastro-oesophagitis reflux in order to avoid recidivism. In this case, the dose should be increased up to 2 capsules once daily.
Children: There is no experience with Omeprazole in children, so the treatment is not recommended.
Old people: There is not needed a dosage adjustment in aged patients.
Patients with impaired renal and/or hepatic dysfunction: It is not necessary to adjust the dosage in patients with altered renal or hepatic function.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Number & Year of Registration: 261060/1997