Oilatum Emollient                                       

Ulcesep Omeprazole

Properties

The Omeprazole acts by inhibiting the hidrogenion bomb in the gastric parietal cell. This way reduces the secretion of gastric acid through a mechanism of new action. Acts rapidly and produces a reversible control of the acid secretion of the stomach with only one daily dose.

Each capsule has:
Omeprazole (D.C.I) Active Ingredient		20mg
Lactose		8 mg
Manitol, Ftalato metilhidroxipropil celulosa, Lactosa anhidra, Metil hidroxipropil celulosa, Hidroxipropil celulosa, Celulosa microcristalina, Alcohol cetílico, Fosfato disódico, Lauril sulfato sódico.		c.s

• Short term treatment of duodenal ulcer

• Zollinger-Ellison Syndrome

Duodenal Ulcer:
The recommended dose is 20 mg. (1 capsule) once a day.  In most patients with duodenal ulcer a quick relieve of the symptoms and the healing is achieved during the first two weeks of treatment.  The patients, whose ulcers could not heal completely after this initial cycle, usually show the healing after and additional period of two weeks.

In patients with duodenal ulcer refractory to other treatment patterns, it was used a 40 mg. dose (2 capsules) once a day, and usually, the healing in a period of four weeks was achieved.

Due to the fact that the experience in prolonged treatments is limited, it is not recommended the maintenance treatment until more data is achieved.

Zollinger Ellison syndrome:
Initially, the recommended dose is of 60 mg. (3 capsules) per day.  This dose must be adjusted individually and the treatment must continue as is clinically indicated.  More than 90% of patients with severe illness and inadequate response to other treatments has been efficiently controlled with daily doses of 20 mg. to 120 mg.  If the dose goes over 80 mg. daily, must be divided and administered in two daily doses, one every 12 hours.

Children: There is no experience in pediatric, therefore this product is not recommended in children.

Elderly: In elderly patients, it is not necessary to adjust the dose.

Renal and hepatic altered function: In patients with a deterioration in the hepatic or renal function, it is not necessary to adjust dose.

This has not been found

Using during the pregnancy or lactation: as it happens with all new medicines, Omeprazole should not be administered during the pregnancy and lactation, unless its use is considered essential.  The studies done with animals has not shown evidence of fetal toxicity or teratogenic effect.

This specialty has lactose.  It has been described cases of intolerance to this component in children and adolescents.  Even if the present quantity  in the preparation is not enough to start the intolerance symptoms, in case of appearance of diarrhea a doctor should be consulted.

Omeprazole could delay the elimination of diazepam and  fenitoine, drugs that are metabolized by oxidation in the liver by the P450 citocrome.  It is recommended to closely observe the patients treated simultaneously with fenitoine, making necessary a reduction in its anti-convulsive dose.

There has not been reported interactions with teofiline.  However, there could be interactions with other drugs that are metabolized also by this metabolization system, as for example warfarine.

There has been no interactions with anti-acids administered simultaneously.

Omeprazole is well tolerated. Rarely has it been any reported case of nausea, headache, diarrhea, constipation and flatulence.

In some patients cases of skin eruptions have been reported. Usually these symptoms were light and through a short time, there was no definitive relation with treatment.

There is not available data about intoxication in men and therefore there is not specific recommendations for its treatment.  Oral unique doses of up to 160 mg and i.v. unique doses of up to 80 mg. has been well tolerated.  It has been administered without side-effects i.v. doses of up to 200 mg. in just one day and up to 520 mg during a period of 3 days.  In case of overdose or accidental intake consult with your local Toxicological Information Service.

This product must not be used beyond the expiration date that appears in the packaging.

14 capsules of 20mg