Bula do remedy Ulcevit

the package insert of the medicine Ulcevit. Active principles Omeprazole. Sale under medical prescription.

Indication of Ulcevit

what For?

The Ulcevit is used in the treatment of duodenal ulcer, gastric ulcer, esophagitis reflux, Zollinger-Elisson and in maintenance treatment for prevention of relapse in patients with duodenal ulcer, patients little responsive with gastric ulcer and maintenance treatment for patients with esophagitis of reflux

Dosage

How to use?

oral, adults, for duodenal ulcer, gastric ulcer and esophagitis reflux, 20 mg before breakfast for two weeks, if there is healing to prolong the treatment for two to six weeks: in patients refractory to other drugs, 40 mg once a day for four weeks to patients with duodenal ulcer and eight weeks for the cases of gastric ulcer or esophagitis of reflux, are not recommended treatments for more than eight weeks.

Zollinger-Ellisson: oral, adults initially, 60 mg once a day, by adjusting individually the dose for a period of time that will be determined by the clinical evolution of the patient; doses above 80 mg daily should be divided in two sockets; the treatment can last for eight weeks or more; in the latter case should be done with medical supervision strict.

Not if they have determined the doses for children.

Side Effects

What are the evils that can cause me?

The adverse reactions due to OMEPRAZOLE are usually mild and reversible. Have been reported the following reactions:
skin Reactions: occur rarely rash and/or itching. In isolated cases:
photosensitivity, erythema multiforme and alopecia.

skeletal Muscle: isolated cases of arthralgia, myalgia, and muscle weakness.

central and peripheral nervous System: headache. Rarely dizziness, paraesthesia, somnolence, insomnia and vertigo. In isolated cases, have occurred the mental confusion, agitation, depression and hallucinations, mainly in patients in serious condition.

Gastrointestinal: diarrhea, abdominal pain, constipation, nausea, vomiting, and flatulence. Isolated reports of stomatitis and candidiasis gastrointestinal.

Endocrine: isolated reports of gynocomastia.

Blood: isolated reports of leucopenia and thrombocytopenia.

Hepatic: Rarely occurs increased liver enzymes. In isolated cases can occur encephalopathy in patients with severe hepatic impairment pre-existing; hepatitis with or without jaundice, liver failure.

Other reactions: rarely malaise. Can occur hypersensitivity reactions, for example, urticaria (rare) and, in isolated cases, angioedema, fever, and bronchospasm.

Changes in laboratory tests: it can be observed an increase in the concentrations of alkaline phosphatase, transaminase glutâmicoxalacética and glutâmicopirúvica. – it Can occur in increased concentrations of gastrin in serum during the first weeks of therapy with OMEPRAZOLE and return after interruption or completion of the treatment.

This elevation is probably due to the inhibition of acid secretion which eliminates the effect of negative feedback of acid on the gastric secretion; and the stimulation of gastric acid, gastrin promotes growth and proliferation of endocrine cells or similar to the enterocromafins in the gastric mucosa.

Overdose

what to do if someone use a larger amount than is recommended?

there is information available about the effects of excessive doses in humans, and there are no specific recommendations for treatment. Single-dose oral up to 160mg doses total daily up to 360mg/day has been tolerated. A possible overdosage treatment should be symptomatic and supportive.

Attention
This product is a new drug and although research has indicated efficacy and safety when properly indicated, can occur adverse reactions unpredictable, not yet described or known. In the case of a suspected adverse reaction, the doctor should be notified.

Composition

Each capsule contains:
Omeprazole…. ….10 or 20mg
Excipient q. s. q.:….01 capsule

Presentation

Capsules 10mg – Box with 14 capsules.

Capsules 20mg – the Box with 7 and 14 capsules

Drug Interactions

Diazepam, warfarin and phenytoin: may have prolonged the time of its elimination, when used concomitantly with OMEPRAZOLE.

Theophylline, beta-blockers, lidocaine, quinidine, and amoxicillin: no interactions were observed with these drugs, but there may be drug interactions with other drugs that are also metabolized through the enzymatic system of the cytochrome P–450.

Sales

Sale under medical prescription.

Introduction

Ulcevit
Omeprazole
Omeprazole d. c. b. : 1615.01-7

Period of Validity

24 months from the manufacture date (SEE CARTRIDGE). Do not use medicine with the term of validity expired. The validity period after the opening of the bottle is 3 months.

The use of Ulcevit is not recommended during pregnancy and breastfeeding. Tell your doctor the occurrence of pregnancy during treatment or after its termination. Also inform them if you are breast-feeding.

it is Recommended the administration of the capsule before breakfast.

“Follow the guidance of your doctor, always respecting the schedules, doses and duration of treatment”.

“do Not stop treatment without the knowledge of your doctor”.

“Follow correctly the mode of use, not disappearing the symptoms seek medical advice”.

Tell your doctor the occurrence of any unpleasant reaction that may occur during treatment, such as: nausea, headache, diarrhea, constipation, and skin rashes.

“ALL MEDICINE SHOULD BE KEPT OUT of REACH OF CHILDREN”.

“Tell your doctor about any medicine you are using, before the beginning or during the treatment”.

contraindications: ( SEE item contraindications).

Precautions: (SEE item precautions).

“do NOT TAKE MEDICINE WITHOUT THE KNOWLEDGE OF YOUR DOCTOR, CAN BE HAZARDOUS TO YOUR HEALTH”.

Patient Info

Ulcevit acts as a potent inhibitor of gastric secretion.

Care of conservation: The bottle should be kept capped at controlled room temperature (15 – 30). Protect from light and moisture.

Use In the Elderly

Should follow the same usual dose of adults.

elderly Patients and patients with renal function or compromised liver: it is not necessary to adjust doses.

Technical Information

THE OMEPRAZOLE is a selective inhibitor of the enzyme H+K+ ATPase (Pump protons) in the parietal cells, thus reducing gastric secretion. This pharmacological action dose-dependent, inhibits the final step of the formation of acid in the stomach, thus providing an inhibition effective in both acid secretion basal and the stimulated, regardless of the stimulus. After oral administration, absorption is usually completed between 3 to 6 hours. After a single oral dose has a bioavailability of about 35% and after their administration in repeated reaches to achieve the 60%. Its binding rate to plasma proteins is on the order of 95%. It is completely metabolized in the liver and its main metabolites (sulfona and sulfide hydroxy-OMEPRAZOLE) are inactive. About 80% of metabolites are excreted through the urine and the remainder in feces.

Against – Indications

Ulcevit is contraindicated in patients who have demonstrated hypersensitivity to the drug, in pregnancy and in lactation.

PRECAUTIONS
In the presence of gastric ulcer, the possibility of malignancy of the lesion should be early removed, as treatment with OMEPRAZOLE may alleviate symptoms and delay the diagnosis of this pathology.

Like other drugs anti-secretórios stomach, the OMEPRAZOLE favors the development of bacteria intragástricas by reduction of volume and acidity of gastric juice.

The use of OMEPRAZOLE is not recommended during pregnancy and during lactation unless the physician’s discretion benefits of treatment outweigh the potential risks to the fetus and/or infant. There is as yet no experience with the use of OMEPRAZOLE

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Attention: the remedy of The earth is a space character only, with issues related to health and well-being, The information here disclosed shall not be used as a substitute for a doctor’s prescription for the treatment of any disease.