Ulsepan
(Pantoprazole)




COMPOSITION

Each enteric coated tablet contains pantaprazole (as sodium salt) 40 mg.

THERAPEUTIC INDICATIONS

- Gastric and duodenal ulcer;
- Erosive and ulcerative esophagitis of the stomach and duodenum associated with the intake of non-steroidal anti-inflammatory agents;
- Gastroesophageal reflux disease (GERD): erosive or ulcerative reflux esophagitis (therapy), symptomatic therapy for GERD (i.e. NERD – non-errosive reflux disease);
- Pathological hypersecretory conditions, including Zollinger-Ellison syndrome;
- Eradication of Helicobacter pylori (in combination with antimicrobial therapy).

CONTRAINDICATIONS

- Hypersensitivity to pantoprazole;
- Hepatitis or hepatocirrhosis followed by severe renal impairment.

PARTICULAR INDICATIONS

Before the treatment, it should be excluded the possibility of malignant tumors in the stomach and in the gullet, as the application of Ulsepan can reduce the symptoms intensity and postpone the correct diagnosis establishment. The reflux-esophagitis diagnosis demands the obligatory endoscopic confirmation.

ADVERSE EFFECTS

The symptoms are usually mild or moderate and transient.
Effects from gastrointestinal tract: diarrhea, dry mouth, limosis, nausea, eructation, vomiting, flatulence, abdominal pains, constipation.
Central nerve system: headache, asthenia, vertigo, somnolescence, insomnia; in some cases there is a possibility of manifestations of nervousness, depression, tremor, visual impairment and tinnitus.
Allergic reactions: skin eruption, itch and nettle rash.
Other effects: very seldom – edemata, temperature rise.

DOSAGE AND ADMINISTRATION

Ulsepan tablet:

- Gastric and duodenal ulcer: 40-80 mg daily. In case of exacerbation of duodenal ulcer the treatment course lasts 2-4 weeks and in case of gastric ulcer it lasts from 4 to 8 weeks.
- Erosive and ulcerative esophagitis of the stomach and duodenum associated with the intake of non-steroidal anti-inflammatory agents: 40-80 mg daily. The duration of treatment is 4-8 weeks.
- Gastroesophageal reflux disease, erosive or ulcerative reflux esophagitis: 40 mg daily. The duration of treatment is 8 weeks. If the healing does not occur the additional 8-week treatment course is recommended.
- Maintenance dose for healing of erosive esophagitis: for adults is 40 mg daily.
- Pathological hypersecretory conditions, including Zollinger-Ellison syndrome: the dose is adjusted individually according to the clinical indication. The recommended initial dose is 40 mg 2 times daily. The dose may be increased to 240 mg daily, and the treatment course may be prolonged up to 2 years.
- Eradication of Helicobacter pylori: 40 mg 2 times daily in combination with antimicrobial agents.

PREGNANCY AND LACTATION

The drug is cautiously prescribed during pregnancy. If the drug administration is necessary during lactation period breast-feeding should be stopped, as it was indicated that pantoprazole is excreted in breast milk.

MANUFACTURED FORM

10 tablets in a blister. 2 blisters in carton box with enclosed leaflet.

Alimentary Tract and Metabolism

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