Rebagit^® (Tablets) Instructions for Use

Marketing Authorization Holder

PRO.MED.CS Praha, a.s. (Czech Republic)

Manufactured By

PRO.MED.CS Praha, a.s. (Czech Republic)

Or

ZiO-Health CJSC (Russia)

Or

Pharmacor Production, LLC (Russia)

Contact Information

PRO.MED.CS JSC (Russia)

ATC Code

A02BX14 (Rebamipide)

Active Substance

Rebamipide (Rec.INN registered by WHO)

Dosage Form

Rebagit®

Film-coated tablets, 100 mg: 30, 90, or 180 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

Excipients : mannitol, croscarmellose sodium, pregelatinized starch, sodium lauryl sulfate, citric acid, talc, magnesium stearate.

Film coating composition Opadry white 03B28796 (hypromellose 6cP, titanium dioxide, macrogol 400).

10 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (9) – carton packs.
10 pcs. – blisters (18) – carton packs.

Clinical-Pharmacological Group

Gastroprotective agent

Pharmacotherapeutic Group

Acid-related disorder treatment agents; antiulcer agents and agents for the treatment of gastroesophageal reflux disease (GERD); other antiulcer agents and agents for the treatment of GERD

Pharmacological Action

Rebamipide increases the content of prostaglandin E2 (PGE2) in the gastrointestinal mucosa and increases the content of PGE2 and PGI2 in the gastric juice. It has a cytoprotective effect on the gastrointestinal mucosa against the damaging effects of ethanol, acids and alkalis, and acetylsalicylic acid.

It promotes the activation of enzymes that accelerate the biosynthesis of high molecular weight glycoproteins and increases the mucus content on the surface of the gastrointestinal mucosa walls. It helps improve blood supply to the gastrointestinal mucosa, activates its barrier function, activates gastric alkaline secretion, enhances the proliferation and turnover of gastrointestinal epithelial cells, cleanses the mucosa of hydroxyl radicals and suppresses superoxides produced by polymorphonuclear leukocytes and neutrophils in the presence of Helicobacter pylori, and protects the gastrointestinal mucosa from bacterial damage and the damaging effects of NSAIDs on the mucosa.

Pharmacokinetics

Absorption

Absorption after oral administration is high. After a dose of 100 mg, C_max is reached in approximately 2 hours and is 340 ng/ml. Repeated doses of the drug do not lead to its accumulation in the body.

Distribution

In vitro experiments have shown that from 98.4% to 98.6% of the drug is bound to plasma proteins.

Metabolism

After a dose of 600 mg, traces of a hydroxylated metabolite can be detected.

Excretion

T_1/2 is approximately 1.0 hour. Approximately 10% of the drug is excreted by the kidneys, mainly unchanged.

Indications

Adults aged 18 years and over

• Gastric ulcer;
• Chronic gastritis with increased gastric acid-forming function in the acute phase, erosive gastritis;
• Prevention of mucosal damage during NSAID use.

May be used as part of combination therapy.

ICD codes

Dosage Regimen

Orally, with a small amount of liquid, in the morning, at lunch, and in the evening or in the morning, in the evening, and before bedtime, according to the patient’s lifestyle.

The drug is prescribed as 1 tablet 3 times/day.

The course of treatment is 2-4 weeks, and if necessary, can be extended to 8 weeks.

The drug has no peculiarities of action upon first administration or upon its discontinuation.

If a dose is missed, the next dose of the drug should be taken at the scheduled time; a double dose of the drug should not be taken.

Special patient groups

Elderly patients

Upon first administration, increased sensitivity to the drug may occur (see the “Special Precautions” section).

Children

The safety and efficacy of rebamipide use in children under 18 years of age have not been established. Data are not available.

Adverse Reactions

Blood and lymphatic system disorders leukopenia, granulocytopenia.

Gastrointestinal disorders constipation, flatulence, diarrhea, nausea, vomiting, abdominal pain, taste disturbance, heartburn.

Hepatobiliary disorders signs of liver dysfunction, increased serum ALT and AST.

Skin and subcutaneous tissue disorders itching, skin rash, eczematous eruptions.

Reproductive system and breast disorders menstrual cycle disorder.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to rebamipide or to any of the excipients included in the drug;
• Pregnancy;
• Breastfeeding period;
• Children under 18 years of age.

With caution

Caution is recommended when first prescribing rebamipide to elderly patients due to the possibility of increased sensitivity to the drug.

Use in Pregnancy and Lactation

Pregnancy

The safety of rebamipide use during pregnancy has not been proven, therefore the use of the drug during pregnancy is contraindicated.

Breastfeeding period

Since Rebamipide is excreted in breast milk, breastfeeding should be discontinued or the issue of artificial feeding of the child should be considered if it is necessary to prescribe rebamipide to the mother during breastfeeding. The use of the drug during breastfeeding is contraindicated.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Caution is recommended when first prescribing rebamipide to elderly patients due to the possibility of increased sensitivity to the drug.

Special Precautions

Effect on ability to drive vehicles and operate machinery

The effect of the drug on the speed of psychomotor reactions and/or the ability to drive vehicles or operate machinery has not been studied. In case of taking the drug, one should be cautious about driving a car and other activities requiring increased concentration.

Overdose

Symptoms of rebamipide overdose have not been described; to date, no information on cases of intentional overdose has been received. Nausea, vomiting, abdominal pain, diarrhea or constipation, headache are possible.

Treatment: specific antidote is unknown. In case of overdose, gastric lavage should be performed and symptomatic therapy should be administered.

Drug Interactions

When rebamipide is used as part of traditional therapy regimens for patients infected with Helicobacter pylori, the efficacy of eradication therapy significantly increases.

Interaction reactions with other medicinal products have not been studied.

Storage Conditions

The drug should be stored out of the reach of children. Does not require special storage conditions.

Shelf Life

Shelf life – 4 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.