Instructions for use: Mucogen film-coated tablets 100 mg strip No. 30
Composition
active ingredient: rebamipide;
1 tablet contains rebamipide 100 mg;
Excipients: mannitol (E 421), croscarmellose sodium, pregelatinized starch, sodium lauryl sulfate, anhydrous citric acid, talc, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide (E 171), propylene glycol.
Dosage form
Film-coated tablets.
Main physicochemical properties: round biconvex tablets, coated, white or almost white in color, smooth on both sides.
Pharmacotherapeutic group
Drugs for the treatment of acid-dependent diseases.
ATX code A02X.
Pharmacological properties
Pharmacodynamics
Rebamipide increases the endogenous content of prostaglandins E2 and I2 (PGE2 and PGI2), which are contained in gastric juice, and also increases the level of prostaglandin E2 (PGE2) in the gastric mucosa, which helps to protect it from damaging factors. Rebamipide has a cytoprotective effect, proven in in vitro studies, improves blood circulation in the gastric mucosa and stimulates cell proliferation. By accelerating the activity of enzymes that stimulate the biosynthesis of high-molecular glycoproteins, rebamipide increases the amount of surface gastric mucus. Rebamipide does not affect basal and stimulated gastric secretion.
Pharmacokinetics
After a single oral dose of 100 mg of rebamipide, the maximum plasma concentration (210 ng/ml) was observed after 2 hours. In vitro experiments showed that approximately 90% of the drug was bound to plasma proteins, but multiple studies have shown that the drug does not accumulate in the body. The drug undergoes minor metabolism in humans, but is mostly excreted unchanged. The plasma half-life is approximately 1.5 hours.
When rebamipide was administered at a dose of 100 mg in patients with renal insufficiency, there were no significant differences in plasma drug concentrations and half-life between healthy and diseased patients.
Indication
As part of the complex treatment of chronic gastritis with increased acid-forming function of the stomach in the acute stage, erosive gastritis, functional dyspepsia.
Prevention of mucosal damage caused by taking nonsteroidal anti-inflammatory drugs.
Contraindication
Hypersensitivity to rebamipide or to any other component of the drug. Malignant diseases of the stomach.
Interaction with other medicinal products and other types of interactions
When rebamipide is used as part of traditional anti-helicobacter regimens, the effectiveness of eradication therapy is likely to increase.
Interaction with other drugs has not been studied.
Application features
The drug should be prescribed with caution to elderly patients to reduce the risk of developing digestive tract disorders, since this category of patients is more sensitive to drugs than younger patients.
Use during pregnancy or breastfeeding
Contraindicated during pregnancy or breastfeeding, as the safety of rebamipide in pregnant women has not been proven.
Since rebamipide passes into breast milk, breastfeeding should be discontinued during use of the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients taking Mukogen should be warned that they may experience dizziness and drowsiness and that in such cases they should refrain from driving, operating machinery, or engaging in other activities that require increased attention and quick reactions.
Method of administration and doses
Tablets should be taken orally, with a small amount of liquid, 1 tablet (100 mg) 3 times a day.
The course of treatment is 2-4 weeks, if necessary it can be extended to 8 weeks.
Children
The drug should not be prescribed to children, as studies on the use of the drug in this age group have not been conducted.
Overdose
To date, no cases of overdose with rebamipide have been observed.
Nausea, vomiting, abdominal pain, diarrhea or constipation, headache, and increased manifestations of adverse reactions are possible.
In case of overdose, gastric lavage and symptomatic therapy should be administered. There is no specific antidote.
Adverse reactions
From the blood and lymphatic system: leukopenia, thrombocytopenia, granulocytopenia.
On the part of the hepatobiliary system: impaired liver function, jaundice, increased levels of liver enzymes (ALT, AST, LF, gammaglutamyltransferase).
Skin and subcutaneous tissue disorders: skin rashes, urticaria, eczema-like skin rashes, itching, swelling.
Neurological disorders: numbness, dizziness, drowsiness.
Reproductive disorders: menstrual irregularities in women, swelling and pain in the mammary glands, gynecomastia, lactation induction, palpitations, fever, hot flashes, numbness of the tongue, cough, respiratory distress.
Others: hypersensitivity reactions, increased urea levels, feeling of a lump in the throat.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging.
Keep out of reach of children.
Packaging
10 tablets in a strip, 3 strips in a cardboard box.
Vacation category
According to the recipe.
Producer
Macleods Pharmaceuticals Limited.
Location of the manufacturer and its business address
Village Theda, PO Lodhimaira, Tehsil Baddi, District Solan, Himachal Pradesh - 174101 (Block No. 1), India.
