Instructions Elkocin film-coated tablets 100 mg blister No. 30
Composition
active ingredient: rebamipide,
1 tablet contains rebamipide 100 mg;
excipients: microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate;
coating mixture: hypromellose, titanium dioxide (E 171), polyethylene glycol (macrogol).
Dosage form
Film-coated tablets.
Main physicochemical properties: white round, smooth on both sides, biconvex tablets, film-coated.
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 contributes to its protection 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 increasing 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 (216 ± 79 ng/ml) was observed after 2.4 ± 1.2 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 elimination half-life is approximately 1.9 ± 0.7 hours. When rebamipide was administered at a dose of 100 mg, patients with renal insufficiency had an increase in plasma concentrations of the drug and a longer half-life compared to healthy patients.
Indication
Gastric ulcer, acute gastritis, period of exacerbation of chronic gastritis, pathological changes in the gastric mucosa (erosion, bleeding, hyperemia, edema).
Contraindication
Hypersensitivity to rebamipide or to any other components 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 traditional therapy is likely to increase. Interactions with other drugs have not been studied.
Application features
Sometimes a decrease in the number of leukocytes and platelets may be observed. If any deviation from the norm is detected, the drug should be discontinued and appropriate measures should be taken to improve the patient's condition.
Sometimes there may be an increase in the level of AST, ALT, γ-GGTP, LF (alkaline phosphatase) and other liver function disorders, jaundice. In the event of such reactions, it is necessary to conduct an appropriate examination, if abnormalities are detected, stop taking the drug and take the necessary measures to improve the patient's condition.
Ability to influence reaction speed when driving vehicles or other mechanisms
When taking rebamipide, dizziness and drowsiness may occur. In such cases, you should refrain from driving, working with mechanisms, and engaging in other activities that require increased attention and quick reactions.
Use during pregnancy or breastfeeding
Since the safety of rebamipide during pregnancy or breastfeeding has not been proven, the drug is contraindicated for use.
Since rebamipide passes into breast milk, breastfeeding should be discontinued during use of the drug.
Method of administration and doses
For oral use.
Stomach ulcer
Adults – 100 mg (1 tablet) 3 times a day in the morning, afternoon and evening.
To improve the condition of acute gastritis, during exacerbation of chronic gastritis, with pathological changes in the gastric mucosa (erosion, bleeding, hyperemia, edema)
Adults – 100 mg (1 tablet) 3 times a day.
Elderly patients.
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 the effects of the drug.
Children
The drug should not be prescribed to children, as studies on its use in this age group have not been conducted.
Overdose
Cases of overdose have not been described. Nausea, vomiting, abdominal pain, diarrhea or constipation, headache, 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
Adverse reactions were classified by system organ class and by frequency of occurrence. The frequency of occurrence is divided into the following categories: very common (> 1/10), common (> 1/100 and <1/10), uncommon (> 1/1000 and <1/100), rare (> 1/10000 and <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).
From the blood and lymphatic system: infrequently - leukopenia, granulocytopenia; frequency unknown - thrombocytopenia.
On the part of the hepatobiliary system: infrequently - increased levels of liver enzymes AST, ALT, gamma-glutamyltransferase, LF and other liver function disorders; frequency unknown - jaundice.
On the part of the immune system: infrequently - skin rash, itching, drug-type eczema, other allergic symptoms; frequency unknown - urticaria.
From the side of the central and peripheral nervous systems: frequency unknown - numbness, dizziness, drowsiness.
Gastrointestinal: infrequently - constipation, feeling of distension and fullness in the abdomen, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, taste disturbance; frequency unknown - thirst.
Respiratory system: frequency unknown - cough, difficulty breathing.
From the genitourinary system: infrequently - menstrual cycle disorders in women; frequency unknown - swelling and pain in the mammary glands, development of "female breasts" in men (gynecomastia), induction of milk secretion.
Laboratory tests: frequency unknown - increased urea level.
General reactions: infrequently - hypersensitivity reactions, edema, sensation of a foreign object in the nasopharynx; frequency unknown - fever, anxiety, flushing (sudden redness of the face), numbness of the tongue, sensation of palpitations.
If symptoms of allergy occur, the drug should be discontinued.
In the event of a significant increase in transaminase levels or in the event of a simultaneous increase in temperature, rash, and other symptoms, the drug should be discontinued and measures should be taken to improve the condition.
Expiration date
2.5 years.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister, 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Kyivmedpreparat".
Location of the manufacturer and its business address
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
