Name:
Betaserc tab 24mg in bl. in pack. No. 20×1
Description:
Tablets of white or almost white color, round, biconvex, with beveled edges, with a risk on one side and engraving “289” on both sides of the risk. The main active ingredient Betahistine Release form Tablets are white or almost white, round, biconvex, with beveled edges, with a risk on one side and engraved “289” on both sides of the risk. Dosage 24mg in bl. in pack. No. 20×1 Special instructions Caution should be used in patients with a history of gastric or duodenal ulcer, in the II and III trimesters of pregnancy, as well as in children. It must be taken into account that the desired clinical effect is achieved after several months of treatment. With dyspeptic symptoms, betahistine is recommended to be taken during or after meals. Pharmacological action An agonist of H1-histamine receptors of the vessels of the inner ear and an antagonist of H3-histamine receptors of the vestibular nuclei of the central nervous system. According to preclinical studies, by relaxing the precapillary sphincters of the vessels of the inner ear, it improves blood circulation in the vascular shelf of the inner ear. Dose-dependently reduces the generation of action potentials in neurons of the lateral and medial vestibular nuclei. Accelerates the recovery of vestibular function after unilateral vestibular neurectomy, accelerating and facilitating central vestibular compensation (due to antagonism with H3-histamine receptors). Relieves symptoms of Meniere’s syndrome and vertigo. Pharmacokinetics When taken orally, betahistine is rapidly and almost completely absorbed from the gastrointestinal tract. After absorption, the drug is rapidly and almost completely metabolized to form an inactive metabolite of 2-pyridylacetic acid. When taking the drug at a dose of 8-48 mg, about 85% of the initial dose is found in the urine in the form of 2-pyridylacetic acid. Excretion of betahistine by the kidneys or through the intestines is negligible. The elimination rate remains constant at oral doses of 8-48 mg of the drug, indicating the linearity of the pharmacokinetics of betahistine, and suggests that the metabolic pathway involved remains unsaturated. When taking the drug with food, the maximum concentration of the drug in the blood is lower than when taken on an empty stomach. However, the total absorption of betahistine is the same in both cases, indicating that the intake only slows down the absorption of betahistine. Indications for use Meniere’s syndrome, characterized by the following main symptoms: dizziness (accompanied by nausea / vomiting) hearing loss (hearing loss) tinnitus Symptomatic treatment of vestibular vertigo (vertigo). Dosage and administration Inside, 8-16 mg 3 times a day. Improvement is usually noted already in the first days of treatment. A stable therapeutic effect is achieved within 2 weeks of treatment and increases when taking the drug for a month or more. The dose and duration of taking the drug are selected individually in accordance with the response to treatment. Use during pregnancy and lactation Pregnancy There are insufficient data on the use of betahistine in pregnant women. The potential risk to humans is unknown. Betahistine should not be used during pregnancy unless absolutely necessary. Lactation It is not known whether betahistine is excreted in breast milk. Do not take the drug during breastfeeding. The question of prescribing the drug to the mother should be taken only after weighing the benefits of breastfeeding against the potential risk to the nursing child. Precautions in the treatment of patients with a history of gastric ulcer and duodenal ulcer. Patients with pheochromocytoma and bronchial asthma during the period of treatment should be regularly observed by a doctor. Interaction with other drugs If you are currently or in the recent past taking other drugs, including without a doctor’s prescription, please inform your doctor about this. Interaction studies in vivo, aimed at studying the interaction with other medicinal products, have not been conducted. These in vitro studies suggest the absence of inhibition of the activity of cytochrome P450 isoenzymes in vivo. Influence on the ability to drive a car and other mechanisms. It is believed that the effect of betahistine on the ability to drive a car and other mechanisms is absent or insignificant, since in the course of clinical studies associated with the use of betahistine, no effects potentially affecting this ability were found. Release form Contraindications hypersensitivity to any of the components of the drug. Betaserc® is not recommended for use in children under the age of 18 due to insufficient data on efficacy and safety. Composition In 1 tab. betahistine dihydrochloride 24 mg Excipients: microcrystalline cellulose – 242 mg, mannitol (E421) – 75 mg, citric acid monohydrate – 7.5 mg, colloidal silicon dioxide – 7.5 mg, talc – 19 mg. Overdose There are several cases of drug overdose. Some patients experienced mild to moderate symptoms (nausea, drowsiness, abdominal pain) after taking the drug in doses up to 640 mg. More serious complications (convulsions, cardiopulmonary complications) have been observed with the deliberate intake of high doses of betahistine, especially in combination with an overdose of other drugs. Symptomatic treatment is recommended. Side effects If you notice any side effects not mentioned in this leaflet, or if any side effect has become serious, please notify your doctor. Gastrointestinal disorders: Common: (> 1/100 to Immune system side: hypersensitivity reaction, including anaphylactic reaction reported. Gastrointestinal side: moderate disorders such as vomiting, gastrointestinal pain, bloating stomach.As a rule, these effects usually disappear after taking the drug simultaneously with food or after lowering the dose.On the part of the skin of subcutaneous fat: Hypersensitivity reactions such as angioedema, urticaria, itching and rash.Storage conditionsIn a dry place at a temperature not higher 25 ° C. Buy Betaserc tablets 24mg No. 20×1 Price for Betaserc tablets 24mg No. 20×1
INN | BETAGISTINE |
---|---|
The code | 20 316 |
Barcode | 8 002 660 024 817 |
Dosage | 24mg |
Active substance | Betahistine |
Manufacturer | Mylan Laboratories SAS, France |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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