Name Vestibo tablets 24mg in a blister in pack No. 10×2 Producer Catalent Jemani Schorndorf GmbH Plant manufacturer Catalent Jemani Schorndorf GmbH Steinbeisstrasse 2, D-73614, Schorndorf, Germany Country of origin Germany Main active ingredient Betahistine Release form Round tablets with a recess along the fault line on one side, white or almost white , diameter about 11.3 mm. 10 tablets in a PVC/PVDC/aluminum foil blister. 2 or 6 blisters in a cardboard box with leaflet. Release of the drug Without a prescription Pharmacological action The Vestibo effect is manifested as a result of exposure to specific receptors (histamine H1 and H3 receptors) located in the inner ear and some areas of the brain. It improves microcirculation and capillary permeability, normalizes endolymph pressure in the organ of balance. The drug does not adversely affect the functioning of the heart, in some cases it can lead to a slight decrease in blood pressure. The clinical manifestation of these effects is a decrease in the frequency and intensity of dizziness, a decrease in tinnitus, and an improvement in hearing in case of its decrease. Indications for use Symptomatic treatment of recurrent dizziness with or without cochlear symptoms. Application during pregnancy and lactation Pregnancy Observational data on animals indicate the absence of a damaging effect on offspring. The safety of betahistine during pregnancy in humans has not been proven and therefore its use in pregnant women is not recommended. Breast-feeding It is not known whether betahistine passes into breast milk. The use of the drug during breastfeeding should be avoided. PrecautionsWith extreme caution appoint: patients with peptic ulcer because of the risk of dyspepsia during treatment; patients with bronchial asthma, urticaria, rash and allergic rhinitis (there is an increased risk for patients with allergic diseases due to the likelihood of aggravation of allergy symptoms during treatment with betahistine); patients with histamine (cluster) headache and migraine due to the risk of provoking seizures during treatment with betahistine; patients taking antihistamines. Betahistine is not recommended for the treatment of the following pathological conditions: benign paroxysmal dizziness; dizziness associated with damage to the central nervous system. Against the background of the use of the drug is not recommended to drink alcohol. The drug contains lactose and should not be used in patients with hereditary galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. Interactions with other medicinal products and other forms of interactionIn vivo studies aimed at studying interactions with other medicinal products have not been conducted. Based on in vitro data, no inhibition of cytochrome P450 enzymes is expected in vivo. In vitro data indicate inhibition of betahistine metabolism by drugs that inhibit monoamine oxidase (MAO) activity, including MAO subtype B (eg, selegiline). It is recommended to exercise caution while taking betahistine and MAO inhibitors (including selective MAO-B). Since betahistine is a histamine analog, the interaction of betahistine with antihistamines could theoretically affect the effectiveness of one of these drugs. Vestibo use and food and drink intake There is no evidence of the need for a special diet or restricted intake of certain foods and drinks during treatment with this drug. Take with food. Contraindications Hypersensitivity to any component of the drug. Active phase of peptic ulcer. Pheochromocytoma. Ingredients Betahistine dihydrochloride 24 mg Excipients: povidone, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, crospovidone, stearic acid. Method of application and doses The dose of the drug is selected individually in accordance with the patient’s response to treatment. Depending on the complaints, the doctor will determine the dose necessary for the treatment of your disease. Adults This formulation is for use in patients requiring a daily dose of 48 mg betahistine. In other cases, lower doses should be used. The usual dosage is 1 tablet 2 times a day. Tablets are taken orally during meals, without chewing, with water. Elderly Betahistine should be used with caution in elderly patients because the available safety data are limited. Although clinical trial data are limited in this group of patients, post-registration experience suggests that dose adjustment is not required. Renal failure Special clinical trials in this group of patients have not been conducted, in accordance with the experience of post-registration use of dose adjustment is not required. Liver failure Special clinical trials in this group of patients have not been conducted, in accordance with the experience of post-registration use of dose adjustment is not required. Children Due to insufficient data on safety and efficacy, the drug is not recommended for use in children and adolescents under the age of 18 years. Overdose There are several cases of overdose of betahistine. Some patients experienced mild to moderate symptoms (nausea, drowsiness, abdominal pain) after taking the drug in doses up to 640 mg. More serious complications (eg, convulsions, pulmonary or cardiovascular complications) have been observed in the case of deliberate use of high doses of betahistine, especially in combination with an overdose of other drugs. For the treatment of overdose, symptomatic therapy is recommended. Side effects In placebo-controlled clinical trials of the use of betahistine, the following side effects (with frequency indication) were recorded very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1000); very rare (<1/10,000). From the gastrointestinal tract Often: nausea, dyspepsia. From the side of the nervous system Often: headache. In addition to the events recorded in clinical trials, the following cases have been recorded in post-marketing practice and in the scientific literature (the available data do not allow to establish the frequency, therefore, in these cases the frequency is “unknown”): From the immune system Hypersensitivity reactions, such as anaphylaxis. On the part of the gastrointestinal tract There were mild disorders of the stomach (nausea, stomach pain, bloating). These adverse events can be easily avoided by taking the drug during a meal or by reducing the dose. From the skin and subcutaneous tissues Hypersensitivity reactions from the skin and subcutaneous tissues were noted, in particular angioedema, urticaria, rash and itching. Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. Expiration date from the date of manufacture 3 (three) years from the date of manufacture. Do not use Vestibo after the expiration date which is stated on the carton. The expiration date corresponds to the last day of the specified month. Do not use Vestibo if you notice a change in the appearance of the tablet. Buy Vestibo tablets 24mg No. 10x2 Price for Vestibo tablets 24mg No. 10x2
INN | BETAGISTINE |
---|---|
The code | 28 031 |
Barcode | 5 690 528 167 115 |
Dosage | 24mg |
Active substance | Betahistine |
Manufacturer | Catalent Germani Schorndorf GmbH, Germany |
Trademark | Actavis |
trade line | Vestibo |
Importer | Foreign unitary trade and manufacturing enterprise "Belinvestfarma", Minsk, Leshchinskogo st., 8/4-2; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, office 1; Limited Liability Company "Farmiko", Minsk district, Senitsky s / s, Kolyadichi village, Lazurnaya st., 9; Additional Liability Company "Farmin", 220125 Minsk, Independence Avenue, 177, room 62; IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2 |
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