Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betahistine (betahistine dihydrochloride)
Brupharmexport sprl
betahistine (betahistine dihydrochloride)
16mg
tablets
Prescription
1/5 _SUMMARY OF PRODUCT CHARACTERISTICS _ 1. NAME OF THE MEDICINAL PRODUCT Brustin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Brustin 16 mg contains 16 mg of Betahistine dihydrochloride. _Excipients, see 6.1. _ 3. PHARMACEUTICAL FORM Tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS The medicine BRUSTIN 16 mg is indicated in the following situations: - Menière's disease, characterised by vertigo, tinnitus and/or loss of hearing, generally accompanied by nausea, ear ache and/or headache. - Vertigo. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The tablets are intended for oral administration, preferably at meal times. The initial daily dose is 48 mg, distributed over the day. The dosage should be adjusted individually, according to the therapeutic response. The maintenance doses vary between 24 and 48 mg/day. 4.3. CONTRAINDICATIONS BRUSTIN 16 mg is contraindicated in patients with hypersensitivity to the active substance (betahistine dihydrochloride) or any of the medicinal product's excipients. Patients with pheochromocytomas and patients with bronchial asthma do not use Brustin. 2/5 Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care should be taken during the treatment of patients with a history of peptic ulcers. Although trials in animals with high doses of betahistine dihydrochloride have not shown teratogenic effects, its administration during pregnancy is not advisable. 4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly. As betahistine is an analogue of histamine, interaction of betahistine with antihistamines may in theory affect the efficacy of one of these drugs. 4.6. PREGNANCY AND BREAST-FEEDING PREGNANCY: Trials in animals did not demonstrate teratogenic effects. Since there are insufficie Đọc toàn bộ tài liệu