Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betahistine (betahistine dihydrochloride)
Mylan Laboratories SAS
N07CA01
betahistine (betahistine dihydrochloride)
8mg
tablets
(30/1x30/) in blister
Prescription
Registered
2019-09-06
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BETASERC ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Betahistine dihydrochloride …........................................................................................... 8.00 mg Betahistine dihydrochloride …............................................................................................ 16.00 mg Betahistine dihydrochloride …........................................................................................... 24.00 mg Complete list of excipients – see paragraph 6.1 3. PHARMACEUTICAL FORM Tablet. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic treatment of recurrent dizziness, with or without cochlear symptoms. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Betaserc 8 mg Usual dosage is 1-2 tablets 3 times a day, but not more than 6 tablets, i.e. 48 mg of betahistine a day. Betaserc 16 mg Usual dosage is ½–1 tablet 3 times a day. Betaserc® 24 mg This form is indicated for use in patients who require the daily dose of 48 mg betahistine. In all other cases, it is recommended to use lower doses. Usual dosage is 1 tablet 2 times a day. _Children and adolescents_ Betaserc is not recommended in children and adolescents under 18 years old due to insufficient data as for its efficiency and safety. _The elderly_ Betahistine should be used in elderly patients with caution, as safety data of such use is limited. _Renal insufficiency_ There is no data on use in patients with renal insufficiency. _Hepatic insufficiency_ There is no data on use in patients with hepatic insufficiency. DURATION OF TREATMENT The recommended duration of treatment is between 2 and 3 months; the treatment can be prolonged depending on course of the disease as intermittent or continuous therapy. 2 METHOD OF ADMINISTRATION Orally, during meals; the tablets should be swallowed without chewing with a glass of water. 4.3. CONTRAINDICATIONS − Hypersensitivity to any drug component; − Active phase of ulcer Baca dokumen lengkap