国家: 亚美尼亚
语言: 英文
来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betahistine (betahistine dihydrochloride)
Pharmacare PLC
N07CA01
betahistine (betahistine dihydrochloride)
16mg
tablets
(30/3x10/) in blister
Prescription
Registered
2016-09-15
CONtr'IDENTIAL Betastino 16 mg Tablets Document status: Final Date: 10 August 2016 Number ofpages: 4 Summary of Product Characteristics L0 August 2016 Betastin@ 16 mg Tablets Summary of Product Characteristics Property of,Pharmacare Int. Co. / Pharmacare PLC COI\.FIDENTIAL May not be used, divulged or otherwise disclosed without the consent of Pharmacare Int. Co. / Pharmacare PLC %{ Page 1 CONFIDENTIAL Betastin@ 16 mg Tablets 1. Name of the Medicinal Produet Betastin@ 16 mg Tablets 2. Qualitative and Quantitative Composition n-methyl-2-pyridineethaaamin dihydrochlorider 2 - (2 - Qnethylamino) ethyl) dihydrochloride; Betahistine HCI ; Betahistine Hydrochloride Each tablet contains 16 mg of Betahistine Hydrochloride. 3. Pharmaceutical Form Tablets for oral use: The Betastinir 16 tablets are round in shape and White or almost white in color tabiet. pyridine 4. Clinical Particulars 4.1 Thcrapeutic indications: Troubles ofthe micro-circulal and vascular tension of the labyrinth. Symptoms of Meniere's disease such as vertigo, tinnitus and hearing loss' 4,2 Posology and rnethod of administration: Betastin@ is-administered orally. Recommended dose of Betahistine HC1 t6 mg is one tablet three times daily. Maximum dose is 48 mg/day in divided doses. This is a long telm medicine when used for the treatrnent of Meniere's disease. Bffect of Betahistine HCI on the symptoms of hearing loss becomes evident only after 2 months. Therefore, it must be taken for at least a period of2 monlhs, depending on the progress of the disease. Advise patient against discontinuation ofthe drug before consultation. 4.3 Contra-indications : - Gasbo-duodenal ulcers. - Pheochromocytoma. 4.4 Special warnings and precautions for use Avoid use in patients with history of ulcers. Be very careful when using with asthma patienls. Use in pregnancy and lactation: Safety and efficacy of using Betasdn in human during pregnalcy ancl breast feeding has not been established. It is not recommended to administer Betahisiine HCI to pregnant womell, though animal c 阅读完整的文件