Betaserc tablets

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

betahistine (betahistine dihydrochloride)

Disponível em:

Mylan Laboratories SAS

Código ATC:

N07CA01

DCI (Denominação Comum Internacional):

betahistine (betahistine dihydrochloride)

Dosagem:

24mg

Forma farmacêutica:

tablets

Unidades em pacote:

(20/1x20/) and (60/3x20/) in blister

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2019-09-06

Características técnicas

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