Betaserc tablets

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

betahistine (betahistine dihydrochloride)

Disponibil de la:

Mylan Laboratories SAS

Codul ATC:

N07CA01

INN (nume internaţional):

betahistine (betahistine dihydrochloride)

Dozare:

8mg

Forma farmaceutică:

tablets

Unități în pachet:

(30/1x30/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2023-05-25

Caracteristicilor produsului

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