Brustin

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

betahistine (betahistine dihydrochloride)

Verfügbar ab:

Brupharmexport sprl

INN (Internationale Bezeichnung):

betahistine (betahistine dihydrochloride)

Dosierung:

16mg

Darreichungsform:

tablets

Verschreibungstyp:

Prescription

Fachinformation

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.
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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