Betahistine dihydrochloride 16 mg Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Betahistine dihydrochloride

Διαθέσιμο από:

Azure Pharmaceuticals Ltd

Φαρμακολογική κατηγορία (ATC):

N07CA01

INN (Διεθνής Όνομα):

Betahistine dihydrochloride

Φαρμακοτεχνική μορφή:

Tablet

Θεραπευτική περιοχή:

betahistine

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2022-01-21

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
21 January 2022
CRN009JZY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betahistine dihydrochloride 16 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg betahistine dihydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, biconvex, scored tablet debossed '16/B' on
one side and plain on other side with a diameter of 8.5
mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betahistine dihydrochloride 16 mg tablet is indicated for vertigo,
tinnitus and hearing loss associated with Ménière's syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly):_
The usual dose is 8 to 16 mg, three times daily taken preferably with
meals.
Maintenance doses are generally in the range 24-48 mg daily.
_Paediatric population:_
Betahistine should not be used in children aged below 18 years due to
insufficient data on safety and efficacy.
_Elderly:_
Although there are limited data from clinical studies in this patient
group, extensive post marketing experience suggests that
no dose adjustment is necessary in this patient population.
_Renal impairment: _
There are no specific clinical trials available in this patient group,
but according to post-marketing experience no dose
adjustment appears to be necessary.
_Hepatic impairment: _
There are no specific clinical trials available in this patient group,
but according to post-marketing experience no dose
adjustment appears to be necessary.
Method of administration.
Oral use.
The tablets should be swallowed without being chewed with a glass of
water during meals.
4.3 CONTRAINDICATIONS

Phaeochromocytoma.

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
21 January 2022
CRN009JZY
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is advised in the