Betahistine dihydrochloride 24 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betahistine dihydrochloride

Available from:

Azure Pharmaceuticals Ltd

ATC code:

N07CA01

INN (International Name):

Betahistine dihydrochloride

Pharmaceutical form:

Tablet

Therapeutic area:

betahistine

Authorization status:

Not marketed

Authorization date:

2022-01-21

Summary of Product characteristics

Health Products Regulatory Authority
21 January 2022
CRN009JZY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betahistine dihydrochloride 24 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 24 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 '24/B' on
one side and plain on other side with a diameter of 10
mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betahistine dihydrochloride 24 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 starting dose of betahistine is 8 to 16 mg, three times
daily, taken preferably with meals.
Maintenance doses are generally in the range 24-48 mg daily.
The 24 mg tablet can be used for twice daily dosing in patients
requiring 48 mg of betahistine per day. For a lower total daily
dose and for three times daily dosing lower strength tablets are
available.
_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