Betahistine dihydrochloride 8 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:

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 8 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg betahistine dihydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat, bevel-edged tablet debossed '8' on
one side and 'B' on other side with a diameter of 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betahistine dihydrochloride 8 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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
21 January 2022
CRN009JZY
Page 2 of 5
Caution is advised in the treatment of patients with a history of
peptic ulcer.