BETAHISTINE DIHYDROCHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BETAHISTINE DIHYDROCHLORIDE

Available from:

Accord Healthcare Limited

ATC code:

N07CA01

INN (International Name):

BETAHISTINE DIHYDROCHLORIDE

Dosage:

8 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

betahistine

Authorization status:

Marketed

Authorization date:

2011-10-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAHISTINE DIHYDROCHLORIDE 8 MG TABLETS
BETAHISTINE DIHYDROCHLORIDE 16 MG TABLETS Betahistine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT
CONTAINTS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Betahistine dihydrochloride tablets is and what it is used for
2. What you need to know before you take Betahistine dihydrochloride
tablets
3. How to take Betahistine dihydrochloride tablets
4. Possible side effects
5. How to store Betahistine dihydrochloride tablets
6. Contents of the pack and other information
1. WHAT BETAHISTINE DIHYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR
Betahistine is a
histamine analogue
medicine that is used to treat symptoms of Ménière’s
syndrome such as dizziness
(vertigo)
, ringing in the ears (tinnitus), loss of hearing and nausea.
This medicine works by improving blood flow in the inner ear. This
lowers the build up of
pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE DIHYDROCHLORIDE
TABLETS
DO NOT TAKE BETAHISTINE DIHYDROCHLORIDE TABLETS:

If you are allergic (hypersensitive) to betahistine dihydrochloride or
any of the other
ingredients of Betahistine dihydrochloride tablets (see section 6,
Contents of the pack and
other information).

if you have
high blood pressure due to adrenal tumour
(phaeochromocytoma), a rare tumour
of the adrenal gland.
WARNING AND PRECAUTIONS

if have a stomach ulcer (peptic ulcer)

if you have asthma

if you have nettle rash, skin rash or a cold in the nose caused by an
allergy, s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betahistine dihydrochloride 8mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
Betahistine dihydrochloride 8 mg
Excipient(s) with known effect:
Each tablet contains 50 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White,
round,
flat,
6.5.mm tablets with bevelled edges with the inscription ‘BE’ on
one side and a breakline on the
other side.
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 is indicated for treatment of Ménière’s syndrome,
symptoms of which may include vertigo, tinnitus, hearing loss and
nausea.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
Adults
Initial oral treatment is 8 to 16 mg three times daily, taken
preferably with meals.
Maintenance doses are generally in the range 24 - 48 mg daily.
Daily dose should not exceed 48 mg.
Dosage can be
adjusted to suit individual patient needs.
Sometimes improvement could be observed only after a couple of weeks
of
treatment.
There is no data available for patients with hepatic impairment.
There is no data available for patients with renal impairment.
There is limited data in the elderly, betahistine should be used with
caution in this population.
Children and adolescents:
Betahistine tablets are not recommended for use in children and
adolescents below age 18 due to lack of data on safety
and efficacy.
4.3 CONTRAINDICATIONS
Betahistine is contraindicated in patients with phaeochromocytoma. As
betahistine is a synthetic analogue of histamine
it may induce the release of catecholamines from the tumor resulting
in severe hypertension.
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