Betahistine 8 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAHISTINE DIHYDROCHLORIDE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

N07CA01

INN (International Name):

BETAHISTINE DIHYDROCHLORIDE 8 mg

Pharmaceutical form:

TABLET

Composition:

BETAHISTINE DIHYDROCHLORIDE 8 mg

Prescription type:

POM

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Authorised

Authorization date:

2014-07-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Betahistine 8 mg tablets
Betahistine 16 mg tablets
Betahistine 24 mg tablets
betahistine dihydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Betahistine is and what it is used for
2.
What you need to know before you take Betahistine
3.
How to take Betahistine
4.
Possible side effects
5.
How to store Betahistine
6.
Contents of the pack and other information
1.
What Betahistine is and what it is used for
Betahistine is a type of medicine called a “histamine analogue”.
Betahistine is used for:
Ménière’s disease – the signs of this include:

feeling dizzy (vertigo)

ringing in the ears (tinnitus)

hearing loss or hearing difficulty
How this medicine works
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
Do not take Betahistine

if you are allergic to betahistine or to any of the other ingredients
of this medicine (listed in
section 6)

if you have a pheochromocytoma, a rare tumour of the adrenal gland
Warnings and precautions
Talk to your doctor or pharmacist before taking Betahistine Aurobindo

if you have or have had 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, since these complaints
may be exacerbated.

if you have low blood pressure
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Betahistine Aurobindo is not the appropriate treatment for the
following f

Summary of Product characteristics

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SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Betahistine 8 mg tablets
Betahistine 16 mg tablets
Betahistine 24 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg Betahistine dihydrochloride
Each tablet contains 16 mg Betahistine dihydrochloride
Each tablet contains 24 mg Betahistine dihydrochloride
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Betahistine 8 mg tablets
White to off-white round (diameter 7.0 mm), flat uncoated tablets
debossed with ‘X’ on one side and
‘87’ on the other side.
Betahistine 16 mg tablets
White to off-white round (diameter 8.5 mm), uncoated tablets debossed
with ‘X’ and a break line on
one side and ‘88’ on the other side.
The tablet can be divided into equal doses.
Betahistine 24 mg tablets
White to off-white round (diameter 10.0 mm), uncoated tablets debossed
with ‘X’ and a break line on
one side and ‘89’ on the other side.
The tablet can be divided into equaldoses.
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. The
daily dose should be given in 2 or
3 divided doses throughout the day. 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.
The best results are sometimes obtained after a few months. There are
indications that treatment from
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the onset of the disease prevents the progression of the disease
and/or the loss of hearing in later
phases of the disease.
Betahistine Aurobindo 8 mg/16 mg:
8 mg tablets
16 mg tablets
1 - 2 tablets
3 times/day
½ - 1 tablet
3 times/day
Betahistine Aurobindo 24mg:
T