Betahistine 16mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betahistine dihydrochloride

Available from:

Accord-UK Ltd

ATC code:

N07CA01

INN (International Name):

Betahistine dihydrochloride

Dosage:

16mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5055565700365

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 CONTAINS
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, si

Summary of Product characteristics

PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Betahistine dihydrochloride 16mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16mg of betahistine dihydrochloride.
One Betahistine dihydrochloride 16mg Tablet contains 140mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, circular, flat bevelled-edge uncoated tablets, impressed B16 on
one
face with a score line on the reverse.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Betahistine tablets are indicated in the treatment of vertigo,
tinnitus and
hearing loss associated with Ménière's disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _
_Initial dosage:_ 1 tablet, 3 times daily, preferably with food.
_Maintenance dose:_ The dose may be adjusted according to response to
a
maintenance dose of between 24 and 48mg daily.
_Elderly:_ No adjustment in dosage is necessary.
_Paediatric population: _Betahistine is not recommended for use in
children
below 18 years due to insufficient data on safety and efficacy.
_Renal impairmen_t: 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.
For oral use.
Betahistine dihydrochloride tablets should be taken with a glass of
water,
preferably with food.
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 tumour resulting in severe hypertension.
Hypersensitivity to betahistine dihydrochloride or any of the
excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Betahistine tablets should be administered with caution in patients
with a history of
peptic ulcer.
Clinical intolerance to betahistine has been demonstr