Betahistine 16mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betahistine dihydrochloride

Available from:

Waymade Healthcare Plc

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

Patient Information leaflet

WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Betahistine
if you have asthma
if you have a stomach ulcer.
OTHER MEDICINES AND BETAHISTINE
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription.
antihistamines to treat allergies and hay fever
monoamine-oxidase inhibitors (MAOI's) to
treat depression and Parkinson's disease.
BETAHISTINE WITH FOOD AND DRINK
Swallow the tablets whole with a drink of water
and take with meals.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Do not breast-feed while taking Betahistine unless
your doctor tells you to. It is not known if
Betahistine passes into breast milk.
DRIVING AND USING MACHINERY
There are no known effects of this medicine on
your ability to drive or use machinery.
However, vertigo, tinnitus and hearing loss
associated with Ménière's disease can make you
feel dizzy or be sick, and may affect your ability to
drive or use machinery.
BETAHISTINE CONTAINS LACTOSE
These tablets contain lactose. If you have been
told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking
this product.
3.
HOW TO TAKE BETAHISTINE
Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Betahistine dihydrochloride
Betahistine dihydrochloride
8mg and 16mg Tablets
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, ta

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