Betahistine 16mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betahistine dihydrochloride

Available from:

Kent Pharma (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: 5015201004530

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT- KENT & ALMUS
BETAHISTINE DIHYDROCHLORIDE
8MG AND 16MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.

IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
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 THE LEAFLET.
WHAT IS IN THIS LEAFLET
1. What Betahistine Dihydrochloride is and what it is used for
2. What you need to know before you take Betahistine
Dihydrochloride
3. How to take Betahistine Dihydrochloride
4. Possible side effects
5. How to store Betahistine Dihydrochloride
6. Contents of the pack and other information
1. WHAT BETAHISTINE DIHYDROCHLORIDE IS AND WHAT IT IS USED FOR
The name of your medicine is Betahistine Dihydrochloride 8mg or 16mg
Tablets. Betahistine
dihydrochloride is a type of medicine called a histamine analogue. It
is used as a treatment for Ménière’s
syndrome, a condition caused by the pressure of excess fluid in the
inner ear. Betahistine dihydrochloride
is thought to work by improving blood flow in the inner ear, which
reduces the build up of pressure. It is
this pressure in the ear which is thought to cause the vertigo
(dizziness), tinnitus (ringing in the ears) and
hearing loss suffered by people with Ménière’s disease
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAHISTINE
DIHYDROCHLORIDE
DO NOT TAKE YOUR MEDICINE IF YOU:

have ever had an allergic reaction to betahistine dihydrochloride or
any of the other ingredients listed
in section 6, Further information
have phaeochromocytoma (a tumour associated with the adrenal gland
which causes high blood
pressure)WARNING AND PRECAUTIONS
Take special care and tell your doctor if:

have or have ever

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