Betahistine 16mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Betahistine dihydrochloride

Disponible desde:

Teva UK Ltd

Código ATC:

N07CA01

Designación común internacional (DCI):

Betahistine dihydrochloride

Dosis:

16mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04060000; GTIN: 5017007300984

Información para el usuario

The name of your medicine is Betahistine
Dihydrochloride Tablets, which will be called
Betahistine Tablets throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
• 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.
Do not pass it on to others. It may harm them,
even if their symptoms 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.
1. WHAT BETAHISTINE TABLETS ARE AND WHAT THEY
ARE USED FOR
2. BEFORE YOU TAKE BETAHISTINE TABLETS
3. HOW TO TAKE BETAHISTINE TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BETAHISTINE TABLETS
6. FURTHER INFORMATION
WHAT BETAHISTINE TABLETS ARE AND
WHAT THEY ARE USED FOR
Betahistine Tablets contain 8 mg or 16 mg of the
active ingredient betahistine dihydrochloride.
Betahistine Tablets belong to a group of
medicines known as histamine analogues,
which means it closely resembles histamine – a
chemical found naturally in the body.
Betahistine works by improving blood flow in
the inner ear, which reduces the build up of
pressure. It is this pressure in the ear that
causes vertigo (dizziness), tinnitus (ringing in
the ears), and hearing loss suffered by people
with Ménière's disease.
BEFORE YOU TAKE BETAHISTINE
TABLETS
DO NOT TAKE BETAHISTINE TABLETS IF YOU:
•
are allergic (hypersensitive) to betahistine
or
any of the other ingredients of Betahistine
Tablets (see list of ingredients in Section 6).
An allergic reaction may include rash, itching,
difficulty breathing or swelling of the face,
lips, throat or tongue.
• have a phaeochromocytoma (a very rare
tumour of the adrenal gland).
TAKE SPECIAL CARE WITH BETAHISTINE TABLETS IF YOU
HAVE:
• had a peptic ulcer. Your doctor will monitor
you closely during your treatment.
• asthma. Your doctor will monitor you closely
during your treatment.
TAK

Ficha técnica

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