Betahistine 8mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Betahistine dihydrochloride

Verfügbar ab:

Teva UK Ltd

ATC-Code:

N07CA01

INN (Internationale Bezeichnung):

Betahistine dihydrochloride

Dosierung:

8mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04060000; GTIN: 5017007301042 5020220270477

Gebrauchsinformation

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

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betahistine Dihydrochloride 8mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Betahistine dihydrochloride 8 mg
Excipient(s) with known effect: Each tablet contains 50 mg lactose
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets for oral administration
Flat white tablets, with bevelled edge. Markings: R3 on one side
scoreline on the
reverse.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betahistine is indicated for the treatment of vertigo, tinnitus and
hearing loss
associated with Ménière's syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Adults _(including the elderly);_
Initially 16mg 3 times daily, taken preferably with meals. Maintenance
doses are
generally in the range 24-48mg daily.
Paediatric population: not recommended for use in children below 18
years due to
insufficient data on safety and efficacy.
Geriatric population: although there are limited data from clinical
studies in this
patient group,
extensive post marketing experience suggests that no dose adjustment
is necessary in
this
patient population.
Renal 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.
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.
METHOD OF ADMINISTRATION:
Swallow the tablet with water.
4.3
CONTRAINDICATIONS
Betahistine is contraindicated in patients with a phaeochromocytoma
and
hypersensitivity to betahistine dihydrochloride or any of the
excipients listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution is advised in the treatment of patients with a history of
peptic ulcer. Clinical
intolerance to betahistine dihydrochlo