Betahistine 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betahistine dihydrochloride

Available from:

Genesis Pharmaceuticals Ltd

ATC code:

N07CA01

INN (International Name):

Betahistine dihydrochloride

Dosage:

8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5060014442598

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAHISTINE DIHYDROCHLORIDE 8MG AND 16MG 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 or pharmacist.
•
This medicine has been prescribed for you only. 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 or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Betahistine 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
These tablets contain Betahistine dihydrochloride.
They are used to treat vertigo, tinnitus (ringing in the ears) and
hearing loss associated with Meniere’s disease.
They work by reducing the pressure in your inner ear.
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
d
ihydrochloride Tablets (listed in section 6). The symptoms of an
allergic reaction include itching, nettle rash,
wheezing or swelling of the hands, throat, mouth or eyelids
•
if you have a phaeochromocytoma ( high blood pressure due to adrenal
tumour).
I
f you think any of the above points apply to you, do not take the
tablets. Talk to your doctor first and follow the advice given.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Betahistine tablets
•
if you have a stomach ulcer
�

Summary of Product characteristics

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