Betahistine 8mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Betahistine dihydrochloride

Διαθέσιμο από:

DE Pharmaceuticals

Φαρμακολογική κατηγορία (ATC):

N07CA01

INN (Διεθνής Όνομα):

Betahistine dihydrochloride

Δοσολογία:

8mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04060000

Φύλλο οδηγιών χρήσης

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
�

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betahistine dihydrochloride 8 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16mg of betahistine dihydrochloride
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Round, biplane white or almost white tablets with bevel-edges on both
sides. The
tablet is marked with ‘B8’ on one side.
4.1. THERAPEUTIC INDICATIONS
Vertigo, tinnitus and hearing loss associated with Ménière’s
syndrome.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including elderly):_ Initially 16 mg three times daily, taken
preferably with
meals. Maintenance doses are generally in the range 24-48 mg 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.
_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.
ROUTE OF ADMINISTRATION: Oral._ _
4.3. CONTRAINDICATIONS
Phaeochromocytoma. Hypersensitivity to the active substance or to 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 in bronchial
asthma patients has been shown in
relatively few patients. These patients need to be carefully monitored
during the therapy.
Contains lactose. Patients with rare hereditary problems of galactose
intolerance, the
Lapp lactase deficiency or glucose-galactose malabsorption should not
take this
medicine.
4.5.
INTERACTION WITH OTHER