Betahistine 8mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Betahistine dihydrochloride

MAH:

Accord-UK Ltd

ATC_code:

N07CA01

INN:

Betahistine dihydrochloride

dosage:

8mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 04060000; GTIN: 5055565700341 5055565700358

PIL

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
�

SPC

OBJECT 1
BETAHISTINE DIHYDROCHLORIDE 8 MG TABLETS
Summary of Product Characteristics Updated 30-May-2018 | Accord
Healthcare Limited
1. Name of the medicinal product
Betahistine dihydrochloride 8 mg tablets
2. Qualitative and quantitative composition
Each tablet contains
Betahistine dihydrochloride 8 mg
Excipient(s) with known effect:
Each tablet contains 50 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White, round, flat, 6.5.mm tablets with bevelled edges with the
inscription 'BE' on one side and a
breakline on the other side.
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 treatment of Ménière's syndrome,
symptoms of which may include vertigo,
tinnitus, hearing loss and nausea.
4.2 Posology and method of administration
Dosage
Adults
Initial oral treatment is 8 to 16 mg three times daily, taken
preferably with meals.
Maintenance doses are generally in the range 24 - 48 mg daily. Daily
dose should not exceed 48 mg.
Dosage can be adjusted to suit individual patient needs. Sometimes
improvement could be observed only
after a couple of weeks of treatment.
There is no data available for patients with hepatic impairment.
There is no data available for patients with renal impairment.
There is limited data in the elderly, betahistine should be used with
caution in this population.
Children and adolescents:
Betahistine tablets are not recommended for use in children and
adolescents below age 18 due to lack of
data on safety and efficacy.
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
tumor resulting in severe hypertension.
Also contraindicated are the following:
• hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
4.4 Special warnings an