Betahistine dihydrochloride 16mg Tablets tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

betahistine (betahistine dihydrochloride)

Available from:

Accord Healthcare Limited

ATC code:

N07CA01

INN (International Name):

betahistine (betahistine dihydrochloride)

Dosage:

16mg

Pharmaceutical form:

tablets

Units in package:

(84/6x14/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-01-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAHISTINE
DIHYDROCHLORIDE 8 MG
TABLETS
BETAHISTINE
DIHYDROCHLORIDE 16 MG
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, pharmacist or nurse.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness 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.
WHAT IS IN THIS LEAFLET
1. What Betahistine dihydrochloride 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
Betahistine is a histamine analogue medicine that
is used to treat symptoms of Ménière’s
syndrome such as dizziness (vertigo), ringing in
the ears (tinnitus), loss of hearing and nausea.
This medicine works by improving blood flow in
the inner ear. This lowers the build up of
pressure. 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 dihydrochloride tablets (see
section 6, Contents of the pack and other
information).
•
if you have high blood pressure due to adrenal
tumour (phaeochromocytoma), a rare tumour of
the adrenal gland.
WARNING AND PRECAUTIONS
•
if have a stomach ulcer (peptic ulcer).
•
if you have asthma.
•
if you have nettle rash, skin rash or a cold in the
nose caused by an allergy, s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betahistine dihydrochloride 16 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Betahistine 2HCl Accord 8 mg tablets
Each tablet contains
Betahistine dihydrochloride 8 mg
Excipient(s) with known effect:
Each tablet contains 50 mg lactose monohydrate
Betahistine 2HCl Accord 16 mg tablets
Each tablet contains
Betahistine dihydrochloride 16 mg
Excipient(s) with known effect:
Each tablet contains 100 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, flat, 9.0. mm tablets with bevelled edges with the
inscription
‘BF’ on one side and a breakline on the other side.
The tablet can be divide into two equal halves.
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 t