Betaserc 16mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC code:

N07CA01

INN (International Name):

BETAHISTINE DIHYDROCHLORIDE 16 mg

Pharmaceutical form:

TABLET

Composition:

BETAHISTINE DIHYDROCHLORIDE 16 mg

Prescription type:

POM

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Authorised

Authorization date:

2006-05-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETASERC 16 MG TABLETS
BETASERC 24 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Betaserc is and what it is used for
2. What you need to know before you use Betaserc
3. How to use Betaserc
4. Possible side effects
5. How to store Betaserc
6. Contents of the pack and other information
1. WHAT BETASERC IS AND WHAT IT IS USED FOR
The group of medicines, to which Betaserc belongs, are medicines for
the treatment of dizziness.
Betaserc is used in Ménière’s disease. The symptoms of this are:
•
feeling dizzy and feeling or being sick
•
ringing in the ears
•
hearing loss or hearing problems.
Feeling dizzy – caused when the part of your inner ear which
controls your balance is not working
properly (called “vestibular vertigo”).
HOW BETASERC WORKS
The mechanism of action of Betaserc is only partially known. Research
shows that Betaserc can prevent
an attack of Meniere’s disease or reduce the severity of attacks.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETASERC
DO NOT TAKE BETASERC :
•
if
you are allergic (hypersensitive) to betahistine (dichloride) or any
of the ingredients of
Betaserc (see section 6).
•
if
you have pheochromocytoma (a rare adrenal gland disorder).
Do not take this medicine if any of the above points apply to you. If
you are not sure, ask your doctor
or pharmacist for advice before taking Betaserc.
WARNINGS AND PRECAUTIONS.
Please note the following points before you start using Beta

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Betaserc
®
16 mg tablets
Betaserc
®
24 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betaserc
®
tablets contain 16 or 24 mg betahistine dihydrochloride equivalent to
10.42 or
15.63 mg betahistine.
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Betaserc
®
tablet, 16 mg:
A round, biconvex, scored, white to almost white tablet with bevelled
edges. The diameter
is 8.5 mm; the tablet weight is about 250 mg. The inscription is 267
on either side of the
score on one tablet-side.
_ _
The tablet can be divided into equal halves
Betaserc
®
tablet, 24 mg:
A round, biconvex, scored, white to almost white tablet with bevelled
edges and relevant
inscriptions. The diameter is 10 mm; the tablet weight is about 375
mg. The inscription is
289 on either side of the score on one tablet-side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ménière's Syndrome as defined by the following triad of core
symptoms:
- vertigo (with nausea/vomiting)
- hearing loss (hardness of hearing)
- tinnitus
Symptomatic treatment of vestibular vertigo.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Betaserc
®
tablets 16 mg:
The dosage for adults is 24-48 mg divided over the day.
Page 2 of 7
_16 mg tablets _
1/2-1 tablet
3 times/day
Betaserc
®
tablets 24mg:
The dosage for adults is 48mg divided over the day.
_24 mg tablets_
1 tablet
2 times/day
The dosage should be individually adapted according to the response.
Improvement can
sometimes only be observed after a couple of weeks of treatment. The
best results are
sometimes obtained after a few months. There are indications that
treatment from the
onset of the disease prevents the progression of the disease and/or
the loss of hearing in
later phases of the disease.
Paediatric population:
Betaserc
®
is not recommended for use in children below 18 years due to
insufficient data
on safety a