Betaserc 24 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC code:

N07CA01

INN (International Name):

BETAHISTINE DIHYDROCHLORIDE 24 mg

Pharmaceutical form:

TABLET

Composition:

BETAHISTINE DIHYDROCHLORIDE 24 mg

Prescription type:

POM

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Product summary:

Licence number in the source country: Romania - 2717/2010/01-02-03-04

Authorization status:

Authorised

Authorization date:

2024-01-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Betaserc and
tell your doctor.
�

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Betaserc 24 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betaserc tablets contain 24 mg betahistine dihydrochloride
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Betaserc 24 mg:
White or almost white, round, biconvex tablets with a score line on
one side and marked
"289" on either side of the scoreline.
The score line is intended to make it easier to break the tablet to
make it easier to take and
not to divide the tablet into 2 equal parts
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 24mg:
The dosage for adults is 48mg divided over the day.
_24 mg tablets _
1 tablet
2 times/day
Page 2 of 7
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 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 nece