Betaserc 24mg Tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

BETAHISTINE DIHYDROCHLORIDE

Available from:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Name):

BETAHISTINE DIHYDROCHLORIDE

Units in package:

20Tablet Tablets; 50Tablet Tablets; 100Tablet Tablets

Manufactured by:

Mylan Laboratories SAS

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
BETASERC® TABLETS
Betahistine dihydrochloride (16mg, 24mg)
Page no. 1
WHAT IS IN THIS LEAFLET
1. What Betaserc® is used for
2. How Betaserc® works
3. Before you use Betaserc®
4. How to use Betaserc®
5. While you are using it
6. Side effects
7. Storage and disposal of Betaserc®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT BETASERC®
IS USED FOR
Betaserc® is used to treat Ménière's
syndrome that has the following
symptoms
•
Dizziness (vertigo) with
nausea and vomiting
•
Ringing in ears (tinnitus)
•
Hearing loss
Betaserc® is also used to treat
vestibular vertigo.
HOW BETASERC® WORKS
Betaserc® contains betahistine which
improves blood flow in the ear that
lowers the buildup of pressure.
BEFORE YOU USE BETASERC®
_- When you must not use it_
Do not take Betaserc® if:
•
You are allergic
(hypersensitive) to
betahistine or any of the
other ingredients of
Betaserc®
•
You have high blood
pressure due to adrenal
tumor.
(Phaeochromocytoma)
Do not use Betaserc® if any of the
above applies to you. If you are not
sure, talk to your doctor or
pharmacist before taking Betaserc®.
_ _
_ _
_- Before you start to use it _
Talk to your doctor or pharmacist
before taking Betaserc® if you suffer
from any medical conditions
or illnesses, in particular:
•
if you have stomach ulcer
•
if you have asthma
Your doctor may want to monitor
your asthma while you take
Betaserc®.
_- Taking other medicines _
It is particularly important to tell your
doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This also
concerns medicines obtained without
a prescription including herbal
medicines. Tell your doctor or
pharmacist if you are taking any of
the following medicines:
•
antihistamines (drug
commonly used in allergies)
•
Monoamine-oxidase
inhibitors (MAOIs) (drug
used to treat depression or
Parkinson’s disease)
HOW TO USE BETASERC®
_- How much to use _
Follow all dir

Summary of Product characteristics

_BETASERC_® _24MG TABLET _
24MG BETAHISTINE DIHYDROCHLORIDE
PRODUCT DESCRIPTION
Betaserc® 24mg Tablet is a round, biconvex, scored, white to almost
white tablet with beveled
edges. The diameter is 10mm; the tablet weight is about 375mg. 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.
Excipients
(non-medicinal
ingredients):
Microcrystalline cellulose, mannitol (E421), citric acid monohydrate,
colloidal anhydrous silica
and talc.
INDICATIONS
Ménière’s Syndrome as defined by the following triad of core
symptoms:
• vertigo (with nausea/vomiting)
• hearing loss (hardness of hearing)
• tinnitus (ringing in the ears)
Symptomatic treatment of vestibular vertigo.
DOSAGE AND ADMINISTRATION
The dosage for adults is 48mg divided over the day.
24 mg tablets
1 tablet
2 times/day
Method of administration:
Betaserc® 24mg Tablet: Should be swallowed with water.
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.
Pediatric population:
Betaserc® 24mg Tablet is not recommended for use in children under
the age of 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-
marketin