BETASERC 16MG TABLETS

Country: Malaysia

Language: English

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

Active ingredient:

(REFER BETA1697)

Available from:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Name):

(REFER BETA1697)

Units in package:

60Tablet Tablets

Manufactured by:

Abbott Healthcare SAS

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
BETASERC
® TABLETS
Betahistine dihydrochloride (16mg, 24mg)
Page no. 1
HAT 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_®
_16 MG _
_ _
16MG BETAHISTINE DIHYDROCHLORIDE
Betaserc 16 mg is a round, biconvex, scored, white tablet with
beveled edges. On the one side, the tablet is scored and the
number 267 is engraved on either side of the score line.This
tablet is for oral administration (to be taken by mouth) and
contains 16 mg of betahistine dihydrochloride. The tablet can
be divided into equal halves.
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
core
symptoms:
• vertigo (with nausea/vomiting)
• hearing loss (hardness of hearing)
• tinnitus (ringing in the ears)
Symptomatic treatment of vestibular vertigo.
DOSAGE AND ADMINISTRATION
Always take Betaserc exactly as your doctor has prescribed.
If you have any questions, contact your doctor or pharmacist.If
you forget to take your tablet(s), do not take a double dose to
compensate for it. If you require further information, please ask
your doctor or pharmacist for advice.
The dosage for adults is 24–48 mg divided over the day.
16 mg tablets
½ – 1 tablet
3 times daily
Your doctor will adjust the dosage according to your response
to the medication. Improvement of symptoms may take up to
two weeks and the best results are sometimes obtained only
after a few months. There are indications that treatment from
the onset of the disease prevents its progression and/or the
loss of hearing in later phases of the disease.
_Pediatric population: _
Betaserc is not recommended for use in children under the age
of 18 years due to insuffi cient data on safety and efficacy.
_ _
_Geriatric population: _
No dose adjustment is required in elderly.
_ _
_Renal impairment: _
No dose adjustment is required in renal impaired patients.
_ _
_Hepatic impairment: _
No dose adjustment is required in hepatic impaired patients.
CONTRAINDICATIONS
Do not take Betaserc if you are hypersensitive (allergic) to the
active substance or to any