Cebrotonin 800mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PIRACETAM

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PIRACETAM

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Artesan Pharma GmbH & Co. KG

Risalah maklumat

CEBROTONIN 800 MG FILM-COATED TABLET
Piracetam (800 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What CEBROTONIN is used for
2.
How CEBROTONIN works
3.
Before you use CEBROTONIN
4.
How to use CEBROTONIN
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
CEBROTONIN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT CEBROTONIN
IS USED FOR
Treatment of the elderly with some degree
of cerebral functional impairment such as
loss of memory, a lack of concentration or
alertness and feeling of dizziness.
CEBROTONIN is indicated for patients
suffering
from
myoclonus
of
cortical
origin, irrespective of aetiology and should
be used in combination with other anti-
myoclonic therapies.
HOW CEBROTONIN WORKS
CEBROTONIN
contains
the
active
ingredient Piracetam. It acts on the brain
and
nervous
system
and
is
thought
to
protect it against a shortness of oxygen.
CEBROTONIN
is
used
in
combination
with other medicines to treat myoclonus.
This is a condition in which the nervous
system causes muscles, particularly in the
arms and legs, to start to jerk or twitch
uncontrollably.
BEFORE YOU USE CEBROTONIN
-
_When you must not use it _
Do not take CEBROTONIN if:
•
You are allergic (hypersensitive) to the
active
ingredient
piracetam,
other
pyrrolidone derivatives or to any of the
other
ingredients
of
CEBROTONIN
(see section Product Description).
•
You
have
ever
had
serious
kidney
problems
•
You
have
ever
experienced
a
brain
haemorrhage
•
You suffer from Huntington’s Disease
(also known as Huntington’s Chorea)
If any of the above applies to you, do not
take
CEBROTONIN
and
talk
to
your
doctor or pharmacist.
_ _
-
_Before you start to use CEBROTONIN _
Check
with
your
doctor
before
taking
CEBROTONIN if:
•
You think your kidneys may not be
working perfectly. (Your doctor may
need to start you on a lower dose)
•
You have ever had any kind of bleeding
problem.
If
you
are
pregnant,
trying
to
become
pregnant or br

Ciri produk

CEBROTONIN
(Piracetam)
NAME OF THE MEDICINAL PRODUCT
CEBROTONIN 800 mg film-coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 800 mg of piracetam.
_Excipients_
Povidone, colloidal anhydrous silica, magnesium stearate, talc,
hypromellose, propylene glycol, macrogol 6000, titanium
dioxide, iron oxide yellow.
PHARMACEUTICAL FORM
Film-coated tablets
Appearance: Slightly yellow to beige, smooth to shine, oblong coated
tablets with breaking notch
CLINICAL INFORMATION
Indications
Treatment of the elderly with some degree of cerebral functional
impairment such as loss of memory, a lack of concentration
or alertness and vertigo. CEBROTONIN is indicated for patients
suffering from myoclonus of cortical origin, irrespective of
aetiology and should be used in combination with other anti-myoclonic
therapies.
Dosage and Administration
Piracetam may be taken with or without food. The film-coated tablets
should be swallowed with liquid. It is recommended to
take the daily dose in two to four sub-doses.
Route of Administration
For oral use.
Adults
The daily dosage should begin at 7.2 g, increasing by 4.8 g every
three or four days up to a maximum of 24 g, in two or three
divided doses. Treatment with other anti-myoclonic medicinal products
should be maintained at the same dosage. Depend-
ing on the clinical benefit obtained, the dosage of other such
medicinal products should be reduced, if possible.
Once started the treatment with piracetam should be continued for as
long as the original cerebral disease persists. In pa-
tients with an acute episode, spontaneous evolution may occur over
time and an attempt should be made every 6 months to
decrease or discontinue the medicinal treatment. This should be done
by reducing the dose of piracetam by 1.2 g every two
days (every three or four days in the case of a Lance- Adams syndrome,
in order to prevent the possibility of sudden relapse
or withdrawal seizures).
Elderly
Adjustment of the dose is recommended in elderly patients with
compromised rena