LECETAM 500MG FILM COATED TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

6 x 10 Tablets; 3x10 Tablets; 10x10 Tablets

Dikeluarkan oleh:

UNISON LABORATORIES CO.LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP)_
1
LECETAM FILM COATED TABLET
Levetiracetam (250mg, 500mg)
WHAT IS IN THIS
LEAFLET
1.
What LECETAM is used
for
2.
How LECETAM
works
3.
Before you use
LECETAM
4.
How to use
LECETAM
5.
While you are using
it
6.
Side
effects
7.
Storage and Disposal of
LECETAM
8.
Product
Description
9.
Manufacturer and
Product
Registration
Holder
10. Date of
revision
WHAT LECETAM IS USED
FOR
LECETAM is
used:
• on its own in adults and
adolescents
from
16 years of age with a certain
type
of newly diagnosed epilepsy. Epilepsy
is
a condition where the patients
have
repeated fits (seizures). Levetiracetam
is
used for the epilepsy form in which
the
fits initially affect only one side of
the
brain, but could thereafter extend
to
larger areas on both sides of the
brain
(partial onset seizures with or
without
secondary generalization). LECETAM
has
been given to you by your doctor
to
reduce the number of
fits.
• as an add-on to other
antiepileptic
medicines to
treat:
- partial onset seizures with or
without
secondary generalization in adults
and
children from 4 years of age
with
epilepsy.
- myoclonic seizures (short,
shock-like
jerks of a muscle or group of
muscles)
in adults and adolescents from
12
years
of age with juvenile
myoclonic
epilepsy
- primary generalized
tonic-clonic
seizures (major fits, including loss
of
consciousness) in adults and
children
from 12 years of age with
Idiopathic
Generalized
Epilepsy.
HOW LECETAM
WORKS
LECETAM is an antiepileptic
medicine
(a
medicine used to treat
seizures
in epilepsy).
BEFORE YOU USE
LECETAM
-
_ When you must not use _
_it_
Do not take
LECETAM
• If you are allergic to
levetiracetam,
pyrrolidone derivatives or any of
the
other ingredients of this medicine
(see
section
PRODUCT
DESCRIPTION
).
_Pregnancy and _
_breastfeeding:_
If you are pregnant or breastfeeding,
think
you may be pregnant or are planning
to
have a baby, ask your doctor for
advice
before taking this
medicine.
LECETAM should not be used
during
pregnancy unless clearly necessary

Ciri produk

IRA Memo 22-096 (D)_Dec 2022 (RA)
_PART II – SECTION P3.2 –QUEST 3+ _
1 of 4
PART II – SECTION P: PRODUCT INFORMATION
P3.
MANUFACTURER
P3.2
Manufacturing
Process and
Process
Controls
The manufacturing process includes the following stages:
0
MACHINE/ EQUIPMENT USED
FOR WEIGHING PROCESS
FOR FINAL BLENDING PROCESS
Weighing Balance
Container Blender (CB240)
FOR PREPARATION OF GRANULATING
LIQUID (BINDER) PROCESS
Container Blender Machine
FOR TABLETING PROCESS
Stainless Steel Tank
Rotary Tableting Machine
Homogenizer
FOR FILM COATING PROCESS
FOR PREMIXING PROCESS
Stainless Steel Tank
Stainless Steel Tank
Homogenizer
High Speed Mixer Machine
Film Coating Machine
FOR WET GRANULATION PROCESS
FOR PRIMARY PACKAGING PROCESS
High Speed Mixer Machine
Blister Packing Machine
Wet Granulator Machine
FOR SECONDARY PACKAGING
PROCESS
FOR DRYING PROCESS
Auto Shrink Machine
Fluid Bed Dryer Machine
Air Blower
FOR SCREENING PROCESS
Stainless Steel Tank
Dry Granulator Machine
Container Blender (CB240)
STAGE 1
: WEIGHING THE INGREDIENTS
The specified quantities of all the ingredients in the formula are
accurately
weighed.
STAGE 2
: PREPARATION OF GRANULATING LIQUID (BINDER)
Dissolve
1.3300
Kg
Povidone
(PVP
K-30)
into
a
stainless
steel
tank
containing 3.4000 Kg Isopropyl alcohol, then add 1.4500 Kg Purified
water.
Switch on a Homogenizer, stir until completely dissolved and a clear
solution
is obtained.
STAGE 3
: PREMIXING
3.1
Pass 50.0000 Kg Levetiracetam and 3.6000 Kg Croscarmellose sodium
through a 40 mesh screen into a stainless steel tank.
3.2
Transfer the ingredients from stage 3.1 into High Speed Mixer Machine
and mix together for 5 minutes.
STAGE 4
: WET GRANULATION
4.1
Add the granulating liquid (stage 2) into High Speed Mixer Machine
and mix for approximately 3 minutes or until a damp mass is obtained
(additional quantity of Purified water and Isopropyl alcohol are
allowed
to be added as appropriate).
4.2
Move out the mixture parts stuck on the inner side of the mixer using
a
clean spatula and add into the mixture then mix