Panadol Caplet 500mg Optizorb Formulation

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Paracetamol

Boleh didapati daripada:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

Paracetamol

Unit dalam pakej:

144 Tablets; 36 Tablets; 36 Tablets; 144 Tablets

Dikeluarkan oleh:

STERLING DRUG (MALAYA) SDN. BHD.

Risalah maklumat

PANADOL CAPLET
_Consumer Medication Information Leaflet (RiMUP) _
500MG OPTIZORB FORMULATION
Paracetamol 500mg, 0.2% w/w sodium parabens
1
WHAT IS IN THIS LEAFLET
1.
What Panadol Caplet
500mg Optizorb
Formulation is used for
2.
How Panadol Caplet
500mg Optizorb
Formulation works
3.
Before you use Panadol
Caplet 500mg Optizorb
Formulation
4.
How to use Panadol Caplet
500mg Optizorb
Formulation
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Panadol Caplet 500mg
Optizorb Formulation
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT PANADOL CAPLET 500MG
OPTIZORB FORMULATION IS USED
FOR
Paracetamol helps to relief pain
(analgesic) and fever
(antipyretic).
Relief of fever.
Relief of headache, migraine,
sore throat, fever and
toothache.
HOW PANADOL CAPLET 500MG
OPTIZORB FORMULATION WORKS
Paracetamol is a fever and pain
reliever. Its mechanism of
action is believed to include
inhibition of prostaglandin
synthesis, primarily within the
central nervous system.
BEFORE YOU USE PANADOL
CAPLET 500MG OPTIZORB
FORMULATION
_- When you must not use it _
Do not use if you are allergic to
paracetamol or any of the other
ingredients in the product.
Do not use this medicine if you
are taking any other
prescription or non-prescription
medicines containing
paracetamol to treat pain, fever,
symptoms of cold and flu, or to
aid sleep.
Do not take Panadol Caplet
500mg Optizorb Formulation if
you are pregnant, trying to get
pregnant or think you may be
pregnant.
Ask your doctor or pharmacist
for advice before taking any
medicine.
_- Before you start to use it _
Check with your doctor before
use if:
•
you have liver or kidney
problems.
•
are underweight or
malnourished.
•
regularly drink alcohol.
You may need to avoid using
this product altogether or limit
the amount of paracetamol that
you take.
Check with your doctor before
use if:
•
you have a severe infection
as this may increase the
risk of metabolic
acidosis.Signs of
metabolic acidiosis
include: deep, rapid,
diff

Ciri produk

National Pharmaceutical Regulatory Agency (NPRA)
Ministry of Health
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz),
46200 Petaling Jaya, Selangor,
Malaysia
GlaxoSmithKline
Consumer Healthcare Sdn Bhd
Lot 89, Jalan Enggang, Ampang/
Hulu Kelang Industrial Estate
68000 Selangor Darul Ehsan
P.O. Box 9, Jalan Semarak
54700 Kuala Lumpur, MALAYSIA
[phone]
HALEON.COM
GlaxoSmithKline Consumer Healthcare Sdn Bhd, Lot 89, Jalan Enggang,
Ampang/Hulu
Kelang Industrial Estate, 68000 Selangor Darul Ehsan, Malaysia
Registered in Malaysia
Registration Number:
195901000115 (3467- X)
12 January 2023
Dear Sir/Madam
POST
APPROVAL
COMMITMENT
–
PANADOL
CAPLET
500MG
OPTIZORB
FORMULATION (MAL14055166XRZ)
We, GlaxoSmithKline Consumer Healthcare Sdn Bhd, hereby commits to
submit for
variation application to remove the pack sizes 30s and 150s from
package insert during
our next artwork change.
The reason artworks change was not performed for variation submission
(variation code:
74366) is because there is large amount of existing printed package
insert for depletion,
and in order to cope with the surge in market demand during the
pandemic and post-
pandemic, we would continue to use the current package insert.
Besides, there is a statement to clarify “not all pack size may be
marketed” on the current
approved package insert which unlikely will cause queries from
consumer on the selling
pack sizes; thus assessed as almost no risk to consumer.
Internally we will also raise this commitment in our system where our
global colleague
will monitor if fulfilment has been completed within the timeframe;
which affirming that
we will not miss this commitment made to authority.
Yours faithfully
CHRISTINE SIEW
Regulatory Affairs Manager
[e-mail]
Christine
Siew
Digitally signed
by Christine Siew
Date: 2023.01.12
13:57:49 +08'00'