Maxigesic 500mg150mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IBUPROFEN; Paracetamol

Boleh didapati daripada:

AFT PHARMACEUTICALS (SE ASIA) SDN BHD

INN (Nama Antarabangsa):

IBUPROFEN; Paracetamol

Unit dalam pakej:

100tablet Tablets; 50tablet Tablets; 32tablet Tablets; 16tablet Tablets; 10tablet Tablets

Dikeluarkan oleh:

Sigma Laboratories Pvt. Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (CMIL) _
_ _
Page 1 of 3
MAXIGESIC®
500MG/150MG FILM COATED TABLETS
(Paracetamol/Ibuprofren 500mg/150mg)
WHAT IS IN THIS LEAFLET

What Maxigesic® is used for

How Maxigesic® works

Before you use Maxigesic®

How to use Maxigesic®

While you are using Maxigesic®

Side effects

Storage and Disposal of Maxigesic®

Product Description

Registration number

Product Owner,
Registration Holder
and Manufacturer

Date of revision
WHAT MAXIGESIC® IS USED FOR
Maxigesic®
is used for relief of pain
and
reduction of fever and
inflammation.
Maxigesic®
is not addictive.
HOW MAXIGESIC®
WORKS
Maxigesic® contains paracetamol and
ibuprofen.
Paracetamol works to stop the pain
messages from getting through to the
brain. It also acts in the brain to
reduce
fever.
Ibuprofen belongs to a group of
medicines called non-steroidal anti-
inflammatory drugs (or NSAIDs). It
relieves pain and reduces inflammation
(swelling, redness or soreness).
BEFORE YOU USE MAXIGESIC®
_WHEN YOU MUST NOT USE IT _
Do not take Maxigesic® if you have
an
allergy to:

any medicine containing
paracetamol;

any medicine containing
ibuprofen;

any of the ingredients listed at
the
end of this leaflet;

aspirin or any other NSAIDs
Many medicines used to treat
headache,
period pain and other aches
and pains contain aspirin or NSAID
medicines. If you are not sure whether
you are taking any of these medicines,
ask your
pharmacist.
Some of the symptoms of an allergic
reaction may include:

shortness of breath;

wheezing or difficulty
breathing;

swelling of the face, lips, tongue
or
other parts of the body;

rash, itching or hives on the
skin;

stomach ache, fever, chills,
nausea
and vomiting;

fainting
If you are allergic to aspirin or NSAID
medicines and take Maxigesic®, these
symptoms may be severe.
Do not take this medicine if:

you are pregnant or intend to
become pregnant;

you are breast-feeding or
intend to
breast-feed;

you are (or have pr

Ciri produk

MM
MM
140 mm
FRONT
360 mm
22.5 mm
4
8
4
16 mm
4
8
4
®
Maxigesic
500mg/150mg Tablets
O
OH
HO
H
N
O
RK
Packaging Development Department
Site QA
Regulatory Affairs
(Contract Giver)
Prepared by
Apporved by
SIGMA LABORATORIES PVT. LTD.
Product Name
Maxigesic 500mg/150mg Tablets
Pharma Code: 30295
360(L) x 140(W) mm
Pack Size
NA
Dimensions
Board
Colours
PM000562-02
Artwork Code No
Superseded Artwork No. :
PM000562-01
Date
40 gsm bible paper
Type
Country : Malaysia
Black
Package Insert
MM
16 mm
06/01/2020
Reason for Change : 1) Product Registra on Holder address changed as
per
Customer Requirement.
NAME OF THE MEDICINE
®
Maxigesic 500mg/150mg Film Coated Tablets
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Paracetamol 500mg Ibuprofen 150mg
Paracetamol:
Chemical name: N-acetyl-p-aminophenol
CAS number: 103-90-2
Structural formula:
Ibuprofen:
Chemical name: (±) - 2 - (p - isobutylphenyl) propionic acid.
CAS number: 15687-27-1
Structural formula:
DESCRIPTION
Each capsule shaped film coated tablet contains Paracetamol 500mg
and Ibuprofen 150mg. Other ingredients are maize starch,
microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
opadry white (HMPC 2910/Hypromellose 15cP (E464), Lactose
Monohydrate, Titanium Dioxide (E171),Trisodium citrate (E331)
Macrogol/PEG 4000) and talc.
PHARMACOLOGY
_PHARMACOKINETICS: _
_Absorption _
Paracetamol is absorbed from the gastrointestinal tract with peak
plasma concentration occurring about 10 to 60 minutes after oral
administration.
Ibuprofen is absorbed following oral administration with maximum
plasma concentrations usually achieved in 60 to 120 minutes.
_Distribution _
Paracetamol is distributed into most body tissues. Ibuprofen is highly
protein bound.
_Metabolism _
Paracetamol is metabolised extensively in the liver and excreted in
the
urine, mainly as inactive glucuronide and sulphate conjugates. Less
that
5% is excreted unchanged. The metabolites of paracetamol include a
minor hydroxylated intermediate which has hepatotoxic activity. This
active intermediate is det