Norgesic tablet

Država: Malezija

Jezik: angleščina

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

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Navodilo za uporabo Navodilo za uporabo (PIL)
16-11-2021
Lastnosti izdelka Lastnosti izdelka (SPC)
27-07-2021

Aktivna sestavina:

ORPHENADRINE CITRATE; Paracetamol

Dostopno od:

iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch

INN (mednarodno ime):

ORPHENADRINE CITRATE; Paracetamol

Enote v paketu:

600 Tablets; 12 Tablets

Izdeluje:

Adcock Ingram Limited - A Medreich Group Company

Navodilo za uporabo

                                1
_Consumer Medication Information Leaflet (RiMUP) _
NORGESIC
® TABLET
Orphenadrine citrate / Paracetamol (35mg/ 450mg)
WHAT IS IN THIS LEAFLET
1.
What Norgesic is used for
2.
How Norgesic works
3.
Before you use Norgesic
4.
How to use Norgesic
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Norgesic
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT NORGESIC IS USED FOR
The name of your medicine is
Norgesic. It contains orphenadrine
citrate and paracetamol.
Norgesic is used to treat tension
headache and headaches caused by
spasm of the muscles in the back of
your head and neck.
It is also used to help relax certain
muscles in your body and to relieve the
pain and discomfort caused by sprains,
strains or other injuries such as
whiplash injuries, acute torticollis,
prolapsed intervertebral disc to your
muscles.
Your doctor may have prescribed
Norgesic for another purpose.
Ask your pharmacist or doctor if you
have any questions about this
medicine.
HOW NORGESIC WORKS
Orphenadrine citrate is a skeletal
muscle relaxant. It acts in the central
nervous system to produce muscle
relaxant effects. Paracetamol is used to
treat or prevent pain and reduce fever.
BEFORE YOU USE NORGESIC
-
_When you must not use it _
Do not take Norgesic if you have
any of the following:
•
glaucoma (high pressure in
the eye);
•
enlarged prostate or bladder
obstruction;
•
myasthenia gravis (a disease
of the muscles causing
drooping eyelids, double
vision, difficulty in speaking
and swallowing, and,
sometimes, muscle weakness
in the arms or legs).
Do not take Norgesic:
•
after the expiry date on the
pack;
•
if the packaging shows signs
of tampering.
•
unless advised by your doctor
_-Before you start to use it _
Tell your doctor or pharmacist if
•
you have allergies to any
other medicines, foods,
preservatives or dyes;
•
you have any heart problems;
•
you have any liver or kidney
problems;
•
you have alcohol abuse
problems.
•
you are taking other
Paracetamol
                                
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Lastnosti izdelka

                                Black
ARTWORK
COLOUR
100%
JOB NO. : JB-02513
UIC
: A5599
SKU
:
100193 104453
A5599_NORGESIC TABLET 600_TABS 12
COMPONENT : LEAFLET
COUNTRY : HK MY
DIELINE REF: Xxxxxx xxxxxx
EMO: ADCOCK
PRINTER: Xxxxxx Xxxxxxxxxxxx
PLEASE NOTE
V1
G247 FILE NAME:
94476_A5599_NORGESIC TABLET
600_TABS 12_HK MY_LT_V1
05.07.21 - V0 - Artwork build - Koragot
23.07.21 - V1 - Amend - Pornpawee
Guide
RE-TYPESET ARTWORK. DUE TO THE NATURE OF THE FILES RECEIVED, THIS
ARTWORK HAS BEEN RE-TYPESET.
THIS HI RES PDF IS NOT TO BE USED AS FINAL ARTWORK
SUPPLIER INFORMATION MAY BE PRESENT ON THE
PACKAGING
EMO/PRINTING VENDOR:
PLEASE SHARE THE ARTWORK PDF TO PRINTER FOR
CHECKS ON:
• COLOURS - NO. OF COLOURS, SEQUENCE, CMYK/PMS
• TEXT - LINE THICKNESS, FONT SIZE
• DIELINE - SIZE, EYEMARK, PRINT DIRECTION
• CODING - SIZE, LOCATION, VFA, FORMAT BKG COLOUR
MOVING FORWARD WHEN POSSIBLE ANY ADDITONAL
INFORMATION AND TECHNICAL CHECK REQUIRED BY EMO
ON THE ARTWORK BEFORE APPROVING.
PRODUCT DESCRIPTION
White, scored, biconvex tablet marked: Upper Face: N/C, Lower Face has
no markings.
Norgesic
®
Tablet
A5599
3.56 mm
2.03 mm
2.03 mm
1.77 mm
A5599
COMPOSITION
PRODUCT DESCRIPTION
Each tablet contains orphenadrine citrate 35mg, paracetamol 450mg
White, scored, biconvex tablet marked: Upper Face: N/C, Lower Face has
no markings.
PHARMACODYNAMICS
Orphenadrine is a skeletal muscle relaxant.
Paracetamol is an analgesic and antipyretic.
PHARMACOKINETICS
Orphenadrine is readily absorbed from the gastrointestinal tract and
is almost completely metabolised to at
least eight metabolites. Orphenadrine and its metabolites are excreted
from the body in the urine, with
a half life of 14 hours.
Paracetamol is also readily absorbed from the gastrointestinal tract
with peak plasma concentrations
occurring about 10 to 60 minutes after oral administration.
Paracetamol is distributed into most body
tissues. It has a half life of between 1 to 3 hours.
INDICATIONS
Tension headache, occipital headaches associated with spasm of
skeletal muscles in the region of the head
and n
                                
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