Norgesic

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Orphenadrine citrate; Paracetamol

Available from:

iNova Pharmaceuticals Australia Pty Ltd

Class:

Medicine Listed (Export Only)

Patient Information leaflet

NORGESIC™

_TABLETS_
_Orphenadrine citrate 35mg & Paracetamol 450mg_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Norgesic tablets.
However it does not contain all the
available information. Your doctor
and pharmacist have more
information about this medicine.
IF YOU HAVE ANY QUESTIONS ABOUT
NORGESIC THAT ARE NOT ANSWERED BY
THIS LEAFLET, PLEASE ASK YOUR DOCTOR
OR PHARMACIST.
All medicines have risks and
benefits. Your doctor has weighed
the risks of your taking Norgesic
against the benefits before
prescribing it for you.
IF YOU ARE WORRIED ABOUT TAKING
THIS MEDICINE PLEASE TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE AS YOU MAY WANT TO READ
IT AGAIN.
WHAT NORGESIC IS USED
FOR
The name of your medicine is
Norgesic. It contains orphenadrine
citrate and paracetamol.
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.
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 injury to your
muscles.
Your doctor may have prescribed
Norgesic for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
NORGESIC
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE NORGESIC IF YOU HAVE
HAD AN ALLERGIC REACTION TO
ORPHENADRINE CITRATE, PARACETAMOL
OR OTHER SIMILAR MEDICINES, OR TO
ANY OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
DO NOT TAKE NORGESIC IF YOU HAVE
ANY OF THE FOLLOWING:
•
glaucoma (high pressure in the
eye);
•
intestinal blockage or
oesophageal disease
•
enlarged prostate or bladder
obstruction;
•
myasthenia gravis (a disease of
the muscles causing drooping
eyelids, double vision, difficulty
in speaking and

Summary of Product characteristics

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PRODUCT INFORMATION 

NORGESIC 
ORPHENADRINE CITRATE AND PARACETAMOL 

NAME OF THE MEDICINE

Active ingredient: 
Orphenadrine citrate 
Chemical name: 
(RS)-N,N-Dimethyl-2-[(2-methylphenyl)phenylmethoxy]ethanamine 
dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate 
CAS number: 
 4682-36-4 
Chemical structure:  

Active ingredient: 
Paracetamol 
Chemical name: 
N-(4-Hydroxyphenyl)acetamide 
CAS number: 
103-90-2 
Chemical structure:

DESCRIPTION 
NORGESIC Tablets contain orphenadrine citrate 35 mg and
paracetamol 450 mg.  
Orphenadrine citrate is white
or almost white, crystalline powder. It is sparingly soluble
in water, 
and slightly soluble in alcohol. Paracetamol is a white
or almost white, crystalline powder that is 
sparingly soluble in water and freely soluble in alcohol
.

Excipients: Cellulose-microcrystalline, magnesium stearate,
silica-colloidal anhydrous, starch-
pregelatinised maize
.

PHARMACOLOGY 
Orphenadrine is a skeletal muscle relaxant.  Paracetamol is an analgesic and antipyretic. 

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INDICATIONS 
Tension headache, occipital headaches associated with spasm
of skeletal muscles in the region of 
the head and neck.  Acute and traumatic conditions of the
limbs and trunk:  sprains, strains, 
whiplash injuries, acute torticollis, prolapsed intervertebral disc. 
CONTRAINDICATIONS 
Glaucoma, prostatic hypertrophy or obstruction at the
bladder neck, myasthenia gravis
,

oesophageal spasm and pyloric or duodenal obstruction.

Hypersensitivity to paracetamol or orphenadrine citrate. 
PRECAUTIONS 
Orphenadrine citrate should be used with caution

in patients with

tachycardia, cardiac 
decompensation, coronary insufficiency or cardiac arrhythmias.  

Paracetamol
should be used with caution in patients with hepatic or renal
dysfunction.

Concomit