NORGESIC paracetamol orphenadrine citrate tablet jar

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

orphenadrine citrate, Quantity: 35 mg; paracetamol, Quantity: 450 mg

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; Gelatin

Administration route:

Oral

Units in package:

24 tablets, 8 tablets (sample pack), 500 tablets, 100 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: white scored biconvex tablet marked "N/C" on one side and no markings on the other side; Container Type: Jar/Can; Container Material: PP; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-04

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 swallowing, and

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – NORGESIC (ORPHENADRINE
AND PARACETAMOL) TABLETS
1
NAME OF THE MEDICINE
Orphenadrine and paracetamol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Orphenadrine citrate 35 mg and paracetamol 450 mg tablets.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, uncoated
White, scored, immediate release tablets marked N/C on one side and no
markings on the other
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
2 tablets three times daily.
4.3
C
ONTRAINDICATIONS
•
Glaucoma
•
Prostatic hypertrophy or obstruction at the bladder neck,
•
Myasthenia gravis
•
Oesophageal spasm and pyloric or duodenal obstruction.
•
Hypersensitivity to paracetamol or orphenadrine citrate.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED 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.
2
Concomitant treatment with other medicines that contain orphenadrine
or paracetamol is not
recommended.
Safety of continuous long-term therapy with orphenadrine has not been
established. Therefore
if orphenadrine is prescribed for prolonged use, periodic monitoring
of blood, urine and liver
function is recommended.
USE IN THE ELDERLY
The elderly should be advised to take a reduced dosage as they may be
more susceptible to anti-
cholinergic side effects at regular doses.
PAEDIATRIC USE
NORGESIC is not recommended for children under 12 years of age.
EFFECTS ON LABORATORY TESTS
4.5
I
NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS
Interactions have been