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White, round, biconvex tablets engraved N scoreline C on one face and 3M on the other side. Each tablet contains orphenadrine citrate 35 mg and paracetamol 450 mg. The tablet formulation is colour-free, preservative-free, sugar-free and does not contain gluten or lactose.
NORGESIC is an analgesic and muscle relaxant. Orphenadrine citrate is a centrally acting compound which in animals selectively blocks facilitory functions of the reticular formation. Orphenadrine does not produce myoneural block, nor does it affect crossed extensor reflexes. Orphenadrine prevents nicotine induced convulsions but not those produced by strychnine.
The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate also possesses anticholinergic activity.
Paracetamol has analgesic and anti-pyretic actions but only weak anti-inflammatory properties. This may be explained by the presence of cellular peroxides at sites of inflammation which prevent inhibition of cyclo-oxygenase by paracetamol. At other sites, in conditions associated with low levels of cellular peroxides (eg pain, fever) paracetamol can successfully inhibit prostaglandin synthesis.
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.
NORGESIC tablets are indicated for use as an analgesic/muscle relaxant for the treatment of mild to moderate pain and musculoskeletal spasm of voluntary muscle. Appropriate use of NORGESIC is for painful conditions where muscular spasm is a component of the pain, such as painful muscular conditions, musculoskeletal spasm, sports muscle injuries and muscle contraction headaches.
Two tablets, three or four times daily.
NORGESIC is not recommended for children under 12 years of age.
The elderly should be advised to take a reduced dosage as they may be more susceptible to anti-cholinergic side effects at regular doses.
Bladder neck or prostate obstruction or hypertrophy, glaucoma, myasthenia, oesophageal spasm and pyloric or duodenal obstruction.
Hypersensitivity to paracetamol or orphenadrine citrate.
Consult a doctor should pain persist or worsen or treatment with NORGESIC exceeds more than 10 days continuously. Concomitant treatment with other medicines that contain orphenadrine or paracetamol is not recommended.
Caution is advised for patients with impaired kidney or liver function, or in patients with cardiac failure, coronary insufficiency, cardiac arrhythmias and tachycardia.
Caution should be advised if blurred vision, drowsiness or dizziness occurs as this may affect ability to drive or use machinery.
NORGESIC is not recommended for use during pregnancy.
It is unknown whether orphenadrine is excreted during lactation. However it is established that paracetamol is excreted into the breast milk, one to two hours after oral administration.
Adverse effects are mainly due to the mild anti-cholinergic action of orphenadrine and are usually associated with higher doses.
Patients taking tricyclic antidepressants and alcohol may have diminished ability to metabolise large doses of paracetamol.
Known symptoms of overdose with orphenadrine include tachycardia, hypersensitivity reactions, pruritus, euphoria, hallucinations, agitation, tremor, vomiting and gastric irritation, excitement, confusion and delerium leading to coma and convulsions. Dilated pupils and urinary retention may occur.
Overdose with paracetamol is known to be associated with gastrointestinal upset with diarrhoea, loss of appetite, nausea or vomiting, stomach cramps or pain and increased sweating. Hepatotoxicity, encephalophathy and death has also been associated with overdose and a possible associated increased risk of renal function impairment with chronic regular use of paracetamol has been suggested. Other severe effects include metabolic acidosis, renal failure and cardiac arrhythmias, jaundice, hypoglycaemia and metabolic acidosis are the major manifestations of liver failure and may take at least three days to develop.
Gastric lavage should be carried out immediately regardless of the estimated ingested dose. Prompt administration of 50 g activated charcoal by mouth may reduce absorption. If more than 15 g of paracetamol has been ingested, administer intravenously 20% acetyl-cysteine immediately. Alternatively administer methionine or 5% acetylcysteine orally.
Convulsions and delirium respond to relatively large doses of diazepam, preferably by mouth. Adequate hydration of the patient is important.
Store below 25°C.
Prescription Medicine
Blister foil strips of 12, 24 or 36 tablets.
Nil.
3M Pharmaceuticals
a division of 3M New Zealand Limited
P.O. Box 2201 Shortland Street
AUCKLAND
Telephone: (09) 444 5289
Facsimile: (09) 444 5770
11 December 1997
™NORGESIC and 3M are registered trademarks.