NORGESIC Tablet, uncoated Ref.[50936] Active ingredients: Orphenadrine Paracetamol

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2021  Publisher: iNova Pharmaceuticals (Australia) Pty Limited, Level 10, 12 Help Street, Chatswood NSW 2067, Australia, Tel: 1800 630 056

4.1. 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.

4.2. Posology and method of administration

2 tablets three times daily.

4.9. Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

No specific information is available on overdosage with NORGESIC.

Overdose of paracetamol can result in severe liver damage and sometimes acute renal tubular necrosis.

Symptoms and Signs

Orphenadrine overdosage: Known symptoms of overdose with orphenadrine include tachycardia, excitement, confusion and delirium leading to coma. Convulsions, dilated pupils and urinary retention may occur.

Paracetamol overdosage: Toxic symptoms following an overdose with paracetamol include vomiting, abdominal pain, hypotension, sweating, central stimulation with exhilaration and convulsions in children, drowsiness, respiratory depression, cyanosis and coma.

In adults, hepatotoxicity may occur after ingestion of a single dose of paracetamol 10 to 15g; a dose of 25g or more is potentially fatal.

Symptoms during the first two days of acute poisoning by paracetamol do not reflect the potential seriousness of the intoxication. Major manifestations of liver failure such as jaundice, hypoglycaemia and metabolic acidosis may take at least three days to develop.

Treatment

Prompt treatment is essential even when there are no obvious symptoms. In cases of overdosage, methods of reducing absorption of ingested medicine are important. Prompt administration of activated charcoal 50 g in 150 mL of water and 150 mL sorbitol 50% solution by mouth may reduce absorption. It is recommended that intravenous fluids such as normal saline be given concurrently. Gastric lavage is indicated if the patient is unwilling or unable to drink an activated charcoal/sorbitol mixture.

If the history suggests that paracetamol 150mg/kg body weight or 15 g total or more has been ingested, administer the following antidote:

Intravenous acetylcysteine 20%: Administer acetylcysteine immediately without waiting for positive urine test or plasma level results if 8 hours or less since overdose ingestion. Initial dose 150 mg/kg over 15 minutes, followed by continuous infusion of 50 mg/kg in glucose 5% 500 mL over four hours and 100 mg/kg in glucose 5% 1 L over 16 hours. If more than eight hours have elapsed since the overdose was taken, the antidote may be less effective.

Convulsions and delirium respond to relatively large doses of diazepam, preferably by mouth. Adequate hydration of the patient is important

6.3. Shelf life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4. Special precautions for storage

Store below 30°C.

6.5. Nature and contents of container

PP jars with PP child-resistant closure: 8 (sample pack), 24, 100, and 500s#

PVC/Al blisters: 8 (sample pack), 24, 100’s.

# - not marketed.

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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