Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2021 Publisher: Beximco Pharmaceuticals Australia, 4 Miami Key, Broadbeach Waters, QLD 4218
Parapane Osteo provides effective relief from persistent pain for up to 8 hours. Effective for the relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache. Parapane Osteo also provides effective temporary relief of pain and discomfort associated with: headache, tension headache, cold and flu, period pain, toothache and pain after dental procedures. Reduces fever.
Adults and children aged 12 years and over: 2 tablets swallowed whole three times a day every 6 to 8 hours. Do not chew or suck, as it impairs the sustained release properties. Maximum of 6 tablets in 24 hours.
Do not use for more than a few days at a time in adults except on medical advice.
Children under 12 years: Not recommended for children under the age of 12 years.
Should not be used for more than 48 hours for children aged 12-17 years except on medical advice.
Take with water or other fluid.
Can be taken with or without food.
Doses should be equally spaced throughout the day.
The tablets must not be crushed.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.
Should not be used with other paracetamol-containing products.
Minimum dosing interval: 6 hours.
Maximum daily dose for children 12 years of age to adults: 4000 mg.
If an overdose is taken or suspected, the patient should go to the nearest hospital straight away. This should be done even if they feel well because of the risk of delayed, serious liver damage (See Section 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS))".
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Because Parapane Osteo is a sustained-release formulation of paracetamol, absorption will be prolonged in overdose. It is recommended that for the management of overdose, where Parapane Osteo is suspected, that an additional plasma paracetamol level be obtained 4-6 hours after the initial measurement. If either level is above or close to the treatment line on the paracetamol overdose nomogram, administration of antidote would be indicated.
Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.
Immediate medical management is required in the event of an overdose, even if the symptoms of overdose are not present.
Administration of N-acetylcysteine may be required.
In cases of overdosage, methods of reducing absorption of ingested drug are important. Activated charcoal may reduce absorption of the medicine if given within one hour after oral ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
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.
Store below 30°C.
Alu-PVDC blister packs of 24, 48 and 96 tablets.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.
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