PARAPANE OSTEO Film-coated tablet Ref.[50302] Active ingredients: Paracetamol

Identified precautions

Contains paracetamol. Do not use with any other paracetamol- containing products. The concomitant use with other products containing paracetamol may lead to an overdose.

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

If symptoms persist, medical advice must be sought.

Keep out of sight and reach of children.

Use in hepatic impairment

Paracetamol should be used with caution in patients with impaired liver function: Underlying liver disease increases the risk of paracetamol-related liver damage.

Patients who have been diagnosed with liver impairment must seek medical advice before taking this medication.

Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, are chronic heavy users of alcohol or have sepsis.

In patients with glutathione depleted states the use of paracetamol may increase the risk of metabolic acidosis.

Use in renal impairment

Paracetamol should be used with caution in patients with impaired kidney function: Administration of paracetamol to patients with moderate to severe renal impairment may result in accumulation of paracetamol conjugates.

Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication.

Use in the elderly

No data available.

Paediatric use

Not recommended for children under 12 years of age.

Effects on laboratory tests

No data available.

The following interactions with paracetamol have been noted:

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Anticoagulant dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.

Paracetamol absorption is increased by substances that increase gastric emptying, e.g. metoclopramide.

Paracetamol absorption is decreased by substances that decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, and narcotic analgesics.

Paracetamol may increase chloramphenicol concentrations.

The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes such as alcohol and anticonvulsant agents.

Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.

Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.

Effects on fertility

No data available.

Use in pregnancy

Pregnancy Category A.

Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.

As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol. The lowest effective dose and shortest duration of treatment should be considered.

Use in lactation

Paracetamol is excreted in breast milk. Human studies with paracetamol have not identified any risk to lactation or the breast-fed offspring. These results are based on immediate release preparations of paracetamol. There is no data available on the excretion of sustained-release paracetamol preparations in breast milk. However, it is not expected that Parapane Osteo would provide any increase in the excretion of paracetamol in breast milk as this product is designed to maintain rather than increase plasma paracetamol concentrations compared to immediate release preparations. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infant.

The effects of this medicine on a person’s ability to drive and use machines were not assessed as part of its registration.

Reporting suspected adverse effects

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reportingproblems.

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled doses and considered attributable are tabulated below by System OrganClass and frequency.

The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse event frequencies have been estimated from spontaneous reports received through postmarketing data.

Table 1. Post marketing data:

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.