PACIMOL Uncoated tablet Ref.[50222] Active ingredients: Paracetamol

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.

Paracetamol should be used with caution in patients with:

• Impaired liver function: Underlying liver disease increases the risk of paracetamol‐related liver damage
• 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 liver or kidney impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol products in patients with liver or kidney impairment are primarily a consequence of the paracetamol content of the drug.

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.

If symptoms persist, medical advice must be sought.

Keep out of sight and reach of children.

Use in children: Not recommended for children under seven years of age.

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 medication is prolonged.

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

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 drugs.

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

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

Use in pregnancy

As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol.

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.

Use in lactation

Paracetamol is excreted in breast milk but not in a clinically significant amount at recommended dosages. Available published data do not contraindicate breast‐feeding.

Paracetamol is unlikely to cause an effect on the ability to drive or use machinery.

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 dose and considered attributable are tabulated below by System Organ Class 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 post‐marketing data.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

No known incompatibilities.