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

Identified precautions

Orphenadrine citrate should be used with caution in patients with tachycardia, cardiac decompensation, coronary insufficiency or cardiac arrhythmias.

Paracetamol should be used with caution in patients with hepatic or renal dysfunction.

Concomitant treatment with other medicines that contain orphenadrine or paracetamol is not recommended.

Safety of continuous long-term therapy with orphenadrine has not been established. Therefore if orphenadrine is prescribed for prolonged use, periodic monitoring of blood, urine and liver function is recommended.

Use in the elderly

The elderly should be advised to take a reduced dosage as they may be more susceptible to anticholinergic side effects at regular doses.

Paediatric use

NORGESIC is not recommended for children under 12 years of age.

Interactions have been reported between orphenadrine and phenothiazines and other drugs with anti-muscarinic properties. Concomitant use with alcohol or other CNS depressants should be avoided.

Anticoagulant dosage may require reduction if paracetamol medication is prolonged. Paracetamol absorption is increased by medicines that increase gastric emptying, e.g., metoclopramide, and decreased by medicines that decrease gastric emptying, e.g., propantheline, antidepressants with anticholinergic properties and narcotic analgesics. Paracetamol may increase chloramphenicol concentrations. The likelihood of paracetamol toxicity may be increased by the concomitant use of enzyme inducing agents such as alcohol or anticonvulsant medicines.

Effects on fertility

No data available

Use in pregnancy

Pregnancy Category B2.

NORGESIC is not recommended for use during pregnancy.

Use in lactation

NORGESIC should not be taken during lactation as orphenadrine and paracetamol are excreted into breast milk.

Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

Adverse effects are mainly due to the anti-cholinergic action of orphenadrine and are usually associated with higher doses.

Orphenadrine citrate

More common reactions: The known adverse effects include dryness of the mouth, tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilation of the pupils, increased ocular tension, weakness, nausea, headache, dizziness, constipation and drowsiness. These effects can usually be eliminated by reducing the dose.

Less common reactions: Sedation, skin rashes and other allergic reactions are very uncommon adverse effects. Infrequently an elderly patient may experience some degree of mental confusion. Very rare cases of aplastic anaemia associated with the use of orphenadrine have been reported.

Paracetamol

Reports of adverse reactions are rare. Although the following reactions have been reported, a causal relationship to the administration of paracetamol has been neither confirmed nor refuted; dyspepsia, nausea, allergic and haematological reactions.

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/reporting-problems.

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