ACUPAN Tablet Ref.[27918] Active ingredients: Nefopam

Hepatic and renal insufficiency may interfere with the metabolism and excretion of nefopam.

ACUPAN should be used with caution in patients with angle closure glaucoma.

Cases of nefopam dependence and abuse have been reported with nefopam use.

ACUPAN should be used with caution in patients with, or at risk of, urinary retention.

The side effects of ACUPAN may be additive to those of other agents with anticholinergic or sympathomimetic activity.

Nefopam may cause adverse sympathomimetic effects including tachycardia and aggravation or precipitation of angina. Caution should be exercised in patients with a history of ischaemic heart disease.

Concomitant therapeutic use of nefopam and another medicine that increases serotonin availability by any mechanism, such as tricyclic antidepressants, SSRI and MAO inhibitors may cause serotonin toxicity including serotonin syndrome. ACUPAN should be used with caution in patients on tricyclic anti-depressants and is contraindicated in patients on MAO inhibitors.

Nefopam may interfere with some screening tests for benzodiazepines and opioids. These tests for benzodiazepines and opioids may give false positive results for patients taking ACUPAN.

ACUPAN is not recommended for pregnant women or those likely to become pregnant unless the expected benefit to the mother outweighs any potential risk to the foetus. There has been little human usage and no evidence of safety during pregnancy can be assumed from preclinical animal studies.

Evidence suggests that nefopam is excreted in human milk. A decision should be made whether to discontinue breastfeeding or discontinue the medication, taking into account the potential for adverse effects for the foetus and the importance of treatment to the mother.

It is recommended that patients do not drive or operate heavy machinery until they know how ACUPAN affects them.

Nausea, nervousness, dry mouth, lightheadedness, urinary retention, hypotension, syncope, palpitations, gastrointestinal disturbances (including abdominal pain and diarrhoea), dizziness, paraesthesia, convulsions, tremor, confusion, hallucinations, angioedema, and allergic reactions may occur.

Less common reactions: Anaphylactic reactions, coma, vomiting, blurred vision, drowsiness, sweating, insomnia, headache, tachycardia and aggravation of angina have been reported.

Rarely a temporary harmless pink discolouration of the urine has occurred.

Hypersensitivity reactions including erythema multiforme have been reported.

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

None known.