NEFOPAM HYDROCHLORIDE

Posology ADULTS:

Dosage may range from 30mg to 90mg three times daily depending on response. The recommended starting dosage is 1 tablet of 60mg three times daily.

OLDER PEOPLE:

Older patients may require reduced dosage due to slower metabolism. It is strongly recommended that the starting dose does not exceed one tablet of 30mg tablets three times daily as older people appear more susceptible to, in particular, the CNS side effects of Nefopam hydrochloride and some cases of hallucinations and confusion have been reported in this age group.

e. 4) PAEDIATRIC POPULATION: The safety and efficacy of Nefopam hydrochloride in children under 12 years has not yet been established. No dosage recommendation can be given for patients under 12 years. Patients with end stage renal disease might experience increased serum peak concentrations during treatment with nefopam.

In order to avoid that, it is recommended the daily dose should be reduced not only for the elderly, but also for patients with terminal renal insufficiency. Method of administration Oral use.

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

Less frequently, anaphylactic reactions, coma, vomiting, blurred vision, drowsiness, sweating, insomnia, headache and tachycardia have been reported.

Rare (may affect up to 1 in 1,000 people) Psychiatric disorders:

Drug dependence Drug dependence Use of Nefopam can lead to drug dependence. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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The side effects of Nefopam hydrochloride may be additive to those of other agents with anticholinergic or sympathomimetic activity. It should not be used in the treatment of myocardial infarction since there is no clinical experience in this indication.

Hepatic and renal insufficiency may interfere with the metabolism and excretion of nefopam. Nefopam should be used with caution in patients with angle closure glaucoma. Drug dependence Use of Nefopam may lead to drug dependence, which may result in drug abuse, particularly in patients with a history of substance use and/or mental health disorders.

In such patients, Nefopam should be prescribed with caution, and signs of dependence should be monitored. Nefopam hydrochloride should be used with caution in patients with, or at risk of, urinary retention. Rarely a temporary, harmless pink discolouration of the urine has occurred.

This product is not suitable for patients requiring the dose of 30mg as the product cannot be divided into two equal halves.

Nefopam hydrochloride is contra-indicated in patients with a history of convulsive disorders and should not be given to patients taking mono-amine-oxidase (MAO) inhibitors. Nefopam hydrochloride is contraindicated in patients with known hypersensitivity to any of the ingredients.