NEFOPAM HYDROCHLORIDE

Posology Adults Dosage may range from 1 to 3 tablets three times daily depending on response. The recommended starting dosage is 2 tablets three times daily. Elderly Older patients may require reduced dosage due to slower metabolism.

It is strongly recommended that the starting dose does not exceed one tablet 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.

Paediatric population The safety and efficacy of nefopam in children under 12 years has not yet been established. No dosage recommendation can be given for patients under 12 years. Renal impairment 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, hallucination, angioedema, and allergic reactions may occur.

Less frequently, anaphylactic reactions, vomiting, blurred vision, drowsiness, sweating, insomnia, headache, tachycardia, confusional state and coma have been reported. System Organ Class Frequency Adverse Reaction Psychiatric disorders Rare Drug dependence Drug dependence Use of nefopam can lead to drug dependence.

The risk of drug dependence may vary depending on a patient's individual risk factors (see section “Special warnings and precautions for use”). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 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.

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.

Lactose Nefopam Hydrochloride film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicine. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Nefopam Hydrochloride is contra-indicated in: - patients with a history of convulsive disorders - patients taking mono-amine-oxidase (MAO) inhibitors. 1.