NEFOPAM HYDROCHLORIDE DAWA

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.

Special populations Elderly:

Dosage adjustment may be required due to slower metabolism. It is strongly recommended that the starting dose does not exceed one tablet three times daily as the elderly appear more susceptible to, in particular, the CNS side effects of Nefopam 30 mg tablets and some cases of hallucinations and confusion have been reported in this age group.

Paediatric population The safety and efficacy of nefopam has not been evaluated in children under 12 years; 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

The following undesirable effects have been reported with the following frequency:

Not known (cannot be estimated from the available data) System organ class Frequency Undesirable effects Immune system disorders Not known Allergic reaction, anaphylactic reactions Not known Nervousness, convulsions, confusional state, hallucination, insomnia Psychiatric disorders Rare Drug dependence Nervous system disorders Not known Light-headedness, syncope, dizziness, paraesthesia, tremor, drowsiness, headache, coma Eye disorders Not known Blurred vision Cardiac disorders Not known Palpitations, tachycardia Vascular disorders Not known Hypotension Gastrointestinal disorders Not known Nausea, vomiting, dry mouth, gastrointestinal disturbances (including abdominal pain and diarrhoea) Skin and subcutaneous tissue disorders Not known Angioedema, sweating Renal and urinary disorders Not known Urinary retention 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The side effects of Nefopam 30 mg tablets 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. Nefopam 30 mg tablets 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.

1. Nefopam is contraindicated in patients with a history of convulsive disorders and should not be given to patients taking mono-amine-oxidase (MAO) inhibitors.