NEFOPAM HYDROCHLORIDE

Posology Adults:

Dosage may range from 1 to 3 tablets (30 – 90 mg) three times daily depending on response. The recommended starting dosage is 2 tablets (60 mg) followed by 1 tablet (30 mg) three times daily. This may be increased as required to the maximum recommended dose of 3 tablets (90 mg) three times a day.

Elderly:

Older patients may require reduced dosage due to slower metabolism. It is strongly recommended that the starting dose does not exceed 1 tablet (30 mg) 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 Hydrochloride in children under 12 years has not yet been established. No dosage recommendation can be given for patients under 12 years.

Special populations:

Patients with end stage renal disease might experience increased serum peak concentrations during treatment with Nefopam Hydrochloride. 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.

Frequency groupings are classified according to the subsequent conventions:

Very common (≥ 1/10), Common (≥ 1/100 to <1/10), Uncommon (≥ 1/1,000 to <1/100), Rare (≥ 1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data). System Organ Class Frequency Adverse Reaction Immune system disorders Not known Hypersensitivity, anaphylactic reaction, angioedema Rare PT Drug dependence* Psychiatric disorders Not known Agitation, hallucination, drug abuse and drug dependence, state of confusion, insomnia Nervous system disorders Not known Somnolence, dizziness, paresthesia, tremor, seizure, headache, coma, syncope Eye disorders Not known Blurred vision Cardiac disorders Not known Tachycardia, palpitations Vascular disorders Not known Hypotension Gastrointestinal disorders Not known Nausea with or without vomiting, dry mouth, abdominal pain, diarrhoea Skin and subcutaneous tissue disorders Not known Hyperhidrosis Renal and urinary disorders Not known Urinary retention, urine discolouration (harmless pink colouring of urine) *Drug dependence Use of Nefopam Hydrochloride 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 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 Hydrochloride. 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.

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.