Nefopam

Nefopam Hydrochloride 30mg Film-coated Tablets

Each coated tablet contains nefopam hydrochloride 30 mg.

For the full list of excipients, see section 6.1.

White to off white, round, biconvex film coated tablets with 'NFP' debossed on one side and plain on other side.

Nefopam is indicated for the relief of acute and chronic pain, including post-operative pain, dental pain, musculo-skeletal pain, acute traumatic pain and cancer pain.

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: Elderly 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 the elderly appear more susceptible to; in particular, the CNS side effects of nefopam 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

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

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

Nefopam 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.

Caution should be exercised when nefopam is administered concurrently with tricyclic antidepressants.

It should be noted that 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 nefopam.

There is no evidence as to the drug safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. Avoid in pregnancy unless there is no safer treatment.

Nefopam may cause drowsiness. If affected do not drive or operate machinery.

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

Not known (cannot be estimated from the available data)

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms

The clinical pattern of nefopam toxicity in overdose is on the neurological (convulsions, hallucinations, coma and agitation) and cardiovascular systems (tachycardia with a hyperdynamic circulation).

Management

Routine supportive measures should be taken and prompt removal of ingested drug by gastric Lavage or induced vomiting with Syrup of Ipecacuanha should be carried out. Oral administration of activated charcoal may help prevent absorption.

Convulsions and hallucinations should be controlled (eg with intravenously or rectally administered diazepam). Beta-adrenergic blockers may help control the cardiovascular complications.

Pharmacotherapeutic group: Other Analgesics and antipyretics, ATC code: N02BG06

Nefopam is a potent and rapidly-acting analgesic. It is totally distinct from other centrally-acting analgesics such as morphine, codeine, pentazocine and propoxyphene.

Unlike the narcotic agents, nefopam has been shown not to cause respiratory depression. There is no evidence from pre-clinical research of habituation occurring with nefopam.

Absorption

Nefopam is absorbed from the gastro-intestinal tract. Peak plasma concentrations occur about 1-3 hours after oral administration.

Distribution

About 73% is bound to plasma proteins. It has an elimination half-life of about 4 hours.

Biotransformation

It is extensively metabolised.

Elimination

Nefopam is excreted mainly in urine. Less than 5% of a dose is excreted unchanged in the urine. About 8% of a dose is excreted via the faeces.

Not applicable

Core Tablet

Calcium Hydrogen Phosphate Dihydrate

Cellulose Microcrystalline

Starch Pregelatinized

Hydrogenated Vegetable Oil

Silica, Colloidal anhydrous

Magnesium Stearate

Coating

Hypromellose (HPMC 2910),

Titanium Dioxide (E171),

Macrogol/PEG

Purified Water

Not applicable.

2 years.

Not applicable

Tablets are packed in either an ALU-ALU blister pack (consisting of ALU/ OPA/PVC (50/25 /60 microns) and Aluminium Foil 25 microns) or PVC – ALU blister pack (consisting of PVC 250 micron and Aluminium Foil 20 microns).

Each pack contains 3 blisters of 30 tablets hence a total pack size of 90 tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Focus Pharmaceuticals Ltd

Dashwood House,

69 Old Broad Street,

London, EC2M 1QS, United Kingdom

PL 20046/0296

09/02/2015

20/12/2023