Nefopam hydrochloride 30 mg film-coated tablets

Each film-coated tablet contains 30 mg nefopam hydrochloride.

For the full list of excipients see section 6.1.

Film Coated Tablet

White to off white, round shape, film coated tablets debossed with "EM" on one side and "62" on the other side. The dimensions of the tablet are approximately 7.00 mm x 3.80 mm.

Nefopam hydrochloride 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.

Special population

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.

Pediatric 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.

Nefopam hydrochloride is contraindicated in patients with a history of convulsive disorders and shouuld 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.

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

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.

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 hydrochloride.

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

Not applicable

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.

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.

The clinical pattern of nefopam toxicity in overdose is on the neurological (coma, convulsions, hallucinations and agitation) and cardiovascular systems (tachycardia with a hyperdynamic circulation). 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: 4.7.1 Non-opioid analgesics and compound analgesic preparations

ATC code: N02BG06.

Nefopam hydrochloride 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 hydrochloride has been shown not to cause respiratory depression. There is no evidence from pre-clinical research of habituation occurring with nefopam hydrochloride.

Nefopam is absorbed from the gastro-intestinal tract. Peak plasma concentrations occur about 1-3 hours after oral administration. About 73% is bound to plasma proteins. It has an elimination half-life of about 4 hours. It is extensively metabolised and 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

Tablet Core:

Microcrystalline cellulose,

Pregelatinized starch,

Dicalcium phosphate dihydrate,

Silica colloidal anhydrous,

Magnesium stearate

Tablet Film-coating:

Hypromellose(6cP),

Titanium dioxide (E171),

Macrogol

Not applicable.

2 Years

This medicinal product does not require any special storage conditions.

Aluminium -PVC/PVDC blister or Aluminium-PVC blister with 30's and 90's tablets

Not all pack sizes may be marketed.

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

Tillomed Laboratories Limited

220 Butterfield

Great Marlings, Luton

LU2 8DL, United Kingdom

PL 11311/0686

22/03/2022

22/03/2022