Summary of Product Characteristics (SmPC) - Nefopam Hydrochloride 60 mg film-coated tablets
1 NAME OF THE MEDICINAL PRODUCT
Nefopam hydrochloride 60 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg nefopam hydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, circular, biconvex, film coated tablets, debossed with ‘NT1’ on one face and plain on other face.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
Posology
ADULTS: Dosage may range from 30mg to 90mg three times daily depending on response. The recommended starting dosage is 1 tablet of 60mg three times daily.
OLDER PEOPLE: Older patients may require reduced dosage due to slower metabolism.
It is strongly recommended that the starting dose does not exceed one tablet of 30mg tablets 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.
For the dose other than 60mg, the use of alternative strength of Nefopam (i.e. Nefopam 30mg tablets) should be considered as necessary (see section 4.4) 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.
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.
4.3 Contraindications
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.
4.4 Special warnings and precautions for use
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.
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.
This product is not suitable for patients requiring the dose of 30mg as the product cannot be divided into two equal halves.
4.5 Interaction with other medicinal products and other forms of interaction
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.
4.6 Fertility, pregnancy and lactation
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
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
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.
Rare (may affect up to 1 in 1,000 people)
Psychiatric disorders: 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 4.4).
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. 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.
4.9 Overdose
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
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.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core:
Microcrystalline cellulose
Calcium hydrogen phosphate dihydrate
Pregelatinised maize starch
Silica, colloidal anhydrous
Hydrogenated castor oil
Magnesium stearate
Tablet coat:
Hypromellose
Titanium dioxide
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
PVC/PVdC- Aluminium blister packs containing 30, 60 and 90 film-coated tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Brown & Burk UK Ltd
Micro House
5 Marryat Close
Hounslow
TW4 5DQ
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 25298/0316
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/11/2023
10 DATE OF REVISION OF THE TEXT
17/03/2026