Summary of Product Characteristics (SmPC) - Nefopam Hydrochloride 30 mg film-coated tablets
1 NAME OF THE MEDICINAL PRODUCT
Nefopam Hydrochloride 30 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg nefopam hydrochloride. For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet, white to off white coloured, round, bevel edged, debossed with ‘N 30’ on one side and plain on other side, having diameter of 7.10mm.
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 1 to 3 tablets three times daily depending on response.
The recommended starting dosage is 2 tablets 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 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. The administration of Nefopam Hydrochloride is not recommended in children under 12 years of age.
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.
4.3 Contraindications
- Hypersensitivity to active substance(s) or to any of the excipients listed in section 6.1
- A history of convulsive disorders
- In patients taking monoamine oxidase inhibitors (MAOIs)
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.
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.
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.
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
Pregnancy
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 considered absolutely necessary by the physician.
Breast-feeding
Nefopam is excreted in human milk. Concentrations are approximately the same as those in maternal plasma. Since there is a risk of adverse effects in the nursing infant, breast-feeding should be discontinued during treatment with Nefopam.
Fertility
In animal studies, no adverse effects on fertility were observed (see Section 5.3). The effects of nefopam on fertility in humans is unknown.
4.7 Effects on ability to drive and use machines
Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected due to Nefopam hydrochloride tablets.
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.
Psychiatric disorders
Rare: Drug dependence
Drug dependence
Use of Nefopam hydrochloride tablets 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 (e.g. with intravenously or rectally administered diazepam). Beta-adrenergic blockers may help control the cardiovascular complications.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: 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
Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Contents of the tablet-core:
Microcrystalline cellulose
Calcium hydrogen phosphate dihydrate
Colloidal anhydrous silica
Pregelatinised starch
Hydrogenated vegetable oil
Magnesium stearate
Film coating contents:
Hypromellose (HPMC E-5)
Titanium dioxide
Macrogols (PEG-400)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Tablets in Alu/PVC blister packs of 10, 14, 20, 28, 30, 50, 56, 60 and 90 Tablets*
*Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7. MARKETING AUTHORISATION HOLDER
Key Pharmaceuticals Ltd.
18 Oxleasow Road,
Redditch, B98 0RE, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 34424/0053
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/09/2026
10 DATE OF REVISION OF THE TEXT
07/10/2026