Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Nefopam hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Nefopam hydrochloride belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers. The active substance, nefopam hydrochloride, interrupts the pain messages being sent to your brain, and it also acts in your brain to stop pain messages being felt. This means that Nefopam hydrochloride does not stop the pain from happening, but you will not be able to feel the pain as much. Nefopam hydrochloride is used to relieve acute and chronic pain (for example pain after an operation, dental pain, joint or muscle pain, after an injury, or pain caused by cancer). Nefopam hydrochloride should not be used to treat the pain from a heart attack.
2.
e Nefopam hydrochloride
Do not take Nefopam hydrochloride tablets if: you are a child under 12 years old you have ever had an allergic reaction to nefopam hydrochloride or any of the ingredients resulting in a skin rash, swelling of the face or difficulty in breathing (see section 6. Contents of the pack and other information) you are taking monoamine oxidase inhibitors (MAOIs) to treat your depression you have, or have ever had, epilepsy (fits). Your dose is less than 60mg. Take special care with Nefopam hydrochloride If the answer to any of the following is 'yes', you must tell your doctor – your doctor may decide to alter your treatment.
Use of Nefopam may lead to dependence and abuse. If you have concerns that you may become dependent on Nefopam, it is important that you consult your doctor. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription and medicines listed below:
Monoamine oxidase inhibitors (known as MAOIs) for depression. You must tell your doctor if you are taking this medicine. Tricyclic antidepressants for depression Anticholinergics Sympathomimetics
Tell your doctor or dentist if you are taking any of these medicines. Pregnancy and breast-feeding Nefopam hydrochloride should not be taken during pregnancy or while breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Please contact your doctor if you become pregnant during your treatment. Driving and using machines Nefopam hydrochloride can cause drowsiness. Do not drive or operate heavy machinery unless you know how Nefopam hydrochloride affects you.
3.
Nefopam hydrochloride
Dosage for adults: Always take Nefopam hydrochloride exactly as your doctor has told you. The usual initial dose is one tablet taken three times a day. Your doctor may increase this dose by adding another strength (i.e. one tablet of Nefopam 30mg) up to a maximum of 90mg taken three times a day according to your needs. Ask your doctor or pharmacist if: you are not sure how many tablets to take or when to take them you think the effect is too strong or too weak Swallow your tablets with water. Do not break this tablet as it cannot be divided into two equal halves. Dosage for children: Over 12 years – as per adults (see above). Under 12 years – Nefopam hydrochloride tablets should not be taken by children under 12. Dosage for older patients : In older patients the doctor may reduce the dose by prescribing Nefopam 30mg tablets. Dosage for patients with kidney and/or liver problems: Your doctor may adjust the dose of Nefopam hydrochloride depending upon your condition. If you take more Nefopam hydrochloride than you should If you accidentally take more tablets than your prescribed dose, tell your doctor or pharmacist immediately and if necessary contact your nearest hospital casualty department. Remember to take the pack and any remaining medicines with you. If you forget to take Nefopam hydrochloride If you forget to take Nefopam hydrochloride, take it as soon as you remember. Do not take more than one dose at the same time to make up for the forgotten dose.
If you stop taking Nefopam hydrochloride Do not stop taking Nefopam hydrochloride without first checking with your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Please stop taking this medicine and contact your doctor as soon as possible if you experience the following rare reactions: swelling of the skin and soft tissue around the eyes, nose and throat (angioedema), or allergic reactions (anaphylaxis).
which may occur most frequently include: feeling sick feeling light-headed, dizzy or nervous, or fainting a decrease in blood pressure numbness or tingling in the extremities a dry mouth having difficulty passing urine convulsions, tremor confusion hallucinations (seeing things that aren't there) awareness of your heartbeat (palpitations) Other side-effects which may occur less frequently include: being sick abdominal pain or diarrhoea blurred vision drowsiness sweating trouble sleeping headaches fast heartbeat (tachycardia) coma Rare (may affect up to 1 in 1,000 people): becoming dependent on Nefopam (drug dependence). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
Nefopam hydrochloride
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month. Do not store above 25 °C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
What Nefopam hydrochloride contains The active substance is nefopam hydrochloride. Each film-coated tablet contains 60 mg nefopam hydrochloride. The other ingredients are: Tablet core: Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, pregelatinised maize starch, silica, colloidal anhydrous, hydrogenated castor oil and magnesium stearate. Tablet coat: Hypromellose and titanium dioxide. What Nefopam hydrochloride looks like and contents of the pack White to off-white, circular, biconvex, film coated tablets, debossed with 'NT1' on one face and plain on other face. The tablets are packaged in blister packs of 30, 60 and 90 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd Micro House 5 Marryat Close Hounslow TW4 5DQ United Kingdom This leaflet was last revised in 3/2026. If you would like a leaflet with larger text, please contact +44 (0)203 384 7188.
Nefopam hydrochloride 60 mg film-coated tablets comes as tablet containing 60mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Nefopam hydrochloride 60 mg film-coated tablets is nefopam hydrochloride.
This leaflet reproduces the patient information leaflet approved for Nefopam hydrochloride 60 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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 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.
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.
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.
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.
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.
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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Nefopam hydrochloride 60 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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