Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
Package leaflet: Information for the user
Nefopam Hydrochloride 30 mg Film-coated tablets
(nefopam hydrochloride)
even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
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). Warnings and precautions Talk to your doctor or pharmacist before using 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. – Are you pregnant or breast feeding?
– Do you have severe problems with your liver or kidneys? – Do you have, or have you had in the past difficulty passing urine? – Are you taking other medicines? – Have you previously been diagnosed with glaucoma (increased pressure in the eye)? 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. Other medicines and Nefopam Hydrochloride Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 (drugs which block acetylcholine, and can be used to treat conditions such as
bowel spasm, overactive bladder and others) for relief of stomach cramps or spasms (e.g. hyoscine butylbromide, propantheline bromide) Sympathomimetics (e.g. pseudoephedrine) Tell your doctor or dentist if you are taking any of these medicines. Pregnancy, breast-feeding and fertility Nefopam Hydrochloride should not be taken during pregnancy or while breast-feeding. Whether or not nefopam affects the fertility in humans is unknown. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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.
reactions (anaphylaxis). Side-effects 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme
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 a double dose to make up for a 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 medicine, ask your doctor or pharmacist.
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
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected]
throw away medicines you no longer use. These measures will help to protect the environment.
UK. Misom Labs Ltd Malta Life Sciences Park, LS2.01.06, Industrial Estate, San Gwann, SGN 3000, Malta This medicinal product is authorised in the Member States of the EEA under the following names: UK: Nefopam Hydrochloride 30 mg Film-coated tablets. IE: Nefopam Hydrochloride 30 mg Film-coated tablets. This leaflet was last revised in 03/2026
Nefopam Hydrochloride 30 mg Film-coated Tablets comes as tablet containing 30mg. 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 30 mg Film-coated Tablets is nefopam hydrochloride.
Medicines with the same active substance, strength and form include: Nefopam hydrochloride 30 mg Film-coated Tablets, Nefopam hydrochloride 30 mg film-coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Nefopam Hydrochloride 30 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 1 to 3 tablets three times daily depending on response. The recommended starting dosage is 1-2 tablets three times daily. 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. 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. 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. Method of administration Oral use. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
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 excipients listed in section 6.1. <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
The side effects of Nefopam Hydrochloride may be additive to those of other agents with Anticholinergic (drugs which block acetylcholine, and can be used to treat conditions such as bowel spasm, overactive bladder and others) 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 Hydrochloride. 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. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
Caution should be exercised when nefopam is administered concurrently with tricyclic antidepressants. It should be noted that Nefopam Hydrochloride 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. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
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.
Not relevant.
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 Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. <summary id="OVERDOSE" data-evt="smpcSectionOpen"
The clinical pattern of Nefopam Hydrochloride 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.
Ask anything about Nefopam Hydrochloride 30 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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