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.
The name of your medicine is Nefopam Hydrochloride 30 mg Film-coated Tablets (referred to as 'Nefopam hydrochloride' throughout this leaflet). Nefopam hydrochloride includes the active substance nefopam hydrochloride.
Nefopam hydrochloride belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers. It 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.
Do not take Nefopam hydrochloride if: • you are a child under 12 years old
• you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6).
• you are taking a medicine to treat your depression known as a monoamine oxidase inhibitor (MAOI)
• you have or have ever had epilepsy (fits).
• you are pregnant or breast-feeding
Warnings and precautions Talk to your doctor before using Nefopam hydrochloride if:
• you have severe problems with your liver or kidneys
• you have or have had in the past difficulty passing urine
• you are taking other medicines
• you have previously been diagnosed with glaucoma (increased pressure in the eye)
If any of the above apply to you, your doctor may decide to alter your treatment.
Children Do not give this medicine to children between the ages of 0 to 12 years as the safety has not yet been established.
Other medicines and Nefopam hydrochloride Do not take Nefopam hydrochloride if you are taking a medicine to treat your depression known as a monoamine oxidase inhibitor (MAOI).
Tell your doctor, dentist or pharmacist if you are taking or have recently taken the medicines listed below:
• Tricyclic antidepressants for depression
• Anticholinergics
• Sympathomimetics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breast-feeding and fertility Nefopam hydrochloride should not be taken during pregnancy or while breast-feeding.
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.
Use of Nefopam hydrochloride may lead to dependence and abuse. If you have concerns that you may become dependent on Nefopam hydrochloride, it is important that you consult your doctor.
Dosage Always take this medicine exactly as your doctor or pharmacist has told you. Check with you doctor or pharmacist if you are not sure.
The recommended dose is two tablets taken three times a day. Your doctor may increase this dose up to a maximum of three tablets 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.
How to take the tablets The tablets are for oral use. They should be swallowed with a glass of water.
Use in children (under 12 years)
Nefopam hydrochloride should not be taken by children under 12 years.
Use in elderly patients
In older patients the doctor may reduce the number of tablets that are taken.
Use in 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 take more tablets than you should, tell your doctor or pharmacist immediately or contact your nearest hospital casualty department. Remember to take the pack and any remaining tablets 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.
STOP taking this medicine and contact your doctor immediately if you experience: • swelling of the skin and soft tissue around the eyes, nose and throat with difficulty breathing (angioedema)
• allergic reactions (anaphylaxis)
• convulsions, tremor
• coma
Other side effects include:
Not known (frequency cannot be estimated from the available data)
• feeling sick (nausea)
• 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
• confusion
• hallucinations (seeing things that are not there)
• being sick (vomiting)
• abdominal pain or diarrhoea
• blurred vision
• drowsiness
• sweating
• trouble sleeping
• headaches
• awareness of your heartbeat (palpitations), or a fast heartbeat (tachycardia).
Rare (may affect up to 1 in 1,000 people):
• becoming dependent on Nefopam hydrochloride (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 the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on carton and blister after EXP. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. Those measures will help protect the environment.
What Nefopam hydrochloride contains The active substance is nefopam hydrochloride 30 mg.
The other ingredients are calcium hydrogen phosphate dehydrate, microcrystalline cellulose, pregelatinised starch, colloidal anhydrous silica, magnesium stearate.
The coating material consists of hydroxypropyl methylcellulose, polyethylene glycol (6000 & 400) and titanium dioxide (E171).
What Nefopam hydrochloride looks like and contents of the pack Nefopam hydrochloride 30 mg film-coated tablets are white to off white, round, film-coated biconvex tablets engraved with "20" on one side and "G" on the other side.
The tablets are available in Alu-Alu blister packs containing 90 tablets.
Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited
Laxmi House
2B Draycott Avenue
Kenton
Middlesex
HA3 0BU
United Kingdom
Manufacturer Glenmark Pharmaceuticals Europe Limited
Building 2
Croxley Green Business Park
Croxley Green
Hertfordshire
WD18 8YA
United Kingdom
Glenmark Pharmaceuticals s.r.o
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
This leaflet was last revised in March 2026
Glenmark Pharmaceuticals Europe Ltd
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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 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.
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 and some cases of hallucinations and confusion have been reported in this age group.
Paediatric Population:
The safety and efficacy of Nefopam 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 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 is contraindicated in patients with known hypersensitivity to any of the ingredients.
The side effects of Nefopam 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 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.
There is no evidence as to the drug safety in human pregnancy, nor is the 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. Psychiatric disorders (PT Drug dependence) may occur rarely.
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, 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.
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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