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Nefopam Hydrochloride 60 mg film-coated tablets – patient leaflet, side effects, dosage

Last updated: · Text from the MHRA, as of · About this document

Medicine status: Prescription only (POM) Details

Medicine strength:
60 mg
Contains active substance:
ATC code:

Patient leaflet - Nefopam Hydrochloride 60 mg film-coated tablets

1. What Nefopam hydrochloride is and what it is used for

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. What you need to know before you take Nefopam hydrochloride

Do not take Nefopam hydrochloride tablets if:

Ÿ you are a child under 12 years old

Ÿ 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)

Ÿ you are taking monoamine oxidase inhibitors

(MAOIs) to treat your depression

Ÿ you have, or have ever had, epilepsy (fits). Ÿ 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.

Ÿ Are you pregnant or breast feeding? Ÿ Do you have severe problems with your liver or

kidneys?

Ÿ Do you have, or have you had in the past

difficulty passing urine?

Ÿ Are you taking other medicines?

Ÿ 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.

Package leaflet: Information for the patient

Nefopam hydrochloride 60 mg film-coated tablets

(nefopam hydrochloride)

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:

Ÿ Monoamine oxidase inhibitors (known as

MAOIs) for depression. You must tell your doctor if you are taking this medicine. Ÿ Tricyclic antidepressants for depression Ÿ Anticholinergics

Ÿ 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. How to take 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:

Ÿ you are not sure how many tablets to take or

when to take them

Ÿ 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:

Ÿ swelling of the skin and soft tissue around the eyes, nose and throat (angioedema), or allergic reactions (anaphylaxis).

Side-effects which may occur most frequently include:

Ÿ feeling sick

Ÿ feeling light-headed, dizzy or nervous, or fainting Ÿ a decrease in blood pressure

Ÿ numbness or tingling in the extremities Ÿ a dry mouth

Ÿ having difficulty passing urine

Ÿ convulsions, tremor

Ÿ confusion

Ÿ hallucinations (seeing things that aren't there) Ÿ awareness of your heartbeat (palpitations)

Other side-effects which may occur less frequently include:

Ÿ being sick

Ÿ abdominal pain or diarrhoea

Ÿ blurred vision

Ÿ drowsiness

Ÿ sweating

Ÿ trouble sleeping

Ÿ headaches

Ÿ fast heartbeat (tachycardia)

Ÿ coma

Rare (may affect up to 1 in 1,000 people): Ÿ 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. How to store 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. Contents of the pack and other information

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.

Size 150(L) x 350(W) mm Front

Size 150(L) x 350(W) mm Back

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.

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PL 25298/0316

Last revision stated in the text: March 2026 · MHRA data as of 13 October 2026

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Nefopam Hydrochloride 60 mg film-coated tablets

Prescription needed? Yes, prescription-only medicine (POM)
Active substance Nefopam
Strength 60 mg
Pharmaceutical form Oral tablet
White to off-white, circular, biconvex, film coated tablets, debossed with ‘NT1’ on one face and plain on other face.
How is it taken Oral
Excipients Microcrystalline cellulose, Calcium hydrogen phosphate dihydrate, Pregelatinised maize starch, Silica, colloidal anhydrous, Hydrogenated castor oil, Magnesium stearate, Hypromellose, Titanium dioxide
Pack sizes 60 tablet
Is it available? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life 3 years
Storage Do not store above 25°C.
Drug group (ATC) 4.7.1 Non-opioid analgesics and compound analgesic preparations
  1. N Nervous system drugs
    1. N02 Analgesics
      1. N02B Other analgesics and antipyretics
        1. N02BG Other analgesics and antipyretics
          1. N02BG06 nefopam
Marketing authorisation PL 25298/0316 (first authorised 15 November 2023)
Marketing authorisation holder Brown & Burk UK Ltd
Codes GTIN 5060124642673 · BNF 04070100

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.2.0 of 19 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.