What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0300 .


Nefopam hydrochloride 30 mg Film-coated Tablets

Package leaflet: Information for the User

Nefopam Hydrochloride 30 mg Film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again
  • If you have any further questions, ask your doctor or pharmacist
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 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 not listed in this leaflet. See section 4.

What is in this leaflet

1. What Nefopam hydrochloride is and what it is used for
2. What you need to know before you use Nefopam hydrochloride
3. How to use Nefopam hydrochloride
4. Possible side effects
5. How to store Nefopam hydrochloride
6. Contents of the pack and other information

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

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.

2. What you need to know before you use Nefopam hydrochloride

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.

3. How to take Nefopam hydrochloride

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.

4. Possible side effects

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).

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.

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 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.

6. Contents of the pack and other information

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
Laxmi House
2B Draycott Avenue
Kenton
Middlesex
HA3 0BU
United Kingdom

Glenmark Pharmaceuticals s.r.o
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

This leaflet was last revised in November 2019