Active ingredient
- nefopam hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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.
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:
Warnings and precautions
Talk to your doctor before using Nefopam hydrochloride if:
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:
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:
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:
Other side effects include:
Not known (frequency cannot be estimated from the available data)
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
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
Manufacturer
This leaflet was last revised in September 2020
Building 2, 1st Floor, Croxley Park, Watford, WD18 8YA
+44 (0)1923 202 950
+44 (0)1923 202 950