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NEFOPAM HYDROCHLORIDE 30 MG TABLETS

Active substance(s): NEFOPAM HYDROCHLORIDE

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Package Leaflet: Information for the user

Nefopam Hydrochloride 30 mg Tablets

Read all of this leaflet carefully before you start using 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.
This medicine is known as the above but will be referred to as Nefopam Hydrochloride throughout this leaflet.
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 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. 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 of 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
 if you are allergic to nefopam hydrochloride or any of the other ingredients of this medicine (listed in section 6)
 if you are taking monoamine oxidase inhibitors (MAOIs) to treat your depression
 if you have, or have ever had, epilepsy (fits)
 if you are pregnant or breast-feeding
Warnings and precautions
Talk to you 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?
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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor, dentist or pharmacist if you are taking or have recently taken the 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
• Sympathomimetics
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 for adults
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 many 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
Swallow your tablets with water.
Use in children and adolescents:
Over 12 years – as per above.
Under 12 years – Nefopam Hydrochloride 30 mg Tablets should not be taken by children under 12.
Use in older 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 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.

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:
• 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:
• 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).
Other side-effects which may occur less frequently include:
• being sick
• 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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nefopam Hydrochloride
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated after ‘EXP’ on the carton and blister. The expiry date refers to the last
day of that month.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
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
Each film-coated tablet contains 30 mg nefopam hydrochloride.
It also contains the following inactive ingredients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch,
magnesium stearate, hydrogenated vegetable oil, colloidal silicon dioxide, hypromellose (2910 (15cps)), titanium dioxide.
What Nefopam Hydrochloride looks like and contents of the pack
The film-coated tablets are white, circular and biconvex marked 'APN' on one side and plain on the other.
The tablets are packaged in blister packs of 30 or 90 tablets. Not all pack sizes may be marketed.
Manufacturer
3M Health Care Limited, 3M House, 1 Morley Street, Loughborough, Leicestershire, LE11 1EP, UK.
Procured from within the EU by the Product Licence Holder:
Expono Ltd, Smethwick, Birmingham, B66 2JT, UK.
Repackaged by:
N.G. Ltd, Birmingham, B66 2JT, UK.

POM

PL 22961/0133 - Nefopam Hydrochloride 30 mg Tablets

Revision Date: 10.05.2016
Ref: 833

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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