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NEFOPAM HYDROCHLORIDE 30MG FILM-COATED TABLETS

Active substance(s): NEFOPAM HYDROCHLORIDE / NEFOPAM HYDROCHLORIDE / NEFOPAM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Nefopam Hydrochloride 30mg film-coated Tablets
Your medicine is known as the above but will be referred to as
Nefopam Hydrochloride throughout the remainder of this
leaf et.
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.
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

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 30mg 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.

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 leaf et.
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.
Store in the original package.
Do not use this medicine after the expiry date, which is stated
on the carton and blister. The expiry date refers to the last day
of the month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6.

Contents of the pack and other information

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.

What Nefopam Hydrochloride contains
The active substance is nefopam hydrochloride 30mg.
Other ingredients are: colloidal silicon dioxide, calcium
hydrogen phosphate dehydrate, microcrystalline cellulose,
vegetable oil hydrogenated, corn starch, magnesium stearate,
titanium dioxide and hypromellose IS 2910 (15cps).

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.

What Nefopam Hydrochloride looks like and contents of
the pack
Nefopam hydrochloride tablets are white, round, biconvex, film
coated tablets with 'APN' embossed on one side and plain on
other side. They are available in blister packs of 90.

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.

Manufacturer
Manufactured by 3M Health Care Ltd - 3M House- 1 Morley
Street - Loughborough Leicestershire - LE11 1EP - UK.
Procured from within the EU and repackaged by the Product
Licence holder: G Pharma Limited, Dakota Avenue, Salford,
M50 2PU.

PL No: 16369/1714

POM

Leaflet revision: 13/02/2017

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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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