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NEFOPAM HYDROCHLORIDE 30 MG FILM-COATED TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nefopam Hydrochloride 30 mg Film-coated tablets
nefopam hydrochloride

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. Do not pass it on to others. It may
harm them, even if their symptoms 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.
In
1.
2.
3.
4.
5.
6.

this leaflet:
What Nefopam tablets are and what they are used for
Before you take Nefopam tablets
How to take Nefopam tablets
Possible side effects
How to store Nefopam tablets
Contents of the pack and other information

1. WHAT NEFOPAM TABLETS ARE
AND WHAT THEY ARE USED FOR
The full name of your medicine is Nefopam Hydrochloride
30 mg Film-coated tablets. In this leaflet the shorter name
Nefopam tablets is used.
Nefopam tablets belong 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 tablets do not stop the pain from
happening, but you will not be able to feel the pain as much.
Nefopam tablets are 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 tablets should not be used to treat the pain from a
heart attack.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE NEFOPAM TABLETS
Do not take Nefopam tablets
• If you are a child under 12 years old.
• You have ever had an allergic reaction to nefopam
hydrochloride or any of the ingredients resulting in a skin
rash, swelling of the face of difficulty in breathing (see
section 6. Contents of the pack and other information).
• You are taking monoamine oxidase inhibitors (MAOIs) to
treat your depression.
• You have, or have ever had, epilepsy (fits).
Warnings and precautions
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?
Other medicines and Nefopam tablets
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription. This includes herbal
medicines. This is because Nefopam tablets can affect the way
some other medicines work.

Also some other medicines can affect the way Nefopam
tablets work.
You must not take this medicine in combination with:
• Monoamine oxidase inhibitors (known as MAOIs) for
depression. You must tell your doctor if you are taking this
medicine.
• Tricyclic antidepressants for depressions
• Anticholinergics for relief of stomach cramps or spasms
(e.g. hyoscine butylbromide, propantheline bromide)
• Sympathomimetics (e.g. pseudoephedrine)
Tell your doctor or dentist if you are taking any of these
medicines.
Nefopam tablets with food, drink and alcohol
Not relevant.
Pregnancy, breast-feeding and fertility
Nefopam tablets 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 or if you are planning to have a baby.
Driving and using machines
This medicine may cause drowsiness. Do not drive vehicles or
use any tools or machines which require your attention.
3. HOW TO TAKE NEFOPAM TABLETS
Always take this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
Use in adults
The usual initial dose is one or 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
Use in children
Over 12 years – same as adults (see above)
Under 12 years - Nefopam tablets should not be taken
by children under 12.
Use in older patients
In older patient the doctor may reduce the number of tablets
that are taken.
Dosage for patients with kidney and/or liver problems
Your doctor may adjust the dose of Nefopam tablets
depending upon your condition.
If you take more Nefopam tablets than you should
If you take more of this medicine than you should talk to a
doctor or go to a hospital straight away. Take the medicine

Bozza no.: 17 / Recto
Data: 06.06.17 Formato: mm 190 x 240
Nefopam Hydrochloride 30 mg RIVO UK Colore: Nero

Lineagrafica sa
6596 Gordola

pack with you, even if there are no tablets left.
Medical treatment can be necessary.
If you forget to take Nefopam tablets
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product,
please contact your doctor or pharmacist.
If you stop taking Nefopam tablets
Do not stop taking Nefopam tablets without first checking
with your doctor.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nefopam tablets contain
The active substance is nefopam hydrochloride.
Nefopam Hydrochloride 30 mg film-coated tablets:
each tablet contains 30 mg of nefopam hydrochloride.
The other ingredients are: cellulose microcrystalline,
povidone (K30), hydrogen phosphate, copovidone,
pregelatinised starch, silica colloidal anhydrous, magnesium.
stearate. The film-coating contains HPMC 2910/Hypromellose
and Titanium dioxide.

If you have any further questions on the use of this product,
ask your doctor or pharmacist.

What Nefopam tablets look like and contents of the pack
Nefopam tablets are white, round, biconvex, film-coated
tablets.

4. POSSIBLE SIDE EFFECTS

They are available in Alu/PVC-PE/PVDC blisters.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Packs of 30 and 90 tablets.
Not all pack sizes may be marketed.

Please stop taking this medicine and contact your doctor as
Marketing Authorisation Holder and Manufacturer
soon as possible if you experience the following rare reactions:
• Swelling of the skin and soft tissue around the eyes, nose
Marketing Authorisation Holder
and throat (angioedema), or allergic reactions (anaphylaxis).
Rivopharm UK Ltd
30th Floor, 40 Bank Street, Canary Wharf
Side-effects which may occur most frequently include:
London E14 5NR
• Feeling sick
United Kingdom
• Feeling light-headed, dizzy or nervous, or fainting
• A decrease in blood pressure
Manufacturer
• Numbness or tingling in the extremities
• Dry mouth
Laboratoires BTT
• Having difficulty passing urine
ZI de Krafft, 67150 Erstein
• Convulsions, tremor
France
• Confusion
• Hallucinations (seeing things that aren’t there).
Rivopharm UK Ltd
30th Floor, 40 Bank Street, Canary Wharf
Other side effects which may occur less frequently include:
London E14 5NR
• Being sick
United Kingdom
• Abdominal pain or diarrhoea
• Blurred vision
This leaflet was last revised in 06/2017
• Drowsiness
• Sweating
• Trouble sleeping
R/MA/0037/PIL/002
• Headaches
• Awareness of your heartbeat (palpitations), or a fast
heartbeat (tachycardia)
• Coma
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 TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not take Nefopam tablets after the expiry date which
is stated on the carton and the blister foil after “EXP”. The
expiry date refers to the last day of that month.
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.

Bozza no.: 17 / Verso
Data: 06.06.17 Formato: mm 190 x 240
Nefopam Hydrochloride 30 mg RIVO UK Colore: Nero

Lineagrafica sa
6596 Gordola

Expand Transcript

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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