Nefopam Hydrochloride 30mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEFOPAM HYDROCHLORIDE 30MG 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
What is in this leaflet
1. What Nefopam is and what it is used for
2. What you need to know before you take Nefopam
3. How to take Nefopam
4. Possible side effects
5. How to store Nefopam
6. Contents of the pack and other information
1. WHAT NEFOPAM IS AND WHAT IT IS USED FOR
The name of your medicine is Nefopam hydrochloride 30mg Film-coated Tablets (referred to as Nefopam throughout this leaflet). Nefopam 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 does NOT stop the pain from happening, but you will not be able to feel the pain as much.
Nefopam 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 should NOT be used to treat the pain from a heart attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEFOPAM
Do not take Nefopam if:
- you are allergic or have ever had an allergic reaction to nefopam hydrochloride or any of the ingredients of this medicine (listed in section 6), particularly if resulting in a skin rash, swelling of the face or difficulty in breathing (see section 4, “Possible side effects”)
- you are taking monoamine oxidase inhibitors (MAOIs) to treat your depression (see “Other medicines and Nefopam”)
- 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 before taking Nefopam - 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
Nefopam is NOT recommended for children under 12 years old (see section 3).
Other medicines and Nefopam
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription.
In particular, tell your doctor if you are taking or have recently taken the following medicines:
- monoamine oxidase inhibitors (known as MAOIs) for depression. Nefopam and MAOIs must NOT be taken together.
- tricyclic antidepressants for depression
- anticholinergics
- sympathomimetics.
Tell your doctor or dentist if you are taking any of these medicines.
Pregnancy, breast-feeding and fertility
Nefopam 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.
Driving and using machines
Nefopam can cause drowsiness. You should NOT drive or use machines when you first start to take this medicine until you are certain that you are not getting any side effects. If in any doubt, speak to your doctor before you drive or use machines.
3. HOW TO TAKE NEFOPAM
Always take Nefopam exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Dosage for adults:
• The usual initial 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.
• Swallow your tablets with water.
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.
Dosage for children:
• Over 12 years - as per adults (see above).
• Under 12 years - Nefopam is NOT to be taken by children under 12 (see section 2, "Children").
Dosage for elderly patients:
In elderly patients 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 depending upon your condition.
If you take more Nefopam than you should
If you think that you, or any other person, may have taken too many tablets, contact your doctor or hospital casualty department immediately. Take any remaining tablets and this leaflet with you so that the medical staff knows exactly what you have taken.
If you forget to take Nefopam
If you forget to take Nefopam, take it as soon as you remember. Do NOT take more than one dose at the same time to make up for the forgotten dose.
If you stop taking Nefopam
Do NOT stop taking Nefopam without checking with your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Nefopam can cause side effects, although not everybody gets them.
If you experience the following rare side effects, STOP taking this medicine and contact your doctor IMMEDIATELY:
• swelling of the skin and soft tissue around the eyes, nose and throat with difficulty breathing (angioedema)
• allergic reactions.
Side effects which may occur most frequently include:
• 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
• convulsions, tremor
• confusion
• hallucinations (seeing things that are not there).
Other side effects which may occur less frequently include:
• being sick (vomitting)
• 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, pharmacist or nurse. 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
• Keep this medicine out of the sight and reach of children.
• 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
What Nefopam contains
The active substance in Nefopam Hydrochloride 30mg Film-coated Tablets is nefopam hydrochloride 30mg.
In addition, the other ingredients are: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, starch pregelatinised, hydrogenated vegetable oil, silica colloidal anhydrous and magnesium stearate.
The coating consists of hydroxyl propyl methylcellulose 2910/hypromellose, titanium dioxide (E171) and macrogol/polyethylene glycol.
What Nefopam looks like and contents of the pack
Nefopam hydrochloride 30 mg Tablets are white to off white, round, biconvex film coated tablets with 'NFP' debossed on one side and plain on other side. The tablets are supplied in blister packs of 90 tablets.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited.
Capital House, 85 King William Street London, EC4N 7BL, UK
Manufacturer
Primegen Limited,
Unit 15 Moorcroft Harlington Road,
Uxbridge, UB8 3HD UK
This leaflet was last revised in December 2015.
Code No: MH/DRUGS/KD/682
103644/LF/335/02