Nefopam Hydrochloride 30mg Tablets
Ref: 0907/130516/1/F
Acupan ® 30mg Tablets / Nefopam Hydrochloride 30mg Tablets
(nefopam hydrochloride)
Patient Information Leaflet
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 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.
Your medicine is called Acupan 30mg Tablets or Nefopam Hydrochloride 30mg Tablets but will be referred to as Acupan throughout this leaflet.
What is in this leaflet
[ft What Acupan is and what it is used for
[3 What you need to know before you take Acupan
[3 How to take Acupan
,4 Possible side effects
^3 How to store Acupan
[3 Contents of the pack and other information
^ What Acupan is and what it is used for
Acupan 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 Acupan does not stop the pain from happening, but you will not be able to feel the pain as much.
Acupan 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). Acupan should not be used to treat the pain from a heart attack.
^3 What you need to know before you take Acupan
Do not take Acupan 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 or 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).
Take special care with Acupan
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?
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription and 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
Tell your doctor or dentist if you are taking any of these medicines. Pregnancy and breast-feeding
Acupan 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.
Driving and using machines
Acupan can cause drowsiness. Do not drive or operate heavy machinery unless you know how Acupan affects you.
[3 How to take Acupan
Dosage for adults:
Always take Acupan exactly as your doctor has told you.
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.
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.
Dosage for children:
Over 12 years - as per adults (see above).
Under 12 years - Acupan 30mg Tablets should not be taken by children under 12.
Dosage for older patients:
In older 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 Acupan depending upon your condition.
If you take more Acupan 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 Acupan
If you forget to take Acupan, 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 Acupan
Do not stop taking Acupan without first checking with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Acupan 30mg Tablets / Nefopam Hydrochloride 30mg Tablets
(nefopam hydrochloride)
Patient Information Leaflet (continued) [4 Possible side effects
Like all medicines Acupan 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, 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.
STORING YOUR MEDICINE
Do not store above 30°C.
Keep out of the sight and reach of children.
IMPORTANT
Remember this medicine is for you. It can only be prescribed to you by a doctor. Never give you medicine to other people. It may harm them, even if their symptoms are the same as yours. This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything to do with this medicine, ask a doctor or pharmacist (chemist). He/she will have additional information and will be able to advise you.
Contents of the pack and other information
What this medicine contains:
Each tablet contains 30mg of Nefopam Hydrochloride as the active ingredient. Acupan also contains the following inactive ingredients: dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinised maize starch, magnesium stearate, hydrogenated vegetable oil, colloidal silicon dioxide, hydroxypropyl methylcellulose 2910 and titanium dioxide.
What this medicine looks like and contents of the pack
Acupan are white, round, film-coated tablets, marked ‘APN' on one side and plain on the reverse. They come in blister packs of 30 and 90 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by 3M Health Care Limited, 3M House, 1 Morley Street, Loughborough, Leicestershire LE11 1EP and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/0907 Acupan 30mg Tablets
^ How to store Acupan
EXPIRY
Do not use this medicine after the date shown on the carton label or blister strip. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to. If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do.
Acupan is a registered trademark of Meda AB.
Revision date: 13/05/16