Nefopam Hydrochloride 30 Mg Tablets
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
Acupan® 30 mg Tablets
(nefopam hydrochloride)
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.
The name of your medicine is Acupan® 30 mg Tablets but it will be referred to as Acupan throughout this leaflet.
In this leaflet
1. What Acupan is and what it is used for
2. What you need to know before you take Acupan
3. How to take Acupan
4. Possible side effects
5. How to store Acupan
6. Contents of the pack and other information
1. 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.
2. 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 other 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 30 mg 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.
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.
5. How to store Acupan
• Keep out of the sight and reach of children.
• Do not store above 30°C.
• Do not use Acupan after the expiry date which is stated after ‘EXP' on the carton and blister, even if there are some tablets left. The expiry date refers to the last day of that month. Ask your doctor to replace them with a new prescription and take any unused tablets back to the pharmacy.
• 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
Description and contents of Acupan 30 mg Tablets
Each film-coated tablet contains 30 mg nefopam hydrochloride.
In addition the other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, magnesium stearate, hydrogenated vegetable oil, colloidal silicon dioxide, hypromellose (2910 (15cps)), titanium dioxide.
The film-coated tablets are round, white and 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.
Manufactured by:
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.
PL 22961/0148 - Acupan® 30 mg Tablets pom
Revision Date: 21.06.2016 Ref: 809
Acupan® is a registered trademark of Meda AB.
Nefopam Hydrochloride 30 mg 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 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.
The name of your medicine is Nefopam Hydrochloride 30 mg Tablets but it will be referred to as Nefopam Hydrochloride throughout this leaflet.
In this leaflet
1. What Nefopam Hydrochloride is and what it is used for
2. What you need to know before you take Nefopam Hydrochloride
3. How to take 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 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 take Nefopam Hydrochloride
Do not take Nefopam Hydrochloride if:
• you are a child under 12 years old
• you have ever had an allergic reaction to nefopam hydrochloride or any of the other 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 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?
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
Nefopam Hydrochloride 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
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 Nefopam Hydrochloride 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 - Nefopam Hydrochloride 30 mg 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 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 more than one dose at the same time to make up for the 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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Nefopam Hydrochloride 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.
5. How to store Nefopam Hydrochloride
• Keep out of the sight and reach of children.
• Do not store above 30°C.
• Do not use Nefopam Hydrochloride after the expiry date which is stated after ‘EXP' on the carton and blister, even if there are some tablets left. The expiry date refers to the last day of that month. Ask your doctor to replace them with a new prescription and take any unused tablets back to the pharmacy.
• 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
Description and contents of Nefopam Hydrochloride 30 mg Tablets
Each film-coated tablet contains 30 mg nefopam hydrochloride.
In addition the other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, magnesium stearate, hydrogenated vegetable oil, colloidal silicon dioxide, hypromellose (2910 (15cps)), titanium dioxide.
The film-coated tablets are round, white and 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.
Manufactured by:
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.
PL 22961/0148 - Nefopam Hydrochloride 30 mg Tablets POM
Revision Date: 21.06.2016
Ref: 810