Acupan 30mg Tablets
Acupan® 30mg Tablets
(nefopam hydrochloride)
Package Leaflet: Information for the user
The name of your medicine is Acupan 30mg Tablets but will be referred to as Acupan throughout this 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.
What is 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 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.
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 this medicine out of the sight and reach of children.
■ Store in the original package.
■ Do not store above 30 °C.
■ Do not use Acupan after the expiry date shown on the carton.
■ If your doctor tells you to stop using the medicine, please take it back to your pharmacist to be destroyed. Only keep this if the doctor tells you to.
■ If the medicine becomes discoloured or show any signs of deterioration, you should seek the advice of your doctor or pharmacist.
■ 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 to protect the environment.
6. Contents of the pack and other information
What Acupan contains
■ The active substance in Acupan is nefopam hydrochloride 30mg. Each film-coated tablet contains 30mg nefopam hydrochloride.
■ The other ingredients are colloidal silicone dioxide, dibasic calcium phosphate dihydrate, microcrystalline cellulose, hydrogenated vegetable oil, maize starch, magnesium stearate, hypromellose 2910(15CPS), titanium dioxide.
What Acupan looks like and contents of the pack
Acupan is film coated, white, round tablet and marked APN on one side and plain on the other side.
Your medicine is available in blister packs of 30 tablets or 90 tablets.
Manufacturer
Manufactured by: 3M Health Care Ltd, 3M House, 1 Morley St, Loughborough, Leicestershire, LE11 1EP.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR, UK.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
POM
PL: 21828/0682
Leaflet issue and revision date: 20.06.16
Acupan® is a registered trademark of Meda AB.
Nefopam Hydrochloride 30mg Tablets
Package Leaflet: Information for the user
The name of your medicine is Nefopam Hydrochloride 30mg Tablets but will be referred to as Nefopam Hydrochloride throughout this 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.
What is 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 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 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 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 this medicine out of the sight and reach of children.
■ Store in the original package.
■ Do not store above 30 °C.
■ Do not use Nefopam Hydrochloride after the expiry date shown on the carton.
■ If your doctor tells you to stop using the medicine, please take it back to your pharmacist to be destroyed. Only keep this if the doctor tells you to.
■ If the medicine becomes discoloured or show any signs of deterioration, you should seek the advice of your doctor or pharmacist.
■ 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 to protect the environment.
6. Contents of the pack and other information
What Nefopam Hydrochloride contains
■ The active substance in Nefopam Hydrochloride is nefopam hydrochloride 30mg. Each film-coated tablet contains 30mg nefopam hydrochloride.
■ The other ingredients are colloidal silicone dioxide, dibasic calcium phosphate dihydrate, microcrystalline cellulose, hydrogenated vegetable oil, maize starch, magnesium stearate, hypromellose 2910(15CPS), titanium dioxide.
What Nefopam Hydrochloride looks like and contents of the pack
Nefopam Hydrochloride is film coated, white, round tablet and marked APN on one side and plain on the other side.
Your medicine is available in blister packs of 30 tablets or 90 tablets.
Manufacturer
Manufactured by: 3M Health Care Ltd, 3M House, 1 Morley St, Loughborough, Leicestershire, LE11 1EP.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR, UK.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
POM
PL: 21828/0682
Leaflet issue and revision date: 20.06.16
Page 2 of 2