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Acupan® 30mg Tablets

(nefopam hydrochloride)

Patient Information 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

The name of your medicine is Acupan 30mg Tablets (referred to as Acupan throughout this leaflet).

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 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

•    Do not use after the expiry date printed on the carton label or blister strip.

•    Do not store above 30°C. Protect from light. Store in the original package

•    KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

•    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.

6)    Contents of the pack and other information What Acupan contains

Each tablet contains 30mg nefopam hydrochloride.

The tablets also contain the following inactive ingredients: Calcium phosphate dibasic dihydrate, microcrystalline cellulose, maize starch, magnesium stearate,hydrogenated vegetable oil, colloidal silicon dioxide, hypromellose 2910 (15cps), titanium dioxide.

What Acupan looks like and contents of the pack

The tablets are round, white and marked 'APN' on one side and plain on the other.

Each pack contains 30 tablets.

PL 10383/1752 Acupan 30mg Tablets    |POM[

Who makes and repackages your medicine:

Your medicine is manufactured by 3M Health Care Ltd, 3M House, 1 Morley Street, Loughborough, Leicestershire, LE11 1EP, UK. Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 27.09.2016

Acupan is a registered trademark of Meda AB, Sweden.