ACUPAN TABLETS

Active substance: NEFOPAM HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Acupan 30mg Tablets

active substance: nefopam hydrochloride
Please read all of this leaflet carefully before you start taking this medicine. If you have any futher questions or are not sure about anything,
please ask your doctor or your pharmacist. 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.
This medicine has been prescribed for you. Do not pass it on to others as it may harm them, even if their symptoms are the same as yours. Ensure you
keep this leaflet because you may need to read it again.
In this leaflet:
1.What Acupan is and what it is used for
2. Before you take Acupan
3. How to take Acupan
4. Possible side effects
5. How to store Acupan
6. Further information

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. 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. Further 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 elderly patients:
In elderly patients the doctor may reduce the number of tablets that are taken.

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1. What Acupan is and what it is used for

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.

5. How to store Acupan





Keep your tablets in the original package and out of the reach and sight of children.
Do not store above 30°C.
Do not use Acupan after the expiry date shown on the carton, even if there are some tablets left.
Ask your doctor to replace them with a new prescription and take any unused tablets back to the pharmacy.
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. Further information
Description and contents of Acupan 30mg Tablets
The active substance in Acupan 30mg Tablets is nefopam hydrochloride 30mg. In addition the other ingredients are dibasic calcium phosphate dihydrate,
microcrystalline cellulose, pregelatinised maize starch, magnesium stearate, hydrogenated vegetable oil, colloidal silicone dioxide,
hydroxypropylmethylcellulose, titanium dioxide.
Acupan 30mg Tablets are round, white and marked ‘APN’ on one side.
The tablets are packaged in blister packs of 90 tablets.
The marketing authorisation holder is:
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU, UK
The manufacturer of this product is:
3M Health Care Limited
3M House
Morley Street
Loughborough
Leicestershire
LE11 1EP, UK
Is this leaflet hard to see or read? Please contact the MA holder at the address above.
6204 2217 6
This leaflet was last revised in 11/2013.
56UK1817110-02

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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.

Studio Oberländer GmbH · Rubensstr.  33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85  ·  Fax: - 87  ·  E-Mail: info@studio-oberlaender.de

SPECIFICATION BOX: Leaflet
MANUFACTURER: Meda Pharma GmbH & Co. KG
PRODUCT:

COLOURS USED:
Black

Acupan 30 mg Tablets

20% Tint of Black


MEDA-NO.: 56UK1817110-02
MFS-NO.:

6204 2217 6

LAETUS-CODE: 415
COUNTRY:

DRAWING REF: PE00180

United Kingdom UK

LANGUAGE: English
PACK SIZE:

191 x 254 mm

CORRECTION: 2.

FONT SIZE:

8,5 pt / 9,25 pt

DATE:

18. 11. 2013

415

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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