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CAMPRAL EC TABLETS

Active substance(s): ACAMPROSATE

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BRIDGED TO
CRESTOR 6464/2069 2070

The name of your medicine is Campral EC tablets, which will be referred to as Campral tablets throughout
this leaflet. ‘EC’ stands for ‘Enteric coated’ which is a type of gastro-resistant tablet.

In this leaflet:
1. What Campral tablets are and what they are used for
2. Before you take Campral tablets
3. How to take Campral tablets
4. Possible side effects
5. How to store Campral tablets
6. Further information
1. What Campral tablets are and what they are used for
Campral is a medicine which acts on the central nervous system (the brain and the spinal cord).
Campral helps people who are dependent on alcohol to abstain from drinking alcoholic drinks. Campral in
combination with counselling will help you not to drink alcohol. It does this by acting on the chemical changes
that have taken place in the brain during the years that you have been drinking alcohol. It does not prevent
the harmful effects of continuous alcohol abuse.

WARNING!

Do not take Campral tablets if you
• have had an allergic reaction, skin rash, swelling of the face, wheezing or difficulty breathing after
taking acamprosate (INN) calcium or any of the other ingredients of Campral (see list of ingredients
in section 6) in the past
• are pregnant or breast-feeding
• suffer from severe kidney disease
• suffer from severe liver disease
DATE:

Campral is not suitable for children or the elderly

UK PIL DATED DEC 2011
REPORTING OF SIDE EFFECTS

6464/1505A

18/12/13

Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant, or planning to become pregnant, you should not take
Campral tablets without consulting your doctor first. If you are breastfeeding, you should not take Campral
tablets.

CODE:

DT

DATE OF PROOF:

Taking Campral tablets with alcohol
Drinking alcohol while taking Campral does not make you feel sick, however do not drink alcohol at
all during your treatment with Campral. Even if you drink a small amount of alcohol you run the risk of
making your treatment fail and you may end up drinking heavily again.

Campral EC Tabs

ARTWORKER:

DATE:

Taking other medicines
• Please tell your doctor if you are taking or have recently taken any medicines, including medicines
obtained without a prescription. Campral has often been given to patients together with other
medicines that are used to treat alcohol withdrawal or maintain abstinence. So far, Campral does not
seem to interfere with the effects of other medicines, however if you are prescribed diuretics (water
tablets) consult your doctor.

PRODUCT:

05-0440
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

Take special care with Campral tablets
If you drink too much alcohol, your body system and in particular your nervous system adapt to the effects of
alcohol. When you then suddenly stop drinking you may experience some unpleasant symptoms known as
alcohol withdrawal syndrome, which can last up to two weeks. You should take Campral tablets as soon as
possible after the withdrawal period.
Because patients who suffer from alcohol dependence often also suffer from depression it is recommended
that you be monitored for symptoms of depression.

Driving and using machines
Campral does not make you sleepy and therefore is not expected to affect your ability to drive or use
machines.
3. How to take Campral tablets
Always take Campral tablets exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Dosage:
If you weigh 60 kg or more:
The usual dose is 6 tablets a day: 2 tablets in the morning, 2 tablets at noon and 2 tablets in the evening with
meals.
If you weigh less than 60 kg
The usual dose is 4 tablets a day: 2 in the morning, 1 at noon and 1 in the evening with meals.
Duration of treatment:
It is recommended that you keep taking Campral for one year.

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WARNING!

CUSTOMER
APPROVED:

2. Before you take Campral tablets
You should not be drinking when you start Campral treatment. Campral will be less effective if you
keep on drinking.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

Campral® EC TABLETS
(acamprosate)
Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

PROOF HISTORY:
v.3 - waymade - 18/12/13

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000A

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

If you take more Campral tablets than you should
If you take too many tablets, call your doctor or hospital casualty department immediately. You may
experience diarrhoea and have raised blood calcium levels.
If you forget to take Campral tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you
remember it and then take the next dose at the right time.

Leaflet Flat Size = 148 x 317

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If you stop taking Campral tablets
Talk to your doctor before you stop taking the tablets and follow their advice. If you have any further
questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Campral tablets can cause side effects, although not everybody gets them.
If you experience any of the following side effects with Campral tablets, STOP taking the tablets and
contact your doctor immediately: A severe allergic reaction, such as angio-oedema (causing large
raised marks on the skin and localised swelling, including the face and throat) or anaphylaxis
(causing difficulty in breathing with rash, swelling, wheezing and feeling faint).
The following side-effects have been reported:
Very common (affects more than 1 in 10 patients):
• diarrhoea
• wind

PROOF HISTORY:
v.3 - waymade - 18/12/13

WARNING!

Common (affects less than 1 in 10 patients):
• stomach ache
• gas
• feeling sick
• vomiting
• itchy or spotty skin rash
• decreased sexual desire
• impotence
• frigidity
Uncommon (affects less than 1 in 100 patients):
• increased sexual desire

Unknown frequency:
• allergic reactions including hives, angio-oedema and anaphylaxis (see the beginning of this section)
• blistering rash characterized by patch of skin filled with fluid
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
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.



5. How to store Campral tablets
Do not use after the expiry date printed on the carton, carton label or blister label.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take it 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer needed. These measures will help to protect the environment.

6. Further information
Your medicine is called Campral EC tablets. It contains 333mg of the active ingredient acamprosate in a
white, round, enteric-coated tablet that is marked ‘333’ on one side and plain on the reverse.

UK PIL DATED DEC 2011
REPORTING OF SIDE EFFECTS

18/12/13
DATE OF PROOF:



6464/1505A

DATE:

DT
ARTWORKER:





CODE:

Q.A.
APPROVED:
05-0440

CUSTOMER: Waymade
PRODUCT: Campral EC Tabs

PRE-PRESS NO.:

By reporting side effects you can help provide more information on the safety of this medicine.

Campral EC tablets also contain the following inactive ingredients;
crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycollate, anhydrous colloidal
silica, magnesium stearate, co-polymer of methacrylic acid and acrylic acid ethyl ester, talc and propylene
glycol.
Campral EC tablets are available in blister packs of 60 and 120 tablets.
POM

PL No: 6464/1505

This product is manufactured by Merck Santé S.A.S., 2 rue du Pressoir Vert, 45400 Semoy, France and is
procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 18.12.2013
Campral is a registered trademark of Merck Sante.

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WARNING!

DATE:

CUSTOMER
APPROVED:

Rare (affects less than 1 in 1000 patients):
• blistering rash

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

27mm

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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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