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CAMPRAL EC

Active substance(s): ACAMPROSATE

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The name of your medicine is Campral EC 333 mg gastro-resistant 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.
Warnings and precautions
Read all of this leaflet carefully before you start
taking this medicine because it contains important
Tell your doctor or pharmacist before taking Campral
information for you.
tablets.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or
You should not be drinking when you start Campral
pharmacist or nurse.
treatment. Campral will be less effective if you keep
− This medicine has been prescribed for you only. Do not
drinking.
pass it on to others. It may harm them, even if their signs
If you drink too much alcohol, your body system and in
of illness are the same as yours.
particular your nervous system adapt to the effects of
− If you get any side effects, talk to your doctor or
alcohol. When you then suddenly stop drinking you may
pharmacist or nurse. This includes any possible side
experience some unpleasant symptoms known as alcohol
effects not listed in this leaflet. See section 4.
withdrawal syndrome, which can last up to two weeks.
What is in this leaflet
You should take Campral tablets as soon as possible after
1. What Campral tablets are and what they are used for
the withdrawal period.
2. What you need to know before you take Campral tablets
Because patients who suffer from alcohol dependence
3. How to take Campral tablets
often also suffer from depression it is recommended that
4. Possible side effects
you be monitored for symptoms of depression.
5. How to store Campral tablets
This medicine is not recommended for children or elderly.
6. Contents of the pack and other information
Other medicines and Campral tablets
1. What Campral tablets are and what they are used
for
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Campral is a medicine which acts on the central nervous
system (the brain and the spinal cord).
Campral has often been given to patients together with
Campral helps people who are dependent on alcohol
other medicines that are used to treat alcohol withdrawal
to abstain from drinking alcoholic drinks. Campral in
or maintain abstinence. So far, Campral does not seem to
combination with counselling will help you not to drink
interfere with the effects of other medicines, however if you
alcohol. It does this by acting on the chemical changes
are prescribed diuretics (water tablets) consult your doctor.
that have taken place in the brain during the years that you
Campral tablets with alcohol
have been drinking alcohol. It does not prevent the harmful
effects of continuous alcohol abuse.
Drinking alcohol while taking Campral does not make
you feel sick, however do not drink alcohol at all
2. What you need to know before you take Campral
during your treatment with Campral. Even if you drink
tablets
a small amount of alcohol you run the risk of making your
Do not take Campral tablets:
treatment fail and you may end up drinking heavily again.
• if you have had an allergic reaction, skin rash, swelling
Pregnancy and breast-feeding
of the face, wheezing or difficulty breathing after
taking acamprosate (INN) calcium or any of the other
If you are pregnant, think you might be pregnant, or
ingredients of Campral (see list of ingredients in section
planning to become pregnant, you should not take Campral
6) in the past
tablets without consulting your doctor first.
• if you are pregnant or breast-feeding
• if you suffer from severe kidney disease
If you are breastfeeding, you should not take Campral
tablets.
• if you suffer from severe liver disease

10

210 mm

acamprosate

82,6 mm

333 mg gastro-resistant tablets

TW871234

Package leaflet: Information for the user

3. How to take Campral tablets
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose
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.
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.
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
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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: may affect more than 1 in 10 people
• diarrhoea
Common: may affect up to 1 in 10 people
• stomach ache
• gas
• feeling sick
• vomiting
• itchy or spotty skin rash
• decreased sexual desire

• impotence
• frigidity
Uncommon: may affect up to 1 in 100 people
• increased sexual desire
Not Known: frequency cannot be estimated from the
available data
• allergic reactions including hives, angio-oedema and
anaphylaxis (see the beginning of this section)
• blistering rash characterised by patches of skin filled
with fluid
Reporting side effects
If you get any side effects, talk to your doctor or 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 Campral Tablets
Keep this medicine out of the sight and reach of children.
Do not use the medicine after the expiry date which is
stated on the carton after ‘EXP’. The expiry date refers to
the last day of that month.
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
What Campral tablets contain
The active substance is 333 mg acamprosate (INN) calcium
The other ingredients are Crospovidone, microcrystalline
cellulose, magnesium silicate, sodium starch glycolate,
anhydrous colloidal silica, magnesium stearate, anionic
copolymer of methacrylic acid and acid ethyl ester, talc
and propylene glycol (inactive ingredients).
What Campral tablets look like and contents of the
pack
Campral tablets are white and round.
They are packed in blister strips and supplied in boxes of
168 tablets.
Marketing Authorisation Holder
Merck Santé s.a.s., 37 rue Saint-Romain, 69379 Lyon cedex
08, France
Manufacturer
Merck Santé s.a.s., 2, rue du Pressoir Vert, 45400 Semoy,
France
For any information about this medicine, please contact:
Merck Serono Ltd, Bedfont Cross, Stanwell Road,
Feltham, Middlesex, TW14 8NX, UK.
This leaflet was last revised in March 2015
FR2575592

Driving and using machines
Campral does not make you sleepy and therefore is not
expected to affect your ability to drive or use machines.

65 mm

10

170 mm

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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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