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CAMPRAL EC 333MG GASTRO-RESISTANT TABLETS

Active substance(s): ACAMPROSATE CALCIUM

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Ref: 1393/050116/1/F

®

Campral EC 333mg gastro-resistant tablets
(acamprosate calcium)
Patient Information 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 or nurse.
* 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 or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

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.

Your medicine is called Campral EC 333mg gastro-resistant tablets but will
be referred to as Campral tablets throughout the rest of this leaflet.
‘EC’ stands for ‘Enteric coated’ which is a type of gastro-resistant tablet.

This medicine is not recommended for children or elderly.

What is in this leaflet

Other medicines and Campral tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

1

What Campral tablets are and what they are used for

2

What you need to know before you take Campral tablets

3

How to take Campral tablets

4

Possible side effects

5

How to store Campral tablets

6

Contents of the pack and other 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.

2

What you need to know before you take Campral
tablets

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
* if you are pregnant or breast-feeding
* if you suffer from severe kidney disease
* if you suffer from severe liver disease
Warnings and precautions
Tell your doctor or pharmacist before taking Campral tablets.
You should not be drinking when you start Campral treatment. Campral
will be less effective if you keep drinking.

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.
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.
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.
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 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.

Ref: 1393/050116/1/B

®

Campral EC 333mg gastro-resistant tablets
(acamprosate calcium)
Patient Information Leaflet (continued)
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.

5

How to store Campral tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store at room temperature (15-25°C).
Do not take Campral tablets after the expiry date which is stated on the
blister or carton labels.
If your doctor tells you to stop taking this medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
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.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
6
4

Possible side effects

Contents of the pack and other information

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

What campral tablets contain:
The active substance is 333mg acamprosate (INN) calcium.
The other ingredients are: crospovidone, microcrystalline cellulose,
magnesium silicate, sodium starch glycolate, colloidal silica dioxide,
magnesium stearate, eudragit L30D, talc and propylene glycol.

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).

What campral tablets look like and contents of the pack
Campral tablets are white, round, enteric coated tablets marked with 333 on
one side and plain on the other side.
The tablets are available in blister packs of 168 tablets.

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.

Manufacturer and Licence Holder
This medicine is manufactured by Merck Sante s.a.s, Centre de production,
2 rue du Pressoir Vert, 45400 SEMOY, France and is procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1393

Campral EC 333mg gastro-resistant tablets

Campral is a registered trademark of Merck Sante.
Revision date: 05/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 1393/050116/2/F

®

Campral EC 333mg gastro-resistant tablets
(acamprosate calcium)
Patient Information 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 or nurse.
* 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 or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

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.

Your medicine is called Campral EC 333mg gastro-resistant tablets but will
be referred to as Campral tablets throughout the rest of this leaflet.
‘EC’ stands for ‘Enteric coated’ which is a type of gastro-resistant tablet.

This medicine is not recommended for children or elderly.

What is in this leaflet

Other medicines and Campral tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

1

What Campral tablets are and what they are used for

2

What you need to know before you take Campral tablets

3

How to take Campral tablets

4

Possible side effects

5

How to store Campral tablets

6

Contents of the pack and other 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.

2

What you need to know before you take Campral
tablets

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
* if you are pregnant or breast-feeding
* if you suffer from severe kidney disease
* if you suffer from severe liver disease
Warnings and precautions
Tell your doctor or pharmacist before taking Campral tablets.
You should not be drinking when you start Campral treatment. Campral
will be less effective if you keep drinking.

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.
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.
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.
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 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.

Ref: 1393/050116/2/B

®

Campral EC 333mg gastro-resistant tablets
(acamprosate calcium)
Patient Information Leaflet (continued)
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.

5

How to store Campral tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store at room temperature (15-25°C).
Do not take Campral tablets after the expiry date which is stated on the
blister or carton labels.
If your doctor tells you to stop taking this medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
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.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
6
4

Possible side effects

Contents of the pack and other information

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

What campral tablets contain:
The active substance is 333mg acamprosate (INN) calcium.
The other ingredients are: crospovidone, microcrystalline cellulose,
magnesium silicate, sodium starch glycolate, colloidal silica dioxide,
magnesium stearate, eudragit L30D, talc and propylene glycol.

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).

What campral tablets look like and contents of the pack
Campral tablets are white, round, enteric coated tablets marked with 333 on
one side and plain on the other side.
The tablets are available in blister packs of 168 tablets.

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.

Manufacturer and Licence Holder
This medicine is manufactured by Merck SL, Poligono Merck Mollet Del
Valles 08100, Barcelona, Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1393

Campral EC 333mg gastro-resistant tablets

Campral is a registered trademark of Merck Sante.
Revision date: 05/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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