Skip to Content

CAMPRAL EC 333MG TABLETS

Active substance(s): ACAMPROSATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Campral® EC 333mg Tablets
(acamprosate)

The name of your medicine is Campral EC 333mg Tablets,
which will be referred to as Campral tablets throughout this
leaflet.
‘EC’ stands for ‘Enteric coated’ which is a type of gastroresistant tablet.

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,
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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet

1.
2.
3.
4.
5.
6.

What Campral tablets are and what they are used for
What you need to know before you take Campral tablets
How to take Campral tablets
Possible side effects
How to store Campral tablets
Contents of the pack and other information

1. What Campral tablets are and what they
are used for
Campral tablets are a medicine which acts on the central
nervous system (the brain and the spinal cord).
Campral tablets help people who are dependent on alcohol to
abstain from drinking alcoholic drinks. Campral tablets 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

Warnings and precautions

Tell your doctor or pharmacist before taking Campral tablets.
You should not be drinking when you start Campral
tablets treatment. Campral tablets will be less effective
if you keep drinking.
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.
This medicine is not recommended for children or elderly.

Other medicines and Campral tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Campral tablets have often been given to patients together
with other medicines that are used to treat alcohol withdrawal
or maintain abstinence. So far, Campral tablets do 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 tablets does not
make you feel sick, however do not drink alcohol at all
during your treatment with Campral tablets. 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 breast-feeding, you should not take Campral
tablets.

Driving and using machines

Campral tablets do not make you sleepy and therefore is not
expected to affect your ability to drive or use machines.

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 tablets (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
Page 1 of 2

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 60kg 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 60kg

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 tablets 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.

What Campral tablets look like and contents of the
pack
The enteric coated tablets are white and round and marked
‘333’ on one side and plain on the reverse.
Campral tablets are supplied in blister packs 60 tablets.

Manufacturer

Manufactured by:
Merck Santé S.A.S., Centre de Production de Lacassagne,
115 Avenue Lacassagne, 69003 Lyon, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0143

POM

Leaflet revision & issue date (Ref): 22.03.16
Campral® is a registered trademark of Merck Santé.

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 ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
Don't take Campral tablets after the Expiry date shown
on the box. If your tablets are out of date, take them to
the pharmacist who will dispose of them safely.
If the tablets become discoloured or show signs of
deterioration, you should seek the advice of your
pharmacist.
If your doctor decides to stop your treatment, take any
tablets you have left 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 needed. These measures will help
to protect the environment.

6. Contents of the pack and other
information
What Campral tablets contain

Each gastro-resistant tablet contains 333mg
acamprosate (I.N.N.) calcium as the active ingredient.
Also contains crospovidone, microcrystalline cellulose,
magnesium silicate, sodium starch glycollate,
anhydrous colloidal silica, magnesium stearate,
anionic copolymer of methacrylic acid and acrylic ethyl ester,
talc and propylene glycol (inactive ingredients).
Page 2 of 2

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.

Hide