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ACAMPROSATE 333MG GASTRO-RESISTANT TABLETS

Active substance(s): ACAMPROSATE CALCIUM

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Acamprosate 333 mg
Gastro-resistant Tablets
acamprosate calcium

What is in this leaflet

1. What Acamprosate is and what it is used for
2. What you need to know before you
take Acamprosate
3. How to take Acamprosate
4. Possible side effects
5. How to store Acamprosate
6. Contents of the pack and other information

Other medicines and Acamprosate

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Acamprosate has often been given to patients
together with other medicines that are used to
treat alcohol withdrawal or maintain abstinence.
So far, acamprosate does not seem to interfere with
the effects of other medicines, however if you are
prescribed diuretics (water tablets) talk to your doctor.

Acamprosate with alcohol

Drinking alcohol while taking Acamprosate does not
make you feel sick, however do not drink alcohol at
all during your treatment with Acamprosate. 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.

1. What Acamprosate is and
what it is used for

Pregnancy and breast-feeding

Acamprosate is a medicine which acts on the central
nervous system (the brain and the spinal cord).
Acamprosate is used for the treatment of alcohol
dependence. It helps to maintain abstinence in
alcohol-dependent patients.
Acamprosate in combination with counselling will
help you to not 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.

If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

2. What you need to know before
you take Acamprosate
Do not take Acamprosate:

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TBC

Because patients who suffer from alcohol dependence
often also suffer from depression and are at risk of
thinking about suicide, it is recommended that you be
monitored for symptoms of depression and thoughts
of committing suicide.

• if you are allergic to acamprosate or any of the other
ingredients of this medicine (listed in section 6).
• if you are breast-feeding.
• if you suffer from severe kidney disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Acamprosate.
Acamprosate is not recommended for use:
• if you are a patient below the age 18 years or if you
are above the age 65 years.
• if you suffer from severe liver disease.

Pregnancy:

Breast-feeding:

If you are breastfeeding, do not take Acamprosate
because it is not known whether this medicine passes
into breast milk.

Driving and using machines

Acamprosate has no influence on the ability to drive
and use machines.

3. How to take Acamprosate
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Dosage:

Adults within the age range 18-65 years:
• If you weigh 60kg or more, the recommended 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 recommended
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 Acamprosate
for one year.

TBC

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.
• 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. This includes any possible side
effects not listed in this leaflet. See section 4.

If you drink too much alcohol, your body 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. You should
take Acamprosate as soon as possible after the
withdrawal period.

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Package leaflet: Information for the patient

Method of administration

Swallow this tablet whole. Do not chew or crush the
tablet as this may damage the gastro-resistant coating.

If you take more Acamprosate than you should
If you take too many tablets, call your doctor or
hospital casualty department immediately. You may
experience symptoms of diarrhoea such as frequent
loose or watery stools, abdominal cramps, stomach
pains, fever, feeling sick and vomiting.

If you forget to take Acamprosate

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 Acamprosate

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 notice
any of the following serious side effects, stop taking
acamprosate and contact your doctor immediately:
Very rare (may affect up to 1 in 10,000 people)
• severe allergic reaction causing a rash, itching
or hives (urticaria) on the skin, swelling of the
face, lips, tongue or other parts of the body
(angioedema) or shortness of breath, trouble
breathing with rash, swelling, wheezing and
feeling faint (anaphylaxis reaction)

Other side effects include:

Very common (may affect more than 1 in 10 people)
• diarrhoea
Common (may affect up to 1 in 10 people)
• stomach ache
• feeling sick (nausea)
• vomiting
• excessive gas in the stomach or bowel (flatulence)
• spotty red skin rash
• decreased sexual desire (libido)
Uncommon (may affect up to 1 in 100 people)
• increased sexual desire (libido)
Not known (frequency cannot be estimated from the
available data)
• blistering rash characterised by patches of skin
filled fluid (vesiculo-bullous eruptions)
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor
or pharmacist. 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 Acamprosate
Keep this medicine out of the sight and reach
of children.
This medicinal product does not require any special
storage conditions.
Do not use this medicine after the expiry date which
is stated on the carton and blister 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 Acamprosate contains

The active substance is acamprosate calcium.
Each gastro-resistant tablet contains 333 mg
acamprosate calcium.
The other ingredients are glycerol dibehenate,
microcrystalline cellulose, hypromellose, silica colloidal
anhydrous and magnesium stearate. The coating
includes hypromellose, methacrylic acid-ethyl acrylate
copolymer, talc, propylene glycol. The printing ink
contains shellac, iron oxide black (E172), propylene
glycol (E1520) and ammonium hydroxide (E527).

What Acamprosate looks like and contents
of the pack

Acamprosate gastro-resistant tablets are white, round,
biconvex coated tablet with “M” over “AC” printed in
black ink on one side of the tablet and blank on the
other side.
Acamprosate is available in blister packs of 84 and
168 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan
Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Generics [UK] Ltd, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, UK
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komárom Mylan útca 1,
Hungary

This leaflet was last revised in December 2014.
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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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