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CAMPRAL EC - patient leaflet, side effects, dosage

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Patient leaflet - CAMPRAL EC

Campral® EC

(acamprosate calcium)

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

What is in this leaflet

  • 1. What Campral is and what it is used for

  • 2. What you need to know before you take Campral

  • 3. How to take Campral

  • 4. Possible side effects

  • 5. How to store Campral

  • 6. Contents of the pack and other information

1. what campral is and what it is 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

Do not take Campral:

  • 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.

You should not be drinking when you start Campral treatment. Campral 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 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

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

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 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 without consulting your doctor first.

If you are breast-feeding, you should not take Campral.

Driving and using machines

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

Information about sodium content

This medicine contains less than 1mmol sodium (23mg) per dosage unit, that is to say it is essentially ‘sodium free’.

3. how to take campral

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 for one year.

If you take more Campral 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

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

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, 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

5. how to store campral

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.

If the tablets become discoloured or show any other signs of deterioration, seek the advice of your pharmacist.

Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. contents of the pack and other information

What Campral contains

The active ingredient in Campral is acamprosate calcium.

Each gastro-resistant tablet contains 333mg acamprosate calcium.

The other ingredients are crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate, Eudragit L30D, talc and propylene glycol.

What Campral looks like and contents of the pack

Campral is white, round, biconvex tablet marked with ‘333’ on one side and plain on the other.

It is available in blister packs containing 168 tablets.

Manufactured by: Merck Sante s.a.s., Centre de production, 2, rue du Pressoir Vert, 45400 Semoy, France. or

Merck SL, Poligono Merck Mollet Del Valles, 08100 Barcelo­na, Spain.

Procured from within the EU and repackaged by the Product Licence holder : B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Campral® EC; PL 18799/3030

Leaflet date: 05.02.2021

| POM |


Campral is the registered trademark of Merck Sante.

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