CAMPRAL 333 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for theuser

Campral 333 mg film-coated tablets

Acamprosate

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.

Contents of the pack and other information:

1. What is Campral and what is it used for
2. What you need to know before you take Campral
3. How to take Campral
4. Possible side effects

5 Conservation of Campral

1. Contents of the pack and further information

1. What is Campral and what is it used for

Campral is a medicine that acts on the brain. Its action is exerted on certain brain substances that are related to the onset of alcohol dependence.

After the period of alcohol detoxification, Campral is indicated to prevent relapse into alcohol consumption. Treatment with Campral should always be accompanied by psychotherapy to achieve maintenance of alcohol abstinence.

2. What you need to know before you take Campral

Do not take Campral:

• if you are allergic to acamprosate or any of the other ingredients of this medicine (listed in section 6).
• if you have kidney disease (blood creatinine level above 120 micromol/l)
• if you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Campral

• If you are under 18 or over 65 years old.
• If you have severe liver failure.
• Because the relationship between alcohol dependence, depression, and suicide rate is recognized and complex, if you have alcohol dependence and symptoms of depression or suicide, consult your doctor or pharmacist.

Using Campral with other medicines

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

Taking Campral with food, drinks, and alcohol

Administration of Campral with food may reduce its efficacy, so it is recommended to take it before meals.

Although no interactions between Campral and alcohol have been described, it is not recommended to take them together.

Pregnancy, breast-feeding, and fertility

Although no harmful effects have been demonstrated, there is not enough data on the use of Campral in pregnant women.

It is not known whether Campral is excreted in human breast milk; however, since it has been shown to be excreted in animals, Campral should not be used in breast-feeding women.

It is not known whether Campral may affect human fertility.

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

Driving and using machines

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

Campral contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Campral

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

• in patients weighing more than 60 kg, 6 tablets per day divided into 3 doses (2 tablets in the morning, 2 at noon, and 2 in the evening).

• in patients weighing less than 60 kg, 4 tablets per day divided into 3 doses (2 tablets in the morning, 1 at noon, and 1 in the evening).

Use in children and adolescents

The safety and efficacy of Campral in patients under 18 years have not been established, so its use is not recommended in this population.

Method of administration

The tablets are taken without chewing with some liquid.

The tablets should be taken before meals.

Duration of treatment

The recommended duration of treatment is 1 year.

If you take more Campral than you should

Consult your doctor or pharmacist immediately.

Depending on the amount of medicine you have taken, it may be necessary to interrupt treatment.

Acute overdose is usually mild. In reported cases, the only symptom that may be related to overdose is diarrhea.

No case of hypercalcemia (elevated calcium levels) due to overdose has been reported. However, if this happens, treatment should be symptomatic.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91.562.04.20.

If you forget to take Campral

Do not take a double dose to make up for forgotten doses.

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.

Adverse reactions, when they occur, are usually mild and transient.

The following side effects may occur during treatment with Campral:

Very common (may affect more than 1 in 10 people):diarrhea

Common (may affect up to 1 in 10 people):nausea, vomiting, abdominal pain, flatulence, itching, skin rash, chill, decreased libido (sexual desire), and impotence.

Uncommon (may affect up to 1 in 100 people):increased libido.

Very rare (may affect up to 1 in 10,000 people):urticaria, angioedema (swelling under the skin, mainly in the face and neck), anaphylactic reactions (severe generalized allergic reaction).

Not known (frequency cannot be estimated from the available data):vesiculo-bullous eruptions.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Campral

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 protect the environment.

6. Contents of the pack and further information

Composition of Campral

• The active substance is acamprosate. Each tablet contains 333 mg of acamprosate.
• The other ingredients are: microcrystalline cellulose, magnesium silicate, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, crospovidone, sodium carboxymethyl starch (type A) (potato), magnesium stearate, talc, propylene glycol, anhydrous colloidal silica.

Appearance of the product and contents of the pack

Campral is presented in packs of 84 film-coated tablets, white, round, with the inscription 333.

Marketing authorization holder and manufacturer

Marketing authorization holder

Merck Santé s.a.s.

37, rue Saint Romain

69379 Lyon Cedex 08 – France

Manufacturer

MERCK SANTE S.A.S. CENTRO DE PRODUCCION DE SEMOY2 rue du Pressoir Vert (Semoy) - F-45400 - FranceMERCK S.L.Polígono Merck (Mollet del Vallés (Barcelona)) - 08100 - Spain

You can ask for more information about this medicine to the local representative of the marketing authorization holder:

Spain

Merck, S.L.

Tel: + 34 935.65.55.00

Date of last revision of this leaflet: April 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/