Label:information for theuser

Campral 333 mg coated tablets

Acamprosate

Read this label carefully before starting to take this medication, as it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Campral and what is it used for

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

3. How to take Campral

4. Possible adverse effects

5 Storage of Campral

6. Contents of the package and additional information

Campral is a medication that acts at the level of the brain. Its action is exerted on certain brain substances related to the appearance of alcohol dependence.

After the period of alcoholic detoxification, Campral is indicated to prevent the patient's relapse in the consumption of alcohol. Campral treatment must always be accompanied by psychotherapy to achieve the maintenance of alcohol abstinence.

Do not take Campral:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Campral

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

Use of Campral with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or might have to take any other medicine.

Taking Campral with food, drinks, and alcohol

Administering Campral with meals may reduce its effectiveness, so it is recommended to take it before meals.

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

Pregnancy, breastfeeding, and fertility

Although no harmful effects have been demonstrated, there is insufficient data on the use of Campral in pregnant women.

It is unknown whether Campral is excreted through human breast milk; however, since it has been demonstrated to be excreted in animals, Campral should not be used in breastfeeding women.

It is unknown whether Campral can affect or not human fertility.

If you are pregnant or breastfeeding, think you might be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

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

Campral contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

-for patients weighing more than 60 kg, 6 tablets per day taken in 3 doses (2 tablets in the morning, 2 at noon, and 2 at night).

-for patients weighing less than 60 kg, 4 tablets per day taken in 3 doses (2 tablets in the morning, 1 at noon, and 1 at night).

Use in children and adolescents

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

Method of administration

The tablets should be swallowed whole with a 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 medication taken, treatment may need to be interrupted.

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

No cases of hypercalcemia (elevated calcium levels) due to overdose have been reported. However, if this occurs, symptomatic treatment will be required.

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

If you forgot to take Campral

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse reactions that occur are of a mild and transient nature.

The following adverse 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, coldness, 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 produced, primarily, on the face and neck), anaphylactic reactions (severe generalized allergic reaction).

Unknown (frequency cannot be estimated from available data):vesiculobullous eruptions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Campral

-The active ingredient is acamprosate. Each tablet contains 333 mg of acamprosate.

-The other components are: microcrystalline cellulose, magnesium silicate, copolymer of methacrylic acid and ethyl acrylate (1:1), dispersion at 30 percent, crospovidone, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, talc, propylene glycol, anhydrous colloidal silica.

Appearance of the product and contents of the packaging

Campral is presented in packaging of 84 coated white round tablets with the inscription 333.

Holder of the marketing authorization and responsible for manufacturing

Holder

Merck Santé s.a.s.

37, rue Saint Romain

69379 Lyon Cedex 08 – France

Responsible for manufacturing

MERCK SANTE S.A.S. CENTRO DE PRODUCCION DE SEMOY
2 rue du Pressoir Vert (Semoy) - F-45400 - France

MERCK S.L.Polígono Merck (Mollet del Vallés (Barcelona)) - 08100 - Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Spain

Merck, S.L.

Tel: + 34 935.65.55.00

Date of the last review of this prospectus: April 2019

The detailed and updated information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/