Campral

Leaflet attached to the packaging: patient information

Campral

333 mg, enteric-coated tablets

Acamprosate

Please read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Campral and what is it used for
• 2. Important information before taking Campral
• 3. How to take Campral
• 4. Possible side effects
• 5. How to store Campral
• 6. Contents of the packaging and other information

1. What is Campral and what is it used for

The active substance of Campral is acamprosate, which has a chemical structure similar to that of neurotransmitters such as taurine or gamma-aminobutyric acid (GABA). Studies have shown that acamprosate affects alcohol dependence, reducing alcohol consumption without disrupting food and fluid intake.
Campral is indicated for the maintenance of alcohol abstinence in alcohol-dependent patients, with concurrent psychotherapy.

2. Important information before taking Campral

When not to take Campral

120 micromol/l);
• in breastfeeding women.

Warnings and precautions

The safety and efficacy of Campral have not been established in patients under 18 years of age and over 65 years of age, so it is not recommended to use the medicine in these patient populations.
The safety and efficacy of Campral have not been established in patients with severe liver failure.
Due to the well-known and complex interdependence between alcohol dependence, depression, and suicidal tendencies, it is recommended that patients with alcohol dependence, including those treated with acamprosate, be monitored for typical symptoms.
Campral is not indicated for the treatment of acute symptoms of alcohol withdrawal syndrome.
Abuse and dependence: non-clinical studies indicate that acamprosate has no or minimal potential for dependence.

Campral and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No changes in the frequency of clinical and/or biological adverse reactions have been observed when acamprosate is taken with disulfiram, oxazepam, tetrabamate, and meprobamate.
In clinical studies, acamprosate has been safely used in combination with antidepressants, anxiolytics, hypnotics, and sedatives, as well as non-opioid analgesics.

Campral with food and drink

Concurrent consumption of alcohol with Campral does not affect the action of alcohol and acamprosate.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
There are no adequate data on the use of Campral in pregnant women. Animal studies have not shown any evidence of toxic or teratogenic effects on the fetus.
Campral should only be used in pregnancy after a careful assessment of the benefit-risk ratio, when the patient cannot abstain from alcohol without treatment with Campral, and when there is a risk of toxic and teratogenic effects of alcohol on the fetus.
Breastfeeding
Campral passes into the milk of lactating animals. It is not known whether acamprosate passes into human milk. There are no adequate data on the use of acamprosate in infants. Therefore, Campral should not be used in breastfeeding women.
Fertility
In animal studies, no adverse effects on fertility have been observed. It is not known whether acamprosate affects fertility in humans.

Driving and using machines

Campral does not affect the ability to drive and use machines.

Campral contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Campral

This medicine should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
Adults aged 18-65
Patients with a body weight of 60 kg or more should take 2 tablets of acamprosate (666 mg) three times a day (morning, noon, and before bedtime).
Patients with a body weight below 60 kg should take 4 tablets in three divided doses (two tablets in the morning, one at noon, and one before bedtime).
In patients with normal gastrointestinal function, it is recommended to take the medicine between meals. Taking the medicine with food reduces its absorption.
Children and elderly
Acamprosate should not be given to children and the elderly.
The recommended treatment duration is 1 year. Treatment with acamprosate should be started as soon as possible after alcohol withdrawal. An occasional episode of alcohol consumption is not a contraindication to continuing treatment.
If the patient feels that the effect of the medicine is too strong or too weak, they should contact their doctor.

Using a higher dose of Campral than recommended

In case of overdose, Campral usually causes diarrhea; the patient should contact their doctor.

Missing a dose of Campral

In case of a missed dose, the patient should take the dose prescribed by the doctor at the next scheduled time. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Campral can cause side effects, although not everybody gets them.
The following side effects may occur when taking Campral. The frequency is defined as follows: very common (in more than 1 in 10 patients), common (in more than 1 in 100 but less than 1 in 10 patients), uncommon (in more than 1 in 1,000 patients but less than 1 in 100 patients), rare (in more than 1 in 10,000 patients but less than 1 in 1,000 patients), very rare (in less than 1 in 10,000 patients, including single cases), frequency not known (frequency cannot be estimated from the available data).
Very common: diarrhea.
Common: abdominal pain, nausea, vomiting, bloating, itching, rash, decreased libido or impotence, decreased sexual desire.
Uncommon: increased libido.
Very rare: hypersensitivity reactions, including hives, angioedema (swelling affecting deeper skin layers and subcutaneous tissue, which can also involve mucous membranes; angioedema is often localized to the face, lips, and eyelids but can affect any part of the body, as well as the gastrointestinal, respiratory, and urinary tracts) or anaphylactic reactions (itching, flushing, hives of varying severity, sudden drop in blood pressure, tachycardia or bradycardia, shortness of breath, difficulty breathing due to laryngeal edema, abdominal cramps, vomiting, diarrhea, sometimes bloody).
Frequency not known: blistering skin reactions.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 4921 309
website: https://smz.ezdrowie.gov.pl .
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Campral

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Campral contains

• The active substance is acamprosate.
• The other ingredients are: crospovidone, microcrystalline cellulose, magnesium silicate, sodium carboxymethylcellulose, colloidal silica, magnesium stearate, methacrylic acid, and ethyl acrylate copolymer (1:1), 30% dispersion, talc, propylene glycol.

What Campral looks like and contents of the packaging

Campral is a enteric-coated tablet.
The packaging contains 60, 84, 180, or 200 enteric-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sante s.a.s.
37, rue Saint-Romain
69379 Lyon Cedex 08,
France
Logo of the marketing authorization holder

Manufacturer

Merck Sante s.a.s.
2, rue du Pressoir Vert
45400 Semoy,
France
or
Merck, SL
Poligono Merck
Mollet Del Valles, 08100 Barcelona,
Spain
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Merck Sp. z o.o.
tel. 22 53 59 700
fax. 22 53 59 703

Date of last revision of the leaflet: