Campral

• Helps people who are dependent on alcohol to abstain from drinking alcohol
• Reduces the urge to drink
• Take tablets with food
• Not to be used while breastfeeding

Campral contains the active ingredient acamprosate, which has an anti-craving effect. Campral is used to treat alcohol dependence (chronic alcoholism). Treatment with Campral is started after the withdrawal period. It is recommended that you keep taking Campral for one year. Campral has a positive effect on relapse prevention.

Campral tablets should be taken with food. The tablets should not be chewed but swallowed whole with some water. You should take Campral tablets as soon as possible after the withdrawal period.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The general dosage guidelines are as follows:

• Adults weighing less than 60 kg:

The usual dose is four tablets a day: two in the morning, one at noon and one in the evening with meals.

• Adults weighing more than 60 kg:

The usual dose is six tablets a day: two in the morning, two at noon and two in the evening with meals.

Adults with moderate kidney problems require a different dose (see the package leaflet).

Alcohol/driving

Do not drink alcohol at all during your treatment with Campral. Keep taking Campral, even if you drink a small amount of alcohol.

Campral does not affect your ability to drive.

If you use too much/forget to use/stop using Campral

If you take more Campral tablets than you should, talk to your doctor or pharmacist straight away. Signs of an overdose include diarrhoea.

If you forget to take a dose of Campral, do not take a double dose to make up for a forgotten one. Just take your next dose at the usual time.

Do not stop using Campral without talking to your doctor.

Campral is not suitable for everyone. Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Campral contains').
• You suffer from severe kidney disease.
• You are breastfeeding.

When should this medicine be used with caution?

• You should not have any withdrawal symptoms when you start treatment with Campral. Campral will not be effective when you are withdrawing from alcohol.
• This medicine is not recommended for children or elderly.
• Patients with moderate kidney problems may require a different dose.
• This medicine is not recommended for patients with severe kidney disease.
• Patients who suffer from alcohol dependence may often also suffer from depression or develop suicidal thoughts. Contact your doctor immediately if you experience any signs of mental problems such as depression or suicidal thoughts. Family and friends should get medical help immediately if there are any signs of mental problems.

Pregnancy and breastfeeding

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

The effects of Campral on your unborn baby are unknown. Therefore, the benefits and risks should be carefully weighed taking into account the importance of the treatment for the mother and the potential adverse reaction for the infant.

If you are breastfeeding, you should not take Campral. This is because the effects in the nursing infant are unknown.

Other medicines and Campral

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

There are no known interactions of Campral with other medicines.

Like all medicines, this medicine can cause side effects, although some people may not experience any. Side effects that are known to be associated with Campral include:

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

• Diarrhoea.

Common (may affect 1 to 10 in every 100 people):

• Abdominal pain, nausea, vomiting, flatulence.
• Itchy or spotty skin rash (maculopapular rash).
• Sexual indifference (frigidity), impotence, decreased sexual desire (loss of libido).

Uncommon (may affect up to 1 in 100 out of every 1,000 people):

• Increased sexual desire.

Very rare (may affect up to 1 in 10,000 people):

• A severe allergic reaction, including skin rash with symptoms such as severe itching and/or bumps (hives or urticaria), sudden moisture accumulation underneath the skin and in mucous membranes (e.g., throat, tongue), breathing difficulties and/or itching and skin rash (angioedema), or a fall in blood pressure, paleness, restlessness, a weak or very fast pulse, clammy skin, decreased level of consciousness due to strong vessel reactions (vessel widening) as a result of hypersensitivity to certain substances (anaphylactic reactions).

Talk to your doctor or pharmacist if the side effects are severe or if you experience side effects that are not listed in the package leaflet. This includes any possible side effects not listed in this leaflet.

The active substance is acamprosate.

Read the package leaflet before use.