Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Campral EC
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Acamprosate calcium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
What you need to know before you take it
e Campral tablets Do not take Campral tablets:
- 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 tablets. 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 tablets 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 tablets 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 tablets 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 tablets without consulting your doctor first. If you are breastfeeding, you should not take Campral tablets. 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'
How to take it
Campral tablets 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 60 kg 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 60 kg 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 tablets 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 tablets 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 tablets 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.
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 tablets, 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 Reporting side effects 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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Campral Tablets Keep this medicine out of the sight and reach of children. Do not use the medicine after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Campral tablets contain The active substance is 333 mg acamprosate (INN) calcium The other ingredients are Crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate, anionic copolymer of methacrylic acid and acid ethyl ester, talc and propylene glycol (inactive ingredients). What Campral tablets look like and contents of the pack Campral tablets are white and round with '333' engraved on one side and approximately 10 mm in diameter. They are packed in blister strips and supplied in boxes of 168 tablets. Marketing Authorisation Holder Merck Serono Limited, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK Manufacturer Merck Santé s.a.s., 2, rue du Pressoir Vert, 45400 Semoy, France This leaflet was last revised in December 2020 TW 2607469
Frequently asked questions about Campral EC
What is the active substance in Campral EC?
The active substance in Campral EC is acamprosate calcium.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Campral EC, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Campral EC without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: acamprosate calcium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Acamprosate is indicated as therapy to maintain abstinence in alcohol-dependent patients. It should be combined with counselling.
4.2. Posology and method of administration
Posology
Adults within the age range 18-65 years:
- 2 tablets three times daily with meals (2 tablets morning, noon and night) in subjects weighing 60kg or more.
- In subjects weighing less than 60kg, 4 tablets divided into three daily doses with meals (2 tablets in the morning, 1 at noon and 1 at night).
Older people
Acamprosate should not be used in older people
Paediatric population
Acamprosate should not be used in children
The recommended treatment period is one year. Treatment with acamprosate should be initiated as soon as possible after the withdrawal period and should be maintained if the patient relapses.
Acamprosate does not prevent the harmful effects of continuous alcohol abuse. Continued alcohol abuse negates the therapeutic benefit, therefore acamprosate treatment should only be initiated after weaning therapy, once the patient is abstinent from alcohol.
4.3. Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Lactating women (see section 4.6)
- In cases of renal insufficiency (serum creatinine >120 micromol/L)
4.4. Special warnings and precautions for use
The safety and efficacy of Campral has not been established in patients younger than 18 years or older than 65 years. Campral is therefore not recommended for use in these populations.
The safety and efficacy of Campral has not been established in patients with severe liver insufficiency (Childs-Pugh Classification C).
Because the interrelationship between alcohol dependence, depression and suicidality is well- recognised and complex, it is recommended that alcohol-dependent patients, including those treated with acamprosate, be monitored for such symptoms.
Excipients:
This medicine contains less than 1mmol sodium (23mg) per dosage unit, that is to say it is essentially 'sodium free'
Abuse and dependence
Non-clinical studies suggest that acamprosate has little or no abuse potential. No evidence of dependence on acamprosate was found in any clinical study thus demonstrating that acamprosate has no significant dependence potential.
4.5. Interaction with other medicinal products and other forms of interaction
The concomitant intake of alcohol and acamprosate does not affect the pharmacokinetics of either alcohol or acamprosate. Administering acamprosate with food diminishes the bioavailability of the drug compared with its administration in the fasting state.
In clinical trials, acamprosate has been safely administered in combination with antidepressants, anxiolytics, hypnotics and sedatives, and non-opioid analgesics
Pharmacokinetic studies have been completed and show no interaction between acamprosate and diazepam, disulfiram, oxazepam, tetrabamate, meprobamate or imipramine.
There is no information available on the concomitant administration of acamprosate with diuretics.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is no adequate data from the use of Campral in pregnant women. Animal studies do not indicate any evidence of foetotoxicity or tetragenicity. Campral must therefore only be used during pregnancy after a careful benefit/risk assessment, when the patient cannot abstain from drinking alcohol without being treated with acamprosate and when there is consequently a risk of foetotoxicity or teratogenicity due to alcohol.
Breast-feeding
It is known that Campral is excreted in the milk of lactating animals. It is not known whether acamprosate is excreted in human milk. There are no adequate data from the use of acamprosate in infants. Campral must therefore not be used in breastfeeding women.
If a breastfeeding woman cannot abstain from drinking alcohol without being treated with acamprosate, a decision must be made whether to discontinue nursing or to discontinue Campral, taking into account the importance of the medicinal product to the woman.
Fertility
In animal studies, no adverse effects on fertility were observed. Whether or not acamprosate affects the fertility in humans is unknown.
4.7. Effects on ability to drive and use machines
Campral has no influence on the ability to drive and use machines.
4.8. Undesirable effects
According to information collected during clinical trials and spontaneous reports since marketing authorization, the following adverse reactions may occur under treatment with Campral.
The following definitions apply to the frequency terminology used hereafter:
very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000, including isolated cases), frequency not known (cannot be estimated from the available data)
Gastrointestinal disorders:
Very common: Diarrhoea
Common: Abdominal pain, nausea, vomiting, flatulence
Skin and subcutaneous tissue disorders:
Common: Pruritus, maculo-papular rash
Not known: Vesiculo-bullous eruptions
Immune system disorders:
Very rare: Hypersensitivity reactions including urticaria, angio-oedema or anaphylactic reactions.
Reproductive system and breast disorders:
Common: Frigidity or impotence.
Psychiatric disorders:
Common: Decreased libido
Uncommon: Increased libido
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Acute overdose is usually mild. In the reported cases, the only symptom, which can be reasonably related to overdose is diarrhoea. No case of hypercalcaemia has ever been reported. Treatment of overdose is directed to symptoms.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- CampralAcamprosatum calcium · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Campral EC. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.