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.
Acamprosate 333 mg Gastro-resistant Tablets.
⚠ 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
Acamprosate is a medicine which acts on the central nervous system (the brain and the spinal cord). Acamprosate is used for the treatment of alcohol dependence. It helps to maintain abstinence in alcohol-dependent patients. Acamprosate in combination with counselling will help you to not 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. 2.
What you need to know before you take it
e Acamprosate
Do not take Acamprosate:
- if you are allergic to acamprosate or any of the other ingredients of this medicine (listed in section 6).
- if you are breast-feeding.
- if you have reduced kidney function. Warnings and precautions Talk to your doctor or pharmacist before taking Acamprosate. Acamprosate is not recommended for use: –
if you are a patient below the age 18 years or if you are above the age 65 years. if you suffer from severe liver disease.
If you drink too much alcohol, your body and in particular your nervous system adapt to the effects of alcohol. When you then suddenly stop drinking you may experience some unpleasant symptoms
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known as alcohol withdrawal syndrome. You should take Acamprosate as soon as possible after the withdrawal period. Because patients who suffer from alcohol dependence often also suffer from depression and are at risk of thinking about suicide, it is recommended that you be monitored for symptoms of depression and thoughts of committing suicide. Other medicines and Acamprosate Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Acamprosate has often been given to patients together with other medicines that are used to treat alcohol withdrawal or maintain abstinence. So far, acamprosate does not seem to interfere with the effects of other medicines, however if you are prescribed diuretics (water tablets) talk to your doctor. Acamprosate with alcohol Drinking alcohol while taking Acamprosate does not make you feel sick, however do not drink alcohol at all during your treatment with Acamprosate. 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 Pregnancy: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Experience with treatment during pregnancy is limited. Pregnant women should therefore only use Acamprosate when a doctor has assessed that the benefit of treatment outweighs the possible risk to the foetus. Breast-feeding: If you are breastfeeding, do not take Acamprosate because it is not known whether this medicine passes into breast milk. Driving and using machines Acamprosate has no influence on the ability to drive and use machines. Acamprosate contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'. 3.
How to take it
Acamprosate
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Dosage Adults within the age range 18-65 years: If you weigh 60 kg or more, the recommended dose is 6 tablets a day: 2 tablets in the morning, 2 tablets at noon and 2 tablets in the evening with meals.
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If you weigh less than 60 kg, the recommended 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 Acamprosate for one year. Method of administration Swallow this tablet whole. Do not chew or crush the tablet as this may damage the gastro-resistant coating. If you take more Acamprosate than you should If you take too many tablets, call your doctor or hospital casualty department immediately. You may experience symptoms of diarrhoea such as frequent loose or watery stools, abdominal cramps, stomach pains, fever, feeling sick and vomiting. If you forget to take Acamprosate 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 Acamprosate 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. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following serious side effects, stop taking acamprosate and contact your doctor immediately: Very rare (may affect up to 1 in 10 000 people)
- severe allergic reaction causing a rash, itching or hives (urticaria) on the skin, swelling of the face, lips, tongue or other parts of the body (angioedema) or shortness of breath, trouble breathing with rash, swelling, wheezing and feeling faint (anaphylaxis reaction) Other side effects include: Very common (may affect more than 1 in 10 people)
- diarrhoea Common (may affect up to 1 in 10 people)
- stomach ache
- feeling sick (nausea)
- vomiting
- excessive gas in the stomach or bowel (flatulence)
- spotty red skin rash
- decreased sexual desire (libido) Uncommon (may affect up to 1 in 100 people)
- increased sexual desire (libido) 4
Not known (frequency cannot be estimated from the available data)
- blistering rash characterised by patches of skin filled fluid (vesiculo-bullous eruptions) If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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. 5.
How to store it
Acamprosate
Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton and blister 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. 6.
Contents of the pack and other information
What Acamprosate contains The active substance is acamprosate calcium. Each gastro-resistant tablet contains 333 mg acamprosate calcium corresponding to 300 mg of acamprosate. The other ingredients are glycerol dibehenate, microcrystalline cellulose, hypromellose, silica colloidal anhydrous and magnesium stearate. The coating includes hypromellose, methacrylic acidethyl acrylate copolymer, (1:1) dispersion 30% (contains sodium laurilsulfate, polysorbate 80), talc, propylene glycol. What Acamprosate looks like and contents of the pack Acamprosate gastro-resistant tablets are white, round, biconvex, coated tablets plain on both sides and approximately 10 mm diameter. Acamprosate is available in blister packs of 84, 168 and in a multipack of 168 comprising of 2 cartons, each containing 84 tablets or 504 comprising of 6 cartons, each containing 84 tablets. Acamprosate is also available in HDPE bottle containing 250 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland. 5
Mylan Hungary Kft, H-2900 Komárom Mylan útca 1, Hungary This leaflet was last revised in November 2025.
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Frequently asked questions about Acamprosate 333 mg Gastro-resistant Tablets.
How do I take Acamprosate 333 mg Gastro-resistant Tablets.?
Acamprosate 333 mg Gastro-resistant Tablets. comes as tablet containing 333mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Acamprosate 333 mg Gastro-resistant Tablets.?
The active substance in Acamprosate 333 mg Gastro-resistant Tablets. is acamprosate calcium.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Acamprosate 333 mg Gastro-resistant Tablets., 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 Acamprosate 333 mg Gastro-resistant Tablets. 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 in the morning, noon and night) in subjects weighing 60 kg or more.
- In subjects weighing less than 60 kg, 4 tablets divided into three daily doses with meals (2 tablets in the morning, 1 at noon and 1 at night).
Paediatric population and older people
Acamprosate should not be administered to children, adolescents and the elderly.
Duration of treatment
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.
Method of administration
For oral use.
Swallow this tablet whole. Do not chew or crush the tablet as this may damage the gastro-resistant coating.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding women (see section 4.6).
Patients with renal impairment (serum creatinine >120 micromol/l).
4.4. Special warnings and precautions for use
The safety and efficacy of acamprosate have not been established in patients younger than 18 years or older than 65 years. Acamprosate is therefore not recommended for use in these populations.
The safety and efficacy of acamprosate have 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.
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.
Acamprosate contain sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
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.
No change in the frequency of clinical and/or biological adverse reactions has been shown when acamprosate is used concomitantly with disulfiram, oxazepam, tetrabamate or meprobamate.
Pharmacokinetic studies have been completed and show no interaction between acamprosate and diazepam, imipramine.
Since acamprosate is most likely eliminated by active renal secretion, clinically relevant interactions may occur with acidic drugs eliminated in this way, e.g. NSAIDs.
The pharmacokinetics of naltrexone and 6 beta-naltrexol are unaffected by concomitant administration of acamprosate. However, such concomitant administration resulted in a 33% increase in Cmax and a 25% increase in AUC of acamprosate. However, dose adjustment is not recommended for such patients.
The combination of acamprosate and diltiazem may lead to worsening of angina pectoris.
There is no information available on the concomitant administration of acamprosate with diuretics.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of acamprosate in pregnant women. Animal studies do not indicate any evidence of foetotoxicity or teratogenicity. Acamprosate 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 acamprosate 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. Acamprosate 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 breast-feeding or to discontinue Acamprosate, 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
Acamprosate 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 authorisation, the following adverse reactions may occur under treatment with Acamprosate.
The following definitions apply to the frequency terminology used hereafter: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).
Immune system disorders:
Very rare: Hypersensitivity reactions including urticaria, angio-oedema or anaphylactic reactions.
Psychiatric disorders:
Common: Decreased libido.
Uncommon: Increased libido.
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.
Reproductive system and breast disorders:
Common: Frigidity or impotence.
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 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
- 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 Acamprosate 333 mg Gastro-resistant Tablets.. 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.