Campral Ec
000-0000A
Campral® EC TABLETS
(acamprosate) Patient Information Leaflet
The name of your medicine is Campral EC tablets, which will be referred to as Campral tablets throughout this leaflet. ‘EC' stands for ‘Enteric coated' which is a type of gastro-resistant tablet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Campral tablets are and what they are used for
2. Before you take Campral tablets
3. How to take Campral tablets
4. Possible side effects
5. How to store Campral tablets
6. Further information
1. What Campral tablets are and what they are used 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.
2. Before you take Campral tablets
You should not be drinking when you start Campral treatment. Campral will be less effective if you keep on drinking.
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
• are pregnant or breast-feeding
• suffer from severe kidney disease
• suffer from severe liver disease
Campral is not suitable for children or the elderly Take special care with Campral tablets
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.
Taking other medicines
• Please tell your doctor if you are taking or have recently taken any medicines, including medicines obtained without a prescription. 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.
Taking 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.
3. How to take Campral tablets
Always take Campral tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage:
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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Campral tablets 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 (affects more than 1 in 10 patients):
• diarrhoea
• wind
Common (affects less than 1 in 10 patients):
• stomach ache
• gas
• feeling sick
• vomiting
• itchy or spotty skin rash
• decreased sexual desire
• impotence
• frigidity
Uncommon (affects less than 1 in 100 patients):
• increased sexual desire
Rare (affects less than 1 in 1000 patients):
• blistering rash
Unknown frequency:
• allergic reactions including hives, angio-oedema and anaphylaxis (see the beginning of this section)
• blistering rash characterized by patch of skin filled with fluid
If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Campral tablets
• Do not use after the expiry date printed on the carton, carton label or blister label.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• If your doctor tells you to stop taking the tablets, please take it back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.
6. Further information
Your medicine is called Campral EC tablets. It contains 333mg of the active ingredient acamprosate in a white, round, enteric-coated tablet that is marked ‘333' on one side and plain on the reverse.
Campral EC tablets also contain the following inactive ingredients;
crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycollate, anhydrous colloidal silica, magnesium stearate, co-polymer of methacrylic acid and acrylic acid ethyl ester, talc and propylene glycol.
Campral EC tablets are available in blister packs of 60 and 120 tablets.
POM PL No: 6464/1505
This product is manufactured by Merck Sante S.A.S., 2 rue du Pressoir Vert, 45400 Semoy, France and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 18.12.2013
Campral is a registered trademark of Merck Sante.
V.