333 mg enterotablate 
acamprosate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Campral is and what it is used for 
2. What you need to know before taking Campral 
3. How to take Campral 
4. Possible side effects 
5. How to store Campral 6. Contents of the pack 
and other ingredients information

1. What Campral is and what it is used for

Campral reduces the risk of relapse after withdrawal treatment in alcoholic patients. 
It is recommended that the treatment be combined with counseling.

2. What you need to know before taking Campral

Do not take Campral

  • if you are allergic to acamprosate or any of the other ingredients of this medicine (listed in section 6)
  • if you have impaired kidney function
  • if you are breast-feeding

Warnings and cautions

Talk to your doctor or pharmacist before taking Campral:

  • if you have severe hepatic impairment

Campral should not be given to patients under 18 years of age and over 65 years of age.

Other medicines and Campral

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

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

The experience of treatment during pregnancy is small. Pregnant women should therefore only use Campral when a doctor has judged that the benefit of treatment outweighs the potential risk to the fetus.

It is unknown whether Campral is excreted in human milk. Campral should therefore not be used during breast-feeding.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Campral does not affect your ability to drive or use machines.

Campral contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

How to take Campral

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The tablets should be swallowed whole. 
Patients weighing 60 kg or more: 2 tablets three times daily, morning, noon, and evening. 
Patients weighing less than 60 kg: 2 tablets in the morning, 1 tablet in the middle of the day, and 1 tablet at night. 
The recommended treatment time is one year.

If you have the impression that the effect of Campral is too strong or too weak, talk to your doctor or pharmacist.

If you forget to take Campral

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (affects more than 1 user in 10): Diarrhea.

Common side effects (affects more than 1 user in 100): Abdominal pain, nausea, vomitingflatulenceitching, rash, decreased sexual desire, frigidity, and impotence.

Uncommon side effects (affects less than 1 user in 100): Increased sexual desire.

Very rare side effects (affects less than 1 user in 10,000): Allergic reactions such as hives and swelling of the face and throat ( angioedema ) * or allergic shock reaction.

No known frequency: Blisters on the skin or mucous membranes.

* Stop taking Campral and contact a doctor immediately if you get any of the following symptoms ( angioedema ):

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

5. How to store Campral

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is acamprosate
  • The other ingredients are crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate, Eudragit L30D, talc, propylene glycol.

What the medicine looks like and the contents of the pack

White, biconvex tablet, debossed “333” on one side.

The tablets are sold in blister packs of 84, 168, and 6×84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Santé sas

37 Rue Saint Romain

F-69379 Lyon Cedex 08

France

Manufacturer

Merck Santé sas, 2 rue du Pressoir Vert, 45400 Semoy, France

Muhammad Nadeem

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