Pronunciation:

a-KAM-proe-sate

Brand Names:

• Campral

Dosage Forms:

• Tablet, Delayed Release

Classifications:

Therapeutic—

Ethanol Dependency

Uses of This Medicine:

Acamprosate is used to help overcome your drinking problem. It is not a cure for alcoholism, but rather will help you maintain abstinence.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Safety and efficacy in pediatric patients have not been established.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients are more likely to have age-related kidney disease, which may require adjustment of dosage in patients receiving acamprosate .

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease (severe)—Acamprosate is not recommended; serious side effects could occur.

• Depression or
• Suicidal thinking—Acamprosate may make the condition worse.

Proper Use of This Medicine:

Beginning treatment as soon as possible after the period of alcohol withdrawal, and after you have achieved abstinence.

Using acamprosate as part of a treatment program that includes counseling and support.

Continuing acamprosate therapy, even in the event of a relapse.

In addition to beverages, alcohol is found in many other products. Reading the list of ingredients on foods and other products before using them will help you to avoid alcohol. Do not use alcohol-containing foods such as sauces and vinegars.

You may take this medicine with or without food .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • To help overcome drinking problems:
    • Adults—Two tablets (666 mg per dose) taken three times daily.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Extreme feeling of sadness or emptiness

fear

severe depression

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Abdominal pain

confusion

constipation

diarrhea

dry mouth

headache

incoherent speech

increased urination

metallic taste

muscle weakness

nausea

thirst

unusual tiredness

vomiting

weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Discouragement

feeling sad

irritability

lack of appetite

lack or loss of strength

loss of interest or pleasure

nervousness

sleeplessness

tiredness

trouble concentrating

trouble sleeping

Less common

Accidental injury

bloated or full feeling

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

dizziness

dry mouth

excess air or gas in stomach or intestines

itching skin

pain

passing gas

sweating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.