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|Campral

ACAMPROSATE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Campral

† Not commercially available in Canada.

Category

• Alcohol-abuse deterrent

Description

Acamprosate (a-kam-PROE-sate) 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, in the following dosage forms:

• Oral
• Tablets (U.S.)

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 acamprosate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to acamprosate. Also tell your doctor and pharmacist if you are allergic to any other substances, such as sulfites, foods, preservatives, or dyes.

Pregnancy—Acamprosate has not been studied in pregnant women. However, studies in animals have shown that acamprosate can cause birth defects or other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether acamprosate passes into human breast milk. Because acamprosate is passed into the milk of rats acamprosate is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.

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.

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 health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of acamprosate. 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.

Dosing—The dose of acamprosate 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 acamprosate. If your dose is different, do not change it unless your doctor tells you to do so.

• 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—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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

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.

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

Developed: 09/15/2004

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