Acamprosate

WHY is this medicine prescribed?

Acamprosate is used along with counseling and social support to help people who have stopped drinking large amounts of alcohol (alcoholism) to avoid drinking alcohol again. Drinking alcohol for a long time changes the way the brain works. Acamprosate works by helping the brains of people who have drunk large amounts of alcohol to work normally again. Acamprosate does not prevent the withdrawal symptoms that people may experience when they stop drinking alcohol. Acamprosate has not been shown to work in people who have not stopped drinking alcohol or in people who drink large amounts of alcohol and also overuse or abuse other substances such as street drugs or prescription medications.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Acamprosate comes as a delayed-release (releases the medication in the intestine) tablet to take by mouth. It is usually taken with or without food three times a day. To help you remember to take acamprosate, take it around the same times every day. Taking acamprosate with breakfast, lunch, and dinner may help you to remember all three doses. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acamprosate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Acamprosate helps to prevent you from drinking alcohol only as long as you are taking it. Continue to take acamprosate even if you do not think you are likely to start drinking alcohol again. Do not stop taking acamprosate without talking to your doctor.

If you drink alcohol while you are taking acamprosate, continue to take the medication and call your doctor. Acamprosate will not cause you to have an unpleasant reaction if you drink alcohol during treatment.

What SPECIAL PRECAUTIONS should I follow?

Before taking acamprosate,

• tell your doctor and pharmacist if you are allergic to acamprosate, any other medications, sulfites, or any of the ingredients in acamprosate tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention antidepressants ('mood elevators'). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are thinking of, or have ever thought of, harming or killing yourself, if you have ever tried to do so, or if you use or have ever used street drugs or have overused prescription medications. Also tell your doctor if you have or have ever had depression or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acamprosate, call your doctor.

• you should know that acamprosate may affect your thinking, ability to make decisions, and coordination. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that people who drink large amounts of alcohol often become depressed and sometimes try to harm or kill themselves. Taking acamprosate does not decrease and may increase the risk that you will try to harm yourself. You may develop depression while you are taking acamprosate even if you do not go back to drinking. You or your family should call the doctor right away if you experience symptoms of depression such as feelings of sadness, anxiousness, hopelessness, guilt, worthlessness, or helplessness; loss of interest or pleasure in activities you once enjoyed; lack of energy; difficulty concentrating, making decisions, or remembering; irritability; sleep problems; changes in appetite or weight; restlessness; or thinking about harming or killing yourself or planning or trying to do so. Be sure that your family knows which symptoms may be serious so they can call the doctor right away if you are unable to seek treatment on your own.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Acamprosate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• gas
• upset stomach
• loss of appetite
• dry mouth
• dizziness
• itching
• weakness
• nausea
• anxiety
• difficulty falling asleep or staying asleep
• sweating

Some side effects can be serious. The following symptoms are uncommon, but if you experience either of them or those mentioned in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• burning, tingling, or numbness in the hands, feet, arms, or legs
• rash

Acamprosate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• diarrhea

If you take too much acamprosate regularly for a long time, you may experience certain symptoms. Call your doctor if you experience any of these symptoms:

• loss of appetite
• upset stomach
• constipation
• extreme thirst
• tiredness
• muscle weakness
• restlessness
• confusion

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and counselor or support group.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.