Cabergoline

WHY is this medicine prescribed?

Cabergoline is used to treat hyperprolactinemia (high levels of prolactin, a natural substance that helps breast-feeding women produce milk but can cause symptoms such as infertility, sexual problems, and bone loss in women who are not breast-feeding or men). Cabergoline is in a class of medications called dopamine receptor agonists. It works by decreasing the amount of prolactin in the body.

Are there OTHER USES for this medicine?

Cabergoline is also sometimes used to treat Parkinson's disease (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Talk to your doctor about the risks of using this medication for your condition.

HOW should this medicine be used?

Cabergoline comes as a tablet to take by mouth. It is usually taken with or without food two times a week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take cabergoline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of cabergoline and gradually increase your dose, not more often than once every 4 weeks.

Do not stop taking cabergoline without talking to your doctor. Your doctor will probably decrease your dose gradually.

What SPECIAL PRECAUTIONS should I follow?

Before taking cabergoline,

• tell your doctor and pharmacist if you are allergic to cabergoline, ergot medications such as bromocriptine (Parlodel); dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Hydergine), ergotamine (in Cafergot, in Ergomar), methylergonovine (Methergine), methysergide (Sansert), and pergolide (Permax); any other medications, or any of the ingredients in cabergoline tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (in Cafergot, in Ergomar), and methylergonovine (Methergine); haloperidol (Haldol); levodopa (in Parcopa, Sinemet, and Stalevo); medications for high blood pressure, mental illness, or nausea; metoclopramide (Reglan); or thiothixene (Navane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you use or have ever used street drugs and if you have or have ever had high blood pressure or any condition that causes thickening or scarring in your lungs, heart, or abdomen. Also tell your doctor if you have or have ever had heart valve disease. Your doctor will examine you and will order tests to see if your heart valves are healthy. Your doctor may tell you not to take cabergoline if you have signs of heart valve disease or any of these conditions.

• tell your doctor if you have or have ever had liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking cabergoline, call your doctor.

• tell your doctor if you are breast-feeding or plan to breast-feed. Cabergoline may slow or stop the production of breast-milk.

• you should know that cabergoline may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking cabergoline. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that some people treated with cabergoline have developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors. There is not enough information to tell whether the people developed these problems because they took the medication or for other reasons. Call your doctor if you have an urge to gamble that is difficult to control, you have intense urges, or you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem.

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?

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

• nausea
• vomiting
• heartburn
• constipation
• tiredness
• dizziness
• breast pain
• painful menstrual periods
• burning, numbness, or tingling in the arms, hands, legs, or feet

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical help:

• shortness of breath
• difficulty breathing when lying down
• cough
• chest pain
• swelling of the hands, feet, ankles, or lower legs
• decrease in urination
• pain in the back, side, or groin
• lumps or pain in the stomach area
• abnormal vision

Cabergoline 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 the following:

• stuffy nose
• fainting
• hallucinations (seeing things or hearing voices that do not exist)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests and other tests to check your body's response to cabergoline.

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.

^¶ This branded product is no longer on the market. Generic alternatives may be available.