Colchicine

WHY is this medicine prescribed?

Colchicine is used to prevent gout attacks (sudden, severe pain in one or more joints caused by abnormally high levels of a substance called uric acid in the blood) in adults. Colchicine (Colcrys) is also used to relieve the pain of gout attacks when they occur. Colchicine (Colcrys) is also used to treat familial Mediterranean fever (FMF; an inborn condition that causes episodes of fever, pain, and swelling of the stomach area, lungs, and joints) in adults and children 4 years of age and older. Colchicine is not a pain reliever and cannot be used to treat pain that is not caused by gout or FMF. Colchicine is in a class of medications called anti-gout agents. It works by stopping the natural processes that cause swelling and other symptoms of gout and FMF.

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?

Colchicine comes as a tablet and solution (liquid; Gloperba) to take by mouth with or without food. When colchicine is used to prevent gout attacks or to treat FMF, it is usually taken once or twice a day. When colchicine (Colcrys) is used to relieve the pain of a gout attack, one dose is usually taken at the first sign of pain and a second, smaller dose is usually taken one hour later. If you do not experience relief or have another attack within several days after treatment, talk to your doctor before taking additional doses of medication. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take colchicine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

It is important to use an oral syringe (measuring device) to accurately measure the correct amount of liquid for each dose; do not use a household spoon.

If you are taking colchicine (Colcrys) to treat FMF, your doctor may start you on a low dose and gradually increase your dose. Your doctor may decrease your dose if you experience side effects.

If you are taking colchicine to prevent gout attacks, call your doctor right away if you experience a gout attack during your treatment. Your doctor may tell you to take an extra dose of colchicine, followed by a smaller dose one hour later. If you take extra doses of colchicine to treat a gout attack, you should not take your next scheduled dose of colchicine until at least 12 hours have passed since you took the extra doses.

Colchicine can prevent attacks of gout and control FMF only as long as you take the medication. Continue to take colchicine even if you feel well. Do not stop taking colchicine without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking colchicine,

• tell your doctor and pharmacist if you are allergic to colchicine, any other medications, or any of the ingredients in colchicine tablets or solution. Ask your doctor or pharmacist or check the medication guide for a list of ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional products, and herbal supplements you are taking, have taken within the past 14 days, or plan to take. Be sure to mention any of the following: antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin), telithromycin (Ketek; not available in the U.S.); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and posaconazole (Noxafil); aprepitant (Emend); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); cyclosporine (GenGraf, Neoral, Sandimmune); digoxin (Digitek, Lanoxin); diltiazem (Cardizem, Dilacor, Tiazac, others); fibrates such as bezafibrate, fenofibrate (Antara, Lipofen), and gemfibrozil (Lopid); medications for HIV or AIDS such as amprenavir (Agenerase), atazanavir (Reyataz), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (in Kaletra, Norvir), and saquinavir (Invirase); nefazodone; ranolazine (Ranexa); and verapamil (Calan, Covera, Isoptin, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with colchicine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had kidneyor liver disease. Your doctor will probably tell you not to take colchicine if you are taking certain other medications or if you have both kidney and liver disease.

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

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice during your treatment with colchicine.

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

Take the missed dose as soon as you remember it. If you are taking colchicine on a regular basis and 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.

However, if you are taking colchicine (Colcrys) to treat an attack of gout that happened while you were taking colchicine to prevent gout attacks and you forget to take the second dose, take the missed dose as soon as you remember it. Then wait at least 12 hours before taking your next scheduled dose of colchicine.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• diarrhea
• stomach cramps or pain

Some side effects can be serious. If you experience any of the following symptoms, stop taking colchicine and call your doctor immediately:

• muscle pain or weakness
• numbness or tingling in the fingers or toes
• unusual bruising or bleeding
• sore throat, fever, chills, and other signs of infection
• weakness or tiredness
• paleness or grayness of the lips, tongue, or palms

Colchicine may decrease fertility in men. Talk to your doctor about the risks of taking colchicine.

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).

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

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.

What should I do in case of OVERDOSE?

In case of overdose, go to the nearest hospital emergency room immediately. Taking too much colchicine may cause death.

Symptoms of overdose may include:

• stomach pain
• nausea
• vomiting
• diarrhea
• unusual bruising or bleeding
• sore throat, fever, chills, and other signs of infection
• paleness or grayness of the lips, tongue, or palms
• slowed breathing
• slowed or stopped heartbeat

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to colchicine.

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.