Mitigare affects the way the body responds to uric acid crystals, which reduces swelling and pain.

Because Mitigare was developed prior to federal regulations requiring FDA review of all marketed drug products, not all uses for this medicine have been approved by the FDA.

The Colcrys brand of colchicine is FDA-approved to treat or prevent gout in adults, and to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.

The Mitigare brand of colchicine is FDA-approved to prevent gout flares in adults.

Generic forms of colchicine have been used to treat or prevent attacks of gout, or to treat symptoms of Behcets syndrome (such as swelling, redness, warmth, and pain).

Mitigare is not a cure for gouty arthritis or Behcets syndrome, and it will not prevent these diseases from progressing. This medicine should not be used as a routine pain medication for other conditions.

Mitigare may also be used for purposes not listed in this medication guide.

Serious drug interactions can occur when certain medicines are used together with Mitigare. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Do not purchase Mitigare on the Internet or from vendors outside of the United States. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Mitigare can be taken with or without food.

To treat a gout attack, for best results take Mitigare at the first sign of the attack. The longer you wait to start taking the medication, the less effective it may be.

You may need to take a second lower dose of colchicine 1 hour after the first dose if you still have gout pain. Follow your doctor's instructions.

Your dose will depend on the reason you are taking this medicine. Mitigare doses for gout and Mediterranean fever are different.

Do not stop using Mitigare unless your doctor tells you to, even if you feel fine.

Call your doctor if your symptoms do not improve, or if they get worse.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

You should not use Mitigare if you are allergic to it.

Some medicines can cause unwanted or dangerous effects when used with Mitigare, especially if you have liver or kidney disease. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cyclosporine;

• nefazodone;

• tipranavir;

• clarithromycin or telithromycin;

• itraconazole or ketoconazole; or

• HIV or AIDS medicine--atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, or saquinavir.

To make sure Mitigare is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• if you take digoxin, or cholesterol-lowering medications.

It is not known whether Mitigare will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Colchicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Mitigare can be fatal.

Overdose symptoms may include diarrhea, nausea, vomiting, stomach pain, muscle weakness, little or no urinating, numbness or tingling, weak pulse, slow heart rate, weak or shallow breathing, or fainting.

Grapefruit and grapefruit juice may interact with Mitigare and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Mitigare may cause serious side effects. Call your doctor at once if you have:

• muscle pain or weakness;

• numbness or tingly feeling in your fingers or toes;

• pale or gray appearance of your lips, tongue, or hands;

• severe or ongoing vomiting or diarrhea;

• fever, chills, body aches, flu symptoms; or

• easy bruising, unusual bleeding, feeling weak or tired.

Common side effects of Mitigare may include:

• nausea, vomiting, stomach pain; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with Mitigare, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine. Give a list of all your medicines to any healthcare provider who treats you.