Mitigare

Mitigare is used in adults to prevent gout flares.

Certain forms of colchicine are also used in adults to treat gout flares or to treat a genetic condition called Familial Mediterranean Fever in adults and children who are at least 4 years old.

Mitigare 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.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Mitigare in larger amounts, or for longer than prescribed.

You may take Mitigare with or without food.

For gout prevention and Familial Mediterranean Fever, Mitigare is given once or twice a day. Your doctor will determine your treatment dose and schedule.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

To treat a gout attack, take Mitigare at the first sign of the attack. You may need to take another dose of colchicine 1 hour after the first dose if you still have gout pain. Follow your doctor's instructions very carefully.

Do not stop the medicine without your doctor's advice. Keep using this medicine even if you feel well.

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

You may need frequent blood tests and your dose or medication schedule may be changed based on the results.

Store tightly closed at room temperature, away from heat, and light.

Tell your doctor about all your other medicines. Some drugs must not be used with Mitigare.

You should not use Mitigare if you are allergic to it, or if you have liver or kidney disease and you also take other drugs that may cause dangerous side effects when used with this medicine.

Some drugs should not be used with Mitigare. Your treatment plan may change if you also take certain other medicines for infections, seizures, birth control, high cholesterol, organ transplant rejection, prevention of nausea and vomiting, HIV, high blood pressure or heart problems.

Tell your doctor if you have or have ever had:

• taken any other medication or medical condition;
• liver or kidney disease.

It may be harder for you to get a woman pregnant while you are using Mitigare.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

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

Stop using Mitigare and call your doctor right away if you have unexplained muscle pain, tenderness, weakness, or numbness and tingling in your fingers or toes.

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

• fever, chills, sore throat, body aches, unusual tiredness, loss of appetite;
• unusual bleeding, bruising;
• mouth sores, skin sores, pale skin, cold hands and feet;
• feeling light-headed or short of breath; or
• severe or ongoing vomiting or diarrhea.

Common side effects of Mitigare may include:

• sore throat;
• 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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

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

Grapefruit may interact with Mitigare and cause side effects. Avoid consuming grapefruit products.

Sometimes, it is not safe to use certain medicines together. Some drugs can change how much of another drug is in your blood, which may increase side effects or make the medicines work less effectively.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect Mitigare, especially:

• cholesterol lowering medicine--atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, gemfibrozil, fenofibrate and others;
• heart medication--ranolazine, digoxin, diltiazem, verapamil, and others;
• medicine to prevent organ transplant rejection including cyclosporine and others;
• antibiotic or antifungal medicine;
• antiviral medicine to treat HIV;
• birth control pills; or
• medicine to prevent or treat nausea and vomiting.

This list is not complete, and many other drugs may affect Mitigare. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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