What is the most important information I should know about colchicine?

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, the uses for colchicine have not been approved by the FDA. Newer drugs have been developed and FDA-approved to treat the conditions that colchicine is used to treat.

You should not use this medication if you are allergic to colchicine, or if you have heart disease, kidney disease, or a severe gastrointestinal disorder.

Before taking colchicine, tell your doctor if you have a stomach ulcer, ulcerative colitis, Crohn's disease, or intestinal bleeding or other disorder.

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

If you use this medication over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Call your doctor at once if you have a serious side effect such as severe vomiting or diarrhea, easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms, numbness, burning, pain, or tingly feeling, blood in your urine, or urinating less than usual or not at all.

What is colchicine?

Because colchicine was developed prior to federal regulations requiring FDA review of all marketed drug products, the uses for colchicine have not been approved by the FDA. Newer drugs have been developed and FDA-approved to treat the conditions that colchicine is used to treat.

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

Colchicine is used to treat or prevent attacks of gout. It is also used to treat symptoms of Behcets syndrome (such as swelling, redness, warmth, and pain).

Colchicine is not a cure for gouty arthritis or Behcets syndrome, and it will not prevent these diseases from progressing.

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

What should I discuss with my healthcare provider before taking colchicine?

You should not use this medication if you are allergic to colchicine, or if you have:

• heart disease;
• kidney disease; or
• a severe gastrointestinal disorder.

Before taking colchicine, tell your doctor if you are allergic to any drugs, or if you have:

• a stomach ulcer;
• ulcerative colitis;
• Crohn's disease; or
• intestinal bleeding or other disorder.

If you have any of these conditions, you may need a dose adjustment or special tests during to safely take colchicine.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether colchicine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take colchicine?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

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

Colchicine is usually taken every 2 hours until you feel relief from pain or until the medication causes side effects. Follow your doctor's instructions.

If you need to take a second course of colchicine, wait until at least 3 days have passed since the start of your last gout attack.

To prevent gout attacks, colchicine may be taken every day or several days a week. Follow your doctor's instructions.

If you use this medication over a long period of time, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Store colchicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of colchicine can be fatal.

Overdose symptoms may include diarrhea (may be bloody and severe), nausea, vomiting, stomach pain, heartburn, a burning feeling in your throat or stomach, muscle weakness, urinating less than usual, numbness or tingling, fainting, or seizure (convulsions).

What should I avoid while taking colchicine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using colchicine.

What are the possible side effects of colchicine?

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

Call your doctor at once if you have a serious side effect such as:

• severe vomiting or diarrhea;
• easy bruising or bleeding, unusual weakness;
• fever, chills, body aches, flu symptoms;
• numbness, burning, pain, or tingly feeling;
• blood in your urine; or
• urinating less than usual or not at all.

Less serious side effects may include:

• mild nausea or stomach pain;
• mild diarrhea;
• muscle pain; or
• hair loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect colchicine?

There may be other drugs that can interact with colchicine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about colchicine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed

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