"The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout f"...
Colcrys Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Stop taking this medication and seek immediate medical attention if any of these rare but serious side effects occur: unusual bleeding/bruising, severe diarrhea or vomiting, muscle weakness or pain, numbness/tingling in your fingers or toes, pale or gray color of the lips/tongue/palms of hands, signs of infection (such as fever, persistent sore throat), unusual weakness/tiredness.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Colcrys (colchicine tablets) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as cirrhosis).
Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this drug.
This medication can affect how well your body absorbs some foods and nutrients (such as vitamin B12). Consult your doctor or pharmacist for more details.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Colchicine can decrease sperm production, which may affect the ability of a male to father a child. Consult your doctor for more information.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. Your doctor may recommend that you separate the time(s) you take your medication apart from breast-feeding.
Additional Colcrys Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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