MITIGARE- colchicine capsule
Hikma Specialty USA Inc.
MITIGARE® (mīt-ah-gär-ay) Capsules
What is the most important information I should know about MITIGARE®?
MITIGARE® can cause serious side effects or death if levels of MITIGARE® are too high in your body.
What is MITIGARE®?
MITIGARE® is a prescription medication used to prevent gout flares in adults.
It is not known if MITIGARE® is safe and effective for the treatment of:
MITIGARE® is not a pain medicine and it should not be taken to treat pain related to other conditions unless specifically for those conditions.
It is not known if MITIGARE® is safe and effective in children.
Who should not take MITIGARE®?
Do not take MITIGARE® if you have liver and kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these people even when taken as directed. See “What is the most important information I should know about MITIGARE®?”
What should I tell my healthcare provider before taking MITIGARE®?
Before you take MITIGARE®, tell your healthcare provider:
Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, or herbal supplements.
Ask your healthcare provider or pharmacist if you are not sure if you take any of the medicines listed above. This is not a complete list of all the medicines that can affect MITIGARE®.
How should I take MITIGARE®?
What should I avoid while taking MITIGARE®?
What are the possible side effects of MITIGARE®?
MITIGARE® can cause serious side effects or death. See “What is the most important information I should know about MITIGARE®?”
Get medical help right away, if you have:
The most common side effects of MITIGARE® include abdominal pain, diarrhea, nausea, and vomiting.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of MITIGARE®. For more information ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store MITIGARE®?
Keep MITIGARE® and all medicines out of the reach of children.
General information about the safe and effective use of MITIGARE®.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take MITIGARE® for a condition for which it was not prescribed. Do not give MITIGARE® to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about MITIGARE®. If you would like more information, talk to your pharmacist or healthcare provider for information about MITIGARE® that is written for health professionals.
For more information, go to www.hikma-americas.com or call 1-800-962-8364.
What are the ingredients in MITIGARE® Capsules?
Active Ingredient: Colchicine
Inactive Ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The capsule shell contains gelatin, purified water, titanium dioxide, erythrosine, Brilliant Blue FCF and Quinoline Yellow.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Hikma Americas Inc.
Memphis, TN 38120
West-Ward Columbus Inc.
Columbus, OH 43228
Revised July 2019