COLCHICINE - colchicine tablet, film coated
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Colchicine tablets (KOL-chi-seen)
Read the Medication Guide that comes with colchicine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about colchicine tablets when you start taking it and at regular checkups.
What is the most important information that I should know about colchicine tablets?
Colchicine tablets can cause serious side effects or death if levels of colchicine are too high in your body.
Colchicine tablets are a prescription medicine used to:
Who should not take colchicine tablets?
Do not take Colchicine Tablets if you have liver or kidney problems and you take certain other medicines. Serious side effects, including death, have been reported in these patients even when taken as directed. See "What is the most important information that I should know about colchicine tablets?"
What should I tell my healthcare provider before starting colchicine tablets?
See "What is the most important information that I should know about colchicine tablets?"
Before you take colchicine tablets, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including ones that you may only be taking for a short time, such as antibiotics. See "What is the most important information that I should know about colchicine tablets?"
Do not start a new medicine without talking to your healthcare provider.
Using colchicine tablets with certain other medicines, such as cholesterol-lowering medications and digoxin, can affect each other, causing serious side effects. Your healthcare provider may need to change your dose of colchicine tablets. Talk to your healthcare provider about whether the medications you are taking might interact with colchicine tablets and what side effects to look for.
How should I take colchicine tablets?
Avoid eating grapefruit or drinking grapefruit juice while taking colchicine tablets. It can increase your chances of getting serious side effects.
What are the possible side effects of colchicine tablets?
Colchicine tablets can cause serious side effects or even cause death. See "What is the most important information that I should know about colchicine tablets?"
Get medical help right away if you have:
FMF: The most common side effects of colchicine tablets in people who have FMF are 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 colchicine tablets. 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 or www.fda.gov/medwatch or Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or go to www. avetpharma.com.
How should I store Colchicine tablets?
General Information about colchicine tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use colchicine tablets for a condition for which it was not prescribed. Do not give colchicine tablets 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 colchicine tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about colchicine tablets that is written for healthcare professionals.
What are the ingredients in colchicine tablets?
Active Ingredient: colchicine.
Inactive Ingredients: carnauba wax, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and Opadry-II 40L500004 Purple (Polydextrose, Hypromellose USP (3mPas), Hypromellose USP (6mPas), Triacetin, Hypromellose USP (50mPas), FD&C Blue # 2/ Indigo carmine AL 3% - 5%, FD&C Red #40 / Allura Red AC Aluminium lake 15 – 17%, Macrogol / PEG NF (8000), Titanium Dioxide).
Dispense with Medication Guide available at: www.avetpharma.com/product.
Strides Pharma Science Ltd.
Avet Pharmaceuticals Inc.
East Brunswick, NJ 08816
This Medication Guide has been approved by the U.S. Food and Drug Administration