COLCHICINE- colchicine tablet, film coated
Granules Pharmaceuticals Inc.
Colchicine (KOL-chi-seen) Tablets, for oral use
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.
• Taking certain medicines with colchicine tablets can cause your level of colchicine to be too high, especially if you have kidney or liver problems.
• Tell your healthcare provider about all your medical conditions, including if you have kidney or liver problems. Your dose of colchicine tablets may need to be changed.
• Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.
• Even medicines that you take for a short period of time, such as antibiotics, can interact with colchicine tablets and cause serious side effects or death.
• Talk to your healthcare provider or pharmacist before taking any new medicine.
• Especially tell your healthcare provider if you take:
|atazanavir sulfate (Reyataz)||clarithromycin (Biaxin)|
|cyclosporine (Neoral, Gengraf, Sandimmune)||darunavir (Prezista)|
|fosamprenavir (Lexiva) with ritonavir||fosamprenavir (Lexiva)|
|indinavir (Crixivan)||itraconazole (Sporanox)|
|ketoconazole (Nizoral)||lopinavir/ritonavir (Kaletra)|
|nefazodone (Serzone)||nelfinavir mesylate (Viracept)|
|ritonavir (Norvir)||saquinavir mesylate (Invirase)|
|telithromycin (Ketek)||tipranavir (Aptivus)|
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 interact with colchicine tablets.
What are colchicine tablets?
Colchicine tablets are a prescription medicine used to:
Colchicine tablets are not a pain medicine, and it should not be taken to treat pain related to other conditions unless specifically prescribed for those conditions.
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?
What should I avoid while taking 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:
• Muscle weakness or pain
• Numbness or tingling in your fingers or toes
• Unusual bleeding or bruising
• Increased infections
• Feel weak or tired
• Pale or gray color to your lips, tongue or palms of your hands
• Severe diarrhea or vomiting
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 1800-FDA-1088.
How should I store colchicine tablets?
• Store colchicine tablets at room temperature between 68° and 77°F (20° and 25°C).
• Keep colchicine tablets in a tightly closed container.
• Keep colchicine tablets out of the light.
Keep colchicine tablets and all medicines out of the reach of children.
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.
For more information, go to www.granulesidia.com or call 1-877-770-3183.
What are the ingredients in colchicine tablets?
Active Ingredient: colchicine.
Inactive Ingredients: FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Trademarks are the property of their respective owners.
Dispense with Medication Guide is also available at: http://www.granulesindia.com/U.S.ProductCatalog.php
Granules Pharmaceuticals Inc.
Chantilly, VA 20151