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COLCHICINE tablet, film coated


  1. What Is The Most Important Information That I Should Know About Colchicine Tablets, Usp?
  2. Especially Tell Your Healthcare Provider If You Take:
  3. Colchicine Tablets, Usp Are A Prescription Medicine Used To:
  4. Who Should Not Take Colchicine Tablets, Usp?
  5. What Should I Avoid While Taking Colchicine Tablets, Usp?
  6. What Are The Possible Side Effects Of Colchicine Tablets, Usp?
  7. Active Ingredient:
  8. Inactive Ingredients:
  9. Patients Should Be Advised To Take Colchicine Tablets, Usp As Prescribed, Even If They Are Feeling Better. Patients Should Not Alter The Dose Or Discontinue Treatment Without Consulting With Their Doctor. If A Dose Of Colchicine Tablets, Usp Is Missed:
  10. Patient Information

What Is The Most Important Information That I Should Know About Colchicine Tablets, Usp? 

Colchicine Tablets, USP can cause serious side effects or death if levels of colchicine are too high in your body.

Taking certain medicines with Colchicine Tablets, USP 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, USP 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, USP 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)
cyclosporine (Neoral, Gengraf, Sandimmune)
fosamprenavir (Lexiva) with ritonavir
indinavir (Crixivan)
ketoconazole (Nizoral)
nefazodone (Serzone)
ritonavir (Norvir)
telithromycin (Ketek)
clarithromycin (Biaxin)
darunavir (Prezista)
fosamprenavir (Lexiva)
itraconazole (Sporanox)
lopinavir/ritonavir (Kaletra)
nelfinavir mesylate (Viracept)
saquinavir mesylate (Invirase)
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, USP.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
Keep Colchicine Tablets, USP out of the reach of children.

Colchicine Tablets, Usp Are A Prescription Medicine Used To: 

prevent and treat gout flares in adults
treat familial Mediterranean fever (FMF) in adults and children age 4 or older

Colchicine Tablets, USP are not a pain medicine, and should not be taken to treat pain related to other conditions unless specifically prescribed for those conditions.

Who Should Not Take Colchicine Tablets, Usp? 

Do not take Colchicine Tablets, USP 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.

Take Colchicine Tablets, USP exactly as your healthcare provider tells you to take them.If you are not sure about your dosing, call your healthcare provider.
Colchicine Tablets, USP can be taken with or without food.
If you take too many Colchicine Tablets, USP go to the nearest hospital emergency room right away.
Do not stop taking Colchicine Tablets, USP even if you start to feel better, unless your healthcare provider tells you.
Your healthcare provider may do blood tests while you take Colchicine Tablets, USP.
If you take Colchicine Tablets, USP daily and you miss a dose, then take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
If you have a gout flare while taking Colchicine Tablets, USP daily, report this to your healthcare provider.

What Should I Avoid While Taking Colchicine Tablets, Usp? 

Avoid eating grapefruit or drinking grapefruit juice while taking Colchicine Tablets, USP. It can increase your chances of getting serious side effects.

What Are The Possible Side Effects Of Colchicine Tablets, Usp? 

Colchicine Tablets, USP can cause serious side effects or even cause death.

Store Colchicine Tablets, USP at room temperature between 68 F and 77 F (20 C and 25 C).
Keep Colchicine Tablets, USP in a tightly closed container.
Keep Colchicine Tablets, USP out of the light.

Keep Colchicine Tablets, USP and all medicines out of the reach of children.

General Information about Colchicine Tablets, USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Colchicine Tablets, USP for a condition for which it was not prescribed. Do not give Colchicine Tablets, USP 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, USP. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Colchicine Tablets, USP that is written for healthcare professionals.

For more information, call 1-877-825-3327.

Active Ingredient: 

colchicine

Inactive Ingredients: 

carnauba wax, 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.

All trademarks are the property of their respective owners.

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320

OS2008-01-75-01

COL345 R1
February 2018

Patients Should Be Advised To Take Colchicine Tablets, Usp As Prescribed, Even If They Are Feeling Better. Patients Should Not Alter The Dose Or Discontinue Treatment Without Consulting With Their Doctor. If A Dose Of Colchicine Tablets, Usp Is Missed: 

For treatment of a gout flare when the patient is not being dosed for prophylaxis, take the missed dose as soon as possible.
For treatment of a gout flare during prophylaxis, take the missed dose immediately, wait 12 hours, then resume the previous dosing schedule.
For prophylaxis without treatment for a gout flare, or FMF, take the dose as soon as possible and then return to the normal dosing schedule. However, if a dose is skipped the patient should not double the next dose.

Fatal Overdose

Instruct patient that fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Colchicine Tablets, USP should be kept out of the reach of children.

Blood Dyscrasias

Patients should be informed that bone marrow depression with agranulocytosis, aplastic anemia and thrombocytopenia may occur with Colchicine Tablets, USP.

Drug and Food Interactions

Patients should be advised that many drugs or other substances may interact with Colchicine Tablets, USP and some interactions could be fatal. Therefore, patients should report to their healthcare provider all of the current medications they are taking and check with their healthcare provider before starting any new medications, particularly antibiotics. Patients should also be advised to report the use of nonprescription medication or herbal products. Grapefruit and grapefruit juice may also interact and should not be consumed during Colchicine Tablets, USP treatment.

Neuromuscular Toxicity

Patients should be informed that muscle pain or weakness, tingling or numbness in fingers or toes may occur with Colchicine Tablets, USP alone or when it is used with certain other drugs. Patients developing any of these signs or symptoms must discontinue Colchicine Tablets, USP and seek medical evaluation immediately.

Patient Information 

8438921/0718
Colchicine Tablets, USP

Read the Medication Guide that comes with Colchicine Tablets, USP 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, USP when you start taking it and at regular checkups.



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