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COLCHICINE capsule


  1. What Are Colchicine Capsules?
  2. It Is Not Known If Colchicine Capsules Are Safe And Effective For The Treatment Of:
  3. Who Should Not Take Colchicine Capsules?
  4. Before You Take Colchicine Capsules, Tell Your Healthcare Provider:
  5. How Should I Take Colchicine Capsules?
  6. What Should I Avoid While Taking Colchicine Capsules?
  7. What Are The Possible Side Effects Of Colchicine Capsules?
  8. Active Ingredient:
  9. Inactive Ingredients:
  10. Patient Information

What Are Colchicine Capsules? 

Colchicine capsules are a prescription medication used to prevent gout flares in adults.

It Is Not Known If Colchicine Capsules Are Safe And Effective For The Treatment Of: 

  • acute gout flares

Colchicine capsules are 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 colchicine capsules are safe and effective in children.

Who Should Not Take Colchicine Capsules? 

Do nottake colchicine capsules 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.

Before You Take Colchicine Capsules, Tell Your Healthcare Provider: 

  • about all of your medical conditions
  • if you have kidney or liver problems
  • if you are pregnant or plan to become pregnant. It is not known if colchicine capsules can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • if you are breastfeeding or plan to breastfeed. Colchicine can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take colchicine capsules.

Tell your healthcare provider about all the medicines you take,including prescription, over-the-counter medicines, vitamins, or herbal supplements.

  • Using colchicine capsules with certain other medicines can affect each other causing serious side effects and/or death.
  • Do not take colchicine capsules with other medicines unless your healthcare provider tells you to.
  • Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
  • Especially tell your healthcare provider if you take:
    • medicines that may affect how your liver works (CYP3A4 inhibitors)
    • cyclosporine (Neoral , Gengraf , Sandimmune )
    • cholesterol lowering medicines
    • antibiotics

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 colchicine capsules.

How Should I Take Colchicine Capsules? 

  • Take colchicine capsules exactly as your healthcare provider tells you to take it.
  • Colchicine capsules can be taken with or without food.
  • If you take too much colchicine capsules, call your healthcare provider or go to the nearest hospital emergency room right away.
  • Do not stop taking colchicine capsules unless your healthcare provider tells you to.
  • If you miss a dose of colchicine capsules, take it as soon as you remember. If it is almost time for your next dose, 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 capsules, tell your healthcare provider.

What Should I Avoid While Taking Colchicine Capsules? 

  • Avoid eating grapefruit or drinking grapefruit juice while taking colchicine capsules. It can increase your chances of getting serious side effects.

What Are The Possible Side Effects Of Colchicine Capsules? 

Colchicine capsules can cause serious side effects or death.

  • Store colchicine capsules at room temperature between 68 to 77 F (20 to 25 C).
  • Keep colchicine capsules in a tightly closed container.
  • Keep colchicine capsules out of the light and away from moisture.

Keep colchicine capsules and all medicines out of the reach of children.

General information about the safe and effective use of colchicine capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take colchicine capsules for a condition for which it was not prescribed. Do not give colchicine capsules 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 capsules. If you would like more information, talk to your pharmacist or healthcare provider for information about colchicine capsules that is written for health professionals.

For more information, go to www.west-ward.com or call 1-800-962-8364.

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.

Distr. by:
West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724

C50000043/02

July 2019

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Dosing Instructions
If a dose of colchicine capsules is missed, advise the patient to 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
Advise the patient that fatal overdoses, both accidental and intentional, have been reported in adults and children who have ingested colchicine. Colchicine capsules should be kept out of the reach of children.

Blood Dyscrasias
Advise patients that bone marrow depression with agranulocytosis, aplastic anemia, and thrombocytopenia may occur with colchicine capsules.

Drug and Food Interactions
Advise patients that many drugs or other substances may interact with colchicine capsules 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, including short-term medications such as antibiotics. Patients should also be advised to report the use of non-prescription medication or herbal products. Grapefruit and grapefruit juice may also interact and should not be consumed during treatment with colchicine capsules.

Neuromuscular Toxicity
Advise patients that muscle pain or weakness, tingling or numbness in fingers or toes may occur with colchicine capsules alone or when it is used with certain other drugs. Patients developing any of these signs or symptoms must discontinue colchicine capsules and seek medical evaluation immediately.

Manufactured by:
West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724

Revised: January 2017
Rx Only



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