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COLCRYS- colchicine tablet, film coated


  1. Patient Information
  2. Colcrys Is A Prescription Medicine Used To:
  3. Who Should Not Take Colcrys?
  4. What Are The Possible Side Effects Of Colcrys?
  5. Distributed By:
  6. Especially Tell Your Healthcare Provider If You Take:
  7. What Should I Avoid While Taking Colcrys?
  8. What Are The Ingredients In Colcrys?
  9. Revised: 4/2012document Id:

Patient Information 

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COLCRYS can cause serious side effects or death if levels of COLCRYS are too high in your body.

Taking certain medicines with COLCRYS can cause your level of COLCRYS 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 COLCRYS may need to be changed.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
Even medicines that you take for a short period of time, such as antibiotics, can interact with COLCRYS and cause serious side effects or death.
Talk to your healthcare provider or pharmacist before taking any new medicine.

Colcrys Is A Prescription Medicine Used To: 

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

COLCRYS is 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 Colcrys? 

Do not take COLCRYS 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 COLCRYS exactly as your healthcare provider tells you to take it.If you are not sure about your dosing, call your healthcare provider.
COLCRYS can be taken with or without food.
If you take too much COLCRYS go to the nearest hospital emergency room right away.
Do not stop taking COLCRYS even if you start to feel better, unless your healthcare provider tells you.
Your healthcare provider may do blood tests while you take COLCRYS.
If you take COLCRYS 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 COLCRYS daily, report this to your healthcare provider.

What Are The Possible Side Effects Of Colcrys? 

COLCRYS can cause serious side effects or even cause death.

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

Keep COLCRYS and all medicines out of the reach of children.

General Information about COLCRYS

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

For more information, go to www.COLCRYS.com or call 1-877-825-3327.

Distributed By: 

Takeda Pharmaceuticals America, Inc.

Deerfield, IL 60015

Rev 01, June 2012

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 COLCRYS.

  • 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 COLCRYS out of the reach of children.

What Should I Avoid While Taking Colcrys? 

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

What Are The Ingredients In Colcrys? 

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.

COLCRYSis a registered U.S. trademark of the URL Pharma, Inc. group of companies. 2009 AR Holding Company, Inc., a URL Pharma, Inc. company
U.S. Patent Nos. 7,601,758; 7,619,004 and other patents pending

Manufactured for:
AR SCIENTIFIC, INC.
Philadelphia, PA 19124 USA
by:
MUTUAL PHARMACEUTICAL COMPANY, INC.

Rev 14, March 2012

PRINCIPAL DISPLAY PANEL - 0.6 mg Tablet Bottle Label


COLCRYS
(colchicine, USP) tablets
0.6 mg

PHARMACIST:
PLEASE DISPENSE WITH
MEDICATION GUIDE ATTACHED



Rx only

PRINCIPAL DISPLAY PANEL - 0.6 mg Tablet Bottle Label
COLCRYS
colchicine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-6256(NDC:13310-119)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Colchicine(UNII: SML2Y3J35T) (Colchicine - UNII:SML2Y3J35T)Colchicine0.6 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax(UNII: R12CBM0EIZ)
FD&C blue no. 2(UNII: L06K8R7DQK)
FD&C red no. 40(UNII: WZB9127XOA)
hypromelloses(UNII: 3NXW29V3WO)
lactose monohydrate(UNII: EWQ57Q8I5X)
magnesium stearate(UNII: 70097M6I30)
cellulose, microcrystalline(UNII: OP1R32D61U)
polydextrose(UNII: VH2XOU12IE)
polyethylene glycols(UNII: 3WJQ0SDW1A)
starch, corn(UNII: O8232NY3SJ)
sodium starch glycolate type A potato(UNII: 5856J3G2A2)
titanium dioxide(UNII: 15FIX9V2JP)
triacetin(UNII: XHX3C3X673)
Product Characteristics
ColorPURPLE (Film Coated)Score2 pieces
ShapeOVAL (capsule-shaped)Size8mm
FlavorImprint CodeAR;374
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-6256-030 in 1 BOTTLE, PLASTIC
2NDC:54868-6256-190 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02235210/19/2011
Labeler -Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel, repack

Revised: 4/2012document Id: 

6429e27f-6b2a-477f-8f53-56fa6e1129d7Set id: 4e936802-5b5d-4772-8b1d-4f30867ffa59Version: 2Effective Time: 20120424Physicians Total Care, Inc.



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