Seeing blue may lead to saving green. Ask your doctor if Mitigare®
(colchicine) 0.6 mg capsules may
be an affordable option for gout fl are prevention in adults. Visit
mitigare.com to learn more about True Blue Savings.
Summary of Information about Mitigare®
What is the most important information I should know about MITIGARE™?
MITIGARE™ can cause serious side effects or death if levels of MITIGARE™ are too high in your body.
• Taking certain medicines with MITIGARE™ can cause your level of MITIGARE™ 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 MITIGARE™ may need to be changed.
• Even medicines that you take for a short period of time, such as antibiotics, can interact with MITIGARE™ and cause serious side effects or death.
What is MITIGARE™?
MITIGARE™ is a prescription medication used to prevent gout fl ares in adults. It is not known if MITIGARE™ is safe and effective for the treatment of:
• acute gout fl ares
MITIGARE™ is not a pain medicine and it should not be taken to treat pain related to other conditions unless specifi cally for those conditions.
It is not known if MITIGARE™ is safe and effective in children.
Who should not take MITIGARE™?
Do not take MITIGARE™ 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. See “What is the most important information I should know about MITIGARE™?”
What should I tell my healthcare provider before taking MITIGARE™?
Before you take MITIGARE™, 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 MITIGARE™ 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. MITIGARE™ 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 MITIGARE™.
Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, or herbal supplements.
• Using MITIGARE™ with certain other medicines can affect each other causing serious side effects and/ or death.
• Do not take MITIGARE™ 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 MITIGARE™.
How should I take MITIGARE™?
• Take MITIGARE™ exactly as your healthcare provider tells you to take it.
• MITIGARE™ can be taken with or without food.
• If you take too much MITIGARE™ call your healthcare provider or go to the nearest hospital emergency room right away.
• Do not stop taking MITIGARE™ unless your healthcare provider tells you to.
• If you miss a dose of MITIGARE™, 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 fl are while taking MITIGARE™, tell your healthcare provider.
What should I avoid while taking MITIGARE™?
• Avoid eating grapefruit or drinking grapefruit juice while taking MITIGARE™. It can increase your chances of getting serious side effects.
What are the possible side effects of MITIGARE™?
MITIGARE™ can cause serious side effects or death. See “What is the most important information I should know about MITIGARE™?”
Get medical help right away, if you have: • unusual bleeding or bruising • increased infections • weakness or fatigue • muscle weakness or pain • numbness or tingling in your fi ngers or toes
• pale or gray color to your lips, tongue, or palms of your hands
• severe diarrhea or vomiting
The most common side effects of MITIGARE™ include 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 MITIGARE™. 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.
® How should I store MITIGARE™?
• Store MITIGARE™ at room temperature between 68° to 77°F (20° to 25°C).
• Keep MITIGARE™ in a tightly closed container.
• Keep MITIGARE™ out of the light and away from moisture.
Keep MITIGARE™ and all medicines out of the reach of children.
General information about the safe and effective use of MITIGARE™
.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take MITIGARE™ for a condition for which it was not prescribed. Do not give MITIGARE™ 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 MITIGARE™. If you would like more information, talk to your pharmacist or healthcare provider for information about MITIGARE™ that is written for health professionals.
For more information, go to
www.hikma-americas.com or call 1-877-233-2001.
What are the ingredients in MITIGARE™ Capsules? Active Ingredient: Colchicine
Inactive Ingredients: Colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The capsule shell contains gelatin, purifi ed water, titanium dioxide, erythrosine, Brilliant Blue FCF and Quinoline Yellow.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for: Hikma Americas, Inc. Memphis, TN 38120
Manufactured by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724
Indication
Mitigare® is indicated for prophylaxis of gout fl ares in adults. The safety and effectiveness of Mitigare® for acute treatment of gout fl ares during prophylaxis has not been studied. Mitigare® is not an analgesic medication and should not be used to treat pain from other causes.
The risk information provided here is not comprehensive. To learn more, talk about Mitigare® with your health care provider or pharmacist.
The full FDA-approved product labeling for Mitigare® can be found at
www.mitigare.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/ medwatch, or call 1-800-FDA-1088.
Mitigare® is a registered trademark of West-Ward Pharmaceuticals Corp. ©2018 West-Ward Pharmaceuticals Corp. All rights reserved.
WW00492
Free* First 30 days
$5* refills
Seeing blue may lead to saving green with Mitigare® True Blue Savings.
Patient/Caregiver: Give this card to your pharmacist along with a valid prescription for the authorized generic colchicine 0.6 mg capsules or the brand Mitigare® (colchicine) 0.6 mg capsules.
Valid on the authorized generic colchicine 0.6 mg capsules (NDC 00143-3018-01) or the brand Mitigare®
(NDC 59467-0318-01). Please refer to
the back of this card for the program requirements and restrictions.
Pharmacist: Submit claim to MedImpact using the detailed processing information below. Processor requires Valid Prescription ID #, Patient Name, PCN # and DOB for claim adjudication. Please refer to the back of this card for the program requirements and restrictions.
Activation required prior to presenting card to the pharmacy with your prescription. Cards can be activated by visiting
www.mitigare.com or by calling 1-877-259-6893.
No matter your coverage, contact us to better understand how to best afford your medication.
www.mitigare.com | 1-877-259-6893
Free* First 30 days
$5* refills
Seeing blue may lead to saving green with Mitigare® True Blue Savings.
Patient/Caregiver: Give this card to your pharmacist along with a valid prescription for the authorized generic colchicine 0.6 mg capsules or the brand Mitigare® (colchicine) 0.6 mg capsules.
Valid on the authorized generic colchicine 0.6 mg capsules (NDC 00143-3018-01) or the brand Mitigare®
(NDC 59467-0318-01). Please refer to
the back of this card for the program requirements and restrictions.
Pharmacist: Submit claim to MedImpact using the detailed processing information below. Processor requires Valid Prescription ID #, Patient Name, PCN # and DOB for claim adjudication. Please refer to the back of this card for the program requirements and restrictions.
tivation required ting card to the pharmacy with your b activated by visiting 7259-6893.
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