Colchicine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat and prevent attacks of gout. This medicine is also used to treat people with familial Mediterranean fever (FMF). This is a very strong medicine. Take it exactly as directed. Fatal or life-threatening overdoses of this medicine have happened in adults and children.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antigout

Generic and brand names: colchicine, oral; Colcrys

What is this medicine used for?

This medicine is used to treat and prevent attacks of gout. This medicine is also used to treat people with familial Mediterranean fever (FMF).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have:

• An allergy to any medicine
• A blood disorder
• Heart disease
• Kidney disease
• Liver disease
• Ulcers or other stomach problems

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. If you are not sure about your dosing, call your healthcare provider. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Taking too much of this medicine may cause life-threatening or fatal side effects. Do not stop taking this medicine without your healthcare provider's approval.

If you are using this medicine for gout, check with your healthcare provider before using this medicine in children under age 16 years.

If you are using this medicine for FMF, check with your healthcare provider before using this medicine in children under age 4 years.

Take the medicine with a full glass of water. You may take this medicine with or without food. Taking it with meals may lessen the chance the medicine will upset your stomach.

If you are taking this medicine only when you have a gout attack, start at the first signs of an attack. The medicine should relieve pain within 12 hours after you take it. Stop taking the medicine as soon as the pain is relieved or at the first sign of diarrhea, nausea, vomiting, or stomach pain. Your healthcare provider may limit how often you take this medicine, regardless of the frequency of attacks.

Talk with your healthcare provider about how much medicine you should drink while taking this medicine.

What if I miss a dose?

If you take this medicine regularly to prevent gout or for FMF, and you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider. If you have a gout flare while taking this medicine daily, contact your healthcare provider.

What if I overdose?

Fatal or life-threatening overdoses of this medicine have happened in adults and children. Keep the medicine in a safe place.

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, stomach pain, diarrhea, muscle weakness, burning in your throat or stomach, flushing, trouble breathing, trouble urinating, blood in your urine, confusion, seizures.

What should I watch out for?

This is a very strong medicine. It must be used only as directed. Do not use this medicine for any other condition unless your healthcare provider approves.

Follow the diet program your healthcare provider recommends. Alcohol and foods such as beef, chicken, pork, liver, anchovies, and sardines may cause gout attacks. Talk with your healthcare provider about this.

If you have a gout attack while you are taking this medicine regularly to prevent gout attacks, contact your healthcare provider.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Your healthcare provider should check you regularly to see how this medicine affects you. You may need to have blood tests. Keep all appointments.

Use of alcohol while you are taking this medicine may increase stomach problems. Do not drink alcohol unless your healthcare provider approves.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe diarrhea, severe nausea or vomiting, skin rash, unusual tiredness or weakness, numbness or tingling in hands or feet, muscle pain or weakness, bloody or tarry bowel movements, unusual bruising or bleeding, severe stomach pain, unexplained fever, cough, sore throat; pale or gray color to your lips, tongue, or palms of your hands, decreased urination.

Other: Loss of appetite, hair loss, mild nausea, mild diarrhea, mild stomach pain or cramping.

What products might interact with this medicine?

Taking certain medicines while taking this medicine can cause serious side effects or death. Even medicines that you take for a short time can be dangerous. Tell your healthcare provider and pharmacist about any other prescription or nonprescription medicines, or natural remedies that you take. Do not take any other medicines unless your healthcare provider approves. Talk to your healthcare provider or pharmacist before taking any new medicine.

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Antibiotics such as chloramphenicol, clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), telithromycin (Ketek), and tetracycline
• Antidepressants such as desipramine (Norpramin) and nefazodone
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as haloperidol (Haldol) and iloperidone (Fanapt)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and simeprevir (Olysio)
• Aprepitant (Emend)
• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), bicalutamide (Casodex), crizotinib (Xalkori), dasatinib (Sprycel), ibrutinib (Imbruvica), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), osimertinib (Tagrisso), palbociclib (Ibrance), sunitinib (Sutent), tamoxifen, vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), fluvastatin (Lescol), gemfibrozil (Lopid), lomitapide (Juxtapid), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Dipyridamole (Persantine)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), quinidine, ranolazine (Ranexa), reserpine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• Mefloquine
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Red yeast rice
• Ulipristal (ella)
• Vitamin B-12

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.