Uses

This medication is used by people with heart disease to help reduce the risk of getting serious related heart and blood vessel problems (such as stroke, heart attack). It is thought to work by decreasing inflammation in the arteries.

Colchicine is not a pain medication and should not be taken to relieve pain.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking colchicine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your medical condition, other drugs/foods you may be taking, and response to treatment. To reduce your risk for serious side effects, do not increase your dose, take it more often, or take it for a longer time than directed by your doctor. Serious side effects may occur even at usual prescribed doses.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Side Effects

Diarrhea, nausea, cramping, abdominal pain, and vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• fast heartbeat
• shortness of breath
• signs of infection (such as sore throat that doesn't go away, fever, chills)
• signs of kidney problems (such as change in the amount of urine)
• unusual bleeding/bruising
• unusual weakness/tiredness

Stop taking this medication and get medical help right away if you have any very serious side effects, including:

• muscle weakness or pain
• numbness/tingling in your fingers or toes
• pale or gray color of the lips/tongue/palms of hands

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blood problems
• kidney problems
• liver problems

This medication can affect how well your body absorbs some foods and nutrients (such as vitamin B12). Consult your doctor or pharmacist for more details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially muscle weakness/pain and numbness/tingling in their fingers or toes.

This medication can affect fertility in males. Ask your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. Your doctor may recommend that you separate the time you take your medication apart from breast-feeding.

Drug Interactions

See also How to Use and Precautions sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of colchicine from your body, which may affect how colchicine works or increase the risk of serious side effects. Examples include atazanavir, certain azole antifungals (such as itraconazole, ketoconazole), diltiazem, macrolide antibiotics (such as clarithromycin, erythromycin), ritonavir, telithromycin, verapamil, among others.

Colchicine may rarely cause a certain kind of serious (even fatal) muscle damage (rhabdomyolysis). This muscle damage releases substances that can lead to serious kidney problems. The risk may be increased if other drugs that may also cause rhabdomyolysis are taken along with colchicine. Some affected drugs include: atorvastatin, digoxin, gemfibrozil, pravastatin, simvastatin, among others.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting/diarrhea, abdominal pain, trouble breathing, weakness.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, kidney/liver function) may be done while you are taking this medication. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.