Colcrys 0.6 mg tablet

Generic name:
Colchicine - oral

Pronunciation
(KOL-chi-seen)

Brand name(s)
Colcrys

This medication is used to prevent or treat gout attacks (flares). Usually gout symptoms develop suddenly and involve only one or a few joints. The big toe, knee, or ankle joints are most often affected. Gout is caused by too much uric acid in the blood. When uric acid levels in the blood are too high, the uric acid may form hard crystals in your joints. Colchicine works by decreasing swelling and lessening the build up of uric acid crystals that cause pain in the affected joint(s).

This medication is also used to prevent attacks of pain in the abdomen, chest, or joints caused by a certain inherited disease (familial Mediterranean fever). It is thought to work by decreasing your body's production of a certain protein (amyloid A) that builds up in people with familial Mediterranean fever.

Colchicine is not a pain medication and should not be used to relieve other causes of pain.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to reduce swelling and inflammation of the sac that covers the outside of the heart, a condition called pericarditis.

Colchicine is also available in other brands and strengths to reduce the risk of serious heart disease and lower the risk of death from heart disease. Do not take this medication with any other product that contains colchicine.

Read the Medication Guide provided by 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, exactly as directed by your doctor. Dosing recommendations vary widely and may be different from the following recommendations. Taking more than the recommended dose may not increase this drug's effectiveness and may increase your risk for side effects. Ask your doctor or pharmacist for more details.

If you are taking this medication to treat a gout attack, carefully follow the directions given by your doctor. This medication works best if you take it at the first sign of an attack. The recommended dose is 1.2 milligrams at the first sign of an attack, followed by 0.6 milligrams one hour later. The maximum recommended dose is 1.8 milligrams taken over a 1-hour period. Ask your doctor ahead of time about how soon you can repeat treatment with this medication if you have another gout attack.

If you are taking this medication to prevent gout attacks or for pericarditis, ask your doctor about the dose and schedule you should follow. Carefully follow your doctor's directions.

If you are taking this medication to prevent attacks of pain caused by familial Mediterranean fever, the usual dose is 1.2 to 2.4 milligrams daily. The total dose may be taken once daily or divided into two doses a day. Your doctor may need to adjust your dose to control your symptoms or if you have side effects.

The dosage is based on your medical condition, other medications you may be taking, and response to treatment. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Serious side effects may occur even at usual prescribed doses.

If your doctor directs you to take colchicine regularly, use it regularly to get the most benefit from it. To help you remember, take it at the same time(s) 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.

If you are taking this medication to treat symptoms due to familial Mediterranean fever, tell your doctor if your condition does not get better or if it gets worse.

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.

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

• unusual bleeding/bruising
• severe diarrhea or vomiting
• muscle weakness or pain
• numbness/tingling in your fingers or toes
• pale or gray color of the lips/tongue/palms of hands
• signs of infection (such as sore throat that doesn't go away, fever)
• unusual weakness/tiredness
• fast heartbeat
• shortness of breath
• signs of kidney problems (such as change in the amount of urine)

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.

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:

• kidney problems
• liver problems (such as cirrhosis)

Alcohol can decrease this drug's effectiveness. Limit alcohol while taking this drug.

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.

Colchicine can decrease sperm production, which may affect the ability of a male to father a child. Consult your doctor for more information.

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 breastfeeding. Your doctor may recommend that you separate the time(s) you take your medication apart from breastfeeding.

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 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: digoxin, gemfibrozil, pravastatin, simvastatin, among others.

Do not take this medication with any other product that contains colchicine.

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.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea/vomiting/diarrhea, abdominal pain, trouble breathing, weakness.

Do not share this medication with others.

Being overweight, drinking too much alcohol, and eating certain foods may worsen gout symptoms. Limit alcohol and ask your doctor, pharmacist, or dietitian about avoiding foods high in purines that may worsen gout (such as anchovies, bacon, beer, sardines, organ meats including liver/kidneys).

Lab and/or medical tests (such as blood tests, liver/kidney function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you are taking colchicine regularly and 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.

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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.