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This medication comes with important safety information that should be reviewed carefully. If you have any questions or concerns, please discuss them with your healthcare provider.

• Low Blood Cell Counts: Lodoco (colchicine) may decrease your blood cell counts, which can be severe and potentially life-threatening. This increases the risk of serious infections, bleeding, and anemia. Contact your healthcare provider immediately if you experience any signs of infection, such as fever, fatigue, chills, cough, or difficulty breathing, or if you notice symptoms of blood issues like pale skin, rapid heartbeat, dizziness, or blood in your urine or stool. Risks are heightened if you are taking other medications that affect blood cell counts or increase Lodoco levels in your body, or if you have kidney or liver issues.

• Severe Muscle Pain and Damage: Lodoco (colchicine) may cause muscle pain and, in rare cases, a serious condition called rhabdomyolysis, which can be life-threatening. Stop using the medication and seek medical attention immediately if you experience severe muscle pain, dark urine, weakness, or fatigue. The risk increases when using statins or fibrates alongside Lodoco, other medications that raise Lodoco levels, or if you have kidney or liver problems.

• Life-Threatening Overdose: An overdose of Lodoco (colchicine) can be extremely dangerous. Always follow your healthcare provider’s instructions on dosage and keep the medication out of reach of children. Early signs of overdose include stomach pain, nausea, vomiting, and diarrhea, which may lead to dehydration. If an overdose is suspected, contact the Poison Control Center at 1-800-222-1222 or seek medical help immediately.

Contraindications: Avoid using this medication if you have:

• Interactions with certain other medications.
• Severe kidney or liver problems.
• A history of blood cell issues or low blood cell counts.

Please ensure you discuss these conditions with your healthcare provider before taking Lodoco (colchicine).

When taking this medication, you may experience some common side effects such as diarrhea, nausea, cramping, abdominal pain, vomiting, and muscle pain. These effects are generally mild and should not cause alarm, but if they persist or worsen, it is advisable to consult your healthcare provider for further guidance.

In addition to these, there are other side effects that can occur, including changes in the amount of urine and unusual tiredness or weakness. If you notice any of these symptoms, especially if they become severe, it is important to seek medical advice promptly.

Serious side effects, although rare, demand immediate medical attention. These include a fast heartbeat, shortness of breath, signs of infection like persistent sore throat, fever, or chills, and signs of kidney problems. Additionally, severe muscle damage, known as rhabdomyolysis, may manifest as dark brown urine, severe muscle weakness or pain, fever, or extreme tiredness.

A very serious allergic reaction to this medication is also rare, but if you experience rash, itching, swelling particularly of the face, tongue, or throat, severe dizziness, or trouble breathing, seek urgent medical help. While this is not an exhaustive list of side effects, any other unusual symptoms should be discussed with your doctor or pharmacist.

Colchicine can interact with several other medications, influencing its effectiveness and potentially increasing the risk of serious side effects. Drugs that can alter the way colchicine is processed in your body include adagrasib, certain azole antifungal medications (like itraconazole and ketoconazole), diltiazem, HIV protease inhibitors (such as atazanavir and darunavir), macrolide antibiotics (including clarithromycin and erythromycin), ritonavir, telithromycin, tucatinib, and verapamil.

Colchicine has the potential to cause a rare but serious muscle condition called rhabdomyolysis. This condition can release substances that may harm your kidneys. The risk of developing rhabdomyolysis is higher when colchicine is used with other medications that also carry this risk, including atorvastatin, digoxin, gemfibrozil, pravastatin, and simvastatin.

Additionally, colchicine may interfere with certain laboratory tests, leading to inaccurate results. It is important to inform laboratory personnel and all your healthcare providers that you are taking colchicine. Avoid using any other product that contains colchicine simultaneously.