Colchicine Lirca film-coated tablets 1 mg 60 pcs.

• active ingredient: colchicine;
• 1 tablet contains 1 mg of colchicine;
• excipients: lactose monohydrate; sucrose; gum arabic; magnesium stearate.

• Hypersensitivity to the active substance or to any of the excipients.
• Severe heart, kidney and/or gastrointestinal failure.
• Patients with renal or hepatic impairment who are taking P-glycoprotein or CYP3A4 inhibitors (see section 4.5). Life-threatening and fatal toxicity of colchicine has been reported in these patients at therapeutic doses.
• Pregnancy and breastfeeding.
• Patients on dialysis.

In high doses, this drug can cause profuse diarrhea, gastrointestinal bleeding, rash, and kidney and liver damage. However, to obtain an adequate therapeutic effect, this drug must be used in full dose.

Colchicine can cause reversible impairment of vitamin B12 absorption, which disrupts the function of the ileal mucosa.

Dosage

Gouty arthritis

Treatment of acute gout attacks should be started as soon as possible (within the first 12 hours of the onset of the gout attack). The expected effect will occur within 12 hours.

First, take 1 tablet (1 mg of the drug), then 1 hour later, take ½ tablet (0.5 mg of the drug). After that, do not take the tablet for 12 hours.

If necessary, the dose can be repeated after 12 hours. The maximum daily dose is ½ tablet (0.5 mg of the drug) every 8 hours until symptoms improve.

The course of treatment should be completed after symptoms have subsided or 6 tablets (6 mg) have been taken. No more than 6 tablets (6 mg) should be taken during the course of treatment.

A repeated course of treatment is carried out no earlier than 3 days (72 hours) after the end of the previous course.

Prevention of gout attacks: Adults should take ½–1 tablet (0.5–1 mg of the drug) per day for up to 6 months. The individual duration of treatment should be determined after assessing factors such as the frequency of exacerbations, the duration of the disease, and the presence and size of tophus.

Acute and recurrent pericarditis

The recommended daily dose of colchicine for acute and recurrent pericarditis is ½–1 tablet (0.5 mg–1 mg) per day: 0.5 mg twice daily for adult patients weighing > 70 kg or 0.5 mg once daily for adult patients weighing ≤ 70 kg, or for patients who cannot tolerate higher doses, for at least six months for recurrent pericarditis and at least three months for acute pericarditis.

In most clinical trials, the dose of colchicine used is 1 tablet (1 mg).

For oral use. The tablet can be swallowed whole or divided into 2 halves along the score line to obtain a single dose of 0.5 mg.

The recommended dose may vary depending on the patient’s kidney and liver function status.

Colchicine is potentially toxic, so it is important not to exceed the dose prescribed by a specialist who has the necessary knowledge and experience.

Use during pregnancy or breastfeeding

Use is contraindicated.

Children

The drug is not used in children.

Ability to influence reaction speed when driving vehicles or other mechanisms

Colchicine Lirca does not affect the ability to drive vehicles and operate other mechanisms.

Overdose and disregard for drug interaction recommendations can cause poisoning, which is accompanied by severe pain and can also be fatal.

Colchicine has a narrow therapeutic range and is extremely toxic in overdose. Patients with renal or hepatic impairment, gastrointestinal or cardiac disease, and the elderly are at particular risk of toxicity. Patients with colchicine overdose, even in the absence of early symptoms, should seek immediate medical attention.

Acute intoxication may occur after oral ingestion of approximately 20 mg (20 tablets) of colchicine in adults and 5 mg (5 tablets) in children. Chronic intoxication may occur after repeated doses of the drug in patients with gout after taking doses of 10 mg or more over several days.

Because colchicine inhibits mitosis, organs with a higher rate of proliferation are more affected.

Keep out of reach of children. No special storage conditions required.