Irinotecan-Promomed is intended for the treatment of adult patients over the age of 18 with locally advanced or metastatic colon and rectal cancer:
- in combination with fluorouracil and calcium folinate in patients who had not previously received chemotherapy;
- in monotherapy in patients with disease progression after standard antitumor therapy.

If you overdose with Irinotecan-Promomed, diarrhea (diarrhea) may occur or neutropenia may develop, which may manifest itself with symptoms such as soreness, swelling, or mouth ulcers.
Overdose treatment should be carried out under the supervision of a doctor in a hospital. If you have any questions about the use of the drug, contact your doctor.

Like all medications, Irinotecan-Promomed can cause undesirable reactions, but they do not occur in everyone.
Some adverse reactions can be serious and life-threatening.
Tell your doctor immediately if you experience any of the following adverse reactions:
• dizziness, fatigue, weakness, tinnitus, shortness of breath when climbing stairs, decreased performance, decreased appetite, pale skin (possible signs of anemia) can occur very often - in more than 1 person out of 10
• bleeding gums, spontaneous bruising, the presence of blood or dark brown clots in vomit, blood in urine and feces (possible signs of thrombocytopenia) can occur very often - in more than 1 person out of 10
• fever, bleeding gums, pain when swallowing (possible signs of leukemia) can occur very often - in more than 1 person out of 10
• soreness, swelling, ulcers in the mouth (possible signs of neutropenia) can occur very often - in more than 1 person out of 10
• difficulty breathing, a feeling of lack of air, a feeling of pressure in the chest, rash, itching, swelling of the lips, tongue, face, sudden weakness or other signs of a sharp deterioration in well-being (possible signs of anaphylactic shock or anaphylactoid reactions) occur rarely - no more than 1 person out of 1,000
• diarrhea, frequent watery stools with mucus and blood, fever, general feeling unwell — weakness, weakness, nausea, vomiting, abdominal pain that increases before defecation, there may be false urges (possible signs of pseudomembranous colitis) occur rarely - no more than 1 person
of 1,000
• abdominal pain, bloating and flatulence, nausea, repeated vomiting (possible signs of intestinal obstruction) are rare - no more than 1 person out of 1,000
• bleeding from the gastrointestinal tract is rare - no more than 1 person out of 1,000
• severe abdominal pain, which increases with movement along with nausea and vomiting (possible signs of gastrointestinal perforation), is rare - no more than 1 person out of 1,000
• seizures are rare - no more than 1 person out of 1,000
(For more information about all possible adverse reactions, see the leaflet)

Do not use the drug Irinotecan-Promomed:

• if you are allergic to irinotecan or any other components of the drug (listed in section 6 of the leaflet);
• if you have chronic inflammatory bowel diseases and/or intestinal obstruction disorders;
• if you have severe suppression of bone marrow hematopoiesis;
• if your serum bilirubin concentration exceeds the upper limit of normal by more than 3 times;
• if your general condition is assessed by a doctor above 2 on a five-point scale, which is used to assess the general condition of an ECOG cancer patient;
• simultaneously with the yellow fever vaccine;
• if you are pregnant or breastfeeding.

Be sure to tell your doctor if you are taking:
• preparations containing salts of suxamethonium,
• non-depolarizing muscle relaxants (e.g. tubocurarin, pipecuronium, atracurium, pancuronium, vecuronium, rocuronium, mivacurium, doxacurium), • drugs that are inhibitors of the isoenzyme CYP3A4 and/or UGT1A1, atazanavir and /or ketoconazole. The doctor should consider possible interactions when using these drugs together with the drug Irinotecan-Promomed.

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
An organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

The drug Irinotecan-Promomed is contraindicated during pregnancy, as its use can lead to fetal damage in pregnant women. It is recommended that you stop breastfeeding while using Irinotecan-Promomed due to possible serious adverse reactions in breastfed children.

Do not store at temperatures above 25 °C. Store in the original packaging (pack/box). Do not freeze.