In breast cancer, the amount of a protein called the human epidermal growth factor (HER2) receptor may increase in tumor cells. As a result, cancer cells begin to grow and divide intensively. The drug Lapatinib-Promomed blocks the action of this protein and thus slows down the growth and division of cancer cells, and it is also able to destroy them. If there is no improvement or you feel worse, you should consult a doctor.

Lapatinib-Promomed is indicated for use in adults over the age of 18 for the treatment of breast cancer that has spread beyond the original tumor or to other organs (locally advanced or metastatic breast cancer) and in which the amount of a certain protein increases in cancer cells (HER2 overexpression). Lapatinib-Prommed is taken together with one of the following antitumor drugs: in combination with capecitabine (if you have previously been treated for metastatic breast cancer using trastuzumab, anthracyclines and taxanes); with trastuzumab (if you do not have certain hormone receptors and have previously been treated for metastatic breast cancer using trastuzumab together with other antitumor drugs); with aromatase inhibitors (if you have a period of cessation of the menstrual cycle due to the loss of ovarian function (postmenopause), and a hormone-sensitive variant of breast cancer has been identified ).

If you have taken too much of the drug Lapatinib-Promomed, immediately seek advice from your doctor or hospital. Show the packaging of the drug Lapatinib-Promomed. Medical intervention may be required.

Like all medications, Lapatinib-Promomed can cause undesirable reactions, but they do not occur in everyone.
Some adverse reactions can be serious
If you experience serious adverse reactions, stop taking this medication and inform your doctor immediately.
Very often – may occur in more than 1 person out of 10
• fever, sore throat, frequent infections as signs of low white blood cell count (leukopenia)
• pallor of the skin, weakness, dizziness, tinnitus as signs of low hemoglobin and red blood cell levels (anemia)
Common – may occur in no more than 1 person out of 10
• irregular heartbeat and shortness of breath (decreased left ventricular ejection fraction)
Infrequent – may occur in no more than 1 person out of 100
Itching, yellow eyes or skin (jaundice), dark urine, or pain/discomfort in the upper right side of the stomach (hepatotoxicity or hyperbilirubinemia)
• cough or shortness of breath (interstitial lung disease and/or pneumonitis)
Rare – may occur in no more than 1 person out of 1,000
• skin rash (including itchy, bumpy rash), redness of the skin, urticaria, uncharacteristic wheezing, coughing or difficulty breathing, swollen eyelids, lips, face or tongue, bluish coloration of lips, tongue or skin, muscle or joint pain, fainting, dizziness, loss of consciousness (fainting) hypotension (signs of severe allergic reactions)

(For more information about all possible adverse reactions, see the leaflet)

Do not take Lapatinib Promomed in the following cases::

• If you are allergic to lapatinib or to any of the other components of the drug listed in section 6 of the leaflet.

Be sure to tell your doctor if you are taking any of the following medications:
• Medications used to treat infections such as erythromycin, telithromycin, ketoconazole, itraconazole, posaconazole, voriconazole, rifabutin, rifampicin • medicines used for the treatment of human immunodeficiency virus (HIV), such as ritonavir, saquinavir • medicines used to treat diseases of the digestive system, such as cisapride • medications used to treat peptic ulcer or digestive disorders that reduce stomach acidity, such as esomeprazole • medications used to treat heart disease, such as quinidine or digoxin • medications used to treat hypertension or angina, such as verapamil • medications used to treat high cholesterol, such as rosuvastatin • medications used to treat diabetes, such as repaglinide
• medications used to treat seizures, such as phenytoin or carbamazepine • Medications used to treat mental illness, such as pimozide
• medications used to treat depression, such as nefazodone or the herbal preparation St. John's wort (also known as Hypericum perforatum)
• medications used for sedation before surgery (anesthesia), such as midazolam • medications used to prevent rejection of transplanted organs, such as cyclosporine • medications used to treat cancer, such as topotecan, paclitaxel, docetaxel, or irinotecan

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
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

Keep the drug out of the reach of the child so that the child cannot see it. Do not take the drug after the expiration date (shelf life) indicated on the package. The expiration date is the last day of the given month.

Lapatinib-Promomed is not indicated for use in patients under the age of 18.

The effect on the ability to drive vehicles and engage in other activities requiring increased concentration and speed of psychomotor reactions has not been studied. Based on the mechanism of action of the drug Lapatinib-Promomed, it is impossible to assume an adverse effect on such activities, but the general condition should be taken into account. Care must be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.