The need to supplement the instructions for the use of medicinal products with the following information is revealed:
1. The section "With caution" should be presented in the following edition: "If the liver function is of medium and severe severity, in patients with known risk factors for lengthening the interval QT or taking drugs that extend the interval QT; with the simultaneous use of "slow" calcium channels with cyclosporine or blockers, with drugs depressing microsomal oxidation of drugs (cimetidine and ketoconazole), with preparations, mainly metabolized with the participation of isoenzyme CYP3A4, with a deficiency of lactase, lactose intolerance, glucose galactose malabsorption. "
2. In the section "Side effect" side effects in following edition: "Adverse effects arising from the application of bicalutamide - tablets, film-coated 50 mg. - very frequently (≥1 / 10): anemia, gynecomastia (can be maintained even after cessation of therapy, especially in the case of taking the drug for a long time), breast pain, fatigue, rash.- frequent (≥1 / 100 - <1/10): hot flashes, anemia, dizziness, abdominal pain, constipation, nausea, swelling, hematuria, hepatotoxicity, transient increase in activity of the hepatic "Transaminase, jaundice (described changes in liver function were rarely estimated as serious, often worn transient, completely disappeared or decreased with continued therapy or after drug withdrawal), decreased appetite, decreased libido, depression, drowsiness, dyspepsia, flatulence, alopecia, hirsutism or hair regrowth, dry skin, pruritus, erectile dysfunction, chest pain, weight gain, myocardial infarction (reported fatal cases), ** heart failure **, the lengthening of the interval QT. - rarely (≥1 / 10,000 - ≤1 / 1,000): hypersensitivity reactions, angioedema, urticaria, interstitial lung disease (reported cases of fatalities) ** photosensitivity reactions. - very rarely (≤1 / 10,000): liver failure (reported fatal cases). * When taking the drug in combination with the analogues of gonadotropin-releasing hormone (GnRH), the side effect was observed very often.** A side effect was observed when taking the drug. Side effects associated with the use of bicalutamide-coated tablets 150 mg: - very often (≥ 1/10): gynecomastia (may persist even after discontinuation of therapy, especially when taking the drug for a long time), tenderness of the mammary glands, skin rash, asthenia. - often (≥1 / 100 - <1/10): depression, anorexia, dizziness, drowsiness, hot flashes, itching, abdominal pain, constipation, dyspepsia, flatulence, alopecia or hair regrowth / hirsutism, decreased sexual desire, erectile dysfunction, chest pain, swelling, weight gain, increased transaminase activity, hepatotoxicity, jaundice, anemia, decreased appetite. - infrequently (≥1 / 1,000 - ≤1 / 100): hypersensitivity reactions, including angioedema and urticaria, interstitial lung diseases (reported fatal cases) *. - rarely (≥1 / 10,000 - ≤1 / 1,000): photosensitivity reactions, liver failure (reported fatal cases) *. Transient increase in the activity of "liver" transaminases,cholestasis and jaundice were rarely evaluated as serious, transient in nature, completely disappeared or decreased with continued therapy or after drug withdrawal. Very rarely on the background of treatment with bicalutamide, hepatic insufficiency developed, but the causal relationship between the development of liver failure and drug treatment was not established reliably. * According to the post-registration application of bicalutamide. "
3. In the section "Interaction with other drugs" it is recommended to supplement "Since with antiandrogen therapy there is a risk of lengthening the interval QT, caution should be exercised with the simultaneous use of bicalutamide with drugs that cause lengthening of the interval QT or drugs capable of inducing ventricular tachycardia such as pirouettes, such as antiarrhythmic drugs of the class IA (eg, quinidine, disopyramide), Class III (for example, amiodarone, sotalol, dofetilide, ibutilide), methadone, moxifloxacin, neuroleptics, etc. ".
4. In the section "Special instructions" it is recommended to supplement that with antiandrogen therapy there is a risk of lengthening the interval QT. Before prescribing the drug should carefully evaluate the relationship between the benefits and risk of ventricular tachycardia such as "pirouette" in patients with known risk factors for lengthening the interval QT or taking drugs that extend the interval QT.