Bicalutamide-Vista film-coated tablets 150 mg blister No. 30




Bicalutamide-Vista is indicated for monotherapy or as adjuvant therapy in combination with radical prostatectomy or radiation therapy in patients with locally advanced prostate cancer at high risk of disease progression.
Bicalutamide-Vista is also indicated for the treatment of patients with locally advanced non-metastatic prostate cancer for whom surgical castration or other medical intervention is unacceptable or cannot be applied.
Composition
Active ingredient: bicalutamide;
1 film-coated tablet contains bicalutamide - 150 mg;
Excipients: lactose, povidone, crospovidone, sodium lauryl sulfate, magnesium stearate, shell: lactose, hypromellose, titanium dioxide (E 171), macrogol (PEG 4000).
Contraindication
Bicalutamide-Vista is contraindicated in women and children.
Bicalutamide-Vista should not be prescribed to patients who have experienced hypersensitivity reactions to the active substance or any of the excipients included in the preparation.
Concomitant use of bicalutamide with terfenadine, astemizole, or cisapride is contraindicated.
Method of application
Adult male patients, including elderly patients, take one 150 mg tablet orally once a day.
Bicalutamide-Vista should be taken for a long time, at least up to 2 years or until signs of disease progression appear.
Application features
Pregnant women
Contraindicated.
Children
Contraindicated.
Drivers
With caution.
Overdose
There are no data on overdose in humans. There is no specific antidote; treatment is symptomatic. Dialysis may be ineffective because bicalutamide is extensively protein bound and is not recovered unchanged in the urine. In case of overdose, general supportive care is indicated, including monitoring of vital signs.
Side effects
Blood and lymphatic system disorders. Anemia. Metabolic and nutritional disorders. Decreased appetite. Mental disorders. Decreased libido, depression. Nervous system disorders. Dizziness, drowsiness. Cardiac disorders. QT prolongation. Vascular disorders. Hot flashes. Digestive system disorders. Abdominal pain, constipation, dyspepsia, flatulence, nausea. Skin and subcutaneous tissue disorders. Rash, alopecia, hirsutism/hair regrowth, dry skin, itching. Renal and urinary disorders. Hematuria. Reproductive system and breast disorders. Gynecomastia and breast tenderness, erectile dysfunction. General disorders and administration site conditions. Asthenia, breast pain, edema.Interaction
Caution should be exercised when prescribing bicalutamide with drugs that may inhibit the oxidation of the product (such as cimetidine, ketoconazole). Theoretically, this may lead to an increase in bicalutamide plasma concentrations and may lead to an increase in the side effects of the drug.
Due to the fact that antiandrogen therapy may lead to prolongation of the QT interval, caution should be exercised when prescribing bicalutamide concomitantly with drugs that can prolong the QT interval or cause the development of torsade de pointes, such as class IA (quinidine, disopyramide) or class III (amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic drugs, methadone, moxifloxacin, neuroleptics, etc.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 5 years.
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