Medicinal Products

BICALUTAMIDE MYLAN PHARMA 50 mg

Generic drug of Casodex
Therapeutic class: Oncology and hematology
Active ingredients: Bicalutamide
laboratory: Mylan

Coated tablet
Box of 30
All forms

Indication

Treatment of advanced prostate cancer in combination with LHRH analogues (luteinizing hormone releasing hormone) or after surgical castration.

Dosage BICALUTAMIDE MYLAN PHARMA 50 mg Film-coated tablet Box of 30

Adults and elderly patients

One tablet once a day.

Children and women

BICALUTAMIDE MYLAN PHARMA 50 mg should not be used in women, children and adolescents

Renal insufficiency

No dosage adjustment is necessary in patients with renal impairment. Given the paucity of data regarding the use of Bicalutamide in patients with severe renal impairment (creatinine clearance <30 ml / min), bicalutamide should be used with caution in these patients.

Hepatic insufficiency

No dose adjustment is necessary in patients with mild hepatic impairment. Caution is advised when administering bicalutamide to patients with moderate to severe hepatic impairment; see section Warnings and precautions for use .

The tablets should be taken with a glass of water, without being chewed.

This medicine can be taken with or without food. Compliance is improved when the drug is always taken at the same time of day.

The duration of treatment is fixed by your doctor.

Treatment with BICALUTAMIDE MYLAN PHARMA 50 mg should begin at the same time as administration of the LHRH analogue or completion of the orchiectomy.

Against indications

· Hypersensitivity to bicalutamide or any of the excipients in this medication.

BICALUTAMIDE MYLAN PHARMA 50 mg is contraindicated in women, children and adolescents.

Concomitant administration of terfenadine, astemizole or cisapride with Bicalutamide is contraindicated.

Side effects Bicalutamide Mylan Pharma

The following frequencies are used to evaluate adverse effects: very common (≥ 1/10), common (≥ 1/100, ≤ 1/10), uncommon (≥ 1/1000, ≤ 1/100), rare (≥ 1/10000, £ 1/1000), very rare (≥ 1/10000), including isolated reports.

The following side effects have been reported with BICALUTAMIDE MYLAN PHARMA 50 mg:

The most commonly reported adverse reactions were breast tenderness, gynecomastia and flushing, which can be reduced by concomitant castration. The table below lists the full list of side effects.

Table 1 Frequency of adverse effects

Class of organ system

Very common

Frequent

Rare

Rare

(≥ 1/10)

(≥ 1/100, ≤ 1/10)

(≥ 1/1000, ≤ 1/100)

(≥ 1/10000, ≤ 1/1000)

Immune system disorders

Hypersensitivity reactions, including angioneurotic edema and urticaria

Respiratory, thoracic and mediastinal disorders

Interstitial lung diseases

Gastrointestinal disorders

Diarrhea

nausea

vomiting

Hepatobiliary disorders

Hepatic insufficiency (elevated transaminases, jaundice) 2

Skin and subcutaneous tissue disorders

Dryness of the skin

Disorders of reproductive organs and breast

Breast sensitivity 1

Gynecomastia 1

General disorders and administration site conditions

Flushing 1

Asthenia

itching

1. Can be alleviated by concomitant castration.

2. In rare cases, severe hepatic impairment has been observed. In general, hepatic disorders have been transient and have disappeared or improved upon discontinuation or discontinuation of therapy (see Warnings and Precautions ).

In addition, the following adverse events have been observed in clinical studies as monotherapy and adjunctive therapy for LHRH analogues.

The most commonly observed side effects were decreased libido, constipation and decreased sexual potency up to total impotence. The table below lists the full list of side effects.

Table 2 Frequency of adverse events

Class of organ system

Very common

(≥ 1/10)

Frequent

(≥ 1/100, ≤ 1/10)

Rare

(≥ 1/1000, ≤ 1/100)

Very rare

(≤ 1/10000)

Blood and lymphatic system disorders

Anemia

thrombocytopenia

Metabolism and nutrition disorders

Weight gain, diabetes mellitus

Increased blood sugar, weight loss

Nervous system disorders

Decreased libido

Dizziness, drowsiness

Insomnia

Heart conditions

Angina pectoris, arrhythmias, heart failure, prolongation of RA and QT, nonspecific ECG abnormalities.

Respiratory, thoracic and mediastinal disorders

Dyspnea

Gastrointestinal disorders

Constipation

Anorexia, dry mouth, digestive disorders, gastric and intestinal pains, flatulence

Hepatobiliary disorders

Liver disorders (cholestatic jaundice, hyperbilirubinemia, hepatomegaly, elevated liver enzymes) 1.

Skin and subcutaneous tissue disorders

Rash, maculopapular rash, heavy sweating, hirsutism

Hair loss

Renal and urinary disorders

Nighttime urination

Disorders of reproductive organs and breast

Decrease in sexual potency to complete impotence

general disorders and abnormalities at the site of administration

Edema (facial surface, extremities / trunk), pelvic pain, systemic pain, chills

Gastric pain, chest pain, headache, neck pain, low back pain

1. These were generally transient and disappeared or improved upon discontinuation or discontinuation of treatment. In these cases, liver tests (bilirubin, transaminases and alkaline phosphatases) should be performed regularly. In a few isolated cases, severe liver problems have also been observed (see Warnings and precautions for use ).

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