BICUSAN 50mg. 30 tablets

WHAT BICUSAN?
Bicusan is a medicine that inhibits certain hormones / androgens / in the body and thus prevents the development of prostate tumors. Bicusan 50 mg is administered to treat advanced prostate cancer in combination with treatment with an LHRH analogue, or surgical castration.

BEFORE YOU TAKE BICUSAN
Bicusan not apply to:
- Women and children
- Hypersensitivity to the active ingredients of the product
- Co-administration with terfenadine, astemizole, cisapride

Take care with Bicusan:
Bicusan processed largely in the liver. In subjects with severe hepatic impairment output can be fun and lead to the accumulation of the product. In these patients, the product should be used with caution and to conduct periodic assessment of liver function due to possible changes in the liver. More likely is that to occur in the first six months of treatment.
In patients with established objective disease progression and increased prostate specific antigen Bicusan treatment should be discontinued.
It has been shown that the product inhibits certain enzymes in the liver, and therefore, caution should be used when co-administered with drugs that are processed preferably by means of this system.

Pregnancy and lactation
Bicusan not apply to women.

DRIVE AND USE MACHINES
It is unlikely that the product affect driving or operating machinery. However, it can not be excluded drowsiness, which requires attention.

DETAILS OF OTHER SUBSTANCES
This product contains lactose, which makes it unsuitable for patients with lactase deficiency, galactosemia or glucose / galactose malabsorption.

HOW TO TAKE BICUSAN
Adult males including the elderly: one tablet of 50 mg once daily. Treatment should start at least 3 days prior to treatment with the LHRH analogue or surgical castration.
The product should be administered continuously for at least two years or until disease progression.
Patients with renal impairment:
There is no need for dosage adjustment in patients with renal impairment.

Patients with hepatic impairment:
There is no need for dosage adjustment in patients with mild hepatic impairment. Those with moderate to severe damage can be observed increased accumulation of the product.

POSSIBLE SIDE EFFECTS
Immune system disorders:
Uncommon - hypersensitivity reactions, including. angioneurotic edema and urticaria.

Mental disorders:
Uncommon - depression

Respiratory, thoracic and mediastinal disorders:
Uncommon - interstitial lung disease

Gastrointestinal disorders:
Common - diarrhea, nausea
Rare - vomiting

Hepatobiliary disorders:
Common - liver changes
Very rare - liver failure

Skin and subcutaneous tissue disorders:
Common - persistent itching
Rare - dry skin

Renal and urinary disorders:
Uncommon - blood in urine

Reproductive system and breast disorders:
Very common - breast tenderness, breast enlargement

General disorders and administration site conditions:
Very common - hot flushes
Common - fatigue

ADDITIONAL INFORMATION:
Contents Bicusan?
The active ingredient is bicalutamide.
The other ingredients are lactose monohydrate, povidone, crospovidone, sodium lauryl sulphate, magnesium stearate.
Composition of the tablet coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol