BICALUTAMIDE TEVA 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BICALUTAMIDE

Available from:

TEVA ISRAEL LTD

ATC code:

L02BB03

Pharmaceutical form:

TABLETS

Composition:

BICALUTAMIDE 150 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

BICALUTAMIDE

Therapeutic area:

BICALUTAMIDE

Therapeutic indications:

In patients with locally advanced prostate cancer (T3-T4 any N M0 T1-T2 N+ M0) Bicalutamide is indicated as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. The management of patients with locally advanced non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.

Authorization date:

2014-05-31

Patient Information leaflet

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with
a doctor’s prescription only
Bicalutamide Teva
150 mg
Tablets
Composition:
Each tablet contains:
Bicalutamide 150 mg
For information about inactive and
allergenic ingredients in the preparation,
see section 2 “Important information
about some of the ingredients of the
medicine” and section 6 – “Further
Information”.
Read the leaflet carefully in its entirety
before using the medicine. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for
the treatment of your ailment. Do not pass
it on to others. It may harm them, even if it
seems to you that their ailment is similar.
This medicine is not intended
for women or children, including
pregnant and breastfeeding women.
1.
WHAT IS THE MEDICINE INTENDED
FOR?
For treatment of prostate cancer.
Therapeutic group
An anti-androgenic agent that interferes
with some of the activities of androgens
)male hormones( within the body.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• You are sensitive )allergic( to the
active ingredient bicalutamide or
to any of the additional ingredients
contained in the medicine (see
section
6
–
“Further
Information”(.
•
You
are
a
woman.
•
Yo u
a r e
a l r e a d y
t a k i n g
a
medicine
called
cisapride
or
certain antihistamine medicines
)terfenadine,
astemizole(.
The medicine must not be given to
children.
If you have further questions regarding
use of the medicine, consult the doctor
or pharmacist.
Special warnings regarding use of
the medicine:
Tell the doctor or pharmacist if:
• You suffer from liver problems. Your
doctor may refer you for blood tests
before and during the treatment with
Bicalutamide Teva 150 mg.
• You suffer from heart or blood vessel
problems, including heart rhythm
disorders
)arrhythmias(,
or
if
you
are
being treated with medicines for any
of these cond