BICALOX bicalutamide 50mg film coated tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bicalutamide, Quantity: 50 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Bicalutamide

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; povidone; sodium starch glycollate type A; magnesium stearate; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

500 tablets, 28 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of advanced prostate cancer in combination with LHRH agonist therapy.

Product summary:

Visual Identification: A white to off-white, round, film-coated, biconvex tablet, engraved with 'BC 50' on one face and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-05-24

Patient Information leaflet

BICALOX™
CONSUMER MEDICINE INFORMATION
Bicalutamide 50 mg film-coated tablets WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
BICALOX. It does not contain all the
information that is known about BICALOX.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your
doctor will have weighed the risks of you taking BICALOX against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT BICALOX IS USED FOR
BICALOX is used in combination with other medicines to treat locally
advanced prostate cancer.
BICALOX is an anti-androgen medicine. Androgens such as testosterone
are natural male sex hormones. In
some types of prostate cancer, androgens can help the cancer cells to
grow. Bicalutamide interferes with some
of the actions of these hormones.
BICALOX SHOULD ONLY BE TAKEN BY MEN.
YOU MUST FOLLOW ALL THE DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR. They
may differ from the information in this
leaflet.
Your doctor may prescribe this medicine for another use.
ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION.
BICALOX is not addictive.
BICALOX is only available with a doctor’s prescription. BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE BICALOX IF YOU ARE A WOMAN. Women are not normally treated
with BICALOX.
DO NOT GIVE BICALOX TO CHILDREN. There is no experience of its use in
children.
DO NOT TAKE BICALOX IF YOU ARE ALLERGIC TO BICALUTAMIDE OR ANY OF THE
OTHER INGREDIENTS IN BICALOX.
DO NOT TAKE BICALOX IF YOU ARE TAKING CISAPRIDE OR THE ANTIHISTAMINES,
TERFENADINE AND ASTEMIZOLE.
DO NOT TAKE BICALOX AFTER THE USE BY (EXPIRY) DATE PRINTED ON THE
PACK. It may have no effect at all or an
unexpected effect if you take it after the expiry date.
DO NOT TAKE BICALOX IF THE PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
DO NOT USE IT TO TREAT ANY OTHER COMPLAINTS UNLESS YOUR DOC

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – BICALOX (BICALUTAMIDE)
1
NAME OF THE MEDICINE
Bicalutamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BICALOX tablet contains 50 mg bicalutamide.
Bicalutamide is a white to almost white powder. Practically insoluble
in water, freely soluble in
acetone, slightly soluble in anhydrous ethanol and in methylene
chloride.
Excipients with known effect: lactose monohydrate. For the full list
of excipients, see Section 6.1
List of excipients.
3
PHARMACEUTICAL FORM
A white to off-white, round, film-coated, biconvex tablet, engraved
with 'BC 50' on one face and
plain on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with LHRH agonist
therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULT MALES, INCLUDING THE ELDERLY
One tablet (50 mg), once a day.
Treatment with bicalutamide 50 mg should be started at the same time
as treatment with a
LHRH agonist.
RENAL IMPAIRMENT
No dosage adjustment is necessary for patients with renal impairment.
HEPATIC IMPAIRMENT
No dosage adjustment is necessary for patients with mild hepatic
impairment.
Increased accumulation may occur in patients with moderate to severe
hepatic impairment
(see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). In such
cases, a lower or less
frequent dose may be considered.
4.3
C
ONTRAINDICATIONS
BICALOX is contraindicated in females and children; also in case of
known hypersensitivity to
bicalutamide or any other constituents of the formulation.
2
Co-administration of terfenadine, astemizole or cisapride with
bicalutamide is contraindicated
(see section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF
INTERACTIONS).
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
HYPERGLYCAEMIA
A reduction in glucose tolerance has been observed in males receiving
LHRH agonists. This may
manifest
as
diabetes
or
loss
of
glycaemic
control
in
those
with
pre-existing
diabetes.
Consideration should therefore be given to monitoring blood glucose in
patients receiving
bic