CALUTEX bicalutamide 50 mg tablets blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

bicalutamide, Quantity: 50 mg

Fáanlegur frá:

Aspen Pharma Pty Ltd

INN (Alþjóðlegt nafn):

Bicalutamide

Lyfjaform:

Tablet, film coated

Samsetning:

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

Stjórnsýsluleið:

Oral

Einingar í pakka:

28 tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Treatment of advanced prostate cancer in combination with LHRH agonist therapy. Prevention of disease flare associated with the use of LHRH agonists.

Vörulýsing:

Visual Identification: White, biconvex tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2007-12-20

Upplýsingar fylgiseðill

Calutex – Consumer Medicine Information
Page 1 of 4
CALUTEX
_ _
_bicalutamide 50 mg tablets _
CONSUMER MEDICINE INFORMATION (CMI)
_ _
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Calutex. It does not contain all
the information and does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risk of you taking
Calutex against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT CALUTEX IS
USED FOR
Calutex is used in combination
with other medicines to treat
advanced prostate cancer.
Calutex contains bicalutamide
as the active ingredient.
Bicalutamide belongs to a
group of medicines called anti-
androgens.
Androgens such as
testosterone are natural male
sex hormones. In some types
of prostate cancer, androgens
may help the cancer cells to
grow. Calutex interferes with
some of the actions of these
hormones.
Calutex should only be taken
by men.
FOLLOW ALL DIRECTIONS GIVEN TO
YOU BY YOUR DOCTOR.
They may differ from the
information in this leaflet.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed this medicine for
another reason.
Calutex is only available with a
doctor’s prescription.
It is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CALUTEX IF YOU
ARE A WOMAN.
DO NOT GIVE THIS MEDICINE TO
CHILDREN.
There is no experience of its
use in children.
DO NOT TAKE CALUTEX IF YOU
ARE ALLERGIC TO BICALUTAMIDE
OR ANY OF THE OTHER TABLET
INGREDIENTS LISTED AT THE END
OF THE LEAFLET.
Symptoms of an allergic
reaction may include shortness
of breath, wheezing or difficulty
in breathing; swelling of the
face, lips, tongue or any other
part of the body; rash, itching
or hives on the skin.
DO NOT TAKE CALUTEX IF YOU
ARE TAKING CISAPRIDE OR THE
ANTIHISTAMINES, TERFENADINE
AND ASTEMIZOL

Vara einkenni

Calutex (bicalutamide) – Product Information
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION
CALUTEX (BICALUTAMIDE) TABLETS
1.
NAME OF THE MEDICINE
Bicalutamide.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calutex tablets contain bicalutamide 50 mg as the active ingredient.
Excipients with known effect include lactose monohydrate. For the full
list of excipients, see
section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Calutex is a white, film coated biconvex tablet containing
bicalutamide 50 mg as the active
ingredient.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of advanced prostate cancer in combination with LHRH agonist
therapy.
Prevention of disease flare associated with the use of LHRH agonists.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adult males, including the elderly
One tablet (50 mg) once a day. Treatment with Calutex 50 mg should be
started at the same
time as treatment with a LHRH agonist.
Use in adult males with renal impairment
No dosage adjustment is necessary for patients with renal impairment.
Use in adult males with 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
CONTRAINDICATIONS
Females; children; known hypersensitivity to bicalutamide or any other
constituents of the
formulation.
Calutex (bicalutamide) – Product Information
Page 2 of 9
Coadministration of terfenadine, astemizole or cisapride with Calutex
is contraindicated (see
section 4.5: Interactions with other medicines and other forms of
interactions).
4.4
SPECIAL 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
pa