APO-BICALUTAMIDE bicalutamide 50mg film-coated tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

bicalutamide, Quantity: 50 mg

Tilgængelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Bicalutamide

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

28 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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

Produkt oversigt:

Visual Identification: White to off white round, biconvex, film coated tablets debossed 'B 50' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Licence status A

Autorisation dato:

2012-04-13

Indlægsseddel

APO-BICALUTAMIDE TABLETS
1
APO-BICALUTAMIDE
TABLETS
_Bicalutamide _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about bicalutamide. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Bicalutamide is used in combination
with other medicines called LHRH
agonists to treat advanced prostate
cancer and to prevent a side effect of
LHRH agonists.
_HOW IT WORKS _
Bicalutamide is an anti-androgen
medicine. Androgens such as
testosterone are natural male sex
hormones. In some types of prostate
cancer, androgens may help the
cancer cells to grow.
Bicalutamide interferes with some of
the actions of these hormones.
Bicalutamide should only be taken
by men.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
This medicine must not be used in
children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
bicalutamide
•
any of the ingredients listed at the
end of this leaflet
•
lactose
Some of the symptoms of an allergic
reaction may include:
•
cough, shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
•
fainting or hayfever-like
symptoms.
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING CISAPRIDE, TERFENADINE OR
ASTEMIZOLE
DO NOT TAKE THIS ME

Produktets egenskaber

1
AUSTRALIAN PRODUCT INFORMATION
APO-BICALUTAMIDE 50 MG (BICALUTAMIDE) TABLETS
1
NAME OF THE MEDICINE
Bicalutamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg bicalutamide as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White to off white, round, biconvex, film coated tablets debossed
“B50” on one side and plain
on other side.
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
APO-Bicalutamide tablets 50 mg are intended for oral administration.
DOSAGE
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.
2
4.3
CONTRAINDICATIONS
•
Bicalutamide is contraindicated in females and children.
•
Known hypersensitivity to bicalutamide or any other constituents of
the formulation.
•
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
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
patients receivin