ANANDRON nilutamide 150mg tablet blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

nilutamide

Доступна з:

Sanofi-Aventis Australia Pty Ltd

Статус Авторизація:

Registered

інформаційний буклет

ANANDRON
®
_Nilutamide_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Anandron. 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 taking Anandron
against the benefits Anandron is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING ANANDRON, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT ANANDRON IS
USED FOR
Anandron is a medicine for treating
prostate cancer in men. It contains
the active ingredient Nilutamide.
Anandron belongs to a family of
medicines called non-steroidal anti-
androgens. These medicines work by
blocking the effect of androgen
hormones that are naturally produced
by your body. Prostate cancer cells
are dependent on these hormones,
and blocking their effect is intended
to stop the growth of the cancer.
Anandron is more effective when
used at the same time as other
medicines known generally as LHRH
agonists or, alternatively, following
surgery designed to treat prostate
cancer.
Your doctor may have prescribed
Anandron for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ANANDRON HAS
BEEN PRESCRIBED FOR YOU.
Anandron is available only with a
doctor's prescription.
BEFORE YOU TAKE
ANANDRON
_WHEN YOU MUST NOT TAKE IT_
Anandron must only be taken by
men. It is not suitable for women or
children.
DO NOT TAKE ANANDRON IF:
-
YOU HAVE AN ALLERGY TO:
NILUTAMIDE OR ANY OF THE OTHER
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET (SEE PRODUCT DESCRIPTION).
Symptoms of an allergic reaction to
these medicines may include:
•
asthma, wheezing or shortness of
breath
•
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing
•
hives, itching or skin rash
•
fainting
-
YOU HAVE SEVERE LIVER PROBLEMS
-
YOU HAVE SEVERE BREATHING
PROBLEMS
-
YOU HAVE PREVIOUSLY TAKEN
ANOTHER ANTI-ANDRO

Характеристики продукта

anandron-ccdsv5-piv4-11dec20
1
AUSTRALIAN PRODUCT INFORMATION – ANANDRON
®
(NILUTAMIDE) TABLETS
1
NAME OF THE MEDICINE
Nilutamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nilutamide is a non-steroidal orally-active specific antiandrogen.
Each ANANDRON tablet contains nilutamide 150 mg as active ingredient.
Excipients with known effect: sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Practically white, biconvex cylindrical tablet, approx. 10 mm in
diameter, marked "168D" on
one side with company logo "RU" on reverse side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ANANDRON is indicated for the treatment of previously untreated
metastatic prostatic
carcinoma, in conjunction with surgical or medical castration.
ANANDRON prevents the disease flare associated with the use of LHRH
agonists.
4.2
DOSE AND METHOD OF ADMINISTRATION
ANANDRON tablets are taken orally as either a once daily dose or as
divided daily doses. To
achieve maximum benefits, treatment should begin on the day of medical
castration (eg.
using an LHRH agonist) or surgical castration and continue without
interruption.
The following dosages are recommended, irrespective of renal function:
INITIAL TREATMENT
The dosage for the first four weeks of treatment is 300 mg per day
administered either as a
once daily dose or as divided doses (eg. 150 mg twice daily). After
four weeks, maintenance
anandron-ccdsv5-piv4-11dec20
2
treatment should be commenced (see below). Maintenance treatment may
be commenced
earlier if undesirable effects, especially vomiting or visual effects,
occur.
MAINTENANCE TREATMENT
Immediately following four weeks of initial treatment, the dosage is
reduced to 150 mg per
day administered as a once daily dose.
4.3
CONTRAINDICATIONS
ANANDRON is contraindicated in the following patients:
•
Patients who are hypersensitive to nilutamide or any excipient
•
Patients with severe hepatic impairment
•
Patients with severe respiratory insufficiency
•
Women
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