APO-FINASTERIDE 5 finasteride 5 mg film-coated tablet blister pack

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

العنصر النشط:

finasteride, Quantity: 5 mg

متاح من:

Pharmacor Pty Ltd

INN (الاسم الدولي):

Finasteride

الشكل الصيدلاني:

Tablet, film coated

تركيب:

Excipient Ingredients: lactose monohydrate; lauroyl macrogolglycerides; microcrystalline cellulose; pregelatinised maize starch; sodium starch glycollate type A; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000; indigo carmine aluminium lake

طريقة التعاطي:

Oral

الوحدات في الحزمة:

30 tablets

نوع الوصفة الطبية :

(S4) Prescription Only Medicine

الخصائص العلاجية:

APO-FINASTERIDE 5 is indicated for the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.

ملخص المنتج:

Visual Identification: Blue, 7 mm, round, biconvex, film-coated tablet, marked 'F5' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

الوضع إذن:

Licence status A

تاريخ الترخيص:

2010-03-26

نشرة المعلومات

APO-Finasteride 5
1
APO-FINASTERIDE 5
_Finasteride _
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 finasteride. 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
FINASTERIDE IS FOR USE BY MEN ONLY.
Finasteride is used to treat a medical
condition in men called benign
prostatic hyperplasia (BPH). BPH is
a condition where your prostate
gland (which is near your bladder)
has become bigger, making it more
difficult for you to pass urine. This
can lead to symptoms such as:

weak or interrupted stream of
urine

feeling that you cannot empty
your bladder completely

a delay before you start to pass
urine

needing to pass urine often,
especially at night

feeling that you must pass urine
right away
BPH occurs only in men and is
common over the age of 50 years.
The prostate gland takes years to
grow. Therefore, the symptoms of
BPH take a long time to develop. In
some men, BPH can lead to serious
problems, including urinary tract
infections and the sudden inability to
pass urine at all (acute urinary
retention). BPH may also require
surgery to improve the flow of urine.
_HOW IT WORKS _
Finasteride works by slowly reducing
the size of your prostate gland. This
may lead to gradual improvement in
your urine flow and other symptoms
over several months. Finasteride also
helps reduce the risk of developing a
sudden inability to pass urine and the
need for surgery. This may happen
whether or not you notice any
improvement or change in your
symptoms.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THI

خصائص المنتج

1
AUSTRALIAN PRODUCT INFORMATION
APO-FINASTERIDE 5 (FINASTERIDE) FILM-COATED
TABLETS
1
NAME OF THE MEDICINE
Finasteride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Finasteride 5 mg.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-Finasteride 5 comes as a blue, round, biconvex, film-coated
tablets, marked ‘F5’ on one
side and plain on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
APO-Finasteride 5 is indicated for the treatment of patients with
symptomatic benign
prostatic hyperplasia (BPH) with an enlarged prostate.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended dosage is one 5 mg tablet daily with or without food.
RENAL IMPAIRMENT
Adjustments
in
dosage
are
not
necessary
in
patients
with
varying
degrees
of
renal
insufficiency (creatinine clearances as low as 9 mL/min) as
pharmacokinetic studies did not
indicate any change in the disposition of finasteride.
DOSAGE IN THE ELDERLY
No adjustment in dosage is required although pharmacokinetic studies
indicated the
elimination of finasteride is somewhat decreased in patients more than
70 years of age.
2
4.3
CONTRAINDICATIONS
APO-Finasteride 5 is contraindicated in the following:
•
Use in women when they are or may potentially be pregnant (see
sections 4.6
FERTILITY, PREGNANCY AND LACTATION - USE IN PREGNANCY; EXPOSURE TO
FINASTERIDE -
RISK TO A MALE FOETUS)
•
Hypersensitivity to any component of this product
APO-Finasteride 5 is not indicated for use in women or children.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
Since the beneficial response to APO-Finasteride 5 may not be
manifested immediately,
patients with large residual urine volume and/or severely diminished
urinary flow should be
carefully monitored for obstructive uropathy.
APO-Finasteride 5 may not reduce inconvenience to patients arising
from benign prostatic
hyperplasia symptoms in patients with mild to moderate enlargement in
prostate (< 40 mL
size).
EFFECTS ON PSA