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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

finasteride, Quantity: 5 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Finasteride

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2010-03-26

Patient Information leaflet

Version 3.0
1
PHARMACOR FINASTERIDE 5
Finasteride Tablets 5 mg
CONSUMER MEDICINE INFORMATION
_WHAT IS IN THIS LEAFLET _
This leaflet answers some common
questions
about
Pharmacor
Finasteride 5. 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 Pharmacor
Finasteride 5 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 _
_PHARMACOR _
_FINASTERIDE 5 IS USED FOR _
Pharmacor Finasteride 5 is for use
by men only.
Pharmacor Finasteride 5 is used to
treat a medical condition in men
called benign prostatic hyperplasia
or 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
streamof urine

Feeling
that
you
cannotempty
your
bladdercompletely

A delay before
you start
topass urine

Needing
to
pass
urine
often,especially at night

Feeling
that
you
must
passurine right away
BPH occurs only in men and is
common over the age of 50
years. In some men, BPH can
lead
to
serious
problems,
including urinary tract infections
and the sudden inability to pass
urine at all. BPH can also lead
to the need for surgery such as
procedures to improve the flow
of urine.
The prostate gland takes years
to
grow.
Therefore,
the
symptoms of BPH take a long
time
to
develop.
Pharmacor
Finasteride 5 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.
Pharmacor Finasteride 5 also
helps
reduce
the
risk
of
developing a sudden inability to
pass
urine
(acute
urinary
retention)
and
the
need
for
surgery.
This
may
happen
whether or not you notice any
improvement or change in your
symptoms.

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – PHARMACOR
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
Pharmacor 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
T
HERAPEUTIC INDICATIONS
Pharmacor Finasteride 5 is indicated for the treatment of patients
with symptomatic benign prostatic
hyperplasia (BPH) with an enlarged prostate.
4.2
D
OSE AND METHOD OF ADMINISTRATION
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.
4.3
C
ONTRAINDICATIONS
Pharmacor 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
Pharmacor Finasteride 5 is not indicated for use in women or children.
2
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
Since the beneficial response to Pharmacor 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.
Pharmacor Finasteride 5 may not reduce inconvenience to patients
arising from benign prostatic
hyperplasia symptoms in patients with mild to moderate enlarg