FINIDE 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:

Alphapharm Pty Ltd

INN (International Name):

Finasteride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; microcrystalline cellulose; lactose monohydrate; docusate sodium; sodium starch glycollate type A; titanium dioxide; indigo carmine aluminium lake; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

28 tablets, 30 Tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.

Product summary:

Visual Identification: Blue coloured, oval shaped, biconvex, film-coated tablet, debossed with 'FIN' on one side and '5' on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-06-18

Patient Information leaflet

FINIDE
_Finasteride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FINIDE. 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 FINIDE
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 FINIDE IS USED
FOR
FINIDE is for use by men only.
FINIDE 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 stream of
urine
•
feeling that you cannot empty
your bladder completely
•
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. 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.
FINIDE 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. FINIDE 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.
Your doctor may have prescribed
FINIDE for another reason. Ask your
doctor if you have any questions
about why FINIDE has been
prescribed for you.
FINIDE is not addicti

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FINIDE
_Finasteride film coated tablet _
1
NAME OF THE MEDICINE
Finasteride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Finide film coated tablets contain 5 mg of finasteride 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
Finide 5 mg tablets are blue colored, oval shaped, biconvex,
film-coated tablets, debossed with ‘FIN’ on one
side and ‘5’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of patients with symptomatic benign prostatic hyperplasia
(BPH) with an enlarged prostate.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage is one 5 mg tablet daily with or without food.
DOSAGE IN IMPAIRED RENAL FUNCTION
Adjustments in dosage are not necessary in patients with varying
degrees of renal insufficiency (creatinine
clearances as low as 9 mL/minute) 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 that the elimination of
finasteride is somewhat decreased in patients aged over 70 years.
4.3
CONTRAINDICATIONS
Finide is contraindicated in the following:
•
Use in women when they are or may potentially be pregnant (see Section
4.6 FERTILITY,
PREGNANCY AND LACTATION, USE IN PREGNANCY, EXPOSURE TO FINASTERIDE,
RISK TO A MALE FOETUS
, and Section
6.4 SPECIAL PRECAUTIONS FOR STORAGE
).
•
Hypersensitivity to any component of this product.
•
Use in women or children.
Finide – PRODUCT INFORMATION
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
Since the beneficial response to finasteride may not be manifested
immediately, patients with large residual
urine volume and/or severely diminished urinary flow should be
carefully monitored for obstructive uropathy.
Finasteride may not reduce inconvenience to patients arising from
benign prostatic hyperplasia (BPH)
symptoms in patient