FINASTERIDE MYLAN 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:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; lauroyl macrogolglycerides; lactose monohydrate; pregelatinised maize starch; microcrystalline cellulose; sodium starch glycollate type A; 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:

FINASTERIDE MYLAN 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:

Registered

Authorization date:

2020-05-04

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
FINASTERIDE MYLAN 5
(finasteride) film-coated tablet
What is in this leaflet
This leaflet answers some
common questions about
Finasteride Mylan 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
Finasteride Mylan 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 Finasteride Mylan 5
is used for
Finasteride Mylan 5 is for use by
men only.
Finasteride Mylan 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 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. 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. Finasteride
Mylan 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. Finasteride
Mylan 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.
Your doctor may have
prescribed Finast

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – FINASTERIDE MYLAN 5
(finasteride) film-coated tablet
1
NAME OF THE MEDICINE
Finasteride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Finasteride Mylan 5 film-coated tablets contain 5 mg of finasteride.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Finasteride Mylan 5 film-coated tablets are blue, round, biconvex,
film-coated tablets, marked ‘F5’ on
one side and plain on the other.
4
CLINICAL PARTICULARS
4.1 Therapeutic Indications
Finasteride Mylan 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
The recommended dosage is one 5 mg tablet daily with or without food.
Dosage in Renal Insufficiency
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.
Finasteride Mylan 5 v0.2
Page 2 of 14
(finasteride) film-coated tablet
4.3 Contraindications
Finasteride Mylan 5 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.
Finasteride Mylan 5 is not indicated for use in women or children.
4.4 Special Warnings and Precautions for Use
General
Since the beneficial response to Finasteride Mylan 5 may not be
manifested immediately, patients with
large residual urine volume and/or severely diminished urinary flow
should be carefully monitored for
obs