FINASTA finasteride 5 mg film-coated tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

finasteride, Quantity: 5 mg

Disponível em:

Sandoz Pty Ltd

Forma farmacêutica:

Tablet, film coated

Composição:

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

Via de administração:

Oral

Unidades em pacote:

30 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

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

Resumo do produto:

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

Status de autorização:

Registered

Data de autorização:

2020-05-04

Folheto informativo - Bula

CONSUMER MEDICINE INFORMATION
FINASTA® 5 MG
(FINASTERIDE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
FINASTA 5 mg. 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
FINASTA 5 mg 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 FINASTA 5 MG IS
USED FOR
FINASTA 5 mg is for use by
men only.
FINASTA 5 mg 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. FINASTA 5 mg
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. FINASTA 5 mg
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 FINASTA 5 mg for
another reason. Ask your doctor
if you have

Características técnicas

AUSTRALIAN PRODUCT INFORMATION – FINASTA®
(FINASTERIDE) 5 MG FILM-COATED TABLET
1
NAME OF THE MEDICINE
Finasteride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FINASTA 5 mg 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
FINASTA 5 mg 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
FINASTA 5 mg 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.
FINASTA 5 MG v1
Page 2 of 14
(finasteride) film-coated tablet
4.3 CONTRAINDICATIONS
FINASTA 5 mg 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.
FINASTA 5 mg is not indicated for use in women or children.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
Since the beneficial response to FINASTA 5 mg may not be manifested
immediately, patients with large
residual urine volume and/or severely diminished urinary flow should
be carefully monitored for
obstructive uropathy.
FINASTA 5 mg may not reduce inconveni