FINNACAR finasteride 5 mg tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

finasteride, Quantity: 5 mg

Dostupné z:

Arrotex Pharmaceuticals Pty Ltd

INN (Medzinárodný Name):

Finasteride

Forma lieku:

Tablet, film coated

Zloženie:

Excipient Ingredients: magnesium stearate; purified talc; lactose monohydrate; hypromellose; pregelatinised maize starch; titanium dioxide; hyprolose; sodium starch glycollate; microcrystalline cellulose; macrogol 6000

Spôsob podávania:

Oral

Počet v balení:

30 tablets

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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

Prehľad produktov:

Visual Identification: White rounded triangle tablet with "R\G" on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2008-12-17

Príbalový leták

FINNACAR- Consumer Medicine Information
Page 1 of 3
FINNACAR
finasteride
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
FINNACAR.
It does not contain all of the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking FINNACAR
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with your
medicine. You may need to read
it again.
WHAT FINNACAR IS USED
FOR
FINNACAR is for use in men only.
It must not be taken by women.
FINNACAR is used to treat benign
prostatic hyperplasia (BPH). BPH
is a condition where your
prostate gland (which is near
your bladder) has become bigger
making it difficult to pass urine.
This can cause symptoms such
as:
•
a weak or interrupted stream
of urine
•
the feeling that you cannot
completely empty your
bladder
•
a delay before you start to
pass urine
•
the need to pass urine often,
especially at night
•
the urgent feeling that you
need to 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 so the symptoms of BPH
can take a long time to develop.
FINNACAR 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. FINNACAR 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
FINNACAR for another reason.
Ask your doctor if you have

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION – FINNACAR (FINASTERIDE)
TABLETS
1
NAME OF THE MEDICINE
Finasteride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FINNACAR tablets contain 5 mg of finasteride.
Excipients with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_FINNACAR _
White, rounded triangle tablet marked with R/G on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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.
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.
Use 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.
Handling
Crushed or broken tablets of FINNACAR should not be handled by women
when they are or may
potentially be pregnant (see section 4.6 FERTILITY, PREGNANCY AND
LACTATION, Use in pregnancy,
Risk to a male fetus of exposure to finasteride).
2
4.3
C
ONTRAINDICATIONS
Use in women when they are or may potentially be pregnant (see section
4.6 FERTILITY, PREGNANCY
AND LACTATION, Use in pregnancy, Risk to a male fetus of exposure to
finasteride and s e c t i o n
4 . 2 DOSE AND METHOD OF ADMINISTRATION Handling).
Hypersensitivity to any component of this product.
Use in women or children.
4.4
S
PECIAL 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