PROSCAR finasteride 5mg tablet, blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

finasteride, Quantity: 5 mg

제공처:

ORGANON PHARMA PTY LTD

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: docusate sodium; titanium dioxide; lactose monohydrate; indigo carmine; iron oxide yellow; purified talc; hypromellose; sodium starch glycollate; pregelatinised maize starch; magnesium stearate; microcrystalline cellulose; hyprolose

관리 경로:

Oral

패키지 단위:

30 tablets, 5 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

For the treatment and control of symptomatic benign prostatic hyperplasia (BPH) in patients who are not candidates for immediate surgery. Efficacy has been established in double blind clinical studies for treatment of BPH for periods up to 12 months. Patients have been treated in open extension studies at the recommended dosage for up to 3 years during which the drug was generally well tolerated. INDICATIONS AS AT 3 MARCH 1999: PROSCAR is indicated for the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.

제품 요약:

Visual Identification: Blue, apple-shaped film-coated tablet one side marked "MSD 72" the other side "PROSCAR".; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

승인 상태:

Registered

승인 날짜:

1993-10-26

환자 정보 전단

PROSCAR
®
_Finasteride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROSCAR. 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 PROSCAR
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 PROSCAR IS
USED FOR
PROSCAR is for use by men only.
PROSCAR 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.
PROSCAR 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.
PROSCAR 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
PROSCAR for another reason. Ask
your doctor if you have any questions
about why PROSCAR has been
prescribed for you.
PROSCAR

제품 특성 요약

S-IPC-PSC-T-072013
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
PROSCAR
®
(FINASTERIDE) TABLETS
1
NAME OF THE MEDICINE
Finasteride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PROSCAR contains 5 mg of finasteride as the active ingredient.
List of excipients with known effect: lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PROSCAR 5 mg: A blue apple shaped film coated tablet engraved MSD72
one side,
PROSCAR on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROSCAR 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.
4.3
CONTRAINDICATIONS
PROSCAR 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 PROSCAR
is not indicated for use in women or children.
S-IPC-PSC-T-072013
Page 2 of 14
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
Since the beneficial response to PROSCAR may not be manifested
immediately, patients with
large residual urine volume and/or severely diminished urinary flow
should be carefully
monitored for obstructive uropathy.
PROSCAR
may
not
reduce
inconvenience
to
patients
arising
from
benign
prostatic
hyperplasia symptoms in patients with mild t