AVODART dutasteride 500 microgram soft capsule blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

dutasteride, Quantity: 500 microgram

Saatavilla:

GlaxoSmithKline Australia Pty Ltd

Lääkemuoto:

Capsule, soft

Koostumus:

Excipient Ingredients: titanium dioxide; mono- and di- glycerides; lecithin; iron oxide yellow; butylated hydroxytoluene; medium chain triglycerides; Gelatin; glycerol

Antoreitti:

Oral

Kpl paketissa:

10 capsules "Medical Sample. Not for Sale", 30 capsules, 90 capsules

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

AVODART is indicated for use as monotherapy for the management of symptomatic benign prostatic hyperplasia (BPH) or as combination therapy with an alpha blocker which is approved for use in BPH and which has been dose titrated in accordance with the relevant recommendations in the product information for that alpha blocker.

Tuoteyhteenveto:

Visual Identification: Yellow, opaque, oblong, soft gelatin capsules marked with GX CE2; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2002-11-14

Pakkausseloste

AVODART
®
_(Dutasteride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take AVODART.
This leaflet answers some common
questions about AVODART. 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 risks and
benefits. Your doctor has weighed
the expected benefits of you taking
AVODART against the risks this
medicine could 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 IS AVODART
USED FOR?
AVODART (dutasteride) belongs to
a group of medicines called 5 alpha
reductase enzyme inhibitors which
are used in men who have a
condition known as benign prostatic
hyperplasia (BPH).
BPH is a non-cancerous enlargement
of the prostate gland which is located
at the lower portion of the urinary
bladder surrounding the urethra
(urine carrying tube). In men with
BPH, the prostate gland becomes
large enough to squeeze the urine
tube running through it. If the urine
tube is squeezed it narrows, making
it more difficult for you to pass urine
normally and you may have some or
all of the following symptoms:
•
difficulty in starting to urinate
•
an interrupted, weak urinary
stream
•
more frequent urination,
especially at night
•
feeling that you need to urinate
right away
•
leaking or dribbling
•
a feeling that you cannot empty
your bladder completely
As the disease progresses, untreated
BPH can lead to an increased risk of
complete blockage of urine flow
(acute urinary retention) and/or the
need for surgery.
Prostate growth is caused by a
hormone in the blood called
dihydrotestosterone (DHT).
AVODART lowers DHT production
in the body, leading to shrinkage of
the enlarged prostate in most men.
Just as your prostate became large
over a long period of time, reducing
the size of your prostate and
improving your symptoms may take
time.
AVODART may also be taken in
com

Valmisteyhteenveto

1
AUSTRALIAN PI – AVODART (DUTASTERIDE) SOFT CAPSULES
1
NAME OF THE MEDICINE
Dutasteride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dutasteride 500 µg.
EXCIPIENTS WITH KNOWN EFFECT
Lecithin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Yellow, opaque, oblong, soft gelatin capsules marked with GX CE2.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AVODART is indicated for use as monotherapy for the management of
symptomatic benign
prostatic hyperplasia (BPH) or as combination therapy with an alpha
blocker which is approved
for
use
in
BPH
and
which
has
been
dose
titrated
in
accordance
with
the
relevant
recommendations in the product information for that alpha blocker.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dutasteride can be administered alone or in combination with an alpha
blocker.
ADULT MALES (INCLUDING ELDERLY)
The recommended dose is one 500

g capsule daily. The capsules should be swallowed
whole and not chewed or opened, as contact with the capsule contents
may result in irritation
of the oropharyngeal mucosa. AVODART may be taken with or without
food.
Although early improvements in symptoms may be seen in some patients,
treatment for at
least 6 months is generally necessary to assess whether a beneficial
response in symptom
relief has been achieved.
DOSAGE IN RENAL IMPAIRMENT
The effect of renal impairment on dutasteride pharmacokinetics has not
been studied.
However, no adjustment in dosage is anticipated for patients with
renal impairment (see
Section 5.2 PHARMACOKINETIC PROPERTIES).
2
DOSAGE IN HEPATIC IMPAIRMENT
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied (see
Section
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR
USE
and
Section
5.2
PHARMACOKINETIC PROPERTIES). The use of dutasteride in patients with
severe hepatic
impairment is contraindicated.
COMBINATION USE WITH AN ALPHA BLOCKER
Implementation of the combination therapy of AVODART and an alpha
blocker requires
consideration of the combin