APO-Dutasteride dutasteride 500 microgram soft capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dutasteride, Quantity: 500 microgram

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Dutasteride

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: titanium dioxide; Gelatin; glycerol; iron oxide yellow; butylated hydroxytoluene; glyceryl caprylate/caprate; propylene glycol; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This medicine 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.

Product summary:

Visual Identification: An oily colourless to pale yellow liquid absent of visible particles and/or crystals in a pale yellow oblong gelatin capsule printed with with 'A 0.5' on one side in red ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-02-28

Patient Information leaflet

APO-DUTASTERIDE SOFT CAPSULES
1
APO-DUTASTERIDE
_Contains the active ingredient dutasteride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about dutasteride. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
DUTASTERIDE Soft Capsules. It
contains the active ingredient
dutasteride.
This medicine 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

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO- DUTASTERIDE (DUTASTERIDE) SOFT CAPSULES
1
NAME OF THE MEDICINE
Dutasteride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 500 µg of dutasteride as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-DUTASTERIDE 500 ΜG SOFT GEL CAPSULES
An oily colourless to pale yellow liquid absent of visible particles
and/or crystals in a pale yellow
oblong gelatin capsule printed with 'A 0.5' on one side in red ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dutasteride 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
APO- DUTASTERIDE 500 µg soft gel capsules are intended for oral
administration.
DOSAGE
Dutasteride can be administered alone or in combination with an alpha
blocker.
ADULT MALES (INCLUDING ELDERLY):
The recommended dose is one 500 µg 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. Dutasteride 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.
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
HEPATIC IMPAIRMENT
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied (see
sections
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR
USE
and
5.2
PHARMA