ISOTRETINOIN Gx isotretinoin10mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isotretinoin, Quantity: 10 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Isotretinoin

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: Soya Oil; yellow beeswax; hydrogenated soya oil; partially hydrogenated soya oil; Gelatin; glycerol; titanium dioxide; iron oxide red; iron oxide yellow; propylene glycol; brilliant blue FCF; ethanol; purified water; Shellac; strong ammonia solution

Administration route:

Oral

Units in package:

60 capsule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of severe cystic acne. A single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

Product summary:

Visual Identification: red-orange, size 3, oval, soft gelatin capsules, marked 'P10'; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-07-27

Patient Information leaflet

________________________________________________________________________________
C: Products/Isotretinoin/Isotretinoin Gx/CMI
Page
1 of 4
ISOTRETINOIN GX
_contains the active ingredient isotretinoin_
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some common
questions about Isotretinoin Gx
capsules. 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 Isotretinoin Gx capsules
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 Isotretinoin Gx is
used for
Isotretinoin Gx contains the active
ingredient isotretinoin.
Isotretinoin Gx is used to treat acne.
Isotretinoin Gx belongs to a group of
medicines called retinoids, which are
similar to vitamin A.
The retinoids work by reducing the
amount of the oily substance (i.e.
sebum) made by glands in your skin,
reducing bacteria, reducing
inflammation and opening clogged
pores.
There are many different types of
medicines used to treat acne.
Isotretinoin Gx is used for more severe
cases.
YOUR DOCTOR, HOWEVER, MAY HAVE
PRESCRIBED ISOTRETINOIN GX FOR
ANOTHER PURPOSE.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ISOTRETINOIN GX
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a
doctor's prescription.
Isotretinoin Gx is not addictive.
Before you take it
_When you must not take it _
DO NOT TAKE ISOTRETINOIN GX IF:
1.
YOU ARE PREGNANT, OR FOR AT
LEAST ONE MONTH BEFORE YOU
PLAN TO FALL PREGNANT
If you fall pregnant while
taking Isotretinoin Gx there is
an extremely high risk of
having a baby that is severely
deformed. You must use
effective contraception for one
month before, during and one
month after treatment.
2.
YOU ARE BREASTFEEDING
Breastfeeding must stop before
treatment begins. Do not
breastfeed while taking
I

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ISOTRETINOIN GX (ISOTRETINOIN) CAPSULES
1
NAME OF THE MEDICINE
Isotretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isotretinoin Gx 10 mg capsules contain 10 mg Isotretinoin.
Isotretinoin Gx 20 mg capsules contain 20 mg Isotretinoin.
Excipients with Known effect:
Contains Soya oil, hydrogenated soya oil and partially hydrogenated
soya oil.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ISOTRETINOIN Gx 10 mg Capsules is a soft gelatin, oval (red-orange,
size 3) marked P10;
ISOTRETINOIN Gx 20 mg Capsules is a soft gelatin, oval (red-orange,
size 6) marked P20
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Treatment of severe cystic acne: A single course of therapy has been
shown to result in complete and
prolonged remission of disease in many patients. If a second course of
therapy is needed, it should
not be initiated until at least eight weeks after completion of the
first course, since experience has
shown that patients may continue to improve while off the drug.
Because of significant adverse effects associated with its use,
isotretinoin should be reserved for
patients with severe cystic acne who are unresponsive to conventional
therapy, including systemic
antibiotics.
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
The therapeutic response to isotretinoin is dose related and varies
between patients. This necessitates
individual adjustment of dosage according to the response of the
condition and the patient's tolerance
of the drug. In most cases complete or near complete suppression of
acne is achieved with a 16 week
course of treatment.
All patients should initially receive ISOTRETINOIN Gx at doses up to
0.5 mg/kg/day bodyweight daily
for a period of two to four weeks, when their responsiveness to the
drug will usually be apparent. It
should be noted that transient exacerbation of acne is occasionally
seen during this initial period.
Satisfactory initial responses have been reported from 0.05 mg/kg/day.
Relapse rates on the lower
doses are