ISOTRETINOIN LUPIN isotretinoin 20 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isotretinoin, Quantity: 20 mg

Available from:

Southern Cross Pharma Pty Ltd

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 6, oval, soft gelatin capsules, marked 'P20'; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-12-02

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ISOTRETINOIN LUPIN
(ISOTRETINOIN) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Isotretinoin Lupin. 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 Lupin 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 LUPIN
IS USED FOR
Isotretinoin Lupin contains the
active ingredient isotretinoin.
Isotretinoin Lupin is used to treat
acne.
Isotretinoin Lupin 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
(ie. 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 Lupin is used for
more severe cases.
YOUR DOCTOR, HOWEVER, MAY
HAVE PRESCRIBED ISOTRETINOIN
LUPIN FOR ANOTHER PURPOSE.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
ISOTRETINOIN LUPIN HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
Isotretinoin Lupin is not
addictive.
BEFORE YOU TAKE
ISOTRETINOIN LUPIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ISOTRETINOIN LUPIN
IF:
1. YOU ARE PREGNANT, OR FOR
AT LEAST ONE MONTH
BEFORE YOU PLAN TO FALL
PREGNANT.
If you fall pregnant while
taking Isotretinoin Lupin
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 Isotretinoin Lupin.
3. YOU HAVE HAD AN ALLERGIC
REACTION TO ISOTRETINOIN
LUPIN, VITAMIN A, OTHER
RETINOIDS OR ANY OTHER
INGREDI

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – ISOTRETINOIN LUPIN
(ISOTRETINOIN) CAPSULES
1
NAME OF THE MEDICINE
Isotretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isotretinoin Lupin 10 mg capsules contain 10 mg isotretinoin.
Isotretinoin Lupin 20 mg capsules contain 20 mg isotretinoin.
List of 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 Lupin 10 mg capsules are soft gelatin, oval, red-orange,
size 3 capsules marked P10.
Isotretinoin Lupin 20 mg capsules are soft gelatin, oval, red-orange,
size 6 capsules 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 Lupin 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