APO-ISOTRETINOIN isotretinoin 20mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

isotretinoin, Quantity: 20 mg

Available from:

Arrotex Pharmaceuticals 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 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:

Licence status A

Authorization date:

2011-12-15

Patient Information leaflet

APO-ISOTRETINOIN
1
APO-ISOTRETINOIN
_Isotretinoin _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about isotretinoin. 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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Isotretinoin is used to treat severe
acne, where other treatments have
not worked.
It belongs to a group of medicines
called retinoids, which are like
Vitamin A.
_HOW IT WORKS _
Isotretinoin works by reducing the
amount of the oil (sebum) made by
glands in your skin. It also reduces
bacteria and inflammation and helps
to open clogged pores.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
isotretinoin
•
vitamin A
•
other retinoids
•
soya
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT, OR FOR AT LEAST ONE
MONTH BEFORE YOU PLAN TO FALL
PREGNANT.
If you fall pregnant while taking this
medicine, there is an extremely high
risk of having a baby that is severely

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-ISOTRETINOIN (ISOTRETINOIN) CAPSULES
1
NAME OF THE MEDICINE
Isotretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg or 20 mg of isotretinoin as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Sulfites, phenylalanine, and soy bean products
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-ISOTRETINOIN 10 MG CAPSULE
Red-orange, size 3, oval, soft gelatin capsules marked P10.
APO-ISOTRETINOIN 20 MG CAPSULE
Red-orange, size 6, oval, soft gelatin capsules marked P20.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Isotretinoin is indicated for the 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.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Isotretinoin capsules are intended for oral administration.
DOSAGE
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 doses up to 0.5 mg/kg 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 the transient exacerbation of acne is occasionally seen
during this initial period.
Satisfactory initial responses have been reported from 0.05 mg/kg/day.
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