ORATANE isotretinoin 10mg capsule

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

isotretinoin, Quantity: 10 mg

Fáanlegur frá:

Douglas Pharmaceuticals Australia Pty Ltd

Lyfjaform:

Capsule, soft

Samsetning:

Excipient Ingredients: Gelatin; Soya Oil; sorbitol solution (70 per cent) (non-crystallising); yellow beeswax; brilliant scarlet 4R; dl-alpha-tocopherol; disodium edetate; purified water; glycerol; butylated hydroxyanisole; iron oxide black; titanium dioxide; partially hydrogenated soya oil; hydrogenated vegetable oil

Stjórnsýsluleið:

Oral

Einingar í pakka:

30 capsules, 15 capsules, 60 capsules, 90 capsules

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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.

Vörulýsing:

Visual Identification: Light violet coloured oblong soft gelatin capsules, containing a yellow-orange opaque viscous liquid; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2001-02-12

Upplýsingar fylgiseðill

ORATANE
®
Consumer Medicine Information
Isotretinoin 5mg, 10mg, 20mg, 30mg and 40mg capsules
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about ORATANE

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
ORATANE

capsules against the benefits the medicine is expected to 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 ORATANE
®
USED FOR
The active ingredient in ORATANE
 capsules is isotretinoin, a substance very similar to vitamin
A.
ORATANE

belongs to a group of medicines called retinoids.
ORATANE

_ _capsules are used to treat acne. Of the many acne medicines,
ORATANE

_ _is used
for more severe cases.
ORATANE

capsules work by cutting down the amount of oily substances (sebum)
made by
glands in your skin. ORATANE

capsules will also help to reduce bacteria, inflammation and
open clogged pores.
YOUR DOCTOR MAY HAVE PRESCRIBED ORATANE
 CAPSULES FOR ANOTHER PURPOSE.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ORATANE
 CAPSULES HAVE BEEN
PRESCRIBED FOR YOU.
ORATANE

capsules are not addictive.
BEFORE YOU TAKE ORATANE
®
_ _
_WHEN YOU MUST NOT TAKE ORATANE_

_ CAPSULES _
Do not take ORATANE

capsules if:
1.
YOU ARE PREGNANT OR FOR AT LEAST ONE MONTH BEFORE YOU INTEND TO BECOME
PREGNANT.
If you fall pregnant while taking Oratane

Capsules, there is an extremely high risk of having a
baby that is severely deformed. This means that you must use effective
contraception for one
month before, during and one month after treatment with Oratane

Capsules.
2.
YOU ARE BREASTFEEDING
.
Breastfeeding must stop before Oratane

treatment can start. Do not breastfeed while taking
Oratane

Capsules.
3.
YOU
HAVE
HAD
AN
ALLERGIC
REACTION
TO
ORATANE

_ _

Vara einkenni

1
AUSTRALIAN PRODUCT INFORMATION – ORATANE (ISOTRETINOIN)
SOFT CAPSULES
1
NAME OF THE MEDICINE
Isotretinoin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oratane® capsules contain either 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg
of isotretinoin.
Isotretinoin is related to both retinoic acid and retinol (Vitamin A).
Isotretinoin is a yellow - orange to
orange crystalline powder that is practically insoluble in water,
soluble in methylene chloride,
sparingly soluble in ether and slightly soluble in alcohol. It is
sensitive to air, heat and light, especially
in solution.
Excipients with known effect: soy bean oil
For full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Oratane

5
mg
capsules
are
soft,
oval,
faint
pinkish/cream
to
cream
in
colour
containing
a
yellow/orange liquid.
Oratane

10 mg capsules are light violet coloured soft capsules containing a
yellow/orange viscous
liquid.
Oratane

20 mg capsules are maroon coloured soft capsules containing a
yellow/orange viscous liquid.
Oratane

30 mg capsules are pink coloured soft capsules containing a
yellow/orange viscous liquid.
Oratane

40 mg capsules are orange coloured soft capsules containing a
yellow/orange viscous liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oratane

is indicated for the treatment of severe cystic acne and 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
2
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
D
OSE AND METHOD OF ADMINISTRATION
The therapeutic response to isotretinoin is dose related and varies
between patients. This necessitates
in