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Roaccutane (istretinoin) consumer medicine information (cmi)

Roaccutane®
contains the active ingredient isotretinoin Consumer Medicine Information
What is in this leaflet
Your doctor, however, may have
Vibramycin®, doxycycline
prescribed ROACCUTANE for
hydrochloride, Doryx®,
another purpose.
Frakas®, Minomycin®)
Ask your doctor if you have any
5. you have severe liver disease
questions about why
6. you have very high fat levels
ROACCUTANE has been
(cholesterol, triglycerides) in
It does not take the place of talking to prescribed for you.
your blood
7. you have hypervitaminosis A
8. the packaging is torn or shows
signs of tampering
Before you take
9. the expiry date (EXP) printed
If you have any concerns about
ROACCUTANE
on the pack has passed.
taking this medicine, ask your
doctor or pharmacist.

When you must not take it
If you take this medicine after the expiry date has passed, it may not Keep this leaflet with the medicine.
Do not take ROACCUTANE if:
1. you are pregnant, or for at least
If you are not sure if you should
one month before you plan to
start taking ROACCUTANE,
fall pregnant
contact your doctor.
What ROACCUTANE
If you fall pregnant while
Do not give ROACCUTANE to
is used for
taking ROACCUTANE there is
children.
an extremely high risk of
having a baby that is severely
deformed. You must use
effective contraception for one
month before, during and one
Before you start to take it
month after treatment.
2. you are breastfeeding
You must tell your doctor if:
Breastfeeding must stop before
1. you have any allergies to any
treatment begins. Do not
other medicines, foods,
breastfeed while taking
preservatives or dyes
ROACCUTANE.
3. you have had an allergic
reaction to ROACCUTANE,
vitamin A, other retinoids or
any other ingredients of
2. you have or have had any other
ROACCUTANE (listed at the
health problems or issues
end of this leaflet)
including:
4. you are taking tetracycline
antibiotics (such as Akamin®,
How to take
ROACCUTANE
At the end of this time your acne should have cleared up significantly. How much to take
Follow all directions given to you
by your doctor or pharmacist
carefully.
3. you drink large amounts of
alcohol.
Take ROACCUTANE exactly as
If you have not told your doctor
your doctor has prescribed.
about any of the above, tell them
before you start taking
ROACCUTANE.
If you forget to take
ROACCUTANE
Taking other medicines
Do not try to make up for missed
Tell your doctor or pharmacist if
doses by taking an extra dose.
you are taking any other
medicines, including any that you
get without a prescription, from a
pharmacy, supermarket or health
If it is almost time for your next
food shop.
dose, skip the dose you missed and
How to take it
take the next dose when you are
meant to.
When to take it
If you take too much
ROACCUTANE (overdose)
Immediately telephone your
doctor, or Poisons Information
Female patients should wait until
Centre (telephone 13 11 26) for
advice, or go to Accident and
the 2nd or 3rd day of the next
Emergency at your nearest
normal menstrual period before
starting ROACCUTANE

hospital, if you think you or
treatment.
anyone else may have taken too
much ROACCUTANE. Do this
even if there are no signs of
discomfort or poisoning.
How long to take
ROACCUTANE

Continue taking ROACCUTANE
for as long as your doctor
prescribes.
Ask your doctor or pharmacist if
Keep telephone numbers for these
you are not sure about this list of
places handy.
medicines.
to 8 months. In the first few weeks of treatment your acne will probably get a little worse before it gets better. While you are taking
dose without first checking with
ROACCUTANE
your doctor.
Do not let yourself run out of
may cause dermatitis and dermabrasion may cause scarring Things you must do
medicine over the weekend or on
holidays.

If you become pregnant while
Do not give ROACCUTANE to
taking ROACCUTANE, stop
anyone else even if their symptoms
Avoid using facial peels,
taking it and tell your doctor
seem similar to yours.
electrolysis and some hair
immediately.
treatments.
Do not use ROACCUTANE to
treat other complaints unless your
doctor says to.
Do not donate blood during
treatment with ROACCUTANE or
for at least 1 month after stopping
Further Information
treatment.
Things to be careful of
Be careful driving or operating
machinery until you know how
ROACCUTANE affects you.

Tell all doctors, dentists and
pharmacists who are treating you

that you are taking
Side Effects
ROACCUTANE.
or operate machinery. However altered night vision and other visual Tell your doctor if, for any reason,
you have not taken your medicine
exactly as prescribed.
Tell your doctor if you feel
ROACCUTANE capsules are not
Wearing contact lenses during
helping your condition.
treatment with ROACCUTANE
Be sure to keep all of your
may cause discomfort.
appointments with your doctor so
that your progress can be checked.
Ask your doctor or pharmacist to
answer any questions you may
Tell your doctor if you notice any
of the following and they worry
you:

If you are intending to do a lot of
heavy lifting or exercise, tell your
Avoid excessive sun exposure and
solariums and apply a sunscreen
while taking ROACCUTANE.
Avoid waxing and dermabrasion
Things you must not do
while taking ROACCUTANE and
Do not stop taking
for 5 to 6 months after stopping
ROACCUTANE or change the
ROACCUTANE treatment.
Keep the blister pack in a cool dry
place where the temperature stays
below 25°C.
Do not store ROACCUTANE, or
any other medicine, in a bathroom
or near a sink.
Do not leave it in the car or on
window sills.
Keep ROACCUTANE where
young children cannot reach it.
Protect ROACCUTANE from
Disposal
If your doctor tells you to stop
taking ROACCUTANE, or the
capsules have passed their expiry
date, ask your pharmacist what to
do with any capsules that are left
These may be serious side effects. You may need urgent medical Product Description
Availability
Tell your doctor if you notice
anything else that is making you
feel unwell, even if it is not on this
Ask your doctor or pharmacist if
you don't understand anything in
What ROACCUTANE looks
this list.
like
After taking
ROACCUTANE
colour and has "ROA 20" printed on Storage
Keep your capsules in the blister
pack until it is time to take them.
Ingredients
large blisters and end with peeling of layers of skin, that may Active ingredient - isotretinoin
Inactive ingredients -
· soya oil · yellow beeswax · partially hydrogenated soya oil · hydrogenated soya oil. Soya oil may contain traces of arachidic acid (a component of peanut oil). · gelatin · glycerol · sorbitol · mannitol · maize starch product · titanium dioxide · iron oxide, red ROACCUTANE does not contain sucrose or gluten. Manufacturer
Please check with your pharmacist for the latest Consumer Medicine Information. ROACCUTANE 10 mg capsules - AUST R 50840 ROACCUTANE 20 mg capsules - AUST R 50839

Source: http://www.roche-australia.com/content/dam/internet/corporate/roche/en_AU/files/retinoids/roaccutane-cmi.pdf

Microsoft word - completemed1.doc

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