Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Roaccutane?
Roaccutane contains the active ingredient isotretinoin. Roaccutane is used to treat
acne. For more information, see Section
1. Why am I using Roaccutane? in the full CMI.
2. What should I know before I use Roaccutane?
Do not use if you have ever had an allergic reaction to Roaccutane or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.For more information, see Section
2. What should I know before I use Roaccutane? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Roaccutane?
Your doctor will tell you how many Roaccutane capsules to take each day, take them
exactly as your doctor has prescribed.
Roaccutane capsules should be swallowed whole with a glass of water or milk and must
always be taken with food.
5. What should I know while using Roaccutane?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Roaccutane.
Use effective contraception for one month before, during and one month after treatment.
If you become pregnant while taking Roaccutane, stop taking it and tell your doctor
immediately.
Tell your doctor if you are intending to do a lot of heavy lifting or exercise.
Your skin may be more sensitive while on Roaccutane. Avoid excessive sun exposure
and certain skin and hair treatments.
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Things you should not do
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Do not stop taking Roaccutane suddenly, change the dose or let yourself run out of
medicine over the weekend or on holidays.
Do not give Roaccutane to anyone else even if their symptoms seem similar to yours.
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 treatment.
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Driving or using machines
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Be careful driving or operating machinery until you know how Roaccutane affects you.
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Drinking alcohol
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You must tell your doctor if you drink large amounts of alcohol.
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Looking after your medicine
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Keep the blister pack in a cool dry place where the temperature stays below 25°C.
Protect Roaccutane from light.
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6. Are there any side effects?
Roaccutane helps most people with acne but it may have unwanted side effects in a
few people. Sometimes they are serious, most of the time they are not. You may need
medical treatment if you get some of the side effects. When you are using Roaccutane,
you can have some serious side effects. Serious side effects may include nausea, vomiting,
persistent headache, blurred vision or visual disturbances, changes in your hearing
or ringing in your ears, severe upper stomach pain, unexpected muscle pain, tenderness
or weakness, blood in stools or severe diarrhoea, severe bruising, sudden red or itchy
spots, painful red areas, fever and chills, aching muscles, feeling depressed with
or without suicidal thoughts and thinking, seeing or hearing things that are not real.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
isotretinoin
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Roaccutane. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Roaccutane.
Where to find information in this leaflet:
1. Why am I using Roaccutane?
Roaccutane contains the active ingredient isotretinoin. Roaccutane belongs to a group of medicines called retinoids, which are similar to
vitamin A.
Retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands
in your skin, reducing bacteria and inflammation and opening clogged pores.
Roaccutane is used to treat acne. There are many different types of medicines used
to treat acne. Roaccutane is used for more severe cases.
Your doctor, however, may have prescribed Roaccutane for another purpose.
Ask your doctor if you have any questions about why Roaccutane has been prescribed
for you.
This medicine is available only with a doctor's prescription. Roaccutane is not addictive.
2. What should I know before I use Roaccutane?
Warnings
Do not use Roaccutane if:
you are allergic to isotretinoin, have had an allergic reaction to Roaccutane, vitamin
A, other retinoids or any of the ingredients listed at the end of this leaflet. Always
check the ingredients to make sure you can use this medicine.
you are pregnant, or for at least one month before you plan to fall pregnant. If you
fall pregnant while taking Roaccutane 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.
you are breastfeeding. You must stop breastfeeding before treatment begins. Do not
breastfeed while taking Roaccutane.
you are taking tetracycline antibiotics such as doxycycline
you have severe liver disease
you have very high fat levels (cholesterol, triglycerides) in your blood
you have hypervitaminosis A. This is a condition caused by an excessive amount of
vitamin A in the diet.
the packaging is torn or shows signs of tampering
the expiry date (EXP) printed on the pack has passed. If you take this medicine after
the expiry date has passed, it may not work as well.
If you are not sure if you should start taking Roaccutane, contact your doctor.
Do not give Roaccutane to children.
Roaccutane may be associated with slowing of growth when used in children before puberty.
The use of Roaccutane in children less than 12 years of age is not recommended.
Check with your doctor if you:
you drink large amounts of alcohol
you have any allergies to any other medicines, foods, preservatives or dyes. Roaccutane
capsules contain soya oil, which may contain traces of arachidic acid (a component
of peanut oil).
you have or have had any other health problems or issues including:
diabetes, or a history of diabetes in your family
depression
liver disease
kidney disease
lipid (cholesterol or triglyceride) disorder
hormone disorder
eye disorders
stomach or bowel disease
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
If you become pregnant while taking Roaccutane, stop taking it and tell your doctor
immediately.
Roaccutane can cause birth defects (damage to unborn babies). You must use strict
birth control, starting at least 1 month before you begin taking Roaccutane, for the
whole time you are taking Roaccutane and for 1 month after you finish taking Roaccutane.
There is no known risk to males who wish to father children.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Roaccutane and affect how it works. These include:
tetracycline antibiotics such as Doxycycline
vitamin A, or preparations containing vitamin A (including vitamin supplements)
other medicines you are using to treat your acne
the "mini-pill", a progestogen-only oral contraceptive pill
These medicines may be affected by Roaccutane or may affect how well it works. You
may need to take different amounts of your medicine, or you may need to take different
medicines. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Roaccutane.
4. How do I use Roaccutane?
How much to take
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Take Roaccutane exactly as your doctor has prescribed.
Your doctor will tell you how many Roaccutane capsules to take each day.
The dose will be calculated to suit your individual needs and your body weight. This
dose may be adjusted during treatment when your doctor knows how you respond to Roaccutane.
When to take Roaccutane
Roaccutane may be taken once or twice a day and must always be taken with food.
Female patients should wait until the 2nd or 3rd day of the next normal menstrual
period before starting Roaccutane treatment. This helps ensure that you aren't pregnant
before you start taking Roaccutane.
How to take Roaccutane
Capsules should be swallowed whole with a glass of water or milk.
Do not open the capsules and do not take any capsules that are damaged.
How long to take Roaccutane
Continue taking Roaccutane for as long as your doctor prescribes.
Acne treatment with Roaccutane will usually last 4 to 8 months. In the first few weeks
of treatment your acne may get a little worse before it gets better. This is a sign
that Roaccutane is working.
At the end of this time your acne should have cleared up significantly. Most patients
notice their skin condition continues to improve even after Roaccutane treatment is
finished.
Please note that Roaccutane cannot improve scars or pitting that were present before
treatment started, but it will help prevent such skin damage in the future.
If you forget to use Roaccutane
Roaccutane should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of getting an unwanted side effect.
If you have missed several doses, please inform your doctor and follow the advice
given to you.
If you take too much Roaccutane (overdose)
If you think that you have used too much Roaccutane, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Signs of overdose include transient headache; vomiting; facial flushing; reddened,
cracked lips; stomach pain; headache; dizziness and unsteady walking.
5. What should I know while using Roaccutane?
Call your doctor straight away if you become pregnant while taking Roaccutane, stop
taking it and tell your doctor immediately.
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Roaccutane.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Tell your doctor if you feel Roaccutane capsules are not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked. Your doctor may ask you to have regular blood tests to monitor your liver
function, blood sugar levels and blood cholesterol levels.
If you are intending to do a lot of heavy lifting or exercise, tell your doctor. Your
muscles and joints may be more prone to tenderness or stiffness if you do a lot of
heavy exercise while taking Roaccutane.
If you experience dryness of the lips, mouth, nose or skin, you can use a moisturiser
or petroleum jelly to soften the areas not affected by the acne.
Talk to your doctor if you experience persistent pain in your lower back or buttocks
during treatment with Roaccutane. These symptoms may be signs of sacroiliitis, a type
of inflammatory back pain. Your doctor may discontinue treatment with Roaccutane and
refer you to a specialist for treatment of inflammatory back pain. Further evaluation
may be needed including imaging modalities such as MRI.
Things you should not do
Do not stop taking Roaccutane suddenly or change the dose without first checking with
your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give Roaccutane to anyone else even if their symptoms seem similar to yours.
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 treatment.
Things to be careful of
Wearing contact lenses during treatment with Roaccutane may cause discomfort. Roaccutane
may cause dry eyes. An eye lubricant or artificial tears, available from your pharmacist,
should relieve this problem. Otherwise, you may temporarily need to wear your lenses
for shorter periods or wear glasses instead.
Avoid excessive sun exposure and solariums and apply sunscreen whilst taking Roaccutane.
Your skin may be more prone to sunburn while on Roaccutane.
Avoid waxing and dermabrasion whilst taking Roaccutane and for 5 to 6 months after
stopping Roaccutane treatment. Your skin may be more sensitive while on Roaccutane.
Waxing may cause dermatitis and dermabrasion may cause scarring during and for several
months after Roaccutane treatment.
Avoid using facial peels, electrolysis and some hair treatments. Your skin and hair
may be more delicate during treatment and for a while after Roaccutane treatment.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Roaccutane
affects you.
Normally Roaccutane would not affect your ability to drive a car or operate machinery.
However, altered night vision and other visual disturbances may occur when taking
Roaccutane. Make sure you know how you react to Roaccutane before you drive a car,
operate machinery or do anything else that may be dangerous if your vision is affected.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your capsules in the blister pack until it is time to take them. If you take
the capsules out of the packaging they will not keep as well.
Store it in a cool dry place where the temperature stays below 25°C, away from moisture,
heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep Roaccutane where young children cannot reach it.
When to discard your medicine
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 over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Symptoms associated with an excess of Vitamin A in the body (hypervitaminosis A):
dryness of the lips, mouth, nose and skin
peeling palms of the hands and soles of the feet
eye problems such as dry, sore, swollen or itchy eyes, discharge or trouble seeing
at night
hoarseness
nosebleeds
Symptoms associated with skin and appendage disorders:
fragile skin
change in colour of the skin
itchy skin rash
an increased susceptibility to sunburn
flaring of acne, usually at the start of treatment
sweating
changes to the nails
hair loss (sometimes occurs and is usually temporary but in rare cases has persisted)
excessive hairiness
Symptoms associated with musculoskeletal system disorders:
tenderness or stiffness in your bones, joints or muscles
muscle or joint pain
Symptoms associated the with central nervous system:
headache
tiredness
Symptoms associated with renal and urinary disorders:
inflammation of the urethra
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with an authorised doctor's prescription.
What Roaccutane contains
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Active ingredient
(main ingredient)
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isotretinoin
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Other ingredients
(inactive ingredients)
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Capsule Filling
soya oil
yellow beeswax
partially hydrogenated soya oil
hydrogenated soya oil
Capsule Shell
gelatin
glycerol
sorbitol
mannitol
maize starch product
titanium dioxide
iron oxide, red
Printing Ink
shellac
iron oxide, black.
Roaccutane does not contain sucrose or gluten.
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Potential allergens
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Soya oil may contain traces of arachidic acid (a component of peanut oil)
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Do not take this medicine if you are allergic to any of these ingredients.
Roaccutane is available as a 20 mg capsule in a pack of 60 capsules.
What Roaccutane looks like
Roaccutane 20 mg capsule is soft, oval, half brown-red and half opaque white in colour
and has "ROA 20" printed on it.
Who distributes Roaccutane
Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30-34 Hickson Road
Sydney, NSW 2000
Medical enquiries: 1800 233 950
This leaflet was prepared in April 2024.