Consumer Medicine Information
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
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
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:
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 deformed. You must use effective contraception for
one month before, during and one month after treatment.
Do not take this medicine if you are breastfeeding.
This medicine passes into breast milk and your baby may be affected.
Do not take this medicine if you are taking tetracycline antibiotics (e.g. doxycycline,
Do not take this medicine if you have the following medical conditions:
severe liver disease
very high fat levels (cholesterol, triglycerides) in your blood
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
If you have a peanut allergy, discuss with your doctor the risks and benefits of taking
Some people who are allergic to peanuts may also be allergic to the soya oil in these
In addition, the soya oil in this product is manufactured in a facility which produces
other products containing peanut oil. It cannot be guaranteed that this product does
not contain traces of peanut oil.
Tell your doctor if you have or have had any of the following medical conditions:
diabetes or a family history of diabetes
high fat (lipid) levels or a family history of lipid disorders
stomach or bowel disease
excessive body weight or a family history of obesity
depression or a history of depression
Tell your doctor if you drink large amounts of alcohol or you smoke.
If you have not told your doctor about any of the above, tell them before you start
taking this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines may interact with isotretinoin. These include:
tetracycline antibiotics (e.g. doxycycline, minocycline)
vitamin A, or preparations containing vitamin A
other acne treatments (e.g. strong creams, ointments or gels)
the 'mini-pill', a progestogen-only oral contraceptive pill
contraceptives containing norethisterone or norethisterone acetate
phenytoin, used to treat epilepsy
oral or injectable corticosteroids
These medicines may be affected by this medicine or may affect how well it works.
You may need different amounts of your medicines, or you may need to take different
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Other medicines not listed above may also interact with isotretinoin.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
How much to take
Your doctor will tell you how much of this medicine you should take, depending on
your body weight and how well you respond to isotretinoin.
How to take it
Swallow the capsules whole with a glass of water or milk.
Do not open the capsules or take any capsules that are damaged.
When to take it
Take this medicine at about the same time each day, either once or twice a day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
Isotretinoin must always be taken with food.
Female patients should wait until the 2nd or 3rd day of the next normal menstrual
period before starting isotretinoin therapy.
This helps ensure that you aren't pregnant before you start taking isotretinoin.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
Isotretinoin treatment usually lasts around four months. In some cases a second course
may be needed, usually with a gap of two months between courses.
In the first few weeks of treatment your acne may worsen, but this will usually stop
within seven to ten days. This is a sign that isotretinoin is working.
At the end of the course your acne should have cleared up significantly. Most patients
notice their skin condition continues to improve even after isotretinoin treatment
is finished. Isotretinoin cannot improve scars or pitting that were present before
treatment started, but it will help prevent future skin damage.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your
next dose at the usual time.
Otherwise, take it as soon as you remember and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice or go to Accident and Emergency at your nearest hospital if you
think that you or anyone else may have taken too much of this medicine. Do this even
if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much isotretinoin you may experience a severe but short-lived headache,
nausea, vomiting, facial flushing, reddened lips, stomach pain, drowsiness, irritability,
itching, dizziness or unsteady walking.
For one month following an overdose:
you must not donate blood
females must not become pregnant
males must not father a child, as there is a chance that isotretinoin may be present
in higher levels in semen.
While you are taking this medicine
Things you must do
If you become pregnant while taking isotretinoin, stop taking it and tell your doctor
Isotretinoin causes birth defects in females taking isotretinoin.
You must use strict birth control for at least 1 month before, during and for 1 month
after taking isotretinoin.
There is no known risk to males who wish to father children (except after overdosing;
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Tell your doctor if you are about to have any blood tests.
Tell your doctor if you are planning to do a lot of vigorous exercise while taking
Your muscles and joints may be more prone to tenderness or stiffness if you do a lot
Tell your doctor if you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may occasionally do tests to make sure the medicine is working and to
prevent side effects.
Things you must not do
Do not give this medicine to anyone else, even if they have the same condition as
Do not take your medicine to treat any other complaint unless your doctor tells you
Do not stop taking your medicine or change the dosage without first checking with
Do not donate blood during treatment with isotretinoin or for at least four weeks
after stopping treatment.
Things to be careful of
Tell your doctor if your skin condition does not improve within one to two months
of starting this medicine, or if your skin irritation becomes severe.
During the first three weeks of taking isotretinoin, your skin may become irritated.
Your acne may seem to get worse before it gets better.
Full improvement continues after you stop taking isotretinoin and may take up to six
If you develop any new skin rash (e.g. redness, hives, spots, blisters or flaking
skin) during isotretinoin treatment, contact your doctor immediately.
There have been reports of skin rash associated with this medicine. Some of these
rashes may be serious and can cause severe illness. These serious rashes may be accompanied
or preceded by flu-like symptoms.
Isotretinoin may cause hearing problems in one or both ears (ringing in the ears,
unable to hear certain sounds, deafness).
This may occur during or after finishing a course of isotretinoin. No more isotretinoin
should be taken, and medical attention sought immediately.
Isotretinoin may cause bowel problems. Contact your doctor immediately if you have
severe stomach pains, bleeding from the rectum or bloody diarrhoea.
Isotretinoin may cause dryness of the mouth and nose.
For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice
in your mouth, or use a saliva substitute. However, if dry mouth continues for more
than two weeks, check with your doctor or dentist. Continuing dryness of the mouth
may increase the chance of dental disease, including tooth decay and gum disease.
Moisturiser or petroleum jelly can be used to soften the lining of the nose, lips
and the skin areas not affected by acne.
Isotretinoin may cause mood or behaviour problems, including having thoughts about
self-harm or suicide. Tell your doctor immediately if unusual mood or behaviour problems
Symptoms of depression may include:
feeling sad, having crying spells
losing interest in activities you once enjoyed
sleeping too much or having trouble sleeping
changes in appetite or body weight
having trouble concentrating
withdrawing from friends or family
feeling like you have no energy
feelings of worthlessness or inappropriate guilt.
Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain
or stiffness, or difficulty moving. Tell your doctor if these problems are bothersome.
Your doctor will monitor you for signs of raised lipid (fat) levels in your blood.
You may be able to manage these with diet, weight loss, restricting alcohol intake
and stopping smoking. Tell your doctor straight away if you have severe pains in your
This medicine may affect blood sugar levels.
Tell your doctor if you have diabetes and you notice a change in the results of blood
or urine sugar tests.
Isotretinoin may cause dry eyes.
Wearing contact lenses during treatment with isotretinoin may cause discomfort. You
may temporarily need to wear your lenses for shorter periods or wear glasses instead.
An eye lubricant or artificial tears, available from your pharmacist, should relieve
this problem. Make sure your doctor or eye specialist know if you have dry eyes, so
they can monitor you.
Eye infections, inflammation and hazy vision may also occur and should be monitored
closely by your doctor and eye specialist.
Your skin will be more prone to sunburn, dryness, or irritation, especially during
the first two or three weeks of treatment. It is advised to:
avoid excessive exposure to the sun, UV, sunlamp or solarium, wind or cold weather
use sunscreen with at least SPF15
wear protective clothing and hats
use skin moisturiser and lip balm
Avoid waxing, dermabrasion and laser treatment while taking isotretinoin and for five
to six months after stopping isotretinoin.
Your skin may be more sensitive while on isotretinoin. Waxing may cause dermatitis
and dermabrasion may lift the skin's surface and cause scarring during and for several
months after isotretinoin therapy.
Avoid using facial peels, electrolysis and some hair treatments.
Your skin and hair may be more delicate during treatment and for a while after taking
isotretinoin. Using mild creams and ointments may help.
Be careful driving or operating machinery until you know how this medicine affects
Isotretinoin usually does not affect your ability to drive a car or operate machinery.
However, altered night vision and other visual disturbances may occur when taking
isotretinoin. Some people may also feel drowsy or dizzy. Make sure you know how you
react to isotretinoin before you drive a car, operate machinery or do anything else
that may be dangerous.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking isotretinoin.
This medicine helps most people with severe acne but may have unwanted side effects
in some people. All medicines can have side effects. Sometimes they are serious, most
of the time they are not. You may need medical attention if you get some of the side
Do not be alarmed by the following list of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
dry lips (scaling, redness, burning, pain or other signs of inflammation), mouth,
nose and skin (including rash)
peeling palms of the hands and soles of the feet
nail infection or inflammation
dry throat or hoarse voice
infections e.g. cold sores
muscle, back or tendon pain or stiffness
bleeding or red, swollen gums
feeling lethargic, tired or having no energy
feeling dizzy, drowsy or nervous
feeling sick (nausea)
itchy skin, bruising, mild rash or peeling, change in skin colour
an increased chance of sunburn
initial worsening of acne
hair loss (usually temporary but has persisted in rare cases)
changes in hair growth.
The above list includes the more common side effects. Mostly, these are mild.
Tell your doctor as soon as possible if you notice any of the following:
eye problems (burning, redness, itching or other signs of eye inflammation or infection);
problems wearing contact lenses
loss of appetite, dark urine, pale stools, yellowing of the skin or eyes (jaundice),
bleeding or bruising more easily than normal (signs of liver disease)
bloody or cloudy urine
swollen or itchy veins
frequent infections, fever, severe chills, sore throat or mouth ulcers
tenderness or stiffness in your bones or joints, fractures
blurred or unusual vision
a change in your blood glucose levels, especially if you are diabetic
wounds not healing properly
The above list includes serious side effects. You may need medical attention.
If you experience any of the following, stop taking your medicine and contact your
doctor immediately or go to Accident and Emergency at your nearest hospital:
shortness of breath, wheezing or difficulty breathing; swelling of the face, lips,
tongue, throat or other parts of the body; muscle pain or tenderness or joint pain
or rash, itching or hives on the skin (signs of an allergic reaction)
severe skin reactions with painful red areas, large blisters, peeling of skin layers;
fever, chills, aching muscles, feeling unwell (signs of erythema multiforme, Stevens-Johnson
Syndrome or toxic epidermal necrolysis)
severe diarrhoea, rectal bleeding, black, bloody or tarry stools
severe pain in your upper stomach spreading to your back, nausea, vomiting, fast heart
brown or dark coloured urine, with severe muscle aching and weakness (signs of muscle
sudden and severe headache or pain behind your eyes, nausea, vomiting
hearing problems, hearing loss, or ringing in your ears
psychosis, hallucinations (thinking, seeing or hearing things that are not there)
feeling anxious or agitated, or acting aggressively
fast or unusual heart rate, fainting
feeling unable to think and judge clearly
changing emotions or mood, including crying, self-harm, thoughts of suicide, attempting
feeling depressed, with or without suicidal thoughts
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Storage and disposal
Keep your medicine in the pack until it is time to take it.
If you take your medicine out of the pack it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C. Protect
this medicine from light and moisture.
Do not store your medicine or any other medicine in the bathroom or near a sink. Do
not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine leftover.
What it looks like
10 mg capsules: Red-orange, size 3, oval, soft gelatin capsules marked P10. AUST R
20 mg capsules: Red-orange, size 6, oval, soft gelatin capsules marked P20. AUST R
Available in blister strips of 60 capsules.
* Not all strengths may be available.
Each capsule contains 10 mg or 20 mg of isotretinoin as the active ingredient.
It also contains the following:
beeswax - yellow
soya oil - hydrogenated and partially hydrogenated
ferrous oxide red
ferrous oxide yellow
brilliant blue FCF
This medicine does not contain gluten, lactose, sucrose, tartrazine or any other azo
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was prepared in January 2019.