Contains the active ingredient modafinil
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about modafinil. It does not contain all
the available information. It does not take the place of talking to your doctor or
The information in this leaflet was last updated on the date listed on the last page.
More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
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.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is APO-MODAFINIL tablets. It contains the active ingredient
It is used:
to improve wakefulness in patients with excessive daytime sleepiness associated with
to treat excessive sleepiness associated with moderate to severe chronic shift work
sleep disorder (SWSD), where non-drug therapies have been inappropriate or unsuccessful.
as an adjunct to continuous positive airways pressure (CPAP) in obstructive sleep
apnoea/hypopnoea syndrome (OSAHS) in order to improve wakefulness.
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.
How it works
Precisely how this medicine works is not known, but it is known that it acts on the
central nervous system (the brain). It differs from other stimulant medicines that
promote wakefulness. This medicine increases wakefulness.
There is no evidence that this medicine is addictive.
Use in children
This medicine should not be used in children.
Before you take this medicine
When you must not take it
Do not take this medicine if:
You are pregnant.
You are hypersensitive to, or have had an allergic reaction to, modafinil or any of
the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing,
difficulty breathing or tightness in chest; swelling of the face, lips, tongue, throat
or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like
If you think you are having an allergic reaction, do not take any more of the medicine
and contact your doctor immediately or go to the Accident and Emergency department
at the nearest hospital.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
are under 18 or over 65 years old
history of mental health problems for e.g. depression, anxiety, bipolar disorder etc.
heart problems, including angina(chest pain), previous heart attack, enlarged heart
kidney or liver problems
3. You are currently pregnant or you plan to become pregnant. Do not take this medicine
4. You are currently breastfeeding or you plan to breast-feed. Do not take this medicine
whilst breastfeeding until you and your doctor have discussed the risks and benefits
5. You are planning to have surgery or an anaesthetic.
6. You are currently receiving or are planning to receive dental treatment.
7. You are taking or are planning to take any other medicines. This includes vitamins
and supplements that are available from your pharmacy, supermarket or health food
Taking other medicines
Some medicines may interact with modafinil. These include:
the contraceptive pill
brain stimulants, such as methylphenidate
medicines used to treat depression, including monoamine oxidase inhibitors
medicines to treat epilepsy, such as phenytoin, carbazepine, phenobarbitone
medicines to treat fungal infections, such as ketoconazole and itraconazole
rifampicin, an antibiotic used to treat tuberculosis
cyclosporin, a medicine used to treat organ transplant rejection
propranolol, a medicine used to treat high blood pressure or heart failure.
warfarin, a medicine used to prevent blood clotting
theophylline, a medicine used to treat asthma and lung problems
If you are taking any of these you may need a different dose or you may need to take
Other medicines not listed above may also interact with modafinil.
How to take this medicine
Follow carefully all directions given to you by your doctor. Their instructions may
be different to the information in this leaflet.
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend
on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with
How to take it
Swallow modafinil tablets whole with a glass of water.
It does not matter if you take it before, with or after food.
When to take it
For sleepiness associated with narcolepsy or OSAHS, you should take modafinil tablets
two separate doses, one in the morning and one at midday
one dose, in the morning.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
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 missed dose 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 missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately
telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia)
for advice. Alternatively, go to the Accident and Emergency department at your nearest
Do this even if there are no signs of discomfort or poisoning. You may need urgent
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breastfeeding or are planning to breast-feed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to
prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Things you must not do
Give this medicine to anyone else, even if their symptoms seem similar to yours.
Take your medicine to treat any other condition unless your doctor tells you to.
Stop taking your medicine, or change the dosage, without first checking with your
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects
This medicine may cause dizziness in some people.
Possible side effects
Tell your doctor as soon as possible if you do not feel well while you are taking
modafinil or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any
of them. All medicines can have side effects. Sometimes they are serious but most
of the time they are not.
Tell your doctor if you notice any of the following:
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
yellowing of the skin or white of the eyes
mental (psychiatric) symptoms. including depression, anxiety, aggression, agitation,
irritability, hallucinations, mania, thoughts of suicide or other mental problems.
chest pain or abnormal heart beats
fits or convulsions
If you experience any of the following, stop taking your medicine and contact your
doctor immediately or go to the Accident and Emergency department at your nearest
These are very serious side effects and you may need urgent medical attention or hospitalisation:
fever, skin rash ,or hives(especially affecting the whole body)
sores in your mouth, or your skin blisters and peels
sudden wheeziness, difficulty in breathing and swallowing
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to modanifil, do not take any more
of this medicine and tell your doctor immediately or go to the Accident and Emergency
department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing, difficulty breathing or tightness in chest
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
hay fever-like symptoms.
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
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
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 it has passed its expiry
date, your pharmacist can dispose of the remaining medicine safely.
What APO-MODAFINIL Tablets look like
100 mg tablet: White, round, biconvex tablets. Engraved "MOD" over "100" on one side,
"APO" on the other side.
Available in Blister Pack (PVD/PVDC/Al blister) of 30's and 60's tablets
* Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 100 mg of modafinil as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free
of other azo dyes.
Australian Registration Numbers
APO-Modafinil 100 mg tablet blister pack : AUST R 276420.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was last updated in: