Apo-Modafinil

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

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 pharmacist.
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 modafinil.
It is used:
to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy
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 symptoms.
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
abnormal/irregular heart
rhythm
kidney or liver problems

3. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant.

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 involved.

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 shop.

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 different medicines.
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 your doctor

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 as either:
two separate doses, one in the morning and one at midday
OR
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 hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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 this medicine.

Things you must not do

Do not:
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 doctor.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.
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:
nausea
diarrhoea
dry mouth
poor appetite
runny nose
sore throat
nervous feeling
dizziness
back pain
feeling anxious
upset stomach
indigestion
trouble sleeping
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
dark urine.
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 hospital.
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
swelling
Other side effects not listed above may occur in some patients.

Allergic reactions

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
fainting
hay fever-like symptoms.

Storage and disposal

Storage

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 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.

Disposal

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.

Product description

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.

Ingredients

Each tablet contains 100 mg of modafinil as the active ingredient.
It also contains the following inactive ingredients:
Methylcellulose
Croscarmellose sodium
Magnesium stearate
Silica-colloidal anhydrous
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.

Sponsor

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:
March 2017.