What MODAVIGIL is used for
MODAVIGIL is used to improve wakefulness in people with excessive daytime sleepiness
associated with the medical condition known as narcolepsy or with Obstructive Sleep
Apnoea/Hypopnoea Syndrome (OSAHS), or shift work sleep disorder (SWSD).
In narcolepsy, there is a sudden and irresistible tendency to fall asleep during normal
waking hours. This happens at unpredictable times, even when it is inappropriate or
may be unsafe to do so. MODAVIGIL decreases this unwanted excessive daytime sleepiness.
With OSAHS, daytime sleepiness may occur due to an interrupted night time sleep. MODAVIGIL
only treats the symptom of sleepiness and does not treat the cause of OSAHS. Whilst
taking MODAVIGIL you should continue with treatments intended to help manage your
underlying medical condition, such as Continuous Positive Airway Pressure, unless
your doctor tells you otherwise.
If you have been diagnosed with moderate to severe chronic Shift Work Sleep Disorder
(SWSD) and non-drug therapies have been unsuitable or unsuccessful, MODAVIGIL may
be prescribed to keep you awake during your work shift.
Precisely how MODAVIGIL 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. MODAVIGIL increases wakefulness.
Your doctor may have prescribed MODAVIGIL for another reason. Ask your doctor if you
have any questions about why MODAVIGIL has been prescribed for you.
Before you take MODAVIGIL
When you must not take it
You must not take MODAVIGIL if you:
are allergic to modafinil or any of the other ingredients listed at the end of this
leaflet. (See "MODAVIGIL tablets description"). Signs of allergic reaction may include
a skin rash, itching, shortness of breath or swelling of the face, lips or tongue
are pregnant currently, planning to become pregnant or likely to become pregnant or
are breastfeeding.
If you could become pregnant, you should confirm by a pregnancy test that you are
not pregnant within a week prior to starting treatment.
Modafinil is suspected to cause birth defects if taken during pregnancy.
Do not take MODAVIGIL if the packaging is torn or shows signs of tampering or the
tablets do not look quite right.
Do not take MODAVIGIL if the expiry date on the pack has passed.
If you are not sure about whether you should start taking MODAVIGIL, you should contact
your doctor.
Before you take it
Before you start taking MODAVIGIL you should discuss with your doctor any of the following
points which apply to you. If you:
are under 18 or over 65 years old
have a history of mental health problems
have heart problems, including, for example, angina (chest pain), previous heart attack,
enlarged heart
have an abnormal/irregular heart rhythm
have high blood pressure or your high blood pressure is controlled by medication
have kidney or liver problems
are taking hormonal contraceptives
are pregnant, could become pregnant or are planning to become pregnant
are currently receiving treatment for anxiety
are breastfeeding
are taking brain stimulants, such as methylphenidate
are taking any medicines to treat depression, including those called monoamine oxidase
inhibitors (MAOIs)
are taking medicines to treat epilepsy or fits, such as phenytoin, carbamazepine and
phenobarbitone
are taking medicines to treat fungal infections, such as ketoconazole and itraconazole
are taking medicines to help you sleep (sedatives)
are taking rifampicin, an antibiotic used to treat tuberculosis
are taking cyclosporin, a medicine used to stop organ transplant rejection
are taking propranolol, a medicine used to treat, for example, high blood pressure,
heart problems or migraine
are taking warfarin, a medicine used to prevent unwanted blood clotting
are taking theophylline, a medicine used in asthma and lung problems
are taking any other medicines, including any available without a prescription from
your pharmacy, supermarket or health food shop
Tell your doctor about any of the above before you take MODAVIGIL. Your doctor will
discuss the risks and benefits of using MODAVIGIL.
How to take MODAVIGIL
It is important that you take this medicine as directed by the doctor. Your doctor
will tell you how much you should take, when and how often. Follow your doctor's instructions.
If you are unsure ask your doctor or pharmacist.
How much should you take
Each MODAVIGIL tablet contains 100mg of modafinil.
The usual daily dose of modafinil depends on individual response. For sleepiness associated
with narcolepsy or OSAHS, the dose ranges from 200mg to 400mg.
Each day you should take either:
two MODAVIGIL tablets
or
up to four MODAVIGIL tablets.
For SWSD, a dose of 200mg is recommended.
Do not exceed the recommended daily dose unless directed to do so by your doctor.
When and how should you take the tablets
For sleepiness associated with narcolepsy or OSAHS, you should take your MODAVIGIL
tablets either:
as two separate doses, one in the morning and one at midday,
or
as one dose, in the morning.
For narcolepsy or OSAHS, do not take your MODAVIGIL tablets later than midday, or
you may have trouble sleeping at night.
For SWSD, you should take your MODAVIGIL tablets as a single dose 1 hour prior to
commencing your shift work.
Swallow the tablets whole with a little water.
NOTE: Your doctor may start your treatment with less than two tablets a day.
If you need more than two tablets per day, your doctor should increase the dose stepwise,
one additional tablet at a time, depending on how you respond to the treatment. The
highest dose is four tablets per day.
If you are currently on another treatment for narcolepsy, your doctor will advise
you how best to withdraw from that treatment and begin taking MODAVIGIL. Other stimulants
used for narcolepsy may cause a "high" feeling. Be aware therefore that you may feel
different as you withdraw from other stimulants.
MODAVIGIL only treats the symptom of sleepiness. Other treatments intended to help
manage your underlying medical condition should still be used regularly, unless your
doctor tells you otherwise. You should commence or continue disease-modifying interventions
(for example, Continuous Positive Airway Pressure).
REMEMBER: This medicine is only for you. Only a doctor can prescribe it for you. Never
give it to anyone else. It may harm them, even if their symptoms appear to be the
same as yours.
If you forget to take it
If you miss a dose of MODAVIGIL tablets, just take the next dose at your usual time.
Do not take an extra dose to "catch up".
While you are taking MODAVIGIL
Things you must do
If you could become pregnant, you should confirm by a pregnancy test that you are
not pregnant within a week prior to starting treatment.
Tell your doctor if you are planning to become pregnant.
If you become pregnant while you are taking MODAVIGIL, stop taking it and tell your
doctor immediately.
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking MODAVIGIL.
Tell your doctor if you believe that MODAVIGIL is not helping your condition. Your
doctor may need to change the dose.
Things you must not do
Do not give MODAVIGIL to anyone else, even if they have the same symptoms as you.
Things to be careful of
MODAVIGIL may reduce the effectiveness of hormonal contraceptives (including the contraceptive
pill, implants, injectables and some intrauterine devices (IUDs)).
If you are using hormonal contraception, you should use an alternative non-hormonal
method of birth control together with your current contraceptive whilst taking MODAVIGIL
and for 2 months after you stop treatment with MODAVIGIL.
Do not drive or operate machinery until you know how MODAVIGIL affects you.
Side Effects
MODAVIGIL may cause you to have a serious rash.
Stop MODAVIGIL and call your doctor right away or get emergency treatment if you have
a skin rash, hives, sores in your mouth, or your skin blisters and peels, or if you
have any sudden wheeziness, difficulty in breathing, swelling, rash or itching (especially
affecting the whole body).
MODAVIGIL may cause the following side effects in some people. In clinical studies,
these side effects also occurred in people who received non-active (sugar) tablets.
Tell your doctor if you notice any of these:
headache
nausea
diarrhoea
dry mouth
poor appetite
runny nose
sore throat
nervous feeling
dizziness
back pain
feeling anxious
upset stomach
trouble sleeping
Tell your doctor immediately if any of the following occur:
skin rash, hives, sores in your mouth, or your skin blisters and peels,
swelling of your face, eyes, lips, tongue or throat,
trouble swallowing or breathing
fever, shortness of breath, swelling of the legs, yellowing of the skin or white of
the eyes or 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
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice anything that makes you feel unwell. Do not be alarmed by this list
of possible side effects. You may not experience any of them.
Overdosage
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13
11 26 in Australia or 0800 764 766 in New Zealand), or go to the emergency department
of your nearest hospital, if you think you or anyone else may have taken too much
MODAVIGIL. Do this, even if there are no signs of discomfort or poisoning.
MODAVIGIL tablets description
Each MODAVIGIL tablet contains 100mg of modafinil.
Each tablet also contains the following inactive ingredients:
lactose
starch- pre-gelatinised maize
microcrystalline cellulose
sodium croscarmellose
povidone
magnesium stearate.
MODAVIGIL tablets are white, capsule-shaped, debossed with "100" on one side.
Each pack contains either 10, 30 or 60 tablets.
Storage
Keep MODAVIGIL tablets in the original pack until it is time to take them.
Store MODAVIGIL tablets below 25°C. Keep the pack in a cool, dry place and away from
direct heat and sunlight.
Do not store MODAVIGIL tablets in the bathroom or near a sink.
Keep MODAVIGIL tablets where children cannot reach them. A locked cupboard at least
one-and-a-half metres above the ground is a good place to store medicines.
The Australian Registration Number is AUST R 168497.
This is not all the information available on MODAVIGIL. If you have any more questions
or are unsure about anything, ask your doctor or pharmacist.
MODAVIGIL is supplied in Australia by:
Teva Pharma Australia Pty Limited
37 Epping Rd.
Macquarie park
NSW 2113
Australia
1800 288 382
www.tevapharma.com.au
and in New Zealand by:
Teva Pharma New Zealand Ltd
Auckland, 1541
New Zealand
This leaflet was prepared in February 2020.
MODAVIGIL® is a registered trademark owned by Cephalon, Inc.