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MODAVIGIL®

Modafinil


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about MODAVIGIL tablets. As this leaflet does not contain all the available information, it is important that you talk to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you receiving MODAVIGIL against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

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.

MODAVIGIL may also help to keep you awake during your working shift if you have been diagnosed with moderate to severe chronic Shift Work Sleep Disorder (SWSD).

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. Unlike other stimulants it does not overstimulate or produce a "high" feeling.

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, or likely to become pregnant.

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
  • could 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 is not associated with this "high" feeling. It works on excessive daytime sleepiness.

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 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 oral contraceptives. If you are using these forms of contraceptives while taking MODAVIGIL (and for 1 month after you stop treatment with MODAVIGIL) you should either use: an alternative birth control method or another effective birth control method together with your current contraceptive.

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. Symptoms include depression, anxiety, hallucinations, mania, thoughts of suicide or other mental problems.
  • Chest pain or abnormal heart beats

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- maize
  • magnesium silicate dihydrate
  • sodium croscarmellose
  • povidone
  • purified talc
  • magnesium stearate.

MODAVIGIL tablets are white, round-shaped with smooth convex sides.

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 82350.

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.

Sponsor

MODAVIGIL is supplied in Australia by:
CSL Biotherapies
45 Poplar Road
Parkville 3052 VIC
AUSTRALIA

and in New Zealand by:
CSL Biotherapies (NZ) Limited
666 Great South Road
Central Park,
Auckland 6
NEW ZEALAND
Telephone: 09 579 8105

and manufactured by:
Cephalon France
20 rue Charles Martigny
94700 Maisons-Alfort
FRANCE

This leaflet was prepared in February 2011.

MODAVIGIL® is a registered trademark owned by Cephalon, Inc.

Published by MIMS July 2011

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