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Active substance(s): MODAFINIL

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Modafinil 100mg Tablets/Provigil® 100mg Tablets
Your medicine is known by either of the above names but will be referred to
as Provigil throughout this leaflet. Also available as 200mg tablets.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1) What Provigil is and what it is used for
2) What you need to know before you take Provigil
3) How to take Provigil
4) Possible side effects
5) How to store Provigil
6) Contents of the pack and other information

1) What Provigil is and what it is used for
The active ingredient in the tablets is modafinil. Modafinil can be taken by
adults who suffer from narcolepsy to help them to stay awake.
Narcolepsy is a condition that causes excessive daytime sleepiness and a
tendency to fall asleep suddenly in inappropriate situations (sleep attacks).
Modafinil may improve your narcolepsy and reduce the likelihood that you will
have sleep attacks but there may still be other ways that you can improve
your condition and your doctor will advise you.

2) What you need to know before you take Provigil
Do not take Provigil if you:
• Are allergic to modafinil, or any of the other ingredients of this medicine
(listed in section 6 ‘What Provigil contains’).
• Have an irregular heartbeat.
• Have uncontrolled, moderate to severe high blood pressure
Warnings and precautions
Talk to your doctor or pharmacist before taking Provigil if you:
• Have any heart problems or high blood pressure. Your doctor will need
to check these regularly while you are taking Provigil.
• Have ever had depression, low mood, anxiety, psychosis (loss of
contact with reality) or mania (over-excitement or feeling of extreme
happiness) or bipolar disorder because Provigil may make your condition
• Have kidney or liver problems (because you will need to take a lower
• Have had alcohol or drug problems in the past.
Other things to talk to your doctor or pharmacist about
• Some people have reported having suicidal or aggressive thoughts or
behaviour while taking this medicine. Tell your doctor straight away if
you notice that you are becoming depressed, feel aggressive or hostile
towards other people or have suicidal thoughts or other changes in your
behaviour (see section 4). You may want to consider asking a family
member or close friend to help you look out for signs of depression or other
changes in your behaviour.
• This medicine has the potential for you to become reliant (dependent) on it
after long-term use. If you need to take it for a long time your doctor will
check regularly that it is still the best medicine for you.
Children and adolescents
Children aged less than 18 years should not take this medicine.

Other medicines and Provigil
Tell your doctor or pharmacist if you are taking have recently taken or might
take any other medicines, including medicines obtained without prescription.
Provigil and certain other medicines can affect each other and your doctor
may need to adjust the doses that you are taking. It is especially important if
you are taking any of the following medicines as well as Provigil:
• Hormonal contraceptives (including the contraceptive pill, implants,
intrauterine devices (IUDs) and patches). You will need to consider other
birth control methods while taking Provigil, and for two months after
stopping treatment, because Provigil reduces their effectiveness.
• Omeprazole (for acid reflux, indigestion or ulcers).
• Antiviral medicines to treat HIV infection (protease inhibitors e.g. indinavir or
• Ciclosporin (used to prevent organ transplant rejection, or for arthritis or
• Medicines for epilepsy (e.g. carbamazepine, phenobarbital or phenytoin).
• Medicines for depression (e.g. amitriptyline, citalopram or fluoxetine) or
anxiety (e.g. diazepam).
• Medicines for thinning the blood (e.g. warfarin). Your doctor will monitor
your blood clotting times during treatment.
• Calcium channel blockers or betablockers for high blood pressure or heart
problems (e.g. amlodipine, verapamil or propranalol).
• Statin medicines for lowering cholesterol (e.g. atorvastatin or simvastatin).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
It is not known if your medicine may harm your unborn baby.
Driving and using machines
Provigil can cause blurred vision or dizziness in up to 1 in 10 people. If you
are affected or you find that while using this medication you still feel very
sleepy, do not attempt to drive or operate machinery.
Provigil contains Lactose
Provigil contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.

3) How to take Provigil
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. Tablets should be swallowed
whole with water.
The usual dose is 200 mg a day. This can be taken once daily (in the
morning) or divided into two doses a day (100 mg in the morning and 100 mg
at midday). Your doctor in some cases may decide to increase your daily
dose up to 400 mg.
Elderly patients (over 65 years of age)
The usual dose is 100 mg a day.
Your doctor will only increase your dose (up to the maximum 400 mg a day)
provided that you do not have any liver or kidney problems.
Adults with severe kidney and liver problems
The usual dose is 100 mg a day.
Your doctor will review your treatment regularly to check that it is right for you.
If you take more Provigil than you should
If you take too many tablets you may feel sick, restless, disorientated,
confused, agitated, anxious or excited. You may also have difficulty sleeping,
diarrhoea, hallucinations (sensing things that are not real), chest pain, a
change in the speed of your heart beat or an increase in blood pressure.
Contact your nearest hospital casualty department or tell your doctor or
pharmacist immediately. Take this leaflet and any remaining tablets with you.

If you forget to take Provigil
If you forget to take your medicine take the next dose at the usual time, do not
take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4) Possible Side Effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking this medicine and tell your doctor straight away if:
• You have sudden difficulty breathing or wheeziness or your face, mouth or
throat begins to swell.
• You notice a skin rash or itching (especially if it affects your whole body).
Severe rashes may cause blistering or peeling of the skin, ulcers in your
mouth, eyes, nose or genitals. You may also have a high temperature (fever)
and abnormal blood test results.
• You feel any change in your mental health and wellbeing. The signs may
o mood swings or abnormal thinking,
o aggression or hostility,
o forgetfulness or confusion,
o feeling of extreme happiness,
o over-excitement or hyperactivity,
o anxiety or nervousness,
o depression, suicidal thoughts or behaviour,
o agitation or psychosis (a loss of contact with reality which may include
delusions or sensing things that are not real), feeling detached or numb,
or personality disorder.
Other side effects include the following:
Very common side effects (may affect more than 1 in 10 people):
• Headache.
Common side effects (may affect up to 1 in 10 people):
• Dizziness.
• Sleepiness, extreme tiredness or difficulty sleeping (insomnia).
• Awareness of your heart beat, which may be faster than normal.
• Chest pain.
• Flushing.
• Dry mouth.
• Loss of appetite, feeling sick, stomach pain, indigestion, diarrhoea or
• Weakness. Numbness or tingling of the hands or feet (‘pins and needles’).
• Blurred vision.
• Abnormal blood test results showing how your liver is working (increased
liver enzymes).
• Irritability
Uncommon side effects (may affect up to 1 in 100 people):
• Back pain, neck pain, muscle pain, muscle weakness, leg cramps, joint
pain, twitching or tremor.
• Vertigo (spinning sensation).
• Difficulty moving muscles smoothly or other movement problems, muscle
tension, coordination problems.
• Hayfever symptoms including itchy/runny nose or watery eyes.
• Increased cough, asthma or shortness of breath.
• Skin rash, acne or itchy skin.
• Sweating.
• Changes in blood pressure (high or low), abnormal heart trace (ECG), and
irregular or unusually slow heart beat.
• Difficulty swallowing, swollen tongue or mouth ulcers.
• Excess wind, reflux (bringing back fluid from the stomach), increased
appetite, weight changes, thirst or taste alteration.
• Being sick (vomiting).
• Migraine.
• Speech problems.
• Diabetes with increased blood sugar.

High blood cholesterol.
Swollen hands and feet.
Disrupted sleep or abnormal dreams.
Loss of sex drive.
Nose bleed, sore throat or inflamed nasal passages (sinusitis).
Abnormal vision or dry eyes.
Abnormal urine or more frequent urination.
Abnormal periods.
Abnormal blood test results showing that the numbers of your white blood
cells have changed.
• Restlessness with increased body movement.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: By reporting side effects you can help provide
more information on the safety of this medicine.

5) How to store Provigil
• Keep all medicines out of the sight and reach of children.
• There are no special storage instructions.
• Do not take this medicine after the expiry date shown on the pack. (The
expiry date is the date stamped on the end of the carton and also at one
end of each strip of tablets). Out of date packs should be taken to your
pharmacist who will dispose of them safely.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
• If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.

6) Contents of the pack and other information
What Provigil contains:
Each tablet contains 100mg of the active ingredient modafinil.
Each tablet also contains the following ingredients: lactose monohydrate,
maize starch pregelatinised, microcrystalline cellulose, croscarmellose
sodium, povidone K29/32 and magnesium stearate.
What Provigil looks like and content of the pack
The tablets are white, capsule shaped, debossed with “100” on one side and
plain on the other.
They are packed in blister strips and supplied in boxes of 30 tablets.
PL 10383/1437

Modafinil 100mg Tablets/Provigil 100mg Tablets POM

Who makes and repackages your medicine?
Your medicine is manufactured by Laboratoires Macors, Rue des Caillottes,
ZI Plaine des Isles, 89000 Auxerre, France. Procured from within the EU and
repackaged by Product Licence Holder: Primecrown Ltd., 4/5 Northolt Trading
Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 20.10.2016
Provigil is a registered trademark of Cephalon Inc., USA.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.