Introduction
This leaflet provides important information about Provigil tablets. Please read it carefully before you start to
take your medicine. The leaflet cannot tell you everything about your medicine. If you have any questions or
are not sure about anything, ask your doctor or pharmacist.
Keep this leaflet in a safe place in case you want to read it again. You should also make a habit of re-reading
the leaflet every time you open a new box of Provigil in case the information has changed.
What is Provigil used for?
Provigil is used to treat excessive sleepiness associated with chronic medical conditions, including narcolepsy,
obstructive sleep apnoea/hypopnoea syndrome and moderate to severe chronic shift work sleep disorder.
In these conditions it is common to feel sleepy during the day (or at night if you work night shifts) and/or to
have uncontrollable sleep attacks, even at inappropriate times e.g., when eating, talking etc.
This medicine treats the symptoms of sleepiness. Other treatments intended to help your underlying
medical condition should still be used regularly, unless your doctor tells you otherwise.
When shouldn’t you be treated with Provigil tablets?
This medicine should not be used if you are pregnant, breast-feeding, have untreated moderate or severe
high blood pressure (hypertension), an abnormal heart rhythm (arrhythmia) or are allergic to any of the
ingredients.
You should tell your doctor if you think any of these may apply to you.
Before taking this medicine
If the answer to any of the following questions is “yes”, make sure your doctor knows before you start taking
Provigil.
● Do you have heart disease (thickening of the main heart muscle; poor heart or coronary circulation
diagnosed by ECG; chest pain; floppy mitral valve)?
● Do you have a known abnormal heart rhythm (arrhythmia)?
● Do you have high blood pressure (hypertension)?
● Do you suffer from kidney or liver disease?
● Are you likely to become pregnant, currently pregnant or breast feeding?
● Are you over 65 years of age?
● Is the patient under 12 years of age?
● Do you have an intolerance to some sugars?
● Are you taking any of the following medicines?
• Medicines for the treatment of epilepsy, (in particular phenytoin)
• Oral contraceptive pills
• Medicines for the treatment of depression, or anxiety, or sleeping pills
• Medicines to stop your blood from clotting (for example warfarin)
• Ciclosporin (an immunosupressant used after transplant operations, also sometimes used for arthritis or psoriasis)
• Certain antiviral medicines used to treat HIV infections (known as protease inhibitors)
• Certain medicines for the treatment of high blood pressure or heart problems (known as calcium channel blockers)
• Certain medicines for lowering cholesterol (known as statins)
• Any other medicine which your doctor does not know about, including any available without a prescription
Although this medicine has a low potential for dependence, the chance of this happening with long-term use
cannot be completely ruled out.
Will Provigil tablets affect your ability to drive and use machines?
There is currently no information available about the effect of Provigil on the ability to drive and use
machines. However this medicine might cause blurred vision or dizziness in some people (see “Do Provigil
tablets have any undesirable effects?” below).
How to take Provigil tablets
It is important that you take this medicine as directed by your doctor. The label should tell you how much
should be taken and how often. If you are unsure ask your doctor or pharmacist.
● For excessive sleepiness in narcolepsy or obstructive sleep apnoea, the usual total dose to be taken each
day is two to four tablets (for Provigil 100 mg tablets), or one to two tablets (for Provigil 200 mg tablets).
Provigil is taken once daily (in the morning) or twice daily (in the morning and at noon).
● For excessive sleepiness associated with moderate to severe chronic shift work sleep disorder, the
recommended total daily dose is two tablets (for Provigil 100 mg tablets), or one tablet (for Provigil
200 mg tablets), taken once daily, approximately one hour before the start of your night shift.
● Tablets should be swallowed whole with a little water.
● In certain circumstances, for example, if you are over 65 or have liver or kidney disease, your doctor may
start your treatment with a lower dose.
● Provigil is not recommended for children under 12 years of age.
● 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.
What to do if you accidentally miss a dose
If you miss a dose, just take the next dose at the usual time. Do not take an extra dose to “catch up.”
What to do if you accidentally take/use more than you should
If you take too many tablets, or if a child takes any tablets, contact your doctor or go to the nearest
hospital Accident and Emergency department immediately.
Do Provigil tablets have any undesirable effects?
As with any medicine, there may be one or more of the following undesirable effects in some people. If you
do notice any of these, contact your doctor.
Very common undesirable effects (occurring in more than 1 in 10 people):
Headache.
Common undesirable effects (occurring in less than 1 in 10 people but more than 1 in 100):
Abdominal pain, excessive fatigue, chest pain, unusually fast heart beat, palpitation (‘bounding’ heart beat),
flushing, feeling sick, dry mouth, diarrhoea, decreased appetite, indigestion, constipation, increases in the
amount of some liver enzymes usually present in the blood, irritability / nervousness, insomnia (difficulty
sleeping), anxiety, dizziness, sleepiness, depression, abnormal thinking, confusion, numbness / tingling,
blurred vision.
Uncommon undesirable effects (occurring in less than 1 in 100 people but more than 1 in 1000):
Back pain, minor allergic reaction (such as hay fever), neck pain, increased blood pressure, abnormal ECG,
irregular heart beat, unusually slow heart beat, decreased blood pressure, excess wind, reflux (bringing back fluid
from the stomach), vomiting, increased appetite, thirst, difficulty swallowing, sore tongue, mouth ulcers, sugar
diabetes, increased eosinophils (white cells) in the blood, decreased white cells in the blood, swelling of the
extremities, weight increase, weight decrease, increased blood cholesterol, increased blood sugar, muscle soreness,
muscle weakness, leg cramps, joint pain, twitching, sleep disturbance, dyskinesia (difficulty moving muscles
smoothly), muscle tension, over-activity, agitation, amnesia (forgetfulness), abnormal dreams, mood swings,
migraine, tremor, vertigo, decreased libido (sex drive), hostile behaviour, stimulation, feeling detached,
numbness, co-ordination problems, movement disorder, personality disorder, speech disorder, sore throat,
shortness of breath, rhinitis (itchy / runny nose), increased cough, asthma, nose bleeds, sinusitis, excessive
sweating, skin rash, acne, itchy skin, taste alteration, abnormal vision, dry eyes, abnormal urine, more frequent
urination, menstrual (period) disorder.
You should tell your doctor or pharmacist if you notice any other undesirable effects from your medicine
that are not mentioned here.
How should Provigil tablets be stored?
● There are no special storage instructions.
● KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
● 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.
