MODIODAL 100MG TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Provigil® 100mg Tablets/
Modafinil 100mg Tablets/
Modiodal 100mg Tablets
(modafinil)

This medicine is available in the following strengths: 100mg
and 200mg.
Your tablets are available using the names Provigil 100mg
Tablets/Modafinil 100mg Tablets/Modiodal 100mg Tablets,
but will be referred to as Provigil throughout this leaflet.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

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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 yours.
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.
2.
3.
4.
5.
6.

What Provigil is and what it is used for
What you need to know before you take Provigil
How to take Provigil
Possible side effects
How to store Provigil
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:
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Are allergic to modafinil, or any of the other ingredients
of this medicine (listed in section 6 ‘What Provigil
contains’).
Have an irregular heart beat.
Have uncontrolled, moderate to severe high blood
pressure (hypertension).

Warnings and precautions

Talk to your doctor or pharmacist before taking Provigil if
you:
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Have any heart problems or high blood pressure.
Your doctor will need to check these regularly while you
are taking Provigil.
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Have ever had depression, low mood, anxiety,
psychosis (loss of contact with reality) or mania (overexcitement or feeling of extreme happiness) or bipolar
disorder because Provigil may make your condition
worse.
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Have kidney or liver problems (because you will need
to take a lower dose).
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Have had alcohol or drug problems in the past.

Other things to talk to your doctor or pharmacist
about
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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:
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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.
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Omeprazole (for acid reflux, indigestion or ulcers).
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Antiviral medicines to treat HIV infection (protease
inhibitors e.g. indinavir or ritonavir).
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Ciclosporin (used to prevent organ transplant rejection,
or for arthritis or psoriasis).
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Medicines for epilepsy (e.g. carbamazepine,
phenobarbital or phenytoin).
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Medicines for depression (e.g. amitriptyline, citalopram
or fluoxetine) or anxiety (e.g. diazepam).

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Medicines for thinning the blood (e.g. warfarin). Your
doctor will monitor your blood clotting times during
treatment.
Calcium channel blockers or beta-blockers for high
blood pressure or heart problems (e.g. amlodipine,
verapamil or propranolol).
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 contains 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.

Adults

The usual dose is 200mg a day. This can be taken once daily
(in the morning) or divided into two doses a day (100mg in
the morning and 100mg at midday).
Your doctor in some cases may decide to increase your daily
dose up to 400mg.

Elderly patients (over 65 years of age)
The usual dose is 100mg a day.

Your doctor will only increase your dose (up to the maximum
400mg a day) provided that you do not have any liver or
kidney problems.

Adults with severe kidney and liver problems

The usual dose is 100mg 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:
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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 include:
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mood swings or abnormal thinking,
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aggression or hostility,
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forgetfulness or confusion,
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feeling of extreme happiness,
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over-excitement or hyperactivity,
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anxiety or nervousness,
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depression, suicidal thoughts or behaviour,
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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):
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Headache.

Common side effects (may affect up to 1 in 10 people):
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Dizziness.
Sleepiness, extreme tiredness or difficulty sleeping
(insomnia).
Awareness of your heart beat, which may be faster than
normal.
Chest pain.
Flushing.
Dry mouth.

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Loss of appetite, feeling sick, stomach pain, indigestion,
diarrhoea or constipation.
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):
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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.
Hay fever 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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5. How to store Provigil
There are no special storage instructions.
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the
carton label and blister label. The expiry date refers to the
last day of that month. Out of date packs should be taken to
your pharmacist who will dispose of them safely.
If your tablets appear to be discoloured or show any other
signs of deterioration, please return to your pharmacist who
will advise you.
If you have any left over/unused medicine please return to
your pharmacist for safe disposal.
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.

6. Contents of the pack and other
information
What Provigil contains

Each tablet contains 100mg of the active ingredient modafinil.
Each tablet contains the following inactive ingredients:
lactose, maize starch, magnesium silicate,
croscarmellose sodium, povidone, talc and
magnesium stearate.

What Provigil looks like and the contents of the
pack

The tablets are white, round tablets engraved with ‘M’ on one
side and ‘100’ on the reverse.
They are available in blister packs of 30 tablets.

Manufacturer

Manufactured by: Laboratoires Macors, France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0378

POM

®

Provigil is a registered trademark of Cephalon, Inc.
Leaflet revision and issue date (Ref): 12.07.16