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PROVIGIL 200 MG TABLETS

Active substance(s): MODAFINIL

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Package leaflet: Information for the user
PROVIGIL® 100 mg Tablets
PROVIGIL® 200 mg Tablets
Modafinil
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 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. 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
(hypertension).
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 worse.
• Have kidney or liver problems
(because you will need to take a
lower dose).
• 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.

5(*

Version 

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 ritonavir).
• Ciclosporin (used to prevent organ
transplant rejection, or for arthritis or
psoriasis).
• 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.
Adults
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.

$SSURYHG

3DJHRI

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
include:
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 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):
• 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. How to store PROVIGIL
Keep this medicine out of the sight and
reach of children.
Do not take this medicine after the expiry
date which is stated on the blister strip
and the outer pack after ‘Exp’. The expiry
date refers to the last day of the month.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6. Contents of the pack and other
information
What PROVIGIL contains
The active substance is modafinil. Each
PROVIGIL 100 mg tablet contains
100 mg of modafinil. Each PROVIGIL
200 mg tablet contains 200 mg of
modafinil.
The other ingredients are: lactose
monohydrate, pregelatinised starch
(maize), microcrystalline cellulose,
croscarmellose sodium, povidone
K29/32, magnesium stearate as inactive
ingredients.
What PROVIGIL looks like and the
contents of the pack
The tablets come in a capsule shaped,
white to off-white colour, 13 x 6 mm
with “100” on one side for 100 mg
tablets, or 16 x 7 mm with “200” on
one side for 200 mg tablets.
PROVIGIL is available in blister packs of
10, 20, 30, 50, 60, 90, 100 or
120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
manufacturers
Marketing Authorisation Holder
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturers
Laboratoires Macors,
Rue des Caillottes,
ZI Plaine des Isles,
89000 Auxerre,
France.
This leaflet was last revised in 12/2015
PROVIGIL is a registered trademark of
Cephalon, Inc., or its affiliates

H42783
12024-D

5(*

Version 

$SSURYHG

3DJHRI

Package leaflet: Information for the user
PROVIGIL® 100 mg Tablets
PROVIGIL® 200 mg Tablets
Modafinil
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 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. 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
(hypertension).
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 worse.
• Have kidney or liver problems
(because you will need to take a
lower dose).
• 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 ritonavir).
• Ciclosporin (used to prevent organ
transplant rejection, or for arthritis or
psoriasis).
• 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.
Adults
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
include:
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 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):
• 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. How to store PROVIGIL
Keep this medicine out of the sight and
reach of children.
Do not take this medicine after the expiry
date which is stated on the blister strip
and the outer pack after ‘Exp’. The expiry
date refers to the last day of the month.
This medicinal product does not require
any special storage conditions.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6. Contents of the pack and other
information
What PROVIGIL contains
The active substance is modafinil. Each
PROVIGIL 100 mg tablet contains
100 mg of modafinil. Each PROVIGIL
200 mg tablet contains 200 mg of
modafinil.
The other ingredients are: lactose
monohydrate, pregelatinised starch
(maize), microcrystalline cellulose,
croscarmellose sodium, povidone
K29/32, magnesium stearate as inactive
ingredients.
What PROVIGIL looks like and the
contents of the pack
The tablets come in a capsule shaped,
white to off-white colour, 13 x 6 mm
with “100” on one side for 100 mg
tablets, or 16 x 7 mm with “200” on
one side for 200 mg tablets.
PROVIGIL is available in blister packs of
10, 20, 30, 50, 60, 90, 100 or
120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
manufacturers
Marketing Authorisation Holder
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturers
Laboratoires Macors,
Rue des Caillottes,
ZI Plaine des Isles,
89000 Auxerre,
France.
This leaflet was last revised in 12/2015
PROVIGIL is a registered trademark of
Cephalon, Inc., or its affiliates

H42784
12022-D

Expand view ⇕

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.

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