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MODIODAL 100MG TABLETS

Active substance(s): MODAFINIL

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Ref: 0639/300816/1/F

Patient Information Leaflet

Provigil® 100mg Tablets
(modafinil)
Your medicine is known as Provigil 100mg Tablets but will be referred to as
Provigil throughout the leaflet. Please note that the leaflet also contains
information about the other strength of the medicine, Provigil 200mg tablets.
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.

Patient Information Leaflet (continued)

Ref: 0639/300816/1/B

Provigil ® 100mg Tablets
(modafinil)
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:
- mood swings or abnormal thinking,
- aggression or hostility,
- forgetfulness or confusion,
- feeling of extreme happiness,
- over-excitement or hyperactivity,
- anxiety or nervousness,
- depression, suicidal thoughts or behaviour,
- 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.

How to store Provigil

5

EXPIRY DATE
Do not use this medicine after the expiry date shown on the carton or blister
strip. If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine, if
your doctor tells you to. If your medicine becomes discoloured or shows any
other signs of deterioration, consult your pharmacist who will tell you what to
do.
STORAGE
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* No special precautions for storage.
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.
IMPORTANT
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Contents of the pack and other information

What Provigil contains:
Each tablet contains 100mg of modafinil as the active ingredient.
Inactive ingredients: lactose monohydrate, pregelatinised starch (maize),
microcrystalline cellulose, croscarmellose sodium, povidone K29/32,
magnesium stearate.
What Provigil looks like and contents of the pack
Provigil tablets are capsule shaped, embossed ‘100’ on one side and white
to off-white in colour.
Each blister contains 10 tablets, which comes in boxes of 30 and 60 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Laboratoires Macors, Rue des Caillottes, ZI
Plaine des Isles, 89000 Auxerre, France and are procured from within the
EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/0639

Provigil 100mg Tablets

Provigil is a registered trademark of Cephalon France.
Revision date: 30/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Patient Information Leaflet

Ref: 0639/300816/2/F

®

Modiodal 100mg Tablets
(modafinil)
Your medicine is known as Modiodal 100mg Tablets but will be referred to as
Modiodal throughout the leaflet. Please note that the leaflet also contains
information about the other strength of the medicine, Modiodal 200mg
tablets.
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 Modiodal is and what it is used for
2 What you need to know before you take Modiodal
3 How to take Modiodal
4 Possible side effects
5 How to store Modiodal
6 Contents of the pack and other information

1

What Modiodal 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 Modiodal

Do not take Modiodal if you:
* Are allergic to modafinil, or any of the other ingredients of this
medicine (listed in section 6 ‘What Modiodal 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 Modiodal if you:.
* Have any heart problems or high blood pressure. Your doctor will need
to check these regularly while you are taking Modiodal.
* 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 Modiodal 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 Modiodal
Tell your doctor or pharmacist if you are taking have recently taken or might
take any other medicines, including medicines obtained without prescription.
Modiodal 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
Modiodal:
* Hormonal contraceptives (including the contraceptive pill, implants,
intrauterine devices (IUDs) and patches). You will need to consider other
birth control methods while taking Modiodal, and for two months after
stopping treatment, because Modiodal 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
Modiodal 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.
Modiodal contains Lactose
Modiodal 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 Modiodal

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 Modiodal 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 Modiodal
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.

Patient Information Leaflet (continued)

Ref: 0639/300816/2/B

®

Modiodal 100mg Tablets
(modafinil)
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:
- mood swings or abnormal thinking,
- aggression or hostility,
- forgetfulness or confusion,
- feeling of extreme happiness,
- over-excitement or hyperactivity,
- anxiety or nervousness,
- depression, suicidal thoughts or behaviour,
- 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.

How to store Modiodal

5

EXPIRY DATE
Do not use this medicine after the expiry date shown on the carton or blister
strip. If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine, if
your doctor tells you to. If your medicine becomes discoloured or shows any
other signs of deterioration, consult your pharmacist who will tell you what to
do.
STORAGE
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* No special precautions for storage.
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.
IMPORTANT
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Contents of the pack and other information

What Modiodal contains:
Each tablet contains 100mg of modafinil as the active ingredient.
Inactive ingredients: lactose monohydrate, pregelatinised starch (maize),
microcrystalline cellulose, croscarmellose sodium, povidone K29/32,
magnesium stearate.
What Modiodal looks like and contents of the pack
Modiodal tablets are capsule shaped, embossed ‘100’ on one side and white
to off-white in colour.
Each blister contains 10 tablets, which comes in boxes of 30 and 60 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Laboratoires Macors, Rue des Caillottes, ZI
Plaine des Isles, 89000 Auxerre, France and are procured from within the
EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/0639

Modiodal 100mg Tablets

Modiodal is a registered trademark of Cephalon France.
Revision date: 30/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Patient Information Leaflet

Ref: 0639/300816/3/F

Modafinil 100mg Tablets
Your medicine is known as Modafinil 100mg Tablets but will be referred to as
Modafinil throughout the leaflet. Please note that the leaflet also contains
information about the other strength of the medicine, Modafinil 200mg
tablets.
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 Modafinil is and what it is used for
2 What you need to know before you take Modafinil
3 How to take Modafinil
4 Possible side effects
5 How to store Modafinil
6 Contents of the pack and other information

1

What Modafinil 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 Modafinil

Do not take Modafinil if you:
* Are allergic to modafinil, or any of the other ingredients of this
medicine (listed in section 6 ‘What Modafinil 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 Modafinil if you:.
* Have any heart problems or high blood pressure. Your doctor will need
to check these regularly while you are taking Modafinil.
* 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 Modafinil 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 Modafinil
Tell your doctor or pharmacist if you are taking have recently taken or might
take any other medicines, including medicines obtained without prescription.
Modafinil 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
Modafinil:
* Hormonal contraceptives (including the contraceptive pill, implants,
intrauterine devices (IUDs) and patches). You will need to consider other
birth control methods while taking Modafinil, and for two months after
stopping treatment, because Modafinil 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
Modafinil 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.
Modafinil contains Lactose
Modafinil 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 Modafinil

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 Modafinil 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 Modafinil
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.

Patient Information Leaflet (continued)

Ref: 0639/300816/3/B

Modafinil 100mg Tablets
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:
- mood swings or abnormal thinking,
- aggression or hostility,
- forgetfulness or confusion,
- feeling of extreme happiness,
- over-excitement or hyperactivity,
- anxiety or nervousness,
- depression, suicidal thoughts or behaviour,
- 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.

How to store Modafinil

5

EXPIRY DATE
Do not use this medicine after the expiry date shown on the carton or blister
strip. If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist for safe disposal. Only keep this medicine, if
your doctor tells you to. If your medicine becomes discoloured or shows any
other signs of deterioration, consult your pharmacist who will tell you what to
do.
STORAGE
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
* No special precautions for storage.
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.
IMPORTANT
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Contents of the pack and other information

What Modafinil contains:
Each tablet contains 100mg of modafinil as the active ingredient.
Inactive ingredients: lactose monohydrate, pregelatinised starch (maize),
microcrystalline cellulose, croscarmellose sodium, povidone K29/32,
magnesium stearate.
What Modafinil looks like and contents of the pack
Modafinil tablets are capsule shaped, embossed ‘100’ on one side and white
to off-white in colour.
Each blister contains 10 tablets, which comes in boxes of 30 and 60 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Laboratoires Macors, Rue des Caillottes, ZI
Plaine des Isles, 89000 Auxerre, France and are procured from within the
EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/0639

Modafinil 100mg Tablets

Modafinil is a registered trademark of Cephalon France.
Revision date: 30/08/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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.

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