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.

*    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. Do not pass it on to others. It may harm them, even if their symptoms 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.

In this leaflet:

^ What Provigil is and what it is used for Before you take Provigil How to take Provigil Possible side effects How to store Provigil Further information

^ 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.

_*    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 think that you may be), are planning to become pregnant, or are breast feeding, you should not take Provigil. It is not known if your medicine may harm your unborn baby.

Talk to your doctor about the birth control methods that will be right for you while you are taking Provigil (and for two months after stopping) or if you have any other concerns.

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.

Important information about some of the ingredients of Provigil

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.

Before you take Provigil

Do not take Provigil if you:

*    Are allergic (hypersensitive) to modafinil, or to any of the other ingredients of these tablets (see section 6 ‘What Provigil contains').

_*    Have an irregular heartbeat.

_*    Have uncontrolled, moderate to severe high blood pressure

(hypertension).

Take special care with 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.

Children aged less than 18 years should not take this medicine.

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.

Taking with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken 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:

[3) How to take Provigil

Always take Provigil exactly as your doctor has told you. You should 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 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 the forgotten one.

Provigil ® 100mg Tablets

(modafinil)

^ Possible side effects

Like all medicines, Provigil 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

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.

Further 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: 13/04/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

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.

*    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. Do not pass it on to others. It may harm them, even if their symptoms 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.

In this leaflet:

What Modiodal is and what it is used for ^ Before you take Modiodal How to take Modiodal Possible side effects How to store Modiodal ,6 Further information

^ 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.

_*    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 think that you may be), are planning to become pregnant, or are breast feeding, you should not take Modiodal. It is not known if your medicine may harm your unborn baby.

Talk to your doctor about the birth control methods that will be right for you while you are taking Modiodal (and for two months after stopping) or if you have any other concerns.

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.

Important information about some of the ingredients of Modiodal

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.

Before you take Modiodal

Do not take Modiodal if you:

*    Are allergic (hypersensitive) to modafinil, or to any of the other ingredients of these tablets (see section 6 ‘What Modiodal contains').

_*    Have an irregular heartbeat.

_*    Have uncontrolled, moderate to severe high blood pressure

(hypertension).

Take special care with 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.

Children aged less than 18 years should not take this medicine.

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.

Taking with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken 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:

How to take Modiodal

Always take Modiodal exactly as your doctor has told you. You should 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 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 the forgotten one.

Modiodal 100mg Tablets

(modafinil)

^ Possible side effects

Like all medicines, Modiodal 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

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.

Further 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: 13/04/15

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

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.

*    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. Do not pass it on to others. It may harm them, even if their symptoms 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.

In this leaflet:

What Modafinil is and what it is used for ^ Before you take Modafinil How to take Modafinil Possible side effects How to store Modafinil ,6 Further information

^ 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.

Before you take Modafinil

Do not take Modafinil if you:

*    Are allergic (hypersensitive) to modafinil, or to any of the other ingredients of these tablets (see section 6 ‘What Modiodal contains').

_*    Have an irregular heartbeat.

_*    Have uncontrolled, moderate to severe high blood pressure

(hypertension).

Take special care with 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.

Children aged less than 18 years should not take this medicine.

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.

Taking with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken 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 think that you may be), are planning to become pregnant, or are breast feeding, you should not take Modafinil. It is not known if your medicine may harm your unborn baby.

Talk to your doctor about the birth control methods that will be right for you while you are taking Modafinil (and for two months after stopping) or if you have any other concerns.

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.

Important information about some of the ingredients of Modafinil

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.

How to take Modafinil

Always take Modafinil exactly as your doctor has told you. You should 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 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 the forgotten one.

Modafinil 100mg Tablets

Possible side effects

Like all medicines, Modafinil 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

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.

Further 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

Revision date: 13/04/15

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