Provigil 100mg Tablets
Revision Date: 06/09/2016
Leaflet Reference: PRO100 /UT
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROVIGIL® 100MG 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® 100mg Tablets are and what they are used for
2. What you need to know before you take Provigil®100mg Tablets
3. How to take Provigil® 100mg Tablets
4. Possible side effects
5. How to store Provigil® 100mg Tablets
6. Contents of the pack and other information
1. WHAT PROVIGIL® 100MG TABLETS ARE AND WHAT THEY ARE 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® 100MG TABLETS
Do not take Provigil® 100mg Tablets if you:
• Are allergic to modafinil, or any of the other ingredients of this medicine (listed in section 6 ‘What Provigil® 100mg Tablets 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® 100mg Tablets if you:
• Have any heart problems or high blood pressure. Your doctor will need to check these regularly while you are taking Provigil® 100mg Tablets.
• 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® 100mg Tablets 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® 100mg Tablets
Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines, including medicines obtained without prescription. Provigil® 100mg Tablets 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® 100mg Tablets:
• Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches). You will need to consider other birth control methods while taking Provigil® 100mg Tablets, and for two months after stopping treatment, because Provigil® 100mg Tablets 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® 100mg Tablets 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® 100mg Tablets contain Lactose
Provigil® 100mg Tablets 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® 100MG TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tablets should be swallowed whole with water.
Adults
The usual dose is 200mg a day. This can be taken once daily (in the morning) or divided into two doses a day (100mg in the morning and 100mg at midday).
Your doctor in some cases may decide to increase your daily dose up to 400mg.
Elderly patients (over 65 years of age)
The usual dose is 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® 100mg Tablets 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® 100mg Tablets
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.
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
If you get any side effects, talk to your doctor or pharmacist. 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® 100MG TABLETS
• There are no special storage instructions.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date (This is printed on the carton label).
• 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 tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
• 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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Provigil® 100mg Tablets contains
Each film-coated tablet contains 100mg of the active ingredient modafinil Each tablet also contains lactose monohydrate, pregelatinised starch, microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate.
What Provigil® 100mg Tablets looks like and the contents of the pack
Each capsule shaped, white, film-coated tablet is marked 100 on one side plain on the reverse.
Provigil® 100mg Tablets are available as blister packs of 30 or 60 tablets. Who manufactured your medicine
Provigil® 100mg Tablets are manufactured by Laboratoires Macors, Rue des Cailottes, Zl Plaine des Isles, 89000 Auxerre, France and is procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0475 |POM|
Revision Date: 06/09/2016 Leaflet Reference: PRO100 /UT
Provigil® is a registered trademark of Cephalon Inc., or its affiliates.
PACKAGE LEAFLET: INFORMATION FOR THE USER
MODAFINIL 100MG 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 Modafinil 100mg Tablets are and what they are used for
2. What you need to know before you take Modafinil100mg Tablets
3. How to take Modafinil 100mg Tablets
4. Possible side effects
5. How to store Modafinil 100mg Tablets
6. Contents of the pack and other information
1. WHAT MODAFINIL 100MG TABLETS ARE AND WHAT THEY ARE 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 100MG TABLETS
Do not take Modafinil 100mg Tablets if you:
• Are allergic to modafinil, or any of the other ingredients of this medicine (listed in section 6 ‘What Modafinil 100mg Tablets 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 100mg Tablets if you:
• Have any heart problems or high blood pressure. Your doctor will need to check these regularly while you are taking Modafinil 100mg Tablets.
• 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 100mg Tablets 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 100mg Tablets
Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines, including medicines obtained without prescription. Modafinil 100mg Tablets 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 100mg Tablets:
• Hormonal contraceptives (including the contraceptive pill, implants, intrauterine devices (IUDs) and patches). You will need to consider other birth control methods while taking Modafinil 100mg Tablets, and for two months after stopping treatment, because Modafinil 100mg Tablets 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 100mg Tablets 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 100mg Tablets contain Lactose
Modafinil 100mg Tablets 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 100MG TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tablets should be swallowed whole with water.
Adults
The usual dose is 200mg a day. This can be taken once daily (in the morning) or divided into two doses a day (100mg in the morning and 100mg at midday).
Your doctor in some cases may decide to increase your daily dose up to 400mg.
Elderly patients (over 65 years of age)
The usual dose is 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 100mg Tablets 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 100mg Tablets
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.
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
If you get any side effects, talk to your doctor or pharmacist. 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 MODAFINIL 100MG TABLETS
• There are no special storage instructions.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date (This is printed on the carton label).
• 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 tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
• 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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Modafinil 100mg Tablets contains
Each film-coated tablet contains 100mg of the active ingredient modafinil Each tablet also contains lactose monohydrate, pregelatinised starch, microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate.
What Modafinil 100mg Tablets looks like and the contents of the pack
Each capsule shaped, white, film-coated tablet is marked 100 on one side plain on the reverse.
Modafinil 100mg Tablets are available as blister packs of 30 or 60 tablets. Who manufactured your medicine
Modafinil 100mg Tablets are manufactured by Laboratoires Macors, Rue des Cailottes, Zl Plaine des Isles, 89000 Auxerre, France and is procured from within the EU and repackaged by Product Licence Holder: Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0475 |POM|
Revision Date: 06/09/2016 Leaflet Reference: MOD 100 /UT
2