MODAFINIL 100 MG TABLETS

Active substance: MODAFINIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MODAFINIL 100 mg
TABLETS
(modafinil)

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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Modafinil is and what it is used for.
2. Before you take Modafinil.
3. How to take Modafinil.
4. Possible side effects .
5. How to store Modafinil.
6. Further 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. 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 Modafinil 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 other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other

medicines, including medicines obtained without
a prescription. Modafinil containing medicinal
products 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 containing
medicinal products:
• Hormonal contraceptives (including the
contraceptive pill, implant, 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 inhibitor 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 beta-blockers for
high blood pressure or heart problems (e.g.
amlodipine, verapamil or propranolol).
• Statin medicines for lowering cholesterol (e.g.
atorvastatin or simvastatin).
Pregnancy and breast-feeding
If you are pregnant (or 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 this product
This medicinal product contains lactose.
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor
before taking this medicine.
3. 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. This can be taken
once daily (in the morning) or divided into two
doses a day (50 mg in the morning and 50 mg at
midday).
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.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. 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 (affecting more than 1
in 10 people):
• Headache.
Common side effects (affecting fewer than 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).
Uncommon side effects (affecting fewer than 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.
If any of the side effects become troublesome or
your experience any side effects not listed, please
tell your doctor or pharmacist.
5. HOW TO STORE MODAFINIL
Keep out of reach and sight of children.
Do not take Modafinil after the expiry date, which
is stated on the blister strip and the outer pack
after 'EXP'. The expiry date refers to the last day of
that month.
This medicinal product does not require any
special storage conditions.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Modafinil contains:
The active substance is Modafinil.
Each tablet contains 100 mg modafinil
The other ingredients are: Crospovidone (Type A),
Crospovidone (Type B), Starch (maize)
Pregelatinised, Cellulose Microcrystalline,
Povidone K-90, Povidone K-30, Lactose
Monohydrate, Silica colloidal anhydrous, Talc,
Magnesium Stearate.
What Modafinil looks like and contents of the pack
Modafinil is white to off-white coloured capsule
shaped tablet debossed with 'M' on one side and
'100 MG' on the other side.
Packed in blister pack of 10, 30, 60 or 90.
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United
Kingdom.
Manufacturer:
Orchid Europe Ltd, Building 3, Chiswick Park, 566
Chiswick High Road, Chiswick, London, W4 5YA,
United Kingdom.
Mc Dermott Laboratories Ltd T/A Gerard
Laboratories, 35 - 36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.

This leaflet was last approved in: 04/2011

10003225

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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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