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

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.

Do not take Modafinil:
•If you are allergic to modafinil.
•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.
•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 and adolescents
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 longterm 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.

Other medicines and Modafinil
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. 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 beta-blockers 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.
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.

Modafinil tablet contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars contact your
doctor before taking this medicinal product.
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 recommended 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 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, 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 af
fects 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
 (may affect more than 1 in 10 people):
•Headache.
Common (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
 (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