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MODAFINIL 200 MG TABLETS

Active substance: MODAFINIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Modafinil 100 mg Tablets
Modafinil 200 mg Tablets

Pharmacode
XXXX

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 to any of the
other ingredients of this medicine (listed in
section 6).
• If you have an irregular heartbeat.
• If you 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.
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
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.
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 that
you may be pregnant, or are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine. 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.
Modafinil contains 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.
Older 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

Pharmacode
XXXX

Modafinil

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 dose.
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
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:
o mood swings or abnormal thinking
o aggression or hostility
o forgetfulness or confusion
o feeling of extreme happiness
o over-excitement or hyperactivity
o anxiety or nervousness
o depression, suicidal thoughts or behaviour
o 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the UK 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
Keep this medicine out of the sight and reach of
children.
Do not take this medicine 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 the month.
This medicinal product does not require any
special storage conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.

6. Contents of the pack and other
information
What Modafinil contains
The active substance is modafinil.
Each Modafinil 100 mg tablet contains 100 mg of
modafinil.
Each Modafinil 200 mg tablet contains 200 mg of
modafinil.
The other ingredients (excipients) are: lactose
monohydrate, crospovidone (E1202), lactose
anhydrous, povidone K30 (E1201), silica colloidal
anhydrous (E551), sodium stearyl fumarate and
talc (E553b).
What Modafinil looks like and the contents of
the pack
Modafinil 100 mg: white to off-white, 12.65 mm x
5.55 mm capsule shaped tablet embossed with
‘100’.
Modafinil 200 mg: white to off-white, 16 mm x
7mm capsule shaped tablet embossed with ‘200’.
Modafinil100 mg is available in white opaque
PVC/PVDC/aluminium or white opaque
PVC/PE/PCTFE/aluminium blister packs of 30, 50,
60, 90 or 100 tablets.
Modafinil 200 mg is available in white opaque
PVC/PVDC/aluminium or white opaque
PVC/PE/PCTFE/aluminium blister packs of 30 or
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
MA Holder and Manufacturer:
Chanelle Medical,
Loughrea, Co. Galway, Ireland.
Distributor:
Creo Pharma Ltd
Felsted Business Centre, Felsted
Essex CM6 3LY, UK
This leaflet was last revised in February 2015

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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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