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PROVIGIL 200 MG TABLETS

Active substance(s): MODAFINIL / MODAFINIL

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PROVIGIL 100 mg Tablets
PROVIGIL 200 mg Tablets
®

®

ModaÀnil
Read all of this leaÁet carefully before
you start taking this medicine because
it contains important information for you.
- Keep this leaÁet. 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 leaÁet. See section 4.
What is in this leaÁet:
1. What PROVIGIL is and what it is
used for
2. What you need to know before you
take PROVIGIL
3. How to take PROVIGIL
4. Possible side effects
5. How to store PROVIGIL
6. Contents of the pack and other
information
1. What PROVIGIL is and what it is
used for
The active ingredient in the tablets is
modaÀnil. ModaÀnil 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).
ModaÀnil 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.

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Do not take PROVIGIL if you:
• Are allergic to modaÀnil, or any of the
other ingredients of this medicine (listed
in section 6 ‘What PROVIGIL 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 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.
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 PROVIGIL
Tell your doctor or pharmacist if you are
taking have recently taken or might take
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:
• 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 reÁux, 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
Áuoxetine) 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 can cause blurred vision or
dizziness in up to 1 in 10 people.
If you are affected or you Ànd that while
using this medication you still feel very
sleepy, do not attempt to drive or operate
machinery.
PROVIGIL contains Lactose
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.
3. How to take PROVIGIL
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.
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.

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Provigil 100mg & 200mg tabs All Ce UK
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2. What you need to know before you
take PROVIGIL

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

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If you take more PROVIGIL than you
should
If you take too many tablets you may feel
sick, restless, disorientated, confused,
agitated, anxious or excited.
You may also have difÀculty 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 leaÁet 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 a
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 difÀculty 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
difÀculty 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).
• DifÀculty 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.
• DifÀculty swallowing, swollen tongue or
mouth ulcers.
• Excess wind, reÁux (bringing back Áuid
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 inÁamed
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 leaÁet. 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
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 protect the environment.
6. Contents of the pack and other
information
What PROVIGIL contains
The active substance is modaÀnil.
Each PROVIGIL 100 mg tablet contains
100 mg of modaÀnil. Each PROVIGIL
200 mg tablet contains 200 mg of
modaÀnil.
The other ingredients are: lactose
monohydrate, pregelatinised starch
(maize), microcrystalline cellulose,
croscarmellose sodium, povidone K29/32,
magnesium stearate as inactive ingredients.
What PROVIGIL looks like and the
contents of the pack
The tablets come in a capsule shaped,
white to off-white colour, 13 x 6 mm with
“100” on one side for 100 mg tablets,
or 16 x 7 mm with “200” on one side for
200 mg tablets.
PROVIGIL is available in blister packs of
10, 20, 30, 50, 60, 90, 100 or 120
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
manufacturers
Marketing Authorisation Holder
Teva Pharma B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands
Manufacturers
Laboratoires Macors,
Rue des Caillottes, ZI Plaine des Isles,
89000 Auxerre, France.
This leaÁet was last revised in 12/2015
PROVIGIL is a registered trademark of
Cephalon, Inc., or its afÀliates

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Effective Date: TBD

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Valid For 7 Days from 10-Aug-2016

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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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