PROVIGIL 200 MG TABLETS

Active substance: MODAFINIL

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1577-7 Provigil P1.indd

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5%

Provigil 100mg
UK
PIL (FRONT)
1 (One)
MACORS_PIL_011_V1
H 25.1969 x W 17.7165“
H 420 x W 157 mm
H 210mm x W 157mm
N/A
N/A
code 128: TBA
TBA
Macors
25 Mar 13
371957A01

Schawk
Kingsway North, Team Valley, Gateshead,
Tyne & Wear, NE11 0JH, England
Tel: +44 191 491 7777
V1.08.2007

Artwork Approval Signature Box

Schawk

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Regulatory 1

Legal
(Trademark check)
Packaging Ctrl.

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROVIGIL 100 mg Tablets
PROVIGIL® 200 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 you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet.
In this leaflet:
1. What PROVIGIL is and what it is used for
2. Before you take PROVIGIL
3. How to take PROVIGIL
4. Possible side effects
5. How to store PROVIGIL
6. Further information
1. WHAT PROVIGIL 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 PROVIGIL
Do not take PROVIGIL if you:
• Are allergic (hypersensitive) to modafinil,
or to any of the other ingredients of these
tablets (see section 6 ‘What PROVIGIL
contains’).
• Have an irregular heartbeat.
• Have uncontrolled, moderate
to severe high blood pressure
(hypertension).
Take special care with 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.
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 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 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 think that you may be),
are planning to become pregnant, or are breast
feeding, you should not take PROVIGIL. 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 PROVIGIL (and for two months after
stopping) or if you have any other concerns.
Driving and using machines
PROVIGIL 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 PROVIGIL
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 PROVIGIL 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.
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 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
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, PROVIGIL 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.

Profile Name: MACORS_PIL_011_V1
Component: PIL
Dimensions: H 16.5354 x W 6.1811“
H 420 x W 157 mm
Folded Size:
H 8.2677 x W 6.1811“
H 210 x W 157 mm
Product:
Provigil, Modiodal, Vigil
Markets:
Germany, Spain, France,
Greece, Ireland, Italy,
Netherlands, UK
Version:
01
Date:
29 Nov 12

1577-7 Provigil P1.indd

TINT VALUES
Cephalon Job No.:
Iteration No.:

1577/7
01

TEXT SIZE

Profile Key

Black - 10%

The SMALLEST
BODY text on this
A/W is at:

All Over Varnish Unless Marked

9.0 pt

Non Print
Area

Fold

Varnish Free
Area

Perforation

Black

100%

90%

50%

Product Name
Market
Component
No. of Colours
Profile
Dimensions
Folded Size:
Stock Code
Barcode
Pharmacode
Material No.
Packaging supp.
Date
Schawk Job No.

5%

Provigil 100mg
UK
PIL (BACK)
1 (One)
MACORS_PIL_011_V1
H 25.1969 x W 17.7165“
H 420 x W 157 mm
H 210mm x W 157mm
N/A
N/A
code 128: TBA
TBA
Macors
25 Mar 13
371957A01

Schawk
Kingsway North, Team Valley, Gateshead,
Tyne & Wear, NE11 0JH, England
Tel: +44 191 491 7777
V1.08.2007

Artwork Approval Signature Box

Schawk

Site Packaging

Regulatory 1

Legal
(Trademark check)
Packaging Ctrl.

• 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.

6. FURTHER INFORMATION
What PROVIGIL contains
The active substance is modafinil. Each
PROVIGIL 100 mg tablet contains 100 mg
of modafinil. Each PROVIGIL 200 mg tablet
contains 200 mg of modafinil. 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 30,
60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
manufacturers
Marketing Authorisation Holder
Teva Pharma B.V.
Computerweg 10
3542DR Utrecht
The Netherlands
Manufacturers
Laboratoires Macors,
Rue des Caillottes,
ZI Plaine des Isles,
89000 Auxerre,
France.
This leaflet was last approved in 03/2013
PROVIGIL is a registered trademark of Cephalon, Inc.,
or its affiliates

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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
5. HOW TO STORE PROVIGIL
Keep out of the reach and sight 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.
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.
TBA -1577/7

TBA

Profile Name: MACORS_PIL_011_V1
Component: PIL
Dimensions: H 16.5354 x W 6.1811“
H 420 x W 157 mm
Folded Size:
H 8.2677 x W 6.1811“
H 210 x W 157 mm
Product:
Provigil, Modiodal, Vigil
Markets:
Germany, Spain, France,
Greece, Ireland, Italy,
Netherlands, UK
Version:
01
Date:
29 Nov 12

Expand view ⇕

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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