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ENTACAPONE MYLAN 200 MG FILM-COATED TABLETS

Active substance(s): ENTACAPONE

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170 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

ENTACAPONE
200 mg
FILM-COATED
TABLETS
(entacapone)

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 or
pharmacist. This includes any side effects not listed in
this leaflet.
What is in this leaflet:
1. What Entacapone is and what it is used for.
2. What you need to know before you take Entacapone.
3. How to take Entacapone.
4. Possible side effects.
5. How to store Entacapone.
6. Contents of the pack and other information.
1. WHAT ENTACAPONE IS AND WHAT IT IS USED FOR
Entacapone tablets contain entacapone and are used
together with levodopa to treat Parkinson's disease.
Entacapone aids levodopa in relieving the symptoms of
Parkinson's disease. Entacapone has no effect on
relieving the symptoms of Parkinson's disease unless
taken with levodopa.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ENTACAPONE

Warnings and precautions
Talk to your doctor or pharmacist before taking
Entacapone:
• if you have ever had a heart attack or any other
diseases of the heart
• if you are taking a medicine which may cause dizziness
or light-headedness (low blood pressure) when rising
from a chair or bed
• if you experience any unexplained muscle pain,
tenderness or weakness, or sensitivity to pressure
• if you experience prolonged diarrhoea consult your
doctor as it may be a sign of inflammation of the colon
(large intestine or gut)
• if you experience diarrhoea, monitoring of your weight
is recommended in order to avoid potentially
excessive weight loss
• if you experience increasing loss of appetite, weakness,
exhaustion and weight loss within a relatively short
period of time. Your doctor may consider doing a
general medical evaluation including testing your liver
function.
Tell your doctor if you or your family/carer notices you
are developing urges or cravings to behave in ways that
are unusual for you or you cannot resist the impulse,
drive or temptation to carry out certain activities that
could harm yourself or others. These behaviours are
called impulse control disorders and can include

As Entacapone tablets will be taken together with other
levodopa medicines, please also read the package
leaflets of these medicines carefully.
The dose of other medicines to treat Parkinson's disease
may need to be adjusted when you start taking
Entacapone. Follow the instructions that your doctor has
given you.
Neuroleptic Malignant Syndrome (NMS) is a serious but
rare reaction to certain medicines, and may occur
especially when Entacapone and other medicines to
treat Parkinson's disease are suddenly stopped or the
dose is suddenly reduced. For the symptoms of NMS see
Section 4 (Possible side effects). Your doctor may advise
you to slowly discontinue the treatment with
Entacapone and other medicines to treat Parkinson's
disease.
Entacapone taken with levodopa may cause drowsiness
and may cause you to sometimes suddenly fall asleep. If
this happens, you should not drive or use any tools or
machines (see 'Driving and using machines').
Children and adolescents
Experience with Entacapone in patients under 18 years
is limited. Therefore, the use of Entacapone in children is
not recommended.
Other medicines and Entacapone
Tell your doctor or pharmacist if you are taking,
have recently taken, or might take any other medicines
including medicines obtained without a prescription or
herbal medicines.
In particular please tell your doctor if you are taking any
of the following:
• rimiterole, isoprenaline, adrenaline, noradrenaline,
dopamine, dobutamine, alpha-methyldopa,
apomorphine
• antidepressants: tricyclic antidepressants (such as
amitriptyline), desipramine, maprotiline, venlafaxine,
paroxetine, reversible monoamine oxidase inhibitors
type A (such as moclobemide)
• warfarin (used to thin the blood)
• iron supplements. Entacapone may make it harder for
you to digest iron. Therefore, do not take Entacapone
and iron supplements at the same time. After taking
one of them, wait at least 2 to 3 hours before taking
the other.
Entacapone with food, drink and alcohol
This medicine can be taken with or without food.
Pregnancy, breast-feeding and fertility
Do not use Entacapone during pregnancy or if you are
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.
Driving and using machines
Entacapone taken together with levodopa may
lower your blood pressure, which may make you feel
light-headed or dizzy. Be particularly careful when you
drive or when you use tools or machinery. In addition,
Entacapone taken with levodopa may make you feel
very drowsy, or cause you to sometimes suddenly fall
asleep. Do not drive or operate machinery if you
experience these side effects.
Entacapone contains sucrose.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE ENTACAPONE
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Entacapone is taken together with medicines containing
levodopa (either levodopa/carbidopa preparations or
levodopa/benserazide preparations). You may also use
other medicines to treat Parkinson's disease at the same
time.
The recommended dose of Entacapone is one 200 mg
tablet with each levodopa dose. The maximum
recommended dose is 10 tablets per day, i.e. 2,000 mg of
Entacapone.
If you are receiving dialysis because you have kidney
problems, your doctor may tell you to increase the time
between doses.
If you take more Entacapone than you should
In the event of an overdose, consult your doctor or the
nearest hospital immediately. Symptoms include
confusion, decreased activity, feeling sleepy, decreased
muscle tone, skin discolouration and urticaria (hives).

If you forget to take Entacapone
If you forget to take the Entacapone tablet with your
levodopa dose, you should continue the treatment by
taking the next Entacapone tablet with your next
levodopa dose. Do not take a double dose to make up
for a forgotten tablet.
If you stop taking Entacapone
Do not stop taking Entacapone unless your doctor tells
you to. When stopping, your doctor may need to
re-adjust the dosage of your other medicines to treat
Parkinson's disease. Suddenly stopping Entacapone and
other medicines to treat Parkinson's disease may result
in unwanted side effects. See Section 2 of this leaflet
(Warnings and precautions).
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. Usually side effects
caused by Entacapone are mild to moderate.
Some of the side effects are often caused by the
increased effects of levodopa therapy and are most
common at the start of the treatment. If you experience
such effects at the start of treatment with Entacapone
you should contact your doctor who may decide to
adjust your dosage of levodopa.
Tell your doctor if you get any of the following side
effects:
• Entacapone taken with levodopa may rarely make you
feel very drowsy during the day, and cause you to
suddenly fall asleep.
• Neuroleptic Malignant Syndrome (NMS) is a rare severe
reaction to medicines used to treat disorders of the
nervous system and can happen when these
medicines are discontinued or stopped abruptly. It is
characterised by stiffness, muscle twitching, shaking,
agitation, confusion, coma, high body temperature,
increased heart rate and unstable blood pressure.
• A rare severe muscle disorder (rhabdomyolysis) which
causes pain, tenderness and weakness of the muscles,
sensitivity to pressure, and may lead to kidney
problems.
• Inability to resist the impulse to perform an action that
could be harmful, which may include:
* strong impulse to gamble excessively despite serious
personal or family consequences
* altered or increased sexual interest and behaviour of
significant concern to you or to others, for example,
an increased sex drive
* uncontrollable excessive shopping or spending
* binge eating (eating large amounts of food in a short
time period) or compulsive eating (eating more food
than normal and more than is needed to satisfy your
hunger).
Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing or
reducing these symptoms.
• Heart attack (symptoms include chest pain which can
feel as if it is travelling to other parts of your body such
as your left arm, jaw and neck, shortness of breath,
anxiety, feeling light-headed and nausea (feeling sick)
or vomiting (being sick). This is an uncommon side
effect (may affect up to 1 in 100 people).
• Inflammation of the colon (colitis; symptoms include
prolonged or persistent diarrhoea) or inflammation of
the liver (hepatitis) with yellowing of the skin and
whites of the eyes. The frequency of these side effects
is not known (cannot be estimated from the available
data).
Other side effects:
Very common side effects (may affect more than 1 in
10 people):
• uncontrollable movements with difficulty in
performing voluntary movements (dyskinesias)
• feeling sick (nausea)
• harmless reddish-brown discoloration of urine.
Common side effects (may affect up to 1 in 10 people):
• excessive movements (hyperkinesias), worsening of
symptoms of Parkinson's disease, prolonged muscle
cramps (dystonia)
• being sick (vomiting), diarrhoea, abdominal pain,
constipation, dry mouth
• dizziness, tiredness, increased sweating, falling
• hallucinations (seeing/hearing/feeling/smelling things
that are not really there), sleeplessness, vivid dreams,
and confusion
• heart or artery disease events (e.g. chest pain, angina).

Not known (frequency cannot be estimated from the
available data):
• discolouration of the skin, hair, beard and nails.
When Entacapone is given at higher doses:
In doses of 1,400 to 2,000 mg per day, the following
side effects are more common:
• uncontrollable movements with difficulty in
performing voluntary movements (dyskinesias)
• feeling sick (nausea)
• abdominal pain.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
Also you can help to make sure that medicines remain as
safe as possible by reporting any unwanted side effects
via the internet at http://www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or
fill in a paper form available from your local pharmacy.
5. HOW TO STORE ENTACAPONE
Keep this medicine out of the sight and reach of
children. Do not use this medicine after the expiry date
which is stated on the label, carton, bottle after 'EXP'.
The expiry date refers to the last day of that month.
Blister pack: This medicinal product does not require
any special storage conditions.
Bottle pack: This medicinal product does not require
any special storage conditions. Once open use within
100 days.
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 Entacapone contains
• The active substance(s) is entacapone. Each tablet
contains 200 mg of entacapone.
• The other ingredient(s) in the tablet core are
cellulose, microcrystalline, mannitol,
hydroxypropylcellulose, low-substituted, magnesium
stearate, hydrogenated vegetable oil.
• The film-coating contains hypromellose, titanium
dioxide (E171), glycerin, magnesium stearate, iron
oxide yellow (E172), sucrose, polysorbate 80, iron
oxide red (E172).
What Entacapone looks like and contents of the pack
Entacapone 200 mg film-coated tablets are light
orange, oval-shaped, biconvex, film coated tablets
debossed with 'EE200' on one side of the tablet and 'M'
on the other side. They are packed in blisters, bottles
and cartons containing multiple bottles.
Blister packs comprise of clear transparent
PVC/PE/PVdC film on one side and hard tempered
aluminium foil coated with heat seal lacquer on the
other side containing 30, 60, 100, 200, 300 or 400
tablets, or a perforated blister unit dose pack
containing 100x1 tablets.
Bottle packs comprise of white coloured high-density
polyethylene (HDPE) bottle with white opaque
polypropylene (PP) screw cap containing 30, 50, 60,
100, 250 or 500 tablets.
Cartons containing 200, 300, or 400 tablets as 4, 6 or 8
bottles of 50 tablets. Bottles comprise of white
coloured high-density polyethylene (HDPE) bottle with
white opaque polypropylene (PP) screw cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1,
Hungary.
Generics [UK] Limited, Station Close, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.

Rare side effects (may affect up to 1 in 1,000 people):
• rashes characterised by redness or bumps on the skin,
• abnormal results in liver function tests.
Very rare side effects (may affect up to 1 in 10,000
people):
• agitation
• decreased appetite, weight loss
• hives.
This leaflet was last revised in: 07/2013

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Do not take Entacapone
• if you are allergic to entacapone or any of the other
ingredients of this medicine (listed in Section 6).
Symptoms of allergy include shortness of breath,
wheezing or difficulty breathing; swelling of the face,
lips, tongue or other parts of the body; rash, itching or
hives on the skin
• if you have phaeochromocytoma, a tumour of the
adrenal gland (a gland which sits near the kidney)
because this may increase the risk of severe high blood
pressure
• if you are taking certain antidepressants known as
non-selective monoamine oxidase inhibitors (MAOIs).
Examples include phenelzine and tranylcypromine
(ask your doctor or pharmacist whether your
antidepressive medicine can be taken together with
Entacapone)
• if you are taking reversible monoamine oxidase
inhibitors type A (such as moclobemide) together with
monoamine oxidase inhibitors type B (examples
include selegiline)
• if you have liver disease
• if you have ever suffered from a rare reaction to
antipsychotic medicines called neuroleptic malignant
syndrome (NMS). See Section 4 of this leaflet (Possible
side effects) for the symptoms of NMS.
• if you have ever suffered from a rare muscle disorder
called rhabdomyolysis which was not caused by injury.
Rhabdomyolysis causes pain, tenderness and
weakness of the muscles, sensitivity to pressure, and
may lead to kidney problems.

addictive gambling, excessive eating or spending, an
abnormally high sex drive or an increase in sexual
thoughts or feelings. Your doctor may need to review
your treatments.

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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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