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ENTACAPONE MYLAN 200 MG FILM-COATED TABLETS

Active substance(s): ENTACAPONE / ENTACAPONE / ENTACAPONE

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Package leaflet: Information for the patient

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 possible side
effects not listed in this leaflet. See section 4.

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.

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 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.
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”).

1. What Entacapone is and what it is
used for

Children and adolescents

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.

Other medicines and Entacapone

2. What you need to know before you
take Entacapone
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.

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

Experience with Entacapone in patients under
18 years is limited. Therefore, the use of Entacapone
in children is not recommended.
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.

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. This medicine can be
taken with or without food.
Patients with kidney problems
If you are receiving dialysis because you have kidney
problems, your doctor may tell you to increase the
time between doses.
50062951

Description Entacapone 200 mg 30,100
Component Type Leaflet
Affiliate Item Code 1115770
Superceded Affiliate Item Code 10005285
TrackWise PR No. 1115770
MA No. NA
Packing Site/Printer NA
Supplier Code 50062951

Pharma Code 5164
SAP No. NA
Vendor Job No. 303105
Trackwise Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

Date: 16 Feb 2017
No. of colours
Colours

1

Time: 17:06
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myrid Pro
Dimensions 170 x 360mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v2/Oct 2016

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 (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 (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)

Description Entacapone 200 mg 30,100
Component Type Leaflet
Affiliate Item Code 1115770
Superceded Affiliate Item Code 10005285
TrackWise PR No. 1115770
MA No. NA
Packing Site/Printer NA
Supplier Code 50062951

Pharma Code 5164
SAP No. NA
Vendor Job No. 303105
Trackwise Proof No. 1
Client Market United Kingdom
Keyline/Drawing No. NA
Barcode Info NA

Rare (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 (may affect up to1 in 10,000 people):
• agitation
• decreased appetite, weight loss
• hives
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

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 Yellow Card Scheme website
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 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.
This medicine does not require any special storage
conditions.
For bottle pack only: 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 is entacapone. Each tablet
contains 200 mg of entacapone.
• The other ingredients 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, United
Kingdom.
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
This leaflet was last revised in 02/2017

1115770
50062951

Date: 16 Feb 2017
No. of colours
Colours

1

Time: 17:06
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myrid Pro
Dimensions 170 x 360mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v2/Oct 2016

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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