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ENTACAPONE NICHE 200 MG FILM-COATED TABLETS

Active substance(s): ENTACAPONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Entacapone Niche 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.
In this leaflet:

1. What Entacapone Niche is and what it is used for
2. What you need to know before you take
Entacapone Niche
3. How to take Entacapone Niche
4. Possible side effects
5. How to store Entacapone Niche
6. Contents of the pack and other information

1. What Entacapone Niche is and
what it is used for
Entacapone Niche film-coated tablets contain
entacapone and are used together with levodopa
to treat Parkinson’s disease in adults. Entacapone
Niche improves the therapeutic effect of levodopa
in relieving the symptoms of Parkinson's disease.
Entacapone Niche 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 Niche
Do not take Entacapone Niche:
■ If you are allergic to entacapone or any of the
other ingredients of this medicine (listed in
section 6).
■ If you have a tumour of the adrenal gland
(known as pheochromocytoma; this may
increase the risk of severe high blood pressure);
■ If you are taking certain antidepressants (ask
your doctor or pharmacist whether your
antidepressive medicine can be taken together
with Entacapone Niche);
■ 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 Possible
side-effects for the characteristics of NMS;
■ If you have ever suffered from a rare muscle
disorder called rhabdomyolysis which was not
caused by injury.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Entacapone Niche:
■ 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 prolonged diarrhoea consult
your doctor as it may be a sign of inflammation
of the colon;
■ if you experience diarrhoea, monitoring of your
weight is recommended in order to avoid
potentially excessive weight loss;
■ if you experience excessive gambling or
excessive sexual activity;
■ if you experience increasing loss of appetite,
weakness, exhaustion and weight loss within a
relatively short period of time, a general medical
evaluation including liver function should be
considered.
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 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 Niche 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 Niche. 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 Niche and
other medicines to treat Parkinson’s disease are
suddenly stopped or the dose is suddenly
reduced. For the characteristics of NMS see
section 4 Possible side effects. Your doctor may
advise you to slowly discontinue the treatment
with Entacapone Niche and other medicines to
treat Parkinson’s disease
Entacapone Niche 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").
Other medicines and Entacapone Niche
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. In particular please tell your doctor if
you are taking any of the following:
■ rimiterole, isoprenaline, adrenaline,
noradrenaline, dopamine, dobutamine, alphamethyldopa, apomorphine;
■ antidepressants including desipramine,
maprotiline, venlafaxine, paroxetine;
■ warfarin used to thin the blood;
■ iron supplements. Entacapone Niche may make
it harder for you to digest iron. Therefore, do
not take Entacapone Niche and iron
supplements at the same time. After taking
either one of them, wait at least 2 to 3 hours
before taking the other.
Pregnancy, breast-feeding and fertility
Do not use Entacapone Niche 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 Niche 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 Niche taken with levodopa
may make you feel very drowsy, or cause you to
sometimes find yourself suddenly falling asleep.
Do not drive or operate machinery if you
experience these side effects.
Entacapone Niche 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 Entacapone Niche
Always take thsi medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
Entacapone Niche 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 Niche 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 Niche.
If you are receiving dialysis for renal insufficiency,
your doctor may tell you to increase the time
between doses.

Use in children and adolescents
Experience with Entacapone Niche in patients under
18 years is limited. Therefore, the use of Entacapone
Niche in children cannot be recommended.
If you take more Entacapone Niche than you
should
In the event of an overdose, consult your doctor,
pharmacist or the nearest hospital immediately.
If you forget to take Entacapone Niche
If you forget to take the Entacapone Niche tablet
with your levodopa dose, you should continue the
treatment by taking the next Entacapone Niche
tablet with your next levodopa dose. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Entacapone Niche
Do not stop taking Entacapone Niche 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 Niche and other medicines to treat
Parkinson's disease may result in unwanted side
effects. See section 2 Warnings and precautions.
If you have any further questions on the use of this
product, 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 Niche 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 treatment. If you experience
such side effects at the start of treatment with
Entacapone Niche you should contact your doctor
who may decide to adjust your dosage of levodopa.
The following side effects have been observed
during treatment with entacapone:
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, fall
■ 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)
Uncommon (may affect up to 1 in 100 people):
■ Heart attack
Rare (may affect up to 1 in 1,000 people):
■ Rashes
■ Abnormal results in liver function test
Very rare (may affect up to 1 in 10,000 people):
■ Agitation
■ Decreased appetite, weight loss
■ Hives
Not known (frequency cannot be estimated from
the available data):
■ Inflammation of the colon (colitis), inflammation
of the liver (hepatitis) with yellowing of the skin
and whites of the eyes
■ Discolouration of skin, hair, beard and nails
When Entacapone Niche 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
■ Nausea
■ Abdominal pain
Other important side effects which may occur:
■ Entacapone Niche taken with levodopa may
rarely make you feel 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 central nervous system. It is
characterised by stiffness, muscle twitching,
shaking, agitation and 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 and may lead to kidney problems
You may experience the following side effects:
■ Inability to resist the impulse to perform an
action that could be harmful, which may include:
q strong impulse to gamble excessively despite
serious personal or family consequences,
q altered or increased sexual interest and
behaviour of significant concern to you or to
others, for example, an increased sexual drive,
q uncontrollable excessive shopping or spending,
q 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 the symptoms.
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 (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
United Kingdom
You can report side effects directly using the Yellow
Card scheme at: www.mhra.gov.uk/yellowcard.


5. How to store Entacapone Niche
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 carton and on the bottle
label after ‘EXP’. The expiry date refers to the last
day of that month.
This medicine does not require any special storage
conditions.
Entacapone tablets can be used up to 45 days
after first opening of the container.
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 Niche contains
■ The active substance is entacapone. Each tablet
contains 200 mg of entacapone.
■ The other ingredients in the tablet core are:
maize starch, sodium starch glycollate (type A),
silica (colloidal anhydrous), povidone, polysorbate,
mannitol and magnesium stearate.
■ The film-coating contains: hypromellose, lactose
monoydrate, titanium dioxide (E 171), macrogol,
iron oxide yellow (E 172), talc and iron oxide red
(E 172).
What Entacapone Niche looks like and
contents of the pack
■ Entacapone Niche 200mg film-coated tablets
are brown, capsule-shaped, biconvex filmcoated tablets, with debossing “70” on obverse
side and plain on reverse.
■ There are four different pack sizes (bottles
containing 30, 60, 100 or 175 tablets). Not all
pack sizes may be marketed.
Marketing Authorisation Holder:
Niche Generics Limited, 1 The Cam Centre, Wilbury
Way, Hitchin, Herts SG4 0TW, United Kingdom.
Manufacturer:
Niche Generics Limited, Unit 5, 151 Baldoyle
Industrial Estate, Dublin 13, Ireland.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
United Kingdom, Ireland: Entacapone Niche 200mg
film-coated tablets
Germany: Entacapon Unichem 200mg Filmtabletten
The Netherlands: Entacapone Unichem 200mg
filmomhulde tabletten
This leaflet was last revised: March 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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