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LEVODOPA/CARBIDOPA/ENTACAPONE ACCORD 200 MG/50 MG/200 MG FILM-COATED TABLETS

Active substance(s): CARBIDOPA / ENTACAPONE / LEVODOPA

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Package leaflet: Information for the
user

Placement for Pharmacode no.

Levodopa/Carbidopa/
Entacapone Accord
50 mg/12.5 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/
Entacapone Accord
75 mg/18.75 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/
Entacapone Accord
100 mg/25 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/
Entacapone Accord
125 mg/31.25 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/
Entacapone Accord
150 mg/37.5 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/
Entacapone Accord
200 mg/50 mg/200 mg
film-coated tablets
levodopa/carbidopa/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 Levodopa/Carbidopa/Entacapone
Accord is and what it is used for
2. What you need to know before you take
Levodopa/Carbidopa/Entacapone Accord
3. How to take Levodopa/Carbidopa/
Entacapone Accord
4. Possible side effects
5. How to store Levodopa/Carbidopa/
Entacapone Accord
6. Contents of the pack and other
information

1. What Levodopa/Carbidopa/
Entacapone Accord is and
what it is used for
Levodopa/Carbidopa/Entacapone Accord
contains three active substances
(levodopa, carbidopa and entacapone) in
one film-coated tablet. Levodopa/
Carbidopa/Entacapone Accord is used for
the treatment of Parkinson’s disease.
Parkinson’s disease is caused by low
levels of a substance called dopamine in
the brain. Levodopa increases the amount
of dopamine and hence reduces the
symptoms of Parkinson’s disease.
Carbidopa and entacapone improve the
antiparkinson effects of levodopa.

2. What you need to know
before you take Levodopa/
Carbidopa/Entacapone
Accord
Do not take Levodopa/Carbidopa/
Entacapone Accord if you
- are allergic to levodopa, carbidopa or
entacapone, or any of the other
ingredients of this medicine (listed in
section 6)
- have narrow-angle glaucoma (an eye
disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating
depression (combinations of selective
MAO-A and MAO-B inhibitors, or
non-selective MAO-inhibitors)
- have ever had neuroleptic malignant
syndrome (NMS - this is a rare reaction
to medicines used to treat severe mental
disorders)
- have ever had non-traumatic
rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Levodopa/Carbidopa/Entacapone
Accord if you have or have ever had:
- a heart attack or any other diseases of
the heart including cardiac arrhythmias,
or of the blood vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may
need to be adjusted
- kidney or hormone-related diseases
- stomach ulcers or convulsions
- if you experience prolonged diarrhoea
consult your doctor as it may be a sign of
inflammation of the colon
- any form of severe mental disorder like
psychosis
- chronic wide-angle glaucoma, because
your dose may need to be adjusted and
the pressure in your eyes may need to
be monitored.
Consult your doctor if you are currently
taking:
- antipsychotics (medicines used to treat
psychosis)
- a medicine which may cause low blood
pressure when rising from a chair or bed.
You should be aware that
Levodopa/Carbidopa/Entacapone Accord
may make these reactions worse.
Consult your doctor if during the treatment
with Levodopa/Carbidopa/Entacapone
Accord you:
- notice that your muscles get very rigid or
jerk violently, or if you get tremors,
agitation, confusion, fever, rapid pulse, or
wide fluctuations in your blood pressure.
If any of this happens, contact your
doctor immediately
- feel depressed, have suicidal thoughts,
or notice unusual changes in your
behaviour
- find yourself suddenly falling asleep, or if
you feel very drowsy. If this happens,
you should not drive or use any tools or
machines (see also section 'Driving and
using machines')
- notice that uncontrolled movements
begin or get worse after you started to
take Levodopa/Carbidopa/Entacapone
Accord . If this happens, your doctor may
need to change the dose of your
antiparkinson medicine
- experience diarrhoea: monitoring of your
weight is recommended in order to avoid
potentially excessive weight loss
- experience progressive anorexia,
asthenia (weakness, exhaustion) and
weight decrease within a relatively short
period of time. If this happens, a general
medical evaluation including liver
function should be considered

Size : 150 x 700 mm

- feel the need to stop using Levodopa/
Carbidopa/Entacapone Accord , see
section 'If you stop taking Levodopa/
Carbidopa/Entacapone Accord '.
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
a preoccupation with an increase in sexual
thoughts or feelings. Your doctor may
need to review your treatments.
Your doctor may take some regular
laboratory tests during a long term
treatment with Levodopa/Carbidopa/
Entacapone Accord .
If you must undergo surgery, please tell
your doctor that you are using
Levodopa/Carbidopa/Entacapone Accord.
Levodopa/Carbidopa/Entacapone Accord
is not recommended to be used for
treatment of extrapyramidal symptoms
(e.g. involuntary movements, shaking,
muscle rigidity and muscle contractions)
caused by other medicines.
Children and adolescents
Experience with Levodopa/Carbidopa/
Entacapone Accord in patients under 18
years is limited. Therefore, the use of
Levodopa/Carbidopa/Entacapone Accord
in children is not recommended.
Other medicines and Levodopa/
Carbidopa/Entacapone Accord
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Do not take
Levodopa/Carbidopa/Entacapone Accord
if you are taking certain medicines for
treating depression (combinations of
selective MAO-A and MAO-B inhibitors, or
non-selective MAO inhibitors).
Levodopa/Carbidopa/Entacapone Accord
may increase the effects and side effects
of certain medicines.
These include:
- medicines used to treat depression such
as moclobemide, amitryptiline,
desipramine, maprotiline, venlafaxine
and paroxetine
- rimiterole and isoprenaline, used to treat
respiratory diseases
- adrenaline, used for severe allergic
reactions
- noradrenaline, dopamine and
dobutamine, used to treat heart diseases
and low blood pressure
- alpha-methyldopa, used to treat high
blood pressure
- apomorphine, which is used to treat
Parkinson’s disease.
The effects of
Levodopa/Carbidopa/Entacapone Accord
may be weakened by certain medicines.
These include:
- dopamine antagonists used to treat
mental disorders, nausea and vomiting
- phenytoin, used to prevent convulsions
- papaverine used to relax the muscles.
Levodopa/Carbidopa/Entacapone Accord
may make it harder for you to digest iron.
Therefore, do not take Levodopa/
Carbidopa/Entacapone Accord and iron
supplements at the same time. After
taking one of them, wait at least 2 to 3
hours before taking the other.
Levodopa/Carbidopa/Entacapone
Accord with food and drink
Levodopa/Carbidopa/Entacapone Accord
may be taken with or without food. For
some patients, Levodopa/Carbidopa/
Entacapone Accord may not be well
absorbed if it is taken with, or shortly after
eating protein-rich food (such as meats,
fish, dairy products, seeds and nuts).
Consult your doctor if you think this
applies to you.
Pregnancy, breast-feeding and fertility
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.
You should not breast-feed during
treatment with Levodopa/Carbidopa/
Entacapone Accord .
Driving and using machines
Levodopa/Carbidopa/Entacapone Accord
may lower your blood pressure, which
may make you feel light-headed or dizzy.
Therefore, be particularly careful when
you drive or when you use any tools or
machines.
If you feel very drowsy, or if you
sometimes find yourself suddenly falling
asleep, wait until you feel fully awake
again before driving or doing anything else
that requires you to be alert. Otherwise,
you may put yourself and others at risk of
serious injury or death.

3. How to take Levodopa/
Carbidopa/Entacapone
Accord
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
For adults and elderly:
- Your doctor will tell you exactly how
many tablets of Levodopa/Carbidopa/
Entacapone Accord to take each day.
- The tablets are not intended to be split or
broken into smaller pieces.
- You should take only one tablet each
time.
- Depending on how you respond to
treatment, your doctor may suggest a
higher or lower dose.
- If you are taking Levodopa/Carbidopa/
Entacapone Accord 50 mg/12.5 mg/200
mg, 75 mg/18.75 mg/200 mg, 100 mg/25
mg/200 mg, 125 mg/31.25 mg/200 mg or
150 mg/37.5 mg/200 mg film-coated
tablets, do not take more than 10 tablets
per day.
- If you are taking Levodopa/Carbidopa/
Entacapone Accord 200 mg/50 mg/200
mg film-coated tablets, do not take more
than 7 tablets of this strength per day.
Talk to your doctor or pharmacist if you
think the effect of Levodopa/Carbidopa/
Entacapone Accord is too strong or too
weak, or if you experience possible side
effects.
If you take more Levodopa/Carbidopa/
Entacapone Accord than you should
If you have accidentally taken more
Levodopa/Carbidopa/Entacapone Accord
than you should, talk to your doctor or
pharmacist immediately. In case of an
overdose you may feel confused or
agitated, your heart rate may be slower or
faster than normal or the color of your
skin, tongue, eyes or urine may change.

Placement for Pharmacode no.

Placement for internal code no.

If you forget to take Levodopa/
Carbidopa/Entacapone Accord
Do not take a double dose to make up for
a forgotten tablet.
If it is more than 1 hour until your next
dose:
Take one tablet as soon as you remember,
and the next tablet at the normal time.
If it is less than 1 hour until your next
dose:
Take a tablet as soon as you remember,
wait 1 hour, then take another tablet. After
that carry on as normal.
Placement for Pharmacode no.

Always leave at least an hour between
Levodopa/Carbidopa/Entacapone Accord ,
to avoid possible side effects.
If you stop taking Levodopa/Carbidopa/
Entacapone Accord
Do not stop taking
Levodopa/Carbidopa/Entacapone Accord
unless your doctor tells you to. In such a
case your doctor may need to adjust your
other antiparkinson medicines, especially
levodopa, to give sufficient control of your
symptoms. If you suddenly stop taking
Levodopa/Carbidopa/Entacapone Accord
and other antiparkinsonian medicines it
may result in unwanted side effects.
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. Many of the side effects can be
relieved by adjusting the dose.
If you during the treatment with
Levodopa/Carbidopa/Entacapone Accord
experience the following symptoms,
contact your doctor immediately:
- Your muscles get very rigid or jerk
violently, you get tremors, agitation,
confusion, fever, rapid pulse, or wide
fluctuations in your blood pressure.
These can be symptoms of neuroleptic
malignant syndrome (NMS, a rare
severe reaction to medicines used to
treat disorders of the central nervous
system) or rhabdomyolysis (a rare
severe muscle disorder).
- Allergic reaction, the signs may include
hives (nettle rash), itching, rash, swelling
of your face, lips, tongue or throat. This
may cause difficulties in breathing or
swallowing.
Very common (may affect more than 1 in
10 people):
- uncontrolled movements (dyskinesias)
- feeling sick (nausea)
- harmless reddish-brown discoloration of
urine
- muscle pain
- diarrhoea
Common (may affect up to 1 in 10 people):
- light-headedness or fainting due to low
blood pressure, high blood pressure
- worsening of Parkinson`s symptoms,
dizziness, drowsiness
- vomiting, abdominal pain and discomfort,
heartburn, dry mouth, constipation
- inability to sleep, hallucinations,
confusion, abnormal dreams (including
nightmares), tiredness
- mental changes – including problems
with memory, anxiety and depression
(possibly with thoughts of suicide)
- heart or artery disease events (e.g. chest
pain), irregular heart rate or rhythm
- more frequent falling
- shortness of breath
- increased sweating, rashes
- muscle cramps, swelling of legs
- blurred vision
- anaemia
- decreased appetite, decreased weight
- headache, joint pain
- urinary tract infection
Uncommon (may affect up to 1 in 100
people):
- heart attack
- bleeding in the gut
- changes in the blood cell count which
may result in bleeding, abnormal liver
function tests
- convulsions
- feeling agitated
- psychotic symptoms
- colitis (inflammation of the colon)
- discolourations other than urine (e.g.
skin, nail, hair, sweat)
- swallowing difficulties
- inability to urinate
The following side effects have also been
reported:
- hepatitis (inflammation of the liver)
- itching
You may experience the following side
effects:
- Inability to resist the impulse to perform
an action that could be harmful, which
may include:
- strong impulse to gamble excessively
despite serious or personal family
consequences
- altered or increased sexual interest and
behaviour of significant concern to you or
to others, for example, an increased
sexual 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).

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 to protect the environment.

6. Contents of the pack and
other information
What Levodopa/Carbidopa/Entacapone
Accord contains
- The active substances of Levodopa/
Carbidopa/Entacapone Accord are
levodopa, carbidopa and entacapone.
- Each Levodopa/Carbidopa/Entacapone
Accord 50 mg/12.5 mg/200 mg
film-coated tablet contains 50 mg of
levodopa, 12.5 mg of carbidopa and 200
mg of entacapone.
Each Levodopa/Carbidopa/Entacapone
Accord 75 mg/18.75 mg/200 mg
film-coated tablet contains 75 mg of
levodopa, 18.75 mg of carbidopa and 200
mg of entacapone.
Each Levodopa/Carbidopa/Entacapone
Accord 100 mg/25 mg/200 mg film-coated
tablet contains 100 mg of levodopa, 25 mg
of carbidopa and 200 mg of entacapone.
Each Levodopa/Carbidopa/Entacapone
Accord 125 mg/31.25 mg/200 mg
film-coated tablet contains 125 mg of
levodopa, 31.25 mg of carbidopa and 200
mg of entacapone.
Each Levodopa/Carbidopa/Entacapone
Accord 150 mg/37.5 mg/200 mg
film-coated tablet contains 150 mg of
levodopa, 37.5 mg of carbidopa and 200
mg of entacapone.
Each Levodopa/Carbidopa/Entacapone
Accord 200 mg/50 mg/200 mg film-coated
tablet contains 200 mg of levodopa, 50 mg
of carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core
are microcrystalline cellulose,
crospovidone (Type B), povidone K-30,
magnesium stearate and sodium citrate.
- The ingredients in the film-coating are
hypromellose, macrogol 6000, titanium
dioxide (E171), polysorbate 80, iron
oxide red (E172) and iron oxide yellow
(E172) (for 50 mg/12.5 mg/200 mg, 100
mg/25 mg/200 mg and 150 mg/37.5
mg/200 mg).
What Levodopa/Carbidopa/Entacapone
Accord looks like and contents of the
pack
Levodopa/Carbidopa/Entacapone Accord
50 mg/12.5 mg/200 mg film-coated
tablets: Light brown to grayish red colored,
round, approximately 11.3 mm in diameter,
biconvex, film-coated tablets with
debossed “50” on one side and plain on
other side.
Levodopa/Carbidopa/Entacapone Accord
75 mg/18.75 mg/200 mg film-coated
tablets: Light brown to light pink colored,
oval shaped, approximately 15.2 mm in
length and 7.2 mm in width, film-coated
tablets with debossed “75” on one side
and plain on other side.
Levodopa/Carbidopa/Entacapone Accord
100 mg/25 mg/200 mg film-coated tablets:
Light brown to grayish red colored, oval
shaped, approximately 16.7 mm in length
and 7.7 mm in width, film-coated tablets
with debossed “100” on one side and plain
on other side.
Levodopa/Carbidopa/Entacapone Accord
125 mg/31.25 mg/200 mg film-coated
tablets: Light brown to light pink colored,
elongated-ellipse shaped, approximately
15.2 mm in length and 9.7 mm in width,
film-coated tablets with debossed “125” on
one side and plain on other side.
Levodopa/Carbidopa/Entacapone Accord
150 mg/37.5 mg/200 mg film-coated
tablets: Light brown to grayish red colored,
elongated-ellipse shaped, approximately
16.2 mm in length and 10.2 mm in width,
film-coated tablets with debossed “150” on
one side and plain on other side.
Levodopa/Carbidopa/Entacapone Accord
200 mg/50 mg/200 mg film-coated tablets:
Dark brownish red colored, oval shaped,
approximately 19.15 mm in length and
9.05 mm in width, film-coated tablets with
debossed "200" on one side and plain on
other side.
Levodopa/Carbidopa/Entacapone Accord
comes in three different pack sizes (30,
100 or 130 tablets). Not all pack sizes may
be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Manufacturer :
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
Wessling Hungary Kft.,
Fóti út 56., Budapest
1047, Hungary
Pharmacare Premium Ltd.
HHF 003 Hal Far Industrial Estate,
Hal Far, Birzebbugia
BBG 3000, Malta
This leaflet was last revised in 12/2015.

Tell your doctor if you experience any of
these behaviors; 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 via
For UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
For Malta
ADR Reporting
Website:
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Levodopa/
Carbidopa/Entacapone
Accord

Placement for Pharmacode no.

HDPE bottle pack should be used within 6
months after first opening.
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 bottle and the
carton after EXP. The expiry date refers to
the last day of that month.
xxxxxxx-xxxx

Size : 150 x 700 mm

Placement for internal code no.

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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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