Skip to Content

LEVODOPA/CARBIDOPA/ENTACAPONE MYLAN 100 MG/25 MG/200 MG FILM-COATED TABLETS

Active substance(s): CARBIDOPA / ENTACAPONE / LEVODOPA

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: information for the user

Levodopa/Carbidopa/Entacapone
50 mg/12.5 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/Entacapone
75 mg/18.75 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/Entacapone
100 mg/25mg/200 mg
film-coated tablets
Levodopa/Carbidopa/Entacapone
125 mg/31.25 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/Entacapone
150 mg/37.5 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/Entacapone
175 mg/43.75 mg/200 mg
film-coated tablets
Levodopa/Carbidopa/Entacapone
200 mg/50 mg/200 mg
film-coated tablets
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 symptoms 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 is
and what it is used for
2. What you need to know before you take
Levodopa/Carbidopa/Entacapone
3. How to take Levodopa/Carbidopa/
Entacapone
4. Possible side effects
5. How to store Levodopa/Carbidopa/
Entacapone
6. Contents of the pack and other information

1. What Levodopa/Carbidopa/
Entacapone is and what it is
used for
Levodopa/Carbidopa/Entacapone contains
three active substances (levodopa, carbidopa
and entacapone) in one film-coated tablet.
Levodopa/Carbidopa/Entacapone 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
Do not take Levodopa/Carbidopa/
Entacapone if you

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.
If you must undergo surgery, please tell
your doctor that you are using Levodopa/
Carbidopa/Entacapone.
Levodopa/Carbidopa/Entacapone 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 in patients under 18 years is
limited. Therefore, the use of Levodopa/
Carbidopa/Entacapone in children is
not recommended.

Other medicines and Levodopa/
Carbidopa/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 and herbal medicines.
Do not take Levodopa/Carbidopa/Entacapone
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 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 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 may make
it harder for you to digest iron. Therefore, do
not take Levodopa/Carbidopa/Entacapone
and iron supplements at the same time. After
taking one of them, wait at least 2 to 3 hours
before taking the other.

• 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.

Levodopa/Carbidopa/Entacapone with
food and drink

Warnings and precautions

You should not breast-feed during treatment
with Levodopa/Carbidopa/Entacapone.

Talk to your doctor or pharmacist before
taking Levodopa/Carbidopa/Entacapone if
you have or have ever had:
• a heart attack or any other diseases of the
heart including cardiac arrythmias, 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 may make these reactions worse.
Consult your doctor if during the treatment
with Levodopa/Carbidopa/Entacapone 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 . 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
• feel the need to stop using Levodopa/
Carbidopa/Entacapone, see section 'If
you stop taking Levodopa/Carbidopa/
Entacapone'.

Levodopa/Carbidopa/Entacapone may be
taken with or without food. For some patients,
Levodopa/Carbidopa/Entacapone 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, 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

Levodopa/Carbidopa/Entacapone 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.

Levodopa/Carbidopa/Entacapone
contains Lactose

Levodopa/Carbidopa/Entacapone contains
milk sugar (lactose). If you have been told by
your doctor that you have intolerance to some
sugars, contact your doctor before taking this
medicinal product.

3. How to take Levodopa/Carbidopa/
Entacapone
Always take this medicine exactly as your
doctor or pharmacist has told you. You should
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
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 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 tablets, do not take
more than 10 tablets per day.
* If you are taking Levodopa/Carbidopa/
Entacapone 175 mg/43.75 mg/200 mg
tablets, do not take more than 8 tablets
per day.
* If you are taking Levodopa/Carbidopa/
Entacapone 200 mg/50 mg/200 mg
tablets, do not take more than 7 tablets
per day.
Talk to your doctor or pharmacist if you think
the effect of Levodopa/Carbidopa/Entacapone
is too strong or too weak, or if you experience
possible side effects

A20011561/00

Description Levodopa Carbidopa Entacapone All All
Component Type Leaflet
Affiliate Item Code 596990
Superceded Affiliate Item Code n/a
TrackWise PR No. 596990

Pharma Code 8999
SAP No. n/a
Vendor Job No. 249657
Trackwise Proof No. 12

MA No. n/a

Glams Proof No. n/a

Packing Site/Printer n/a

Client Market UK

Supplier Code A20011561/00 Keyline/Drawing No. n/a
Barcode Info n/a

Date: 01 Dec 2015
No. of colours
Colours

1

Time: 10:14
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 150 x 560 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v1/May 2015

If you take more Levodopa/Carbidopa/
Entacapone than you should

If you have accidentally taken more Levodopa/
Carbidopa/Entacapone tablets 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 colour of
your skin, tongue, eyes or urine may change.

If you forget to take Levodopa/
Carbidopa/Entacapone

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.
Always leave at least an hour between
Levodopa/Carbidopa/Entacapone tablets, to
avoid possible side effects.

If you stop taking Levodopa/Carbidopa/
Entacapone

Do not stop taking Levodopa/Carbidopa/
Entacapone 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 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. If
you experience any of these side effects, talk to
your doctor as soon as possible. Many of the side
effects can be relieved by adjusting the dose.
If you during the treatment with Levodopa/
Carbidopa/Entacapone 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.

Shelf life after first opening the container:
3 months
Store below 25°C.
Only for blistered product: Store in the original
packaging in order to protect from moisture
Only for bottle product: Store in the original
packaging and keep the bottle tightly closed in
order to protect from moisture.
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
contains

• The active substances are levodopa,
carbidopa and entacapone.
* Each film-coated tablet contains 50 mg
of levodopa, 12.5 mg of carbidopa
anhydrous (as 13.5mg carbidopa
monohydrate) and 200 mg of entacapone.
* Each film-coated tablet contains
75 mg of levodopa, 18.75 mg of
carbidopa anhydrous (as 20.24 mg
carbidopa monohydrate) and 200 mg
of entacapone.
* Each film-coated tablet contains
100 mg of levodopa, 25 mg of
carbidopa anhydrous (as 27 mg
carbidopa monohydrate) and 200 mg
of entacapone.
* Each film-coated tablet contains
125 mg of levodopa, 31.25 mg of
carbidopa anhydrous (as 33.74 mg
carbidopa monohydrate) and 200 mg
of entacapone.
* Each film-coated tablet contains
150 mg of levodopa, 37.5 mg of
carbidopa anhydrous (as 40.48 mg
carbidopa monohydrate) and 200 mg
of entacapone.
* Each film-coated tablet contains
175 mg of levodopa, 43.75 mg of
carbidopa anhydrous (as 47.23 mg
carbidopa monohydrate) and 200 mg
of entacapone.
* Each film-coated tablet contains
200 mg of levodopa, 50 mg of
carbidopa anhydrous (as 54 mg
carbidopa monohydrate) and 200 mg
of entacapone.
• The other ingredients in the tablet core
are croscarmellose sodium E468, cellulose
microcrystalline E460, poloxamer 188,
hydroxypropyl cellulose E463, lactose
monohydrate, magnesium stearate E470b.
• The ingredients in the film-coating are

Very common (may affect more than 1 in
10 people)
• uncontrolled movements (dyskinesias)
• feeling sick (nausea)
• harmless reddish-brown discolouration of urine
• muscle pain
• diarrhoea

50mg/12.5mg/200mg; 100mg/25mg/200mg;
150mg/37.5mg/200mg:
Hypromellose, type 2910, Titanium Dioxide
E 171, Glycerol E 422, Red Iron Oxide E172,
Yellow Iron Oxide E172, Magnesium Stearate
E 470b, Polysorbate 80 E433, Hydroxypropyl
cellulose E463

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

75mg/18.75mg/200mg;
125mg/31.25mg/200mg;
175mg/43.75mg/200mg:
Hypromellose, type 2910, Titanium Dioxide
E171, Glycerol E422, Red Iron Oxide E172,
Magnesium Stearate E470b, Polysorbate
80 E433, Hydroxypropyl cellulose E463

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).
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 via the Yellow Card
Scheme at 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 Levodopa/Carbidopa/
Entacapone

200mg/50mg/200mg
Hypromellose, type 2910, Titanium Dioxide
E171, Glycerol E422, Red Iron Oxide E172,
Magnesium Stearate E470b, Polysorbate
80 E433, Hydroxypropyl cellulose E463

What Levodopa/Carbidopa/Entacapone
looks like and contents of the pack

Levodopa/Carbidopa/Entacapone
50 mg/12.5 mg/200 mg film-coated tablets:
brownish red coloured round shaped,
biconvex, film-coated tablets debossed `50’ on
one side and plain on the other side.
Levodopa/Carbidopa/Entacapone
75 mg/18.75 mg/200mg film-coated tablets:
light brownish red coloured oval shaped,
biconvex, film coated tablets debossed “75” on
one side and plain on the other side.
Levodopa/Carbidopa/Entacapone
100 mg/25 mg/200 mg film-coated tablets:
brownish red coloured oval, shaped, biconvex,
film-coated tablets debossed `100’ on one side
and plain on the other side.
Levodopa/Carbidopa/Entacapone
125 mg/31.25 mg/200 mg film-coated tablets:
light brownish red coloured oval shaped,
biconvex, film-coated tablets debossed `125’
on one side and plain on the other side.
Levodopa/Carbidopa/Entacapone
150 mg/37.5 mg/200 mg film-coated tablets:
brownish red coloured oval shaped, biconvex,
film-coated tablets debossed `150’ on one side
and plain on the other side.
Levodopa/Carbidopa/Entacapone
175 mg/43.75 mg/200 mg film-coated tablets:
light brownish red coloured oval shaped,
biconvex, film-coated tablets debossed `175’
on one side and plain on the other side.
Levodopa/Carbidopa/Entacapone
200 mg/50 mg/200 mg film-coated tablets:
dark brownish red coloured oval shaped,
biconvex, film-coated tablets debossed `200’
on one side and plain on the other side.
Levodopa/Carbidopa/Entacapone comes in
different pack sizes as HDPE bottle with an
Aluminium Induction Seal –Cap and Silica Gel
Canister (as a loose component) in the HDPE
bottle and Blister (Aluminium-Aluminium)
containing 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.

Manufacturer

Wessling Hungary Kft, Budapest,
Fóti út.56. 1047, Hungary
Mylan Hungary Kft, H-2900 Komarom,
Mylan utca, Hungary
This leaflet was last revised in 12/2015

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.

596990
A20011561/00

Description Levodopa Carbidopa Entacapone All All
Component Type Leaflet
Affiliate Item Code 596990
Superceded Affiliate Item Code n/a
TrackWise PR No. 596990

Pharma Code 8999
SAP No. n/a
Vendor Job No. 249657
Trackwise Proof No. 12

MA No. n/a

Glams Proof No. n/a

Packing Site/Printer n/a

Client Market UK

Supplier Code A20011561/00 Keyline/Drawing No. n/a
Barcode Info n/a

Date: 01 Dec 2015
No. of colours
Colours

1

Time: 10:14
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 150 x 560 mm

Body Text Size 9.5 pt
Min Text Size used 9.5 pt

Sign-offs

v1/May 2015

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.

Hide