Skip to Content

LEVODOPA/CARBIDOPA/ENTACAPONE TEVA 50 MG/12.5 MG/200 MG FILM-COATED TABLETS

Active substance(s): CARBIDOPA / ENTACAPONE / LEVODOPA

View full screen / Print PDF » Download PDF ⇩
Transcript
LEVODOPA/CARBIDOPA/
ENTACAPONE TEVA
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,
150 mg/37.5 mg/200 mg,
175 mg/43.75 mg/200 mg
AND 200 mg/50 mg/200 mg
FILM-COATED TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

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.

Levodopa/Carbidopa/Entacapone Teva 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 Teva
in children is not recommended.
Other medicines and Levodopa/Carbidopa/
Entacapone Teva
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Do not take Levodopa/Carbidopa/Entacapone
Teva 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 Teva may
increase the effects and side effects of certain
medicines. These include:
• medicines used to treat depression such as
moclobemide, amitriptyline, desipramine,
maprotiline, venlafaxine and paroxetine
• rimiterole and isoprenaline, used to treat
WHAT IS IN THIS LEAFLET:
respiratory diseases
1. What Levodopa/Carbidopa/Entacapone Teva is • adrenaline, used for severe allergic reactions
• noradrenaline, dopamine and dobutamine,
and what it is used for
used to treat heart diseases and low blood
2. What you need to know before you take
pressure
Levodopa/Carbidopa/Entacapone Teva
3. How to take Levodopa/Carbidopa/Entacapone • alpha-methyldopa, used to treat high blood
pressure
Teva
• apomorphine, which is used to treat
4. Possible side effects
Parkinson’s disease.
5. How to store Levodopa/Carbidopa/
Entacapone Teva
The effects of Levodopa/Carbidopa/Entacapone
6. Contents of the pack and other information
Teva may be weakened by certain medicines.
These include:
What
Levodopa/Carbidopa/
1 Entacapone Teva is and what it is used • dopamine antagonists used to treat mental
disorders, nausea and vomiting
for
• phenytoin, used to prevent convulsions
Levodopa/Carbidopa/Entacapone Teva contains
• papaverine used to relax the muscles.
three active substances (levodopa, carbidopa
Levodopa/Carbidopa/Entacapone Teva may make
and entacapone) in one film-coated tablet.
Levodopa/Carbidopa/Entacapone Teva is used for it harder for you to digest iron. Therefore, do not
take Levodopa/Carbidopa/Entacapone Teva and
the treatment of Parkinson’s disease.
iron supplements at the same time. After taking
Parkinson’s disease is caused by low levels of a
one of them, wait at least 2 to 3 hours before
substance called dopamine in the brain.
taking the other.
Levodopa increases the amount of dopamine
and hence reduces the symptoms of Parkinson’s Levodopa/Carbidopa/Entacapone Teva with food
disease. Carbidopa and entacapone improve the and drink
Levodopa/Carbidopa/Entacapone Teva may be
antiparkinson effects of levodopa.
taken with or without food. For some patients,
you need to know before you take Levodopa/Carbidopa/Entacapone Teva may not
2 What
Levodopa/Carbidopa/
be well absorbed if it is taken with, or shortly
Entacapone Teva
after eating protein-rich food (such as meats,
fish, dairy products, seeds and nuts). Consult
Do not take Levodopa/Carbidopa/Entacapone
your doctor if you think this applies to you.
Teva if you:
• are allergic to levodopa, carbidopa or
Pregnancy, breast-feeding and fertility
entacapone, or any of the other ingredients of If you are pregnant or breast-feeding, think you
this medicine (listed in section 6)
may be pregnant or are planning to have a baby,
• have narrow-angle glaucoma (an eye disorder) ask your doctor or pharmacist for advice before
• have a tumour of the adrenal gland
taking this medicine.
• are taking certain medicines for treating
depression (combinations of selective MAO-A You should not breast-feed during treatment
with Levodopa/Carbidopa/Entacapone Teva.
and MAO-B inhibitors, or non-selective
MAO-inhibitors)
Driving and using machines
• have ever had neuroleptic malignant
Levodopa/Carbidopa/Entacapone Teva may lower
syndrome (NMS – this is a rare reaction to
your blood pressure, which may make you feel
medicines used to treat severe mental
light-headed or dizzy. Therefore, be particularly
disorders)
careful when you drive or when you use any
• have ever had non-traumatic rhabdomyolysis
tools or machines.
(a rare muscle disorder)
If you feel very drowsy, or if you sometimes find
• have a severe liver disease.
yourself suddenly falling asleep, wait until you
Warnings and precautions
feel fully awake again before driving or doing
Talk to your doctor or pharmacist before taking
anything else that requires you to be alert.
Levodopa/Carbidopa/Entacapone Teva if you
Otherwise, you may put yourself and others at
have or have ever had:
risk of serious injury or death.
• a heart attack or any other diseases of the heart
including cardiac arrhythmias, or of the blood Levodopa/Carbidopa/Entacapone Teva contains
lactose
vessels
If you have been told by your doctor that you
• asthma or any other disease of the lungs
• a liver problem, because your dose may need have intolerance to some sugars, contact your
doctor before taking this medicinal product.
to be adjusted
• kidney or hormone-related diseases
Levodopa/Carbidopa/Entacapone Teva
• stomach ulcers or convulsions
100 mg/25 mg/200 mg also contains
• if you experience prolonged diarrhoea consult
allura red (E129)
your doctor as it may be a sign of
Allura red (E129) may cause allergic reactions.
inflammation of the colon
• any form of severe mental disorder like
Levodopa/Carbidopa/Entacapone Teva
psychosis
150 mg/37.5 mg/200 mg also contains
• chronic wide-angle glaucoma, because your
carmoisine (E122)
dose may need to be adjusted and the
Carmoisine (E122) may cause allergic reactions.
pressure in your eyes may need to be
monitored.
3 How to take Levodopa/Carbidopa/
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 Teva may make these reactions
worse.

Entacapone Teva

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
Teva to take each day
Consult your doctor if during the treatment with • the tablets are not intended to be split or
broken into smaller pieces
Levodopa/Carbidopa/Entacapone Teva you:
• you should take only one tablet each time
• notice that your muscles get very rigid or jerk
• depending on how you respond to treatment,
violently, or if you get tremors, agitation,
your doctor may suggest a higher or lower
confusion, fever, rapid pulse, or wide
dose
fluctuations in your blood pressure. If any of
this happens, contact your doctor immediately • if you are taking
Levodopa/Carbidopa/Entacapone Teva
• feel depressed, have suicidal thoughts, or
50 mg/12.5 mg/200 mg,
notice unusual changes in your behaviour
75 mg/18.75 mg/200 mg,
• find yourself suddenly falling asleep, or if you
100 mg/25 mg/200 mg,
feel very drowsy. If this happens, you should
125 mg/31.25 mg/200 mg or
not drive or use any tools or machines (see
150 mg/37.5 mg/200 mg tablets, do not take
also section 'Driving and using machines')
more than 10 tablets per day
• notice that uncontrolled movements begin or
• if you are taking Levodopa/Carbidopa/
get worse after you started to take
Entacapone Teva 175 mg/43.75 mg/200 mg
Levodopa/Carbidopa/Entacapone Teva. If this
tablets, do not take more than 8 tablets of this
happens, your doctor may need to change the
strength per day
dose of your antiparkinson medicine
• if you are taking Levodopa/Carbidopa/
• experience diarrhoea: monitoring of your
Entacapone Teva 200 mg/50 mg/200 mg
weight is recommended in order to avoid
tablets, do not take more than 7 tablets of this
potentially excessive weight loss
strength per day.
• experience progressive anorexia, asthenia
(weakness, exhaustion) and weight decrease
Talk to your doctor or pharmacist if you think the
within a relatively short period of time. If this
effect of Levodopa/Carbidopa/Entacapone Teva is
happens, a general medical evaluation
too strong or too weak, or if you experience
including liver function should be considered
possible side effects.
• feel the need to stop using Levodopa/
Carbidopa/Entacapone Teva, see section 'If you If you take more Levodopa/Carbidopa/
Entacapone Teva than you should
stop taking Levodopa/Carbidopa/
If you have accidentally taken more Levodopa/
Entacapone Teva'.
Carbidopa/Entacapone Teva tablets than you
Tell your doctor if you or your family/carer
should, talk to your doctor or pharmacist
notices you are developing urges or cravings to immediately. In case of an overdose you may
behave in ways that are unusual for you or you
feel confused or agitated, your heart rate may be
cannot resist the impulse, drive or temptation to slower or faster than normal or the colour of
carry out certain activities that could harm
your skin, tongue, eyes or urine may change.
yourself or others. These behaviours are called
If you forget to take Levodopa/Carbidopa/
impulse control disorders and can include
Entacapone Teva
addictive gambling, excessive eating or
Do not take a double dose to make up for a
spending, an abnormally high sex drive or a
forgotten tablet.
preoccupation with an increase in sexual
thoughts or feelings. Your doctor may need to
If it is more than 1 hour until your next dose:
review your treatments.
Take one tablet as soon as you remember, and
the next tablet at the normal time.
Your doctor may take some regular laboratory
tests during a long term treatment with
If it is less than 1 hour until your next dose:
Levodopa/Carbidopa/Entacapone Teva.
Take a tablet as soon as you remember, wait
1 hour, then take another tablet. After that carry
If you must undergo surgery, please tell your
on as normal.
doctor that you are using Levodopa/Carbidopa/
Entacapone Teva.
Always leave at least an hour between
Levodopa/Carbidopa/Entacapone Teva tablets, to
avoid possible side effects.

If you stop taking Levodopa/Carbidopa/
Entacapone Teva
Do not stop taking Levodopa/Carbidopa/
Entacapone Teva 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 Teva 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.

• Each Levodopa/Carbidopa/Entacapone Teva
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.
• The other ingredients in the tablet core are
microcrystalline cellulose, anhydrous lactose,
low-substituted hydroxypropylcellulose,
povidone (K-30), colloidal anhydrous silica and
magnesium stearate.
• The ingredients in the film-coating are titanium
dioxide (E171), hypromellose, glycerol (E422),
yellow iron oxide (E172), polysorbate 80, red
iron oxide (E172) and magnesium stearate.

• Each Levodopa/Carbidopa/Entacapone Teva
100 mg/25 mg/200 mg Film-coated Tablet
contains 100 mg of levodopa, 25 mg of
Like all medicines, this medicine can cause side
carbidopa and 200 mg of entacapone.
effects, although not everybody gets them. Many • The other ingredients in the tablet core are
of the side effects can be relieved by adjusting
microcrystalline cellulose, anhydrous lactose,
the dose.
low-substituted hydroxypropylcellulose,
povidone (K-30), colloidal anhydrous silica and
If during the treatment with
magnesium stearate.
Levodopa/Carbidopa/Entacapone Teva you
• The ingredients in the film-coating are titanium
experience the following symptoms, contact
dioxide (E171), hypromellose, glycerol (E422),
your doctor immediately:
polysorbate 80, allura red aluminium lake
• your muscles get very rigid or jerk violently,
(E129), carmine (E120) and magnesium
you get tremors, agitation, confusion, fever,
stearate.
rapid pulse, or wide fluctuations in your blood
pressure. These can be symptoms of neuroleptic • Each Levodopa/Carbidopa/Entacapone Teva
malignant syndrome (NMS, a rare severe
125 mg/31.25 mg/200 mg Film-coated Tablet
reaction to medicines used to treat disorders of
contains 125 mg of levodopa, 31.25 mg of
the central nervous system) or rhabdomyolysis
carbidopa and 200 mg of entacapone.
(a rare severe muscle disorder)
• The other ingredients in the tablet core are
• allergic reaction, the signs may include hives
microcrystalline cellulose, anhydrous lactose,
(nettle rash), itching, rash, swelling of your
low-substituted hydroxypropylcellulose,
face, lips, tongue or throat. This may cause
povidone (K-30), colloidal anhydrous silica and
difficulties in breathing or swallowing.
magnesium stearate.

The ingredients in the film-coating are titanium
Very common (may affect more than 1 in 10
dioxide (E171), hypromellose, glycerol (E422),
people):
yellow iron oxide (E172), polysorbate 80, red
• uncontrolled movements (dyskinesias)
iron oxide (E172) and magnesium stearate.
• feeling sick (nausea)

4

Possible side effects

• harmless reddish-brown discolouration of
urine
• muscle pain
• diarrhoea.

• Each Levodopa/Carbidopa/Entacapone Teva
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.
• The other ingredients in the tablet core are
Common (may affect up to 1 in 10 people):
microcrystalline cellulose, anhydrous lactose,
• light-headedness or fainting due to low blood
low-substituted hydroxypropylcellulose,
pressure, high blood pressure
povidone (K-30), colloidal anhydrous silica and
• worsening of Parkinson`s symptoms, dizziness,
magnesium stearate.
drowsiness

The ingredients in the film-coating are titanium
• vomiting, abdominal pain and discomfort,
dioxide (E171), hypromellose, glycerol (E422),
heartburn, dry mouth, constipation
polysorbate 80, red iron oxide (E172),
• inability to sleep, hallucinations, confusion,
carmoisine aluminium lake (E122) and
abnormal dreams (including nightmares),
magnesium stearate.
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.

• Each Levodopa/Carbidopa/Entacapone Teva
175 mg/43.75 mg/200 mg Film-coated Tablet
contains 175 mg of levodopa, 43.75 mg of
carbidopa and 200 mg of entacapone.
• The other ingredients in the tablet core are
microcrystalline cellulose, anhydrous lactose,
low-substituted hydroxypropylcellulose,
povidone (K-30), colloidal anhydrous silica and
magnesium stearate.
• The ingredients in the film-coating are titanium
dioxide (E171), hypromellose, glycerol (E422),
yellow iron oxide (E172), polysorbate 80, red
iron oxide (E172), black iron oxide (E172) and
magnesium stearate.

Uncommon (may affect up to 1 in 100 people):
• Each Levodopa/Carbidopa/Entacapone Teva
• heart attack
200 mg/50 mg/200 mg Film-coated Tablet
• bleeding in the gut
contains 200 mg of levodopa, 50 mg of
• changes in the blood cell count which may
carbidopa and 200 mg of entacapone.
result in bleeding, abnormal liver function tests • The other ingredients in the tablet core are
• convulsions
microcrystalline cellulose, anhydrous lactose,
• feeling agitated
low-substituted hydroxypropylcellulose,
• psychotic symptoms
povidone (K-30), colloidal anhydrous silica and
• colitis (inflammation of the colon)
magnesium stearate.
• discolourations other than urine (e.g. skin, nail, • The ingredients in the film-coating are titanium
hair, sweat)
dioxide (E171), hypromellose, glycerol (E422),
• swallowing difficulties
yellow iron oxide (E172), polysorbate 80, red
• inability to urinate.
iron oxide (E172), black iron oxide (E172) and
magnesium stearate.
The following side effects have also been reported:
• hepatitis (inflammation of the liver)
• itching.

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

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).

Levodopa/Carbidopa/Entacapone Teva
50 mg/12.5 mg/200 mg: Round, biconvex, light
brown film-coated tablet, marked with “50” on
one side, plain on the other. Dimension: approx.
14 mm diameter.
Levodopa/Carbidopa/Entacapone Teva
75 mg/18.75 mg/200 mg: Oval, biconvex, light
orange film-coated tablet, marked with “75” on
one side, plain on the other. Dimensions: approx.
16x10 mm.
Levodopa/Carbidopa/Entacapone Teva
100 mg/25 mg/200 mg: Oblong, biconvex, pale
red film-coated tablet, marked with “100” on one
side, plain on the other. Dimensions: approx.
17x9 mm.
Levodopa/Carbidopa/Entacapone Teva
125 mg/31.25 mg/200 mg: Round, biconvex,
yellowish brown film-coated tablet, marked with
“125” on one side, plain on the other.
Dimension: approx. 14 mm diameter.
Levodopa/Carbidopa/Entacapone Teva
150 mg/37.5 mg/200 mg: Oval, biconvex, dark red
film-coated tablet, marked with “150” on one
side, plain on the other. Dimensions: approx.
16x10 mm.
Levodopa/Carbidopa/Entacapone Teva
175 mg/43.75 mg/200 mg: Ellipse, biconvex, pale
brown film-coated tablet, marked with “175” on
one side, plain on the other. Dimensions: approx.
17x10 mm.
Levodopa/Carbidopa/Entacapone Teva
200 mg/50 mg/200 mg: Oblong, biconvex, brown
film-coated tablet, marked with “200” on one
side, plain on the other. Dimensions: approx.
17x9 mm.

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,
pharmacist or nurse. 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 Teva

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.
This medicinal product does not require any
special storage conditions.
Shelf life after first opening of the bottle: 175 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 to
protect the environment.

6

Contents of the pack and other
information

What Levodopa/Carbidopa/Entacapone Teva
contains
The active substances of Levodopa/Carbidopa/
Entacapone Teva are levodopa, carbidopa and
entacapone.
• Each Levodopa/Carbidopa/Entacapone Teva
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.
• The other ingredients in the tablet core are
microcrystalline cellulose, anhydrous lactose,
low-substituted hydroxypropylcellulose,
povidone (K-30), colloidal anhydrous silica and
magnesium stearate.
• The ingredients in the film-coating are titanium
dioxide (E171), hypromellose, glycerol (E422),
yellow iron oxide (E172), polysorbate 80, red
iron oxide (E172), black iron oxide (E172) and
magnesium stearate.

Levodopa/Carbidopa/Entacapone Teva is
available in pack sizes of 10, 28, 30, 50, 60, 90, 98,
100, 130, 150, 175, 200 or 250 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical
Works Private Limited Company), Debrecen,
Pallagi út 13, H-4042, Hungary
This leaflet was last revised in 07/2014
PL 00289/1862
PL 00289/1863
PL 00289/1864
PL 00289/1865
PL 00289/1866
PL 00289/1867
PL 00289/1868

70073-A

590 x 170

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