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STANEK 50 MG/12.5 MG/200 MG FILM-COATED TABLETS

Active substance(s): CARBIDOPA / ENTACAPONE / LEVODOPA

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TEVA UK Ref: 231-30-70073-D LEA LEVODOPA/CARBIDOPA/ENTACAPONE A/S FC TAB TUK
STANEK
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
levodopa/carbidopa/entacapone
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.
WHAT IS IN THIS LEAFLET:

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

Version:

1

17 December 2014

Children and adolescents
Experience with levodopa/carbidopa/entacapone
in patients under 18 years is limited. Therefore,
the use of Stanek in children is not
recommended.
Other medicines and Stanek
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Do not take Stanek if you are taking certain
medicines for treating depression (combinations
of selective MAO-A and MAO-B inhibitors, or
non-selective MAO inhibitors).
Stanek 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
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 Stanek 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.

TEVA UK Ref: 231-30-70073-D LEA LEVODOPA/CARBIDOPA/ENTACAPONE A/S FC TAB TUK
Version:

1

17 December 2014

• The ingredients in the film-coating are titanium
dioxide (E171), hypromellose, glycerol (E422),
yellow iron oxide (E172), polysorbate 80, red
Like all medicines, this medicine can cause side
iron oxide (E172) and magnesium stearate.
effects, although not everybody gets them. Many
of the side effects can be relieved by adjusting
• Each Stanek 100 mg/25 mg/200 mg
the dose.
Film-coated Tablet contains 100 mg of
levodopa, 25 mg of carbidopa and 200 mg of
If during the treatment with Stanek you
entacapone
experience the following symptoms, contact

The
other ingredients in the tablet core are
your doctor immediately:
microcrystalline
cellulose, anhydrous lactose,
• your muscles get very rigid or jerk violently,
hydroxypropylcellulose, povidone (K-30),
you get tremors, agitation, confusion, fever,
colloidal anhydrous silica and magnesium
rapid pulse, or wide fluctuations in your blood
stearate
pressure. These can be symptoms of
The ingredients in the film-coating are titanium

neuroleptic malignant syndrome (NMS, a rare
dioxide
(E171), hypromellose, glycerol (E422),
severe reaction to medicines used to treat
polysorbate 80, allura red (E129), carmine
disorders of the central nervous system) or
(E120) and magnesium stearate.
rhabdomyolysis (a rare severe muscle

4

POSSIBLE SIDE EFFECTS

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 discolouration 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.

• Each Stanek 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
• The other ingredients in the tablet core are
microcrystalline cellulose, anhydrous lactose,
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 Stanek 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
microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30),
colloidal anhydrous silica and magnesium
stearate
• The ingredients in the film-coating are titanium
dioxide (E171), hypromellose, glycerol (E422),
polysorbate 80, red iron oxide (E172),
carmoisine (E122) and magnesium stearate.

Stanek may make it harder for you to digest iron.
Therefore, do not take Stanek and iron
supplements at the same time. After taking one
WHAT
STANEK
IS
AND
WHAT
IT
IS
USED
1 FOR
of them, wait at least 2 to 3 hours before taking
the other.
Stanek contains three active substances
Stanek with food and drink
(levodopa, carbidopa and entacapone) in one
Stanek may be taken with or without food. For
film-coated tablet. Stanek is used for the
some patients, Stanek may not be well absorbed
treatment of Parkinson’s disease.
if it is taken with, or shortly after eating
Parkinson’s disease is caused by low levels of a protein-rich food (such as meats, fish, dairy
substance called dopamine in the brain.
products, seeds and nuts). Consult your doctor if
Levodopa increases the amount of dopamine
you think this applies to you.
and hence reduces the symptoms of Parkinson’s
disease. Carbidopa and entacapone improve the Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
antiparkinson effects of levodopa.
may be pregnant or are planning to have a baby,
YOU NEED TO KNOW BEFORE YOU ask your doctor or pharmacist for advice before
2 WHAT
TAKE STANEK
taking this medicine.
Do not take Stanek if you:
You should not breast-feed during treatment
• are allergic to levodopa, carbidopa or
with Stanek.
entacapone, or any of the other ingredients of
Driving and using machines
this medicine (listed in section 6)
• have narrow-angle glaucoma (an eye disorder) Stanek may lower your blood pressure, which
may make you feel light-headed or dizzy.
• have a tumour of the adrenal gland
Therefore, be particularly careful when you drive
• are taking certain medicines for treating
depression (combinations of selective MAO-A or when you use any tools or machines.
and MAO-B inhibitors, or non-selective
If you feel very drowsy, or if you sometimes find
MAO-inhibitors)
yourself suddenly falling asleep, wait until you
• have ever had neuroleptic malignant
feel fully awake again before driving or doing
syndrome (NMS – this is a rare reaction to
anything else that requires you to be alert.
medicines used to treat severe mental
Otherwise, you may put yourself and others at
disorders)
risk of serious injury or death.
• have ever had non-traumatic rhabdomyolysis
(a rare muscle disorder)
Stanek contains lactose
• have a severe liver disease.
Stanek contains anhydrous lactose
(80 mg/tablet).
Warnings and precautions
If you have been told by your doctor that you
Talk to your doctor or pharmacist before taking have intolerance to some sugars, contact your
doctor before taking this medicinal product.
Stanek if you have or have ever had:
• a heart attack or any other diseases of the heart
Stanek 100 mg/25 mg/200 mg also contains
including cardiac arrhythmias, or of the blood
allura red (E129)
vessels
Allura red (E129) may cause allergic reactions.
• asthma or any other disease of the lungs
• a liver problem, because your dose may need Stanek 150 mg/37.5 mg/200 mg also contains
to be adjusted
carmoisine (E122)
• kidney or hormone-related diseases
Carmoisine (E122) may cause allergic reactions.
• stomach ulcers or convulsions
• if you experience prolonged diarrhoea consult 3 HOW TO TAKE STANEK
your doctor as it may be a sign of
Always take this medicine exactly as your doctor
inflammation of the colon
or pharmacist has told you. Check with your
• any form of severe mental disorder like
doctor or pharmacist if you are not sure.
psychosis
• chronic wide-angle glaucoma, because your
For adults and older people:
dose may need to be adjusted and the
• Your doctor will tell you exactly how many
pressure in your eyes may need to be
tablets of Stanek to take each day
monitored.
• The tablets are not intended to be split or

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

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 Stanek may make these
reactions worse.

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

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

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.

By reporting side effects you can help provide
more information on the safety of this medicine.

• Each Stanek 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,
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.

What Stanek looks like and contents of the pack
Stanek 50 mg/12.5 mg/200 mg: Round, biconvex,
light brown tablet, marked with “50” on one
side, plain on the other. Dimension: approx.
14 mm diameter.
Stanek 75 mg/18.75 mg/200 mg: Oval, biconvex,
light orange tablet, marked with “75” on one
side, plain on the other. Dimensions: approx.
16x10 mm.
Stanek 100 mg/25 mg/200 mg: Oblong, biconvex,
pale red tablet, marked with “100” on one side,
plain on the other. Dimensions: approx.
17x9 mm.
Stanek 125 mg/31.25 mg/200 mg: Round,
biconvex, yellowish brown tablet, marked with
“125” on one side, plain on the other.
Dimension: approx. 14 mm diameter.
Stanek 150 mg/37.5 mg/200 mg: Oval, biconvex,
dark red tablet, marked with “150” on one side,
plain on the other. Dimensions: approx.
16x10 mm.
Stanek 175 mg/43.75 mg/200 mg: Ellipse,
biconvex, pale brown tablet, marked with “175”
on one side, plain on the other. Dimensions:
approx. 17x10 mm.

Stanek 200 mg/50 mg/200 mg: Oblong, biconvex,
brown tablet, marked with “200” on one side,
plain on the other. Dimensions: approx.
Keep this medicine out of the sight and reach of 17x9 mm.
children.
Stanek is available in bottles containing 10, 28,
Do not use this medicine after the expiry date
30, 50, 60, 90, 98, 100, 130, 150, 175, 200 or 250
which is stated on the bottle and the carton after tablets. Not all pack sizes may be marketed.
EXP.
Marketing Authorisation Holder
The expiry date refers to the last day of that
TEVA UK Limited,
month.
Eastbourne, BN22 9AG.
This medicinal product does not require any
Manufacturer
special storage conditions.
TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical
Use the tablets within 175 days after first
Works Private Limited Company), Debrecen,
opening of the bottle.
Pallagi út 13, H-4042, Hungary
Do not throw away any medicines via
This leaflet was last revised in 12/2014
wastewater or household waste. Ask your
PL 00289/1958-1964
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

5

HOW TO STORE STANEK

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Stanek contains
The active substances of Stanek are levodopa,
carbidopa and entacapone.
• Each Stanek 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,
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.
• Each Stanek 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,
hydroxypropylcellulose, povidone (K-30),
colloidal anhydrous silica and magnesium
stearate

70073-D

590 x 165

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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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