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STANEK 100 MG/25 MG/200 MG FILM-COATED TABLETS

Active substance(s): CARBIDOPA / ENTACAPONE / LEVODOPA / CARBIDOPA / ENTACAPONE / LEVODOPA / CARBIDOPA / ENTACAPONE / LEVODOPA

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TEVA UK Ref: 231-30-70073-F 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

1

Version:

1

16 December 2015

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, 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 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.
Stanek may make it harder for you to digest

What Stanek is and what it is used for iron. Therefore, do not take Stanek and iron

Stanek contains three active substances
(levodopa, carbidopa and entacapone) in one
film-coated tablet. Stanek is used for the
treatment of Parkinson’s disease.

supplements at the same time. After taking one
of them, wait at least 2 to 3 hours before taking
the other.

Stanek with food and drink
Stanek may be taken with or without food. For
Parkinson’s disease is caused by low levels of a
some patients, Stanek may not be well
substance called dopamine in the brain.
absorbed if it is taken with, or shortly after
Levodopa increases the amount of dopamine
eating protein-rich food (such as meats, fish,
and hence reduces the symptoms of
dairy products, seeds and nuts). Consult your
Parkinson’s disease. Carbidopa and entacapone
doctor if you think this applies to you.
improve the antiparkinson effects of levodopa.
Pregnancy, breast-feeding and fertility
you need to know before you
2 What
If you are pregnant or breast-feeding, think you
take Stanek
may be pregnant or are planning to have a
Do not take Stanek if you:
baby, ask your doctor or pharmacist for advice
• are allergic to levodopa, carbidopa or
before taking this medicine.
entacapone, or any of the other ingredients
You should not breast-feed during treatment
of this medicine (listed in section 6)
with Stanek.
• have narrow-angle glaucoma (an eye
disorder)
Driving and using machines
• have a tumour of the adrenal gland
Stanek may lower your blood pressure, which
• are taking certain medicines for treating
may make you feel light-headed or dizzy.
depression (combinations of selective
Therefore, be particularly careful when you
MAO-A and MAO-B inhibitors, or
drive or when you use any tools or machines.
non-selective MAO-inhibitors)
If you feel very drowsy, or if you sometimes
• have ever had neuroleptic malignant
find yourself suddenly falling asleep, wait until
syndrome (NMS – this is a rare reaction to
you feel fully awake again before driving or
medicines used to treat severe mental
doing anything else that requires you to be
disorders)
• have ever had non-traumatic rhabdomyolysis alert. Otherwise, you may put yourself and
others at risk of serious injury or death.
(a rare muscle disorder)
• have a severe liver disease.
Stanek contains lactose, 100 mg/25 mg/
Warnings and precautions
Talk to your doctor or pharmacist before taking
Stanek 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 Stanek may make these
reactions worse.
Consult your doctor if during the treatment with
Stanek 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 Stanek. 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 Stanek, see
section 'If you stop taking Stanek'.
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 Stanek.
If you must undergo surgery, please tell your
doctor that you are using Stanek.

200 mg also contains allura red and 150 mg/
37.5 mg/200 mg also contains carmoisine.
Stanek contains anhydrous lactose (80 mg/
tablet).
If you have been told by your doctor that you
have intolerance to some sugars, contact your
doctor before taking this medicinal product.

Stanek 100 mg/25 mg/200 mg also contains
allura red (E129). May cause allergic reactions.
Stanek 150 mg/37.5 mg/200 mg also contains
carmoisine (E122). May cause allergic
reactions.

3

How to take Stanek

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 people:
• Your doctor will tell you exactly how many
tablets of Stanek 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 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 or
150 mg/37.5 mg/200 mg tablets, do not take
more than 10 tablets per day
• If you are taking Stanek 175 mg/43.75 mg/
200 mg tablets, do not take more than
8 tablets of this strength per day
• If you are taking Stanek 200 mg/50 mg/
200 mg 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 Stanek is too strong or too weak,
or if you experience possible side effects.
If you take more Stanek than you should
If you have accidentally taken more Stanek
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 Stanek
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 Stanek
tablets, to avoid possible side effects.
If you stop taking Stanek
Do not stop taking Stanek 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 Stanek and other
antiparkinsonian medicines it may result in
unwanted side effects.

If you have any further questions on the use of
Stanek is not recommended to be used for
this medicine, ask your doctor or pharmacist.
treatment of extrapyramidal symptoms (e.g.
involuntary movements, shaking, muscle rigidity
and muscle contractions) caused by other
medicines.

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

1

16 December 2015

• The other ingredients in the tablet core are
microcrystalline cellulose, anhydrous lactose,
hydroxypropylcellulose, povidone (K-30),
Like all medicines, this medicine can cause side
colloidal anhydrous silica and magnesium
effects, although not everybody gets them.
stearate
Many of the side effects can be relieved by
• The ingredients in the film-coating are
adjusting the dose.
titanium dioxide (E171), hypromellose,
glycerol (E422), yellow iron oxide (E172),
If during the treatment with Stanek you
polysorbate 80, red iron oxide (E172) and
experience the following symptoms, contact
magnesium stearate.
your doctor immediately:
• your muscles get very rigid or jerk violently,
• Each Stanek 100 mg/25 mg/200 mg
you get tremors, agitation, confusion, fever,
Film-coated Tablet contains 100 mg of
rapid pulse, or wide fluctuations in your
levodopa, 25 mg of carbidopa and 200 mg of
blood pressure. These can be symptoms of
entacapone
neuroleptic malignant syndrome (NMS, a
• The other ingredients in the tablet core are
rare severe reaction to medicines used to
microcrystalline cellulose, anhydrous lactose,
treat disorders of the central nervous system)
hydroxypropylcellulose, povidone (K-30),
or rhabdomyolysis (a rare severe muscle
colloidal anhydrous silica and magnesium
disorder)
stearate
• allergic reaction, the signs may include hives
• The ingredients in the film-coating are
(nettle rash), itching, rash, swelling of your
titanium dioxide (E171), hypromellose,
face, lips, tongue or throat. This may cause
glycerol (E422), polysorbate 80, allura red
difficulties in breathing or swallowing.
(E129), carmine (E120) and magnesium
stearate.
Very common (may affect more than 1 in 10
people)
• Each Stanek 125 mg/31.25 mg/200 mg
• uncontrolled movements (dyskinesias)
Film-coated Tablet contains 125 mg of
• feeling sick (nausea)
levodopa, 31.25 mg of carbidopa and 200 mg
• harmless reddish-brown discoloration of
of entacapone
urine
• The other ingredients in the tablet core are
• muscle pain
microcrystalline cellulose, anhydrous lactose,
• diarrhoea.
hydroxypropylcellulose, povidone (K-30),
colloidal anhydrous silica and magnesium
Common (may affect up to 1 in 10 people)
stearate
• light-headedness or fainting due to low blood
• The ingredients in the film-coating are
pressure, high blood pressure
titanium dioxide (E171), hypromellose,
• worsening of Parkinson`s symptoms,
glycerol (E422), yellow iron oxide (E172),
dizziness, drowsiness
polysorbate 80, red iron oxide (E172) and
• vomiting, abdominal pain and discomfort,
magnesium stearate.
heartburn, dry mouth, constipation
• inability to sleep, hallucinations, confusion,
• Each Stanek 150 mg/37.5 mg/200 mg
abnormal dreams (including nightmares),
Film-coated Tablet contains 150 mg of
tiredness
levodopa, 37.5 mg of carbidopa and 200 mg
• mental changes – including problems with
of entacapone
memory, anxiety and depression (possibly
• The other ingredients in the tablet core are
with thoughts of suicide)
microcrystalline cellulose, anhydrous lactose,
• heart or artery disease events (e.g. chest
hydroxypropylcellulose, povidone (K-30),
pain), irregular heart rate or rhythm
colloidal anhydrous silica and magnesium
• more frequent falling
stearate
• shortness of breath
• The ingredients in the film-coating are
• increased sweating, rashes
titanium dioxide (E171), hypromellose,
• muscle cramps, swelling of legs
glycerol (E422), polysorbate 80, red iron oxide
• blurred vision
(E172), carmoisine (E122) and magnesium
• anaemia
stearate.
• decreased appetite, decreased weight
• headache, joint pain
• Each Stanek 175 mg/43.75 mg/200 mg
• urinary tract infection.
Film-coated Tablet contains 175 mg of
levodopa, 43.75 mg of carbidopa and 200 mg
Uncommon (may affect up to 1 in 100 people)
of entacapone
• heart attack
• The other ingredients in the tablet core are
• bleeding in the gut
microcrystalline cellulose, anhydrous lactose,
• changes in the blood cell count which may
hydroxypropylcellulose, povidone (K-30),
result in bleeding, abnormal liver function
colloidal anhydrous silica and magnesium
tests
stearate
• convulsions
• The ingredients in the film-coating are
• feeling agitated
titanium dioxide (E171), hypromellose,
• psychotic symptoms
glycerol (E422), yellow iron oxide (E172),
• colitis (inflammation of the colon)
polysorbate 80, red iron oxide (E172), black
• discolourations other than urine (e.g. skin,
iron oxide (E172) and magnesium stearate.
nail, hair, sweat)
• swallowing difficulties
• Each Stanek 200 mg/50 mg/200 mg
• inability to urinate.
Film-coated Tablet contains 200 mg of
levodopa, 50 mg of carbidopa and 200 mg of
The following side effects have also been
entacapone
reported:
• The other ingredients in the tablet core are
• hepatitis (inflammation of the liver)
microcrystalline cellulose, anhydrous lactose,
• itching.
hydroxypropylcellulose, povidone (K-30),
colloidal anhydrous silica and magnesium
You may experience the following side effects:
stearate
• Inability to resist the impulse to perform an
• The ingredients in the film-coating are
action that could be harmful, which may
titanium dioxide (E171), hypromellose,
include:
• strong impulse to gamble excessively
glycerol (E422), yellow iron oxide (E172),
despite serious or personal family
polysorbate 80, red iron oxide (E172), black
consequences
iron oxide (E172) and magnesium stearate.
• altered or increased sexual interest and
behaviour of significant concern to you or What Stanek looks like and contents of the
to others, for example, an increased sexual pack
drive
Stanek 50 mg/12.5 mg/200 mg: Round,
• uncontrollable excessive shopping or
biconvex, light brown tablet, marked with “50”
spending
• binge eating (eating large amounts of food on one side, plain on the other. Dimension:
approx. 14 mm diameter.
in a short time period) or compulsive
eating (eating more food than normal and Stanek 75 mg/18.75 mg/200 mg: Oval,
biconvex, light orange tablet, marked with “75”
more than is needed to satisfy your
on one side, plain on the other. Dimensions:
hunger).
approx. 16x10 mm.
Tell your doctor if you experience any of
Stanek 100 mg/25 mg/200 mg: Oblong,
these behaviours; they will discuss ways of
biconvex, pale red tablet, marked with “100”
managing or reducing the symptoms.
on one side, plain on the other. Dimensions:
approx. 17x9 mm.
Reporting of side effects
If you get any side effects, talk to your doctor or Stanek 125 mg/31.25 mg/200 mg: Round,
biconvex, yellowish brown tablet, marked with
pharmacist. This includes any possible side
“125” on one side, plain on the other.
effects not listed in this leaflet. You can also
Dimension: approx. 14 mm diameter.
report side effects directly via the Yellow Card
Stanek 150 mg/37.5 mg/200 mg: Oval, biconvex,
Scheme at: www.mhra.gov.uk/yellowcard
dark red tablet, marked with “150” on one side,
By reporting side effects you can help provide plain on the other. Dimensions: approx.
more information on the safety of this
16x10 mm.
medicine.
Stanek 175 mg/43.75 mg/200 mg: Ellipse,
biconvex, pale brown tablet, marked with
How
to
store
Stanek
5
“175” on one side, plain on the other.
Dimensions: approx. 17x10 mm.
Keep this medicine out of the sight and reach
Stanek 200 mg/50 mg/200 mg: Oblong,
of children.
biconvex, brown tablet, marked with “200” on
one side, plain on the other. Dimensions:
Do not use this medicine after the expiry date
approx. 17x9 mm.
which is stated on the bottle and the carton
after EXP.
Stanek is available in bottles containing 10, 28,
The expiry date refers to the last day of that
30, 50, 60, 90, 98, 100, 130, 150, 175, 200 or 250
month.
tablets. Not all pack sizes may be marketed.

4

Possible side effects

This medicinal product does not require any
special storage conditions.
Use the tablets within 175 days after first
opening of the bottle.
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

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 12/2015
PL 00289/1958-1964

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

70073-F

590 x 165

Expand Transcript

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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