Patient leaflet - Stanek 50 mg / 12.5 mg / 200 mg film-coated tablets
1. What Stanek is and what it is used for
- The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422), polysorbate 80, allura red (E129), carmine (E120) and magnesium stearate.
alpha-methyldopa, used to treat high blood pressure
urine
2. What you need to know before you take Stanek
- muscle pain
- apomorphine, which is used to treat Parkinson’s disease.
- diarrhoea.
3. How to take Stanek
4. Possible side effects
Common (may affect up to 1 in 10 people)
5. How to store Stanek
The effects of Stanek may be weakened by certain medicines. These include:
light-headedness or fainting due to low blood
- 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
6. Contents of the pack and other information
pressure, high blood pressure
dopamine antagonists used to treat mental disorders, nausea and vomiting
- worsening of Parkinson`s symptoms,
What Stanek is and what it is used for
1
dizziness, drowsiness
- phenytoin, used to prevent convulsions
Stanek contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stanek is used for the treatment of Parkinson’s disease.
vomiting, abdominal pain and discomfort,
- The other ingredients in the tablet core are microcrystalline cellulose, lactose, hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
papaverine used to relax the muscles.
heartburn, dry mouth, constipation
- inability to sleep, hallucinations, confusion,
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 of them, wait at least 2 to 3 hours before taking the other.
abnormal dreams (including nightmares),
tiredness
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.
mental changes – including problems with
- 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.
memory, anxiety and depression (possibly
with thoughts of suicide)
Stanek with food and drink
- heart or artery disease events (e.g. chest
Stanek may be taken with or without food. For some patients, Stanek 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.
pain), irregular heart rate or rhythm
- more frequent falling
What you need to know before you take Stanek
2
shortness of breath
- 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
- increased sweating, rashes
- muscle cramps, swelling of legs
Do not take Stanek if you:
- blurred vision
- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6)
anaemia
- The other ingredients in the tablet core are microcrystalline cellulose, lactose, hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
Pregnancy, breast-feeding and fertility
- decreased appetite, decreased weight
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.
- headache, joint pain
- have narrow-angle glaucoma (an eye disorder)
- urinary tract infection.
have a tumour of the adrenal gland
Uncommon (may affect up to 1 in 100 people)
- The ingredients in the film-coating are titanium dioxide (E171), hypromellose, glycerol (E422), polysorbate 80, red iron oxide (E172), carmoisine (E122) and magnesium stearate.
- are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or
- heart attack
You should not breast-feed during treatment with Stanek.
- bleeding in the gut
- changes in the blood cell count which may
non-selective MAO-inhibitors)
result in bleeding, abnormal liver function
Driving and using machines
have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used to treat severe mental disorders)
tests
Stanek 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.
convulsions
- 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
- feeling agitated
- psychotic symptoms
have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- colitis (inflammation of the colon)
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.
discolourations other than urine (e.g. skin,
- The other ingredients in the tablet core are microcrystalline cellulose, lactose, hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
have a severe liver disease.
nail, hair, sweat)
- swallowing difficulties
Warnings and precautions
- inability to urinate.
Talk to your doctor or pharmacist before taking Stanek if you have or have ever had:
Not known (cannot be estimated from the
- 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.
a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood vessels
available data):
Stanek contains lactose, 100 mg/25 mg/ 200 mg also contains allura red and 150 mg/ 37.5 mg/200 mg also contains carmoisine.
Craving for large doses of Stanek in excess of
that required to control motor symptoms,
asthma or any other disease of the lungs
known as dopamine dysregulation syndrome.
Stanek contains 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.
a liver problem, because your dose may need to be adjusted
Some patients experience severe abnormal
involuntary movements (dyskinesias), mood
- Each Stanek 200 mg/50 mg/200 mg Film-coated Tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone
kidney or hormone-related diseases
swings or other side effects after taking large
stomach ulcers or convulsions
doses of Stanek.
if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon
Stanek 100 mg/25 mg/200 mg also contains allura red (E129).
The following side effects have also been reported:
- The other ingredients in the tablet core are microcrystalline cellulose, lactose, hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica and magnesium stearate
May cause allergic reactions.
- hepatitis (inflammation of the liver)
- any form of severe mental disorder like psychosis
- itching.
Stanek 150 mg/37.5 mg/200 mg also contains carmoisine (E122).
chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
You may experience the following side effects:
May cause allergic reactions.
Inability to resist the impulse to perform an
- 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.
action that could be harmful, which may
How to take Stanek
3
include:
- strong impulse to gamble excessively despite
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Consult your doctor if you are currently taking:
serious or personal family consequences
antipsychotics (medicines used to treat psychosis)
altered or increased sexual interest and
What Stanek looks like and contents of the pack
behaviour of significant concern to you or to
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.
For adults and elderly people:
others, for example, an increased sexual
Your doctor will tell you exactly how many tablets of Stanek to take each day
drive
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.
- uncontrollable excessive shopping or
The tablets are not intended to be split or broken into smaller pieces
spending
Consult your doctor if during the treatment with Stanek you:
- binge eating (eating large amounts of food in
You should take only one tablet each time
a short time period) or compulsive eating
Depending on how you respond to treatment, your doctor may suggest a higher or lower dose
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.
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
(eating more food than normal and more
than is needed to satisfy your hunger).
Tell your doctor if you experience any of these
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
behaviours; they will discuss ways of
managing or reducing the symptoms.
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.
Reporting of side effects
feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
- 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
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')
effects not listed in this leaflet. You can also
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.
report side effects directly via the Yellow Card
Scheme Website: www.mhra.gov.uk/yellowcard
If you are taking Stanek 200 mg/50 mg/ 200 mg tablets, do not take more than 7 tablets of this strength per day.
or search for MHRA Yellow Card in the Google
Play or Apple App Store.
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
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.
By reporting side effects you can help provide
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.
more information on the safety of this medicine.
How to store Stanek
5
experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially excessive weight loss
If you take more Stanek than you should
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.
Keep this medicine out of the sight and reach of children.
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.
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
Do not use this medicine after the expiry date
which is stated on the bottle and the carton
Stanek 200 mg/50 mg/200 mg: Oblong, biconvex, brown tablet, marked with “200” on one side, plain on the other. Dimensions: approx. 17x9 mm.
after EXP.
The expiry date refers to the last day of that
feel the need to stop using Stanek, see section 'If you stop taking Stanek'.
month.
If you forget to take Stanek
This medicinal product does not require any
Stanek is available in bottles containing 10, 28, 30, 50, 60, 90, 98, 100, 130, 150, 175, 200 or 250 tablets. Not all pack sizes may be marketed.
Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Stanek and other medicines used to treat Parkinson’s disease.
Do not take a double dose to make up for a forgotten tablet.
special storage conditions.
Use the tablets within 175 days after first
If it is more than 1 hour until your next dose:
opening of the bottle.
Marketing Authorisation Holder
Take one tablet as soon as you remember, and the next tablet at the normal time.
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Do not throw away any medicines via
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.
wastewater or household waste. Ask your
Manufacturer
If it is less than 1 hour until your next dose:
pharmacist how to throw away medicines you
TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical Works Private Limited Company), Debrecen, Pallagi út 13, H-4042, Hungary
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as normal.
no longer use. These measures will help to
protect the environment.
Contents of the pack and other information
6
This leaflet was last revised in May 2020
Always leave at least an hour between Stanek tablets, to avoid possible side effects.
PL 00289/1958-1964
What Stanek contains
If you stop taking Stanek
The active substances of Stanek are levodopa,
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.
carbidopa and entacapone.
- Each Stanek 50 mg/12.5 mg/200 mg
Film-coated Tablet contains 50 mg of
Your doctor may take some regular laboratory tests during a long term treatment with Stanek.
levodopa, 12.5 mg of carbidopa and 200 mg
of entacapone
If you must undergo surgery, please tell your doctor that you are using Stanek.
- The other ingredients in the tablet core are
microcrystalline cellulose, lactose,
hydroxypropylcellulose, povidone (K-30),
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