Stalevo

Italy

Brand name Stalevo

Form tablets, film-coated

Active substance / Dosage

ENTACAPONE

CARBIDOPA

LEVODOPA

Prescription type Prescription only

ATC code

N04BA03

Registration number 036825

Manufacturer ORION CORPORATION

Table of Contents

Package leaflet: Information for the user
Stalevo 50 mg/12.5 mg/200 mg film-coated tablets
1. What Stalevo is and what it is used for
2. What you need to know before taking Stalevo
3. How to take Stalevo
4. Possible side effects
5. How to store Stalevo
6. Package contents and other information
Package leaflet: information for the user
Stalevo 75 mg/18.75 mg/200 mg film-coated tablets
1. What Stalevo is and what it is used for
2. What you need to know before taking Stalevo
3. How to take Stalevo
4. Possible side effects
5. How to store Stalevo
6. Package contents and other information
Package leaflet: Information for the user
Stalevo 100 mg/25 mg/200 mg film-coated tablets
1. What Stalevo is and what it is used for
2. What you need to know before taking Stalevo
3. How to take Stalevo
4. Possible side effects
5. How to store Stalevo
6. Package contents and other information
Package leaflet: Information for the user
Stalevo 125 mg/31.25 mg/200 mg film-coated tablets
1. What Stalevo is and what it is used for
2. What you should know before taking Stalevo
3. How to take Stalevo
4. Possible side effects
5. How to store Stalevo
6. Package contents and other information
Package leaflet: Information for the user
Stalevo 150 mg/37.5 mg/200 mg film-coated tablets
1. What Stalevo is and what it is used for
2. What you should know before taking Stalevo
3. How to take Stalevo
4. Possible side effects
5. How to store Stalevo
6. Package contents and other information
Package leaflet: information for the user
Stalevo 175 mg/43.75 mg/200 mg film-coated tablets
1. What Stalevo is and what it is used for
2. What you need to know before taking Stalevo
3. How to take Stalevo
4. Possible side effects
5. How to store Stalevo
6. Package contents and other information
Package leaflet: information for the user
Stalevo 200 mg/50 mg/200 mg film-coated tablets
1. What Stalevo is and what it is used for
2. What you need to know before taking Stalevo
3. How to take Stalevo
4. Possible side effects
5. How to store Stalevo
6. Package contents and other information

Package leaflet: Information for the user

Stalevo 50 mg/12.5 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Stalevo is and what it is used for
What you need to know before taking Stalevo
How to take Stalevo
Possible side effects
How to store Stalevo
Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa, and entacapone) in a film-coated tablet. Stalevo is used to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and thereby reduces the symptoms of Parkinson's disease. Carbidopa and entacapone enhance the effectiveness of levodopa's anti-Parkinsonian effects.

2. What you need to know before taking Stalevo

Do not take Stalevo

if you are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
if you have closed-angle glaucoma (a disorder of the eye)
if you have a tumour of the adrenal gland
if you are taking antidepressants (combinations of selective MAO-A inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
if you have previously experienced the rare reaction to certain antipsychotic medicines known as Neuroleptic Malignant Syndrome (NMS)
if you have previously experienced a rare form of muscle disorder called non-traumatic rhabdomyolysis
if you have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Stalevo if you have or have previously had:

a heart attack, other heart diseases including arrhythmias, or blood vessel disorders
asthma or other lung diseases
liver problems, as your dose may need to be adjusted
kidney or hormonal disorders
gastric ulcer or seizures
prolonged diarrhoea – consult your doctor as this may be a sign of inflammation of the colon
severe psychiatric disorders of any kind, such as psychosis
chronic open-angle glaucoma, as your dose may need to be adjusted and your eye pressure monitored.

Talk to your doctor if you are taking:

antipsychotic medicines (medicines used to treat psychosis)
a medicine that may cause low blood pressure when standing up from a sitting or lying position. You should be aware that Stalevo may worsen such reactions.

Talk to your doctor if, during treatment with Stalevo:

you notice the onset of muscle stiffness or strong contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate, or severe fluctuations in blood pressure. In such cases, you must seek immediate medical attention
you feel depressed, have suicidal thoughts, or notice any changes in your behaviour
you experience sudden attacks of sleep or feel unusually sleepy. If this occurs, do not drive or operate machinery (see also section “Driving and using machines”)
you notice the onset of uncontrolled movements or if such movements worsen after taking Stalevo. In this case, consult your doctor, as it may be necessary to adjust the dosage of your anti-Parkinson medicines
you develop diarrhoea: regular monitoring of body weight is recommended to avoid potentially excessive weight loss
you experience progressive anorexia, asthenia (weakness, fatigue), and weight loss over a relatively short period. In such cases, a general medical evaluation should be considered, including liver function tests
you feel the need to stop taking Stalevo; see section “If you stop taking Stalevo”.

Inform your doctor if you or a family member/carer notice the development of symptoms resembling addiction, leading to a desire for high doses of Stalevo and other medicines used to treat Parkinson’s disease.
Inform your doctor if you, or your family members/carers, notice that you develop impulses or strong urges to behave in unusual ways or are unable to resist the impulse, drive, or temptation to carry out activities that could be harmful to yourself or others. These behaviours are known as impulse control disorders and may include compulsive gambling, excessive spending and eating, abnormally increased sexual drive, or preoccupation with an increase in sexual thoughts or urges. Your doctor may need to review your treatment.
During prolonged treatment with Stalevo, your doctor may periodically request laboratory tests.
If you are scheduled for surgery, inform your doctor that you are taking Stalevo.
The use of Stalevo is not recommended for the treatment of extrapyramidal symptoms (e.g. involuntary movements, tremors, muscle rigidity, and muscle contractions) caused by other medicines.

Children and adolescents
Experience with Stalevo in patients under 18 years of age is limited. Therefore, Stalevo is not recommended for use in children or adolescents.

Other medicines and Stalevo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Stalevo if you are taking certain antidepressants (combinations of selective MAO-A inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors).
Stalevo may enhance the effects and side effects of certain medicines. These include:

medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
rimiterol and isoprenaline, used to treat certain respiratory disorders
adrenaline, used in severe allergic reactions
noradrenaline, dopamine and dobutamine, used to treat certain heart conditions and hypotension
alpha-methyldopa, used to treat hypertension
apomorphine, used to treat Parkinson’s disease.

The effects of Stalevo may be reduced by certain medicines. These include:

dopaminergic antagonists used to treat certain psychiatric disorders, nausea and vomiting
phenytoin, used to prevent seizures
papaverine, used to relax muscles.

Stalevo may impair the absorption of iron. Therefore, it is recommended not to take Stalevo at the same time as iron supplements. Stalevo and iron-containing medicines should be taken at least 2–3 hours apart.

Stalevo with food and drink
Stalevo may be taken with or without food. For some patients, Stalevo may not be well absorbed if taken with, or immediately after, high-protein meals (such as meat, fish, dairy products, seeds and nuts). Consult your doctor if you think this may apply to you.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Women must not breastfeed during treatment with Stalevo.

Driving and using machines
Stalevo may lower blood pressure, which can cause dizziness or lightheadedness. Exercise particular caution when driving or operating machinery.
If you experience drowsiness or sudden episodes of sleep, wait until you are fully alert again before resuming driving or any other activity requiring vigilance. Otherwise, you may put yourself and others at serious risk, including risk of death.

Stalevo contains sucrose
Stalevo contains sucrose (1.2 mg/tablet). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e. essentially “sodium-free”.

3. How to take Stalevo

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Adults and elderly:

Your doctor will tell you exactly how many Stalevo tablets to take each day.
The tablet is not intended to be divided into smaller parts.
Take only one tablet at a time.
Depending on your response to treatment, your doctor may recommend a higher or lower dose.
If you are taking Stalevo 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 think that the effect of Stalevo is too strong or too weak, or if you experience possible
side effects, contact your doctor or pharmacist.
Opening the bottle for the first time: open the
Figure 1
closure and then press with your thumb on the seal

A hand holds a small glass vial with the fingers while a black arrow points downward at the container's cap

until it breaks. See figure 1.
If you take more Stalevo than you should
Contact your doctor or pharmacist immediately if you have accidentally taken more Stalevo tablets than prescribed. In case of overdose, you may feel confused or agitated, your heartbeat may become faster or slower, or the colour of your skin, tongue, eyes, or urine may change.
If you forget to take Stalevo
Do not take a double dose to make up for a forgotten tablet.
If more than one hour remains until the next dose:
Take one tablet as soon as you remember, then take the next one at the usual time.
If less than one hour remains until the next dose:
Take one tablet as soon as you remember, wait one hour, then take another tablet. After that, continue as normal.
Always leave at least one hour between consecutive doses of Stalevo to avoid possible side effects.
If you stop taking Stalevo
Do not stop taking Stalevo unless your doctor tells you to do so. In such a case, your doctor may consider it necessary to adjust the dose of other anti-Parkinson medications you are taking, especially levodopa, to adequately control your symptoms. Abruptly stopping treatment with Stalevo and other anti-Parkinson medications may cause unwanted side effects.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Many of the side effects can be reduced simply by adjusting the dose.
If you experience any of the following symptoms while taking Stalevo, contact your doctor immediately:

Muscle stiffness or severe muscle contractions, tremors, agitation, confusion, fever, increased heart rate, or severe fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare and serious reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare and serious muscle disorder).
An allergic reaction, which may include signs such as hives, itching, rash, swelling of the face, lips, tongue, or throat. Swelling of the throat may cause difficulty breathing or swallowing.

Very common (may affect more than 1 in 10 people):

Involuntary movements (dyskinesia)
Feeling unwell (nausea)
Harmless brown-red discoloration of the urine
Muscle pain
Diarrhoea

Common (may affect up to 1 in 10 people):

Feeling of light-headedness or fainting due to low blood pressure, increased blood pressure
Worsening of Parkinsonian symptoms, dizziness, drowsiness
Vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
Insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
Mental disorders including memory problems, anxiety, and depression (including suicidal thoughts)
Heart disease or problems with arteries (e.g. chest pain), irregular heart rhythm or heart rate
Increased frequency of falls
Shortness of breath
Increased sweating, skin rash
Muscle cramps, swelling in the legs
Blurred vision
Anaemia
Decreased appetite, weight loss
Headache, joint pain
Urinary tract infection

Uncommon (may affect up to 1 in 100 people):

Heart attack
Intestinal bleeding
Changes in blood cells which may lead to bleeding, abnormalities in liver function tests
Seizures
Agitation
Psychotic symptoms
Colitis (inflammation of the colon)
Changes in pigmentation other than of the urine (e.g. of the skin, nails, hair, sweat)
Difficulty swallowing, difficulty urinating

Not known (frequency cannot be estimated from the available data):
A desire to take higher doses of Stalevo than required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients may experience severe involuntary abnormal movements (dyskinesias), mood changes, or other side effects after taking high doses of Stalevo.

The following side effects have also been reported:

Hepatitis (inflammation of the liver)
Itching

You may develop the following side effects:

Inability to resist the impulse to carry out an action that could be harmful, which may include:
- A strong urge to gamble excessively, despite serious personal or family consequences;
- Altered or increased sexual interests and behaviours, causing concern to you or others, for example increased sexual drive;
- Uncontrollable excessive shopping or spending;
- Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger).

Inform your doctor if you experience any of these behaviours; they will discuss ways to manage or reduce these symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stalevo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Stalevo contains

The active substances in Stalevo are levodopa, carbidopa and entacapone.
Each Stalevo 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
The excipients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201).
The excipients in the tablet coating are glycerol (85%) (E422), hypromellose, magnesium stearate, polysorbate 80, iron oxide red (E172), sucrose, titanium dioxide (E171) and iron oxide yellow (E172).

Description of the appearance of Stalevo and contents of the pack
Stalevo 50 mg/12.5 mg/200 mg: brown or greyish-red, film-coated, non-scored, round, convex tablets marked with “LCE 50” on one side.
Stalevo 50 mg/12.5 mg/200 mg tablets are available in six pack sizes (containing 10, 30, 100, 130, 175 or 250 tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Orion Pharma BVBA/SPRL UAB Orion Pharma
Tél/Tel: +32 (0)15 64 10 20 Tel. +370 5 276 9499

България Luxembourg/Luxemburg
Orion Pharma Poland Sp z.o.o. Orion Pharma BVBA/SPRL
Tel.: + 48 22 8333177 Tél/Tel: +32 (0)15 64 10 20

Česká republika Magyarország
Orion Pharma s.r.o. Orion Pharma Kft.
Tel: +420 234 703 305 Tel.: +36 1 239 9095

Danmark Malta
Orion Pharma A/S Salomone Pharma
Tlf: +45 8614 0000 Tel: +356 21220174

Deutschland Nederland
Orion Pharma GmbH Orion Pharma BVBA/SPRL
Tel: +49 40 899 6890 Tél/Tel: +32 (0)15 64 10 20

Eesti Norge
Orion Pharma Eesti OÜ Orion Pharma AS
Tel: +372 66 44 550 Tlf: +47 40 00 42 10

Ελλάδα Österreich
Orion Pharma Hellas M.E.Π.E Orion Pharma GmbH
Τηλ: + 30 210 980 3355 Tel: +49 40 899 6890

España Polska
Orion Pharma S.L. Orion Pharma Poland Sp z.o.o.
Tel: + 34 91 599 86 01 Tel.: + 48 22 8333177

France Portugal
Orion Pharma Orionfin Unipessoal Lda
Tel: +33 (0) 1 85 18 00 00 Tel: + 351 21 154 68 20

Hrvatska România
Orion Pharma d.o.o. Orion Corporation
Tel: +386 (0) 1 600 8015 Tel: +358 10 4261

Ireland Slovenija
Orion Pharma (Ireland) Ltd. Orion Pharma d.o.o.
c/o Allphar Services Ltd. Tel: +386 (0) 1 600 8015
Tel: +353 1 428 7777

Ísland Slovenská republika
Vistor hf. Orion Pharma s.r.o
Sími: +354 535 7000 Tel: +420 234 703 305

Italia Suomi/Finland
Orion Pharma S.r.l. Orion Corporation
Tel: + 39 02 67876111 Puh./Tel: +358 10 4261

Κύπρος Sverige
Lifepharma (ZAM) Ltd Orion Pharma AB
Τηλ.: +357 22056300 Tel: +46 8 623 6440

Latvija United Kingdom (Northern Ireland)
Orion Corporation Orion Pharma (Ireland) Ltd.
Orion Pharma pārstāvniecība c/o Allphar Services Ltd.
Tel: +371 20028332 Tel: +353 1 428 7777

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Package leaflet: information for the user

Stalevo 75 mg/18.75 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone
Please read this entire leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Stalevo is and what it is used for
What you need to know before taking Stalevo
How to take Stalevo
Possible side effects
How to store Stalevo
Contents of the pack and other information

1. What Stalevo is and what it is used for

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in a film-coated tablet. Stalevo is used to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and thereby reduces the symptoms of Parkinson's disease. Carbidopa and entacapone enhance the effectiveness of the anti-Parkinson effects of levodopa.

2. What you need to know before taking Stalevo

Do not take Stalevo

if you are allergic to levodopa, carbidopa, or entacapone, or to any of the other ingredients of this medicine (listed in section 6)
if you suffer from closed-angle glaucoma (an eye disorder)
if you have a tumour of the adrenal gland
if you are taking antidepressants (combinations of selective MAO-A inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
if you have previously experienced the rare reaction to certain antipsychotic drugs known as Neuroleptic Malignant Syndrome (NMS)
if you have previously experienced a rare form of non-traumatic muscle disorder called rhabdomyolysis
if you have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Stalevo if you have or have previously had:

a heart attack, other heart diseases including arrhythmias, or blood vessel disorders
asthma or other lung diseases
liver disorders, as your dose may need to be adjusted
kidney or hormonal disorders
gastric ulcer or seizures
prolonged diarrhoea – consult your doctor as this may be a sign of inflammation of the colon
severe psychiatric disorders of any kind, such as psychosis
chronic open-angle glaucoma, as your dose may need to be adjusted and eye pressure monitored.

Talk to your doctor if you are taking:

antipsychotic medicines (medicines used to treat psychosis)
a medicine that may cause low blood pressure when standing up from sitting or lying down. Be aware that Stalevo may worsen such reactions.

Talk to your doctor if, while being treated with Stalevo:

you develop muscle stiffness or strong contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate, or severe blood pressure fluctuations. In such cases, you must seek immediate medical attention
you feel depressed or have thoughts of suicide, or if you notice any changes in your behaviour
you experience sudden attacks of sleep, or feel unusually sleepy. If this occurs, you must not drive or operate machinery (see also section “Driving and using machines”)
you develop uncontrolled movements or if these worsen after taking Stalevo. In this case, consult your doctor, as it may be necessary to adjust the dosage of your anti-Parkinson’s medicines
you develop diarrhoea: regular monitoring of body weight is recommended to avoid excessive weight loss
you experience progressive anorexia, asthenia (weakness, fatigue), and weight loss over a relatively short period of time. In such cases, a general medical evaluation should be considered, including liver function tests.
you feel the need to stop taking Stalevo; see section “If you stop taking Stalevo”.

Inform your doctor if you or a family member/carer notice the development of symptoms suggestive of dependence, leading to a desire for high doses of Stalevo and other medicines used to treat Parkinson’s disease.
Inform your doctor if you, or your family members/carers, notice that you develop impulses or strong urges to behave in unusual ways or are unable to resist the impulse, drive, or temptation to carry out activities that could be harmful to you or others. These behaviours are known as impulse control disorders and may include compulsive gambling, excessive spending and eating, abnormally increased sexual drive, or preoccupation with an increase in sexual thoughts or desires. Your doctor may need to review your treatment.
During prolonged treatment with Stalevo, your doctor may periodically request laboratory tests.
If you are scheduled for surgery, inform your doctor that you are taking Stalevo.
The use of Stalevo is not recommended for the treatment of extrapyramidal symptoms (e.g. involuntary movements, tremors, muscle rigidity, and muscle contractions) caused by other medicines.

Children and adolescents
Experience with Stalevo in patients under 18 years of age is limited. Therefore, Stalevo is not recommended for use in children or adolescents.

Other medicines and Stalevo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Stalevo if you are taking certain antidepressants (combinations of selective MAO-A inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors).
Stalevo may enhance the effects and side effects of certain medicines. These include:

medicines used to treat depression such as moclobemide, amitriptiline, desipramine, maprotiline, venlafaxine, and paroxetine
rimiterol and isoprenaline, used to treat certain respiratory conditions
adrenaline, used in severe allergic reactions
noradrenaline, dopamine, and dobutamine, used to treat certain heart conditions and hypotension
alpha-methyldopa, used to treat hypertension
apomorphine, used to treat Parkinson’s disease.

The effects of Stalevo may be reduced by certain medicines. These include:

dopamine antagonists used to treat certain psychiatric disorders, nausea, and vomiting
phenytoin, used to prevent seizures
papaverine, used to relax muscles.

Stalevo with food and drink
Stalevo can be taken with or without food. For some patients, Stalevo may not be well absorbed if taken with, or immediately after, high-protein foods (such as meat, fish, dairy products, seeds, and nuts). Consult your doctor if you think this may apply to you.

Pregnancy, breast-feeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Women must not breast-feed during treatment with Stalevo.

Driving and using machines
Stalevo may lower blood pressure, which can cause dizziness or lightheadedness. Exercise particular caution when driving or operating machinery.
If you experience drowsiness or sudden sleep attacks, wait until you are fully alert before resuming driving or any other activity requiring vigilance. Otherwise, you may place yourself and others at serious risk, including risk of death.

Stalevo contains sucrose
Stalevo contains sucrose (1.4 mg/tablet). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e. essentially “sodium-free”.

3. How to take Stalevo

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults and elderly:

Your doctor will tell you exactly how many Stalevo tablets to take each day.
The tablet is not designed to be divided into smaller parts.
Take only one tablet at a time.
Depending on your response to treatment, your doctor may recommend a higher or lower dose.
If you are taking Stalevo 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 feel that the effect of Stalevo is too strong or too weak, or if you experience possible
side effects, consult your doctor or pharmacist.
First opening of the bottle: open the
Figure 1
closure and then press with your thumb on the seal

until it breaks. See figure 1.
If you take more Stalevo than you should
Contact your doctor or pharmacist immediately if you have accidentally taken more Stalevo tablets
than prescribed. In case of overdose, you may feel confused or agitated, your heartbeat may speed up or slow down, or the colour of your skin, tongue, eyes, or urine may change.
If you forget to take Stalevo
Do not take a double dose to make up for a forgotten tablet.
If more than one hour remains until the next dose:
Take one tablet as soon as you remember, then take the next dose at the scheduled time.
If less than one hour remains until the next dose:
Take one tablet as soon as you remember, wait one hour, then take another tablet. Then continue as usual.
Always leave at least one hour between consecutive doses of Stalevo to avoid possible side effects.
If you stop taking Stalevo
Do not stop treatment with Stalevo unless your doctor tells you to. In such a case, your doctor may
need to adjust the dose of other anti-Parkinson's medicines you are taking, especially levodopa, to adequately control your symptoms. Abruptly stopping treatment with Stalevo and other anti-Parkinson's medicines may cause side effects.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Many of the side effects can be reduced simply by adjusting the dose.
If you experience any of the following symptoms while taking Stalevo, contact your doctor immediately:

Muscle rigidity or strong contractions, tremors, agitation, confusion, fever, increased heart rate, or severe fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare and serious reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare and serious muscle disorder).
An allergic reaction, which may include signs such as hives, itching, rash, swelling of the face, lips, tongue, or throat. Swelling of the throat may cause difficulty breathing or swallowing.

Very common (may affect more than 1 in 10 people):

Involuntary movements (dyskinesia)
Feeling unwell (nausea)
Harmless brownish-red discoloration of the urine
Muscle pain
Diarrhoea.

Common (may affect up to 1 in 10 people):

Light-headedness or fainting due to low blood pressure, increased blood pressure
Worsening of Parkinsonian symptoms, dizziness, drowsiness
Vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
Insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
Mental disorders including memory problems, anxiety, and depression (including suicidal thoughts)
Heart disease or problems with arteries (e.g. chest pain), irregular heart rhythm or heart rate
Increased frequency of falls
Shortness of breath
Increased sweating, skin rash
Muscle cramps, swelling of the legs
Blurred vision
Anaemia
Decreased appetite, weight loss
Headache, joint pain
Urinary tract infection.

Uncommon (may affect up to 1 in 100 people):

Heart attack
Intestinal bleeding
Changes in blood cells that may cause bleeding, abnormalities in liver function tests
Seizures
Agitation
Psychotic symptoms
Colitis (inflammation of the colon)
Discoloration of tissues other than urine (e.g. skin, nails, hair, sweat)
Difficulty swallowing
Difficulty urinating.

Not known (frequency cannot be estimated from the available data):
Desire for excessively high doses of Stalevo beyond what is needed to control motor symptoms, known as dopamine dysregulation syndrome. Some patients may experience severe involuntary abnormal movements (dyskinesias), mood changes, or other side effects after taking high doses of Stalevo.
The following side effects have also been reported:

Hepatitis (inflammation of the liver)
Itching.

You may develop the following side effects:

Inability to resist the impulse to carry out an action that could be harmful, which may include:
A strong urge to gamble excessively, despite serious personal or family consequences;
Altered or increased sexual interests and behaviours, causing significant concern to you or others, for example increased sexual drive;
Uncontrollable excessive spending or shopping;
Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger).

Inform your doctor if you experience any of these behaviours; they will discuss ways to manage or reduce these symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system referred to in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stalevo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Stalevo contains

The active substances in Stalevo are levodopa, carbidopa and entacapone.
Each Stalevo 75 mg/18.75 mg/200 mg tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
The excipients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201).
The excipients in the tablet coating are glycerol (85%) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).

Description of the appearance of Stalevo and contents of the pack
Stalevo 75 mg/18.75 mg/200 mg: light brownish-red oval tablets marked with
“LCE 75” on one side.
Stalevo 75 mg/18.75 mg/200 mg tablets are available in five pack sizes (containing
10, 30, 100, 130 or 175 tablets). Not all pack sizes may be marketed.

Marketing Authorization Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Orion Pharma BVBA/SPRL UAB Orion Pharma
Tél/Tel: +32 (0)15 64 10 20 Tel. +370 5 276 9499

България Luxembourg/Luxemburg
Orion Pharma Poland Sp z.o.o. Orion Pharma BVBA/SPRL
Tel.: + 48 22 8333177 Tél/Tel: +32 (0)15 64 10 20

Česká republika Magyarország
Orion Pharma s.r.o. Orion Pharma Kft.
Tel: +420 234 703 305 Tel.: +36 1 239 9095

Danmark Malta
Orion Pharma A/S Salomone Pharma
Tlf: +45 8614 0000 Tel: +356 212201741