Leaflet: information for the user

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

Levodopa/carbidopa/entacapona

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Stalevo is and what it is used for

2. What you need to know before you start taking Stalevo

3. How to take Stalevo

4. Possible side effects

5. Storage of Stalevo

6. Contents of the pack and additional information

Stalevo contains three active ingredients (levodopa, carbidopa, and entacapone) in a coated tablet. Stalevo is used to treat Parkinson's disease.

Parkinson's disease is caused by a low concentration in the brain of a substance called dopamine. Levodopa increases the amount of dopamine and thereby reduces the symptoms of Parkinson's disease. Carbidopa and entacapone improve the antiparkinsonian effects of levodopa.

Do not take Stalevo if:

-You are allergic to levodopa, carbidopa, or entacapone, or to any of the other ingredients of this medication (listed in section 6)

• You have narrow-angle glaucoma (a eye disorder)
• You have a tumor of the adrenal glands
• You are taking certain medications for depression (combinations of MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors)
• You have ever had a neuroléptico maligno syndrome (NMS – a rare reaction to medications used to treat severe mental disorders)
• You have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
• You have a severe liver disorder

Warnings and precautions

Consult your doctor or pharmacist before starting Stalevo if you have or have had:

-A heart attack or any other heart or blood vessel disease, including arrhythmias

-Asthma or any other lung disease

• Any liver problem, as your dose may need to be adjusted
• Any kidney or hormone-related disorder
• Stomach ulcers or seizures
• Prolonged diarrhea. Consult your doctor as it may be a sign of colon inflammation
• Any severe mental disorder, such as psychosis
• Open-angle glaucoma, as your dose may need to be adjusted and your intraocular pressure monitored

Consult your doctor if you are taking:

• Antipsychotics (medications for treating psychosis)
• Any medication that can cause a drop in blood pressure when standing up from a chair or bed. You should know that Stalevo may worsen these reactions.

Consult your doctor if during treatment with Stalevo:

• You notice great muscle rigidity or that your muscles contract violently, or if you experience tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. If any of these circumstances occur, contact your doctor immediately
• You feel depressed, have suicidal thoughts, or notice unusual changes in your behavior
• You fall asleep suddenly, or you feel extremely drowsy. If this happens, do not drive or operate machinery (see also the section "Driving and operating machinery")
• You start to notice involuntary movements or they worsen. If this occurs, your doctor may need to change your medication dose
• You experience diarrhea: it is recommended to monitor your weight to avoid excessive weight loss
• You experience progressive loss of appetite, asthenia (weakness, fatigue), and weight loss over a relatively short period. In these cases, a complete medical evaluation, including liver function testing, may be necessary
• You consider stopping Stalevo; see the section "If you interrupt Stalevo treatment"

Inform your doctor if you, or your family/caregiver, notice that you are developing symptoms similar to addiction, which lead to a desire for large doses of Stalevo and other medications used to treat Parkinson's disease.

Inform your doctor if you or your family/caregiver notice that you are developing desires or a propensity to behave in an unusual way in you or that you cannot resist the impulse, determination, or temptation to engage in certain activities that may harm you or others. These behaviors are known as impulse control disorders and may include excessive gaming, eating, or spending, and an abnormally elevated or concerning sexual impulse.Your doctor may need to review your treatment.

During prolonged treatment with Stalevo, your doctor may perform regular laboratory tests.

If you need to undergo surgery, inform your doctor that you are taking Stalevo.

Stalevo is not recommended for the treatment of extrapyramidal symptoms (e.g., involuntary movements, agitation, muscle rigidity, and muscle contractions) caused by other medications.

Children and adolescents

The experience of using Stalevo in patients under 18 years old is limited. Therefore, its administration in children or adolescents is not recommended.

Taking Stalevo with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Stalevo if you are taking certain medications for depression (combinations of MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effect, and also the adverse effects, of certain medications.These include:

• Medications used to treat depression, such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine, and paroxetine
• Rimiterol and isoprenaline, used to treat respiratory diseases
• Adrenaline, used for severe allergic reactions
• Noradrenaline, dopamine, and dobutamine, used to treat heart disease and low blood pressure
• Alpha-methyldopa, used to treat high blood pressure
• Apomorphine, used to treat Parkinson's disease

Certain medications may reduce the effects of Stalevo. These medications are:

-Antidopaminergic medications used to treat mental disorders, nausea, and vomiting

-Phenytoin, used to prevent seizures

-Papaverine, used to relax muscles

Stalevo may make it difficult for the body to absorb iron at the digestive level. Therefore, do not take Stalevo at the same time as taking iron supplements. If you take any of them, wait at least 2 or 3 hours before taking the other.

Taking Stalevo with food and drinks

• Stalevo can be taken with or without food.
• In some patients, Stalevo may not be well absorbed if taken with foods high in protein (meat, fish, dairy products, cereals, and nuts) or shortly after consuming them. Consult your doctor if you think this occurs in your case.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Do not breastfeed your child during treatment with Stalevo.

Driving and operating machinery

Stalevo may lower your blood pressure, which may cause dizziness or fainting. Therefore, be especially careful when handling tools or machinery.

If you feel extremely tired or notice that you fall asleep suddenly, wait until you feel fully awake again before driving or operating machinery (see also the section "Driving and operating machinery"). If you do not, you may put yourself and others at risk of a serious or even fatal accident.

Stalevo contains saccharose

Stalevo contains saccharose (2.3 mg/tablet). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and elderly:

-Your doctor will indicate the exact number of Stalevo tablets you should take per day.

• Do not break or divide the tablets into smaller pieces.
• Take only one tablet at a time.
• Depending on how you respond to treatment, your doctor may indicate that you increase or decrease the dose.
• If you are taking Stalevo tablets of 200mg/50mg/200mg,do not take more than 7tablets per day.

Speak with your doctor or pharmacist if you believe the effect of Stalevo is too intense or too weak, or if you experience possible side effects.

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, speak immediately with your doctor or pharmacist. In case of overdose, you may feel dazed or agitated, that your heart rate is slower or faster than normal, or that you change the color of your skin, tongue, eyes, or urine.

If you forget to take Stalevo

Do not take a double dose to compensate for the missed doses.

If more than 1 hour remains until the next dose:

Take a tablet as soon as you remember, and the next one at the usual time.

If less than 1 hour remains until the next dose:

Take a tablet as soon as you remember, wait 1 hour and then take another tablet. Then, continue as usual.

Always allow 1 hour to pass between Stalevo tablets, to avoid possible side effects.

If you interrupt treatment with Stalevo

Do not stop taking Stalevo unless your doctor tells you to. In that case, your doctor may need to adjust the dose of other Parkinson's medications, especially levodopa, so that your symptoms are adequately controlled. If you stop taking Stalevo and other Parkinson's medications abruptly, you may experience unwanted side effects.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicinemay cause side effects,although not everyone will experience them. Many can be alleviated by adjusting the dose.

If you experience any of these symptoms during treatment with Stalevo,contact your doctor immediately:

• Severe stiffness or violent muscle contractions, tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. They may be symptomsof malignant neuroleptic syndrome (SNM, a rare severe reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare and severe muscle disorder).
• Allergic reaction characterized by signs such as hives, itching, rash, and swelling of the face, lips, tongue, or throat. This reaction can cause difficulty breathing or swallowing.

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

-Uncontrolled movements (dyskinesias)

-Unpleasant sensation (nausea)

-Brownish-red urine discoloration

-Muscle pain

-Diarrhea

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

-Loss of consciousness or fainting due to decreased blood pressure, hypertension

-Worsening of Parkinson's symptoms, dizziness, drowsiness

-Vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation

-Inability to sleep; hallucinations; confusion; abnormal dreams (with nightmares); fatigue

-Mental state changes, including memory problems, anxiety, and depression (possibly with suicidal thoughts)

-Cardiac or arterial discomfort (e.g., chest pain), irregular heart rate

-Frequent falls

-Shortness of breath

-Increased sweating, rashes

-Muscle cramps, leg swelling

-Blurred vision

-Anemia

-Loss of appetite, weight loss

-Headache, joint pain

-Urinary tract infections

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

• Myocardial infarction
• Intestinal hemorrhage
• Blood cell count abnormalities that may cause bleeding; liver function test abnormalities

-Seizures

• Restlessness
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Changes in skin color other than urine discoloration (e.g., skin, nails, hair, sweat)
• Difficulty swallowing

-Inability to urinate

Frequency not known (cannot be estimated from available data):

Desire for large doses of Stalevo exceeding those required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood changes, or other adverse effects after taking large doses of Stalevo.

The following adverse effects have also been reported:

• Hepatitis (inflammation of the liver)
• Itching

You may experience the following adverse effects:

• Inability to resist the urge to perform an action that could be harmful, and which may include:
• • A strong urge to gamble excessively despite severe personal and family consequences
  • Increased or altered sexual interest and behavior that is concerning to you or others, such as increased libido
  • Excessive or uncontrolled spending
  • Compulsive eating (eating large amounts of food in short periods) or excessive eating (eating more food than usual and more than needed to satisfy hunger)

Inform your doctor if you experience any of these behaviors: they will discuss how to manage or reduce these symptoms.

Reporting Adverse Reactions

If you experienceany type of adverse reaction, consult your doctor or pharmacist, even if it is apossibleadverse reaction that does not appear in this leaflet.You can also report them directly through the national notification system included in theAnexo V.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD.The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging or medication that you no longer need. In this way, you will help protect the environment.

Stalevo Composition

• The active principles of Stalevo are levodopa, carbidopa, and entacapone.
• Each Stalevo 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa, and 200 mg of entacapone.
• The other components of the tablet core are croscarmellose sodium, magnesium stearate, cornstarch, mannitol (E 421), and povidone (E 1201).
• The components of the film coating are 85% glycerol (E 422), hypromellose, magnesium stearate, polisorbate 80, iron oxide red (E 172), sucrose, and titanium dioxide (E 171).

Appearance of the product and contents of the package

Stalevo 200 mg/50 mg/200 mg: oval, non-scored, film-coated tablets, dark reddish-brown in color with “LCE 200” engraved on one side.

There are five different package sizes of Stalevo 200 mg/50 mg/200 mg (10, 30, 100, 130, or 175 tablets). Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

For more information about this medication, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet:

Other sources of information

For detailed information about this medication, please visit the website of the European Medicines Agencyhttp://www.ema.europa.eu