STALEVO 50 mg/12.5 mg/200 mg FILM-COATED TABLETS

2. What you need to know before you take Stalevo

Do not take Stalevo if

• you are allergic to levodopa, carbidopa, or entacapone, or any of the other ingredients of this medicine (listed in section 6)
• you have narrow-angle glaucoma (a condition where the pressure in the eye is increased)
• you have a tumor of the adrenal gland
• you are taking certain medicines for depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors)
• you have ever had neuroleptic malignant syndrome (NMS - a rare reaction to medicines used to treat severe mental disorders)
• you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
• you have severe liver disease.

Warnings and precautions

Tell your doctor or pharmacist before you start taking Stalevo if you have or have had:

• a heart attack or any other heart disease, including arrhythmias, or blood vessel disease
• asthma or any other lung disease
• any liver problem, as your dose may need to be adjusted
• any kidney disease or hormone-related disease
• stomach ulcers or seizures
• prolonged diarrhea. Check with 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 eye pressure monitored.

Tell your doctor if you are taking:

• antipsychotics (medicines for treating psychosis)
• any medicine that may cause a drop in blood pressure when standing up from a chair or bed. You should be aware that Stalevo may worsen these reactions.

Tell your doctor if, while taking Stalevo, you:

• notice great stiffness in your muscles or that they contract violently, or if you experience tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. If any of these occur, contact your doctor immediately.
• feel depressed, have suicidal thoughts, or notice unusual changes in your behavior.
• notice that you suddenly fall asleep, or feel very drowsy. If this happens, do not drive or operate machinery (see also section "Driving and using machines").
• start to notice uncontrolled movements or if they get worse. If this happens, your doctor may need to adjust your medication dose.
• experience diarrhea: it is recommended to monitor your weight to avoid excessive weight loss.
• experience progressive loss of appetite, asthenia (weakness, exhaustion), and weight loss over a relatively short period. In these cases, a complete medical evaluation, including liver function tests, should be considered.
• consider stopping Stalevo, see the section "If you stop taking Stalevo".

Tell your doctor if you, or your family member/caregiver, notice that you are developing symptoms similar to addiction, leading to a desire for high doses of Stalevo and other medicines used to treat Parkinson's disease.

Tell your doctor if you, or your family member/caregiver, notice that you are developing desires or tendencies to behave in an unusual way, which you cannot resist, such as an impulse to gamble, eat, or spend excessively, or an abnormally increased sexual drive or preoccupation with sexual thoughts or feelings. These behaviors are called impulse control disorders and may include addiction to gambling, food, or excessive spending, and an abnormally increased sexual drive. Your doctor may need to review your treatment.

During long-term treatment with Stalevo, your doctor may perform regular blood tests.

If you need to undergo surgery, tell 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 medicines.

Children and adolescents

Experience with Stalevo in patients under 18 years is limited. Therefore, it 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 medicines for depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Stalevo may increase the effect, and also the 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 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, used to treat Parkinson's disease.

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

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

Stalevo may interfere with the absorption of iron from the gut. Therefore, do not take Stalevo at the same time as iron supplements. If you take any, 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. However, in some patients, Stalevo may not be absorbed well if taken with protein-rich foods (meat, fish, dairy products, cereals, and nuts) or shortly after eating them. Check with your doctor if you think this applies to you.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not breastfeed while taking Stalevo.

Driving and using machines

Stalevo may lower your blood pressure, which can cause dizziness or fainting. Therefore, be careful when using tools or machines.

If you feel very tired or notice that you suddenly fall asleep, wait until you feel fully awake before driving or doing anything that requires you to be alert. Otherwise, you may put yourself and others at risk of a serious or even fatal accident.

Stalevo contains sucrose

Stalevo contains sucrose (1.2 mg/tablet). If your doctor has told you that you have an intolerance to some sugars, check with them before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per maximum recommended daily dose, i.e., it is essentially "sodium-free".

3. How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults and the elderly:

• Your doctor will tell you exactly how many Stalevo tablets to take each day.
• The tablets must not be broken or divided into smaller pieces.
• Take only one tablet at a time.
• Depending on how you respond to treatment, your doctor may ask you to increase or decrease the 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.

Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you experience possible side effects.

If you take more Stalevo than you should

If you accidentally take more Stalevo tablets than you should, talk to your doctor or pharmacist immediately. In case of overdose, you may feel dizzy or agitated, your heart rate may be slower or faster than normal, or your skin, tongue, eyes, or urine may change color.

If you forget to take Stalevo

Do not take a double dose to make up for forgotten doses.

If it is more than 1 hour until your next dose:

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

If it is less than 1 hour until your next dose:

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

There must be at least 1 hour between Stalevo tablets to avoid possible side effects.

If you stop taking Stalevo

Do not stop taking Stalevo unless your doctor tells you to. If your doctor tells you to stop taking Stalevo, they may need to adjust the dose of your other Parkinson's medicines, especially levodopa, to control your symptoms. If you stop taking Stalevo and other Parkinson's medicines suddenly, you may experience unwanted side effects.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many can be relieved by adjusting the dose.

If you experience any of these symptoms while taking Stalevo, contact your doctor immediately:

• Great stiffness or violent contractions of the muscles, tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. These can be symptoms of neuroleptic malignant syndrome (NMS - a rare and severe reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare and severe muscle disorder).
• An 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 10 people):

• uncontrolled movements (dyskinesias)
• feeling sick (nausea)
• harmless brownish discoloration of urine
• muscle pain
• diarrhea.

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

• fainting 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
• difficulty sleeping, hallucinations, confusion, abnormal dreams (with nightmares), fatigue
• changes in mental state, including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• heart or blood vessel disorders (e.g., chest pain), irregular heartbeats
• more frequent falls
• breathlessness
• increased sweating, rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infections.

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

• heart attack
• intestinal bleeding
• changes in blood cell counts that may cause bleeding, abnormal liver function tests
• seizures
• feeling agitated
• psychotic symptoms
• colitis (inflammation of the colon)
• color changes different from those of urine (e.g., skin, nails, hair, sweat)
• difficulty swallowing
• inability to urinate.

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

Desire for high doses of Stalevo beyond those required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary 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 experience the following side effects:

• Inability to resist the impulse to perform an action that could be harmful, which may include:
• a strong impulse to gamble excessively despite severe personal or family consequences
• an increased or altered interest in sex and a concerning behavior for you or others, such as an increased sexual drive
• excessive or uncontrolled shopping
• eating excessively (eating large amounts of food in short periods) or compulsively (eating more food than usual and more than needed to satisfy hunger).

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

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Stalevo

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Stalevo

• The active ingredients of 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 other components of the tablet core are sodium croscarmellose, magnesium stearate, cornstarch, mannitol (E421), and povidone (E1201).
• The components of the film coating are glycerol 85 percent (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Stalevo 50 mg/12.5 mg/200 mg: reddish-brown or grayish, round, convex, uncoated tablets with a film coating with "LCE 50" engraved on one side.

There are six different package sizes of Stalevo 50 mg/12.5 mg/200 mg (10, 30, 100, 130, 175, or 250 tablets). Not all package 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information about this medication is available on the European Medicines Agency website http://www.ema.europa.eu.