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

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Levodopa/carbidopa/entacapone

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

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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. 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 entacapona) in a single film-coated tablet. Stalevo is used to treat Parkinson's disease.

Parkinson's disease is caused by low levels 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 entacapona enhance 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)
• you have narrow-angle glaucoma (an eye disorder)
• you have a tumour of the adrenal glands
• you are taking certain medicines to treat 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 in the treatment of serious mental disorders)
• you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
• you have severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Stalevo if you have or have ever had:

• a heart attack or any other heart or blood vessel disease, including arrhythmias
• asthma or any other lung disease
• a liver problem, as your dose may need to be adjusted
• any kidney disease or hormone-related disorder
• stomach ulcer or seizures
• prolonged diarrhoea. Consult your doctor, as this may be a sign of inflammation of the colon
• any form of serious mental disorder, such as psychosis
• open-angle glaucoma, as your dose may need to be adjusted and your intraocular pressure monitored.

Talk to your doctor if you are taking:

• antipsychotics (medicines used to treat psychosis)
• any medicine that may cause a drop in blood pressure when standing up from sitting or lying down. Be aware that Stalevo may worsen these reactions.

Talk to your doctor if, during treatment with Stalevo:

• you experience severe muscle stiffness or violent muscle contractions, or if you develop tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. If any of these occur, contact your doctor immediately
• you feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
• you find yourself falling asleep suddenly or feel very drowsy. If this happens, you must not drive or operate tools or machinery (see also section “Driving and use of machines”)
• you begin to experience uncontrolled movements or they worsen. If this occurs, your doctor may need to adjust your dose
• you develop diarrhoea; weight monitoring is recommended to prevent excessive weight loss
• you experience progressive loss of appetite, asthenia (weakness, exhaustion), and weight loss over a relatively short period. In such cases, a full medical evaluation including liver function tests should be considered
• you are considering stopping Stalevo; refer to the section "If you stop taking Stalevo".

Inform your doctor if you, or your family/carer, 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.

Inform your doctor if you or your family/carer notice that you are developing urges or a tendency to behave in ways that are unusual for you or that you cannot resist the impulse, drive, or temptation to carry out certain activities that may harm you or others. These behaviours are known as impulse control disorders and may include gambling addiction, compulsive eating or spending, and abnormally increased sexual drive or preoccupation with increased sexual thoughts or sensations. Your doctor may need to review your treatment.

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

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

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

Children and adolescents

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

Taking Stalevo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 adverse 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 respiratory diseases
• adrenaline, used for severe allergic reactions
• noradrenaline, dopamine, and dobutamine, used to treat heart conditions 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 gastrointestinal absorption of iron. Therefore, do not take Stalevo at the same time as iron supplements. If you take either, wait at least 2 to 3 hours before taking the other.

Taking Stalevo with food and drink

• Stalevo may be taken with or without food.
• In some patients, Stalevo may not be well absorbed if taken with high-protein foods (meats, fish, dairy products, cereals, and nuts) or shortly after eating them. Consult your doctor if you think this applies to you.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breast-feed while taking Stalevo.

Driving and use of machines

Stalevo may lower your blood pressure, which may cause dizziness or fainting. Therefore, take special care when operating tools or machinery.

If you feel very tired or notice that you fall asleep suddenly, wait until you are fully awake again before driving or doing anything that requires alertness. 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 certain sugars, consult with him before taking this medicine.

3. How to take Stalevo

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults and elderly:

• Your doctor will tell you the exact number of Stalevo tablets to take each day.
  • The tablets must not be split or divided into smaller pieces.
  • Take only one tablet at a time.
  • Depending on how you respond to treatment, your doctor may instruct you to increase or decrease the dose.
  • If you are taking Stalevo tablets of 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, 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 adverse effects.

If you take more Stalevo than you should

If you have accidentally taken more Stalevo tablets than you should, contact your doctor or pharmacist immediately. In case of overdose, you may feel dizzy or agitated, your heartbeat may become slower or faster than normal, or you may notice a change in the color of your skin, tongue, eyes, or urine.

If you forget to take Stalevo

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

If more than 1 hour remains until the next dose:

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

If less than 1 hour remains until the next dose:

Take one tablet as soon as you remember, wait 1 hour, and then take another tablet. After that, continue as usual.

There must always be a 1-hour interval between Stalevo tablets to avoid possible adverse 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 need to adjust the dose of your other Parkinson's medications, especially levodopa, to ensure adequate symptom control. If you abruptly stop taking Stalevo and other Parkinson's medications, you may experience unwanted adverse effects.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them. Many of these can be relieved by adjusting the dose.

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

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

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

• Uncontrolled movements (dyskinesias)
• Feeling unwell (nausea)
• Harmless reddish-brown discoloration of urine
• Muscle pain
• Diarrhea

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

• Fainting or collapse due to low blood pressure, hypertension
• Worsening of parkinsonism symptoms, dizziness, drowsiness
• Vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation
• Difficulty sleeping; hallucinations; confusion; abnormal dreams (with nightmares); tiredness
• Changes in mental state, including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• Heart or artery problems (e.g., chest pain), irregular heartbeat
• More frequent falls
• Shortness of breath
• Increased sweating, rashes
• Muscle cramps, leg swelling
• Blurred vision
• Anaemia
• 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 lead to bleeding and abnormalities in liver function tests
• Seizures
• Restlessness
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Discoloration other than that of urine (e.g., skin, nails, hair, sweat)
• Difficulty swallowing
• Inability to urinate

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

A desire to take high doses of Stalevo exceeding those needed to control motor symptoms, known as dopamine dysregulation syndrome. Some patients may experience severe abnormal involuntary movements (dyskinesias), mood changes, or other adverse effects after taking high 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 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
  • an increased or altered interest in sex and behaviour that is concerning to you or others, such as increased sexual urges
  • excessive or uncontrolled shopping or spending
  • eating excessively (consuming large amounts of food in short periods of time) or compulsive eating (eating more food than usual and more than necessary to satisfy hunger).

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Stalevo

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

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 or packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Stalevo

• 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 other components of the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E 421) and povidone (E 1201).
• The components of the film coating are glycerol 85 percent (E 422), hypromellose, magnesium stearate, polysorbate 80, iron oxide red (E 172), sucrose, titanium dioxide (E 171) and iron oxide yellow (E 172).

Nature of the product and pack sizes

Stalevo 50 mg/12.5 mg/200 mg: brownish-red or greyish, round, convex, film-coated tablets without a break line, marked with "LCE 50" on one side.

There are six different pack sizes (10, 30, 100, 130, 175 or 250 tablets). However, only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

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

Date of the most recent review of this leaflet:

Other sources of information

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