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

Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stalevo is used for the treatment of Parkinson?s disease.

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.

Do not take Stalevo if you

• allergic (hypersensitive) to levodopa, carbidopa or entacapone, or any of the other ingredients of Stalevo
• have narrow-angle glaucoma (an eye disorder)
• have a tumour of the adrenal gland
• are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO-inhibitors)
• have ever had neuroleptic malignant syndrome (NMS ? this is a rare reaction to medicines used to treat severe mental disorders)
• have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
• have a severe liver disease.

Take special care with Stalevo

Consult your doctor if you have or have ever had:

• a heart attack or any other diseases of the heart including cardiac arrythmias, or of the blood vessels
• asthma or any other disease of the lungs
• a liver problem, because your dose may need to be adjusted
• kidney or hormone-related diseases
• stomach ulcers or convulsions
• if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon
• any form of severe mental disorder like psychosis
• chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.

Consult your doctor if you are currently taking:

• antipsychotics (medicines used to treat psychosis)
• a medicine which may cause low blood pressure when rising from a chair or bed. You should be aware that Stalevo may make these reactions worse.

Consult your doctor if during the treatment with Stalevo you:

• 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
• feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
• 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')
• notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this happens, your doctor may need to change the dose of your antiparkinson medicine
• experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially excessive weight loss
• 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
• experience excessive gambling or excessive sexual activity
• feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.

Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.

If you must undergo surgery, please tell your doctor that you are using Stalevo.

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

Children
Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children is not recommended.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.

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

Stalevo may increase the effects and side effects of certain medicines. These include:

• medicines used to treat depression such as moclobemide, amitryptiline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterole 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, which is used to treat Parkinson?s disease.

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

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

Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron supplements at the same time. After taking one of them, 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. For some patients, Stalevo 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.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, consult your doctor before taking Stalevo.

You should not breast-feed during treatment with Stalevo.

Driving and using machines

Stalevo 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.

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.

Important information about some of the ingredients of Stalevo

Stalevo contains sucrose (2.3 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.

Always take Stalevo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For adults and elderly:

• Your doctor will tell you exactly how many tablets of Stalevo to take each day.
• The tablets are not intended to be split or broken into smaller pieces.
• You should take only one tablet each time.
• Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.
• If you are taking Stalevo 200 mg/50 mg/200 mg, do not take more than 7 tablets of this strength 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 have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist immediately.

If you forget to take Stalevo

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

If it is more than 1 hour until your next dose:
Take one tablet as soon as you remember, and the next tablet at the normal time.

If it is less than 1 hour until your next dose:
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as normal.

Always leave at least an 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. 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 of Stalevo and other antiparkinsonian medicines it may result in unwanted side effects.

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

Like all medicines, Stalevo can cause side effects, although not everybody gets them. If you experience any of these side effects, talk to your doctor as soon as possible. Many of the side effects can be relieved by adjusting the dose.

The frequencies are defined as:
Very common ( affects more than 1 user in 10)
Common ( affects 1 to 10 users in 100)
Uncommon ( affects 1 to 10 users in 1,000)
Rare ( affects 1 to 10 users in 10,000)
Very rare ( affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).

Very common

• uncontrolled movements (dyskinesias)
• feeling sick (nausea)
• harmless reddish-brown discoloration of urine
• muscle pain
• diarrhoea

Common

• light-headedness or fainting due to low blood pressure, high blood pressure
• worsening of Parkinsons`s symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
• inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness
• mental changes ? including problems with memory, anxiety and depression (possibly with thoughts of suicide)
• heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm
• more frequent falling
• shortness of breath
• increased sweating, rashes
• muscle cramps, swelling of legs
• blurred vision
• anaemia
• decreased appetite, decreased weight
• headache, joint pain
• urinary tract infection

Uncommon

• heart attack
• bleeding in the gut
• changes in the blood cell count which may result in bleeding, abnormal liver function tests
• convulsions
• feeling agitated
• psychotic symptoms
• colitis (inflammation of the colon)
• discolourations other than urine (e.g. skin, nail, hair, sweat)
• swallowing difficulties
• inability to urinate

The following side effects have also been reported:

• hepatitis (inflammation of the liver)
• itching

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

• Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. These can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare severe muscle disorder).
• Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat. This may cause difficulties in breathing or swallowing.

Behavioural changes such as urge to gamble (pathological gambling) or increased sexual desire and urges (increased libido and hypersexuality) have been reported in patients receiving dopamine replacement therapy including Stalevo.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the bottle and the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

What Stalevo contains

• The active substances 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 ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201).
• The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).

What Stalevo looks like and contents of the pack

Stalevo 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ?LCE 200? on one side.

Stalevo 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH AllemagneDeutschland TélTel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Orion Pharma AS Tlf 45 49 12 66 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Orion Pharma GmbH Tel 49 40 899 689-0 Norge Orion Pharma AS Tlf 47 40 00 42 10

Eesti Orion Pharma Eesti OÜ Tel 372 66 44 551 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas .... 30 210 281 17 12 Polska Orion Pharma Poland Sp z.o.o. Tel. 48 22 8333177, 8321036

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50 Ireland Orion Pharma Ireland Ltd. co Allphar Services Ltd. Tel 353 1 404 16 00

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakìa s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Orion Corporation Puh.Tel 358 10 4261

357 22 690 690 Sverige Orion Pharma AB Tel 46 8 623 6440

United Kingdom Orion Pharma UK Ltd. Tel 44 1635 520 300 Latvija Orion Corporation Orion Pharma prstvniecba Tel 371 745 55 63

Lietuva
UAB Orion Pharma
Tel. +370 5 276 9499

This leaflet was last approved on {date}