Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - stalevo

Document Subject

Generated Narrative: MedicinalProductDefinition mpbdb3583748a144c4aaf24f2e42bc1ae4

identifier: http://ema.europa.eu/identifier/EU/1/03/260/001-004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

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

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-bdb3583748a144c4aaf24f2e42bc1ae4

identifier: http://ema.europa.eu/identifier/EU/1/03/260/001-004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - stalevo

Attesters

What is in this leaflet:

1. What Stalevo is and what it is used for
2. What you need to know before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5. How to store Stalevo
6. Contents of the pack and other information

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:

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

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. 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 diseases of the heart including cardiac arrhythmias, 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.

feel the need to stop using Stalevo, see section If you stop taking Stalevo . Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Stalevo and other medicines used to treat Parkinson s disease. Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatments. 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 and adolescents Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children or adolescents is not recommended. 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 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, amitriptyline, 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. 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, breast-feeding and fertility If you are pregnant or breast-feeding, 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 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. Stalevo contains sucrose Stalevo contains sucrose (1.2 mg/tablet). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) sodium per maximum recommended daily dose, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor or pharmacist has told you. 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 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. To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks. See picture 1. Picture 1 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. In case of an overdose you may feel confused or agitated, your heart rate may be slower or faster than normal 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 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 Stalevo and other antiparkinsonian medicines it may result in unwanted side effects. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects can be relieved by adjusting the dose. 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. Very common (may affect more than 1 in 10 people):

uncontrolled movements (dyskinesias)

feeling sick (nausea)

harmless reddish-brown discolouration of urine

muscle pain

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

light-headedness 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

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 (may affect up to 1 in 100 people):

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. Not known (frequency cannot be estimated from the available data): Craving for large doses of Stalevo in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large 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:

strong impulse to gamble excessively despite serious personal or family consequences

altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

uncontrollable excessive shopping or spending

binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger). Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms. Reporting of side effects If you get 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.

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 bottle and the carton. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Stalevo contains

The active substances 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 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, titanium dioxide (E171), and yellow iron oxide (E172). What Stalevo looks like and contents of the pack Stalevo 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with LCE 50 on one side. Stalevo comes in six different pack sizes (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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Belgi /Belgique/Belgien Orion Pharma BVBA/SPRL T l/Tel: +32 (0)15 64 10 Lietuva UAB Orion Pharma Tel. +370 5 276 9 Orion Pharma Poland Sp z.o.o. Tel.: + 48 22 8333Luxembourg/Luxemburg Orion Pharma BVBA/SPRL T l/Tel: +32 (0)15 64 10 esk republika Orion Pharma s.r.o. Tel: +420 234 703 Magyarorsz g Orion Pharma Kft. Tel.: +36 1 239 9Danmark Orion Pharma A/S Tlf: +45 8614 0Malta Salomone Pharma Tel: +356 21220Deutschland Orion Pharma GmbH Tel: +49 40 899 6Nederland Orion Pharma BVBA/SPRL T l/Tel: +32 (0)15 64 10 Eesti Orion Pharma Eesti O Tel: +372 66 44 Norge Orion Pharma AS Tlf: +47 40 00 42
Orion Pharma Hellas M.E. .E : + 30 210 980 3 sterreich Orion Pharma GmbH Tel: +49 40 899 6Espa a Orion Pharma S.L. Tel: + 34 91 599 86 Polska Orion Pharma Poland Sp z.o.o. Tel.: + 48 22 8333France Orion Pharma T l: +33 (0) 1 85 18 00 Portugal Orionfin Unipessoal Lda Tel: + 351 21 154 68 Hrvatska Orion Pharma d.o.o. Tel: +386 (0) 1 600 8Rom nia Orion Corporation Tel: +358 10 4Ireland Orion Pharma (Ireland) Ltd. c/o Allphar Services Ltd. Tel: +353 1 428 7Slovenija Orion Pharma d.o.o. Tel: +386 (0) 1 600 8 sland Vistor hf. S mi: +354 535 7Slovensk republika Orion Pharma s.r.o Tel: +420 234 703 Italia Orion Pharma S.r.l. Tel: + 39 02 67876Suomi/Finland Orion Corporation Puh./Tel: +358 10 4 Lifepharma (ZAM) Ltd .: +357 22056Sverige Orion Pharma AB Tel: +46 8 623 6Latvija Orion Corporation Orion Pharma p rst vniec ba Tel: +371 20028United Kingdom (Northern Ireland) Orion Pharma (Ireland) Ltd. c/o Allphar Services Ltd. Tel: +353 1 428 7This leaflet was last revised in. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: