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AstraZeneca

Levodopa/Carbidopa/Entacapone Orion
levodopa, carbidopa, entacapone

Package leaflet: Information for the user


Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone


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


Talk to your doctor or pharmacist if you think the effect of Levodopa/Carbidopa/Entacapone Orion 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.


image

Picture 1


If you take more Levodopa/Carbidopa/Entacapone Orion than you should


If you have accidentally taken more Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion

Do not take a double dose to make up for a forgotten tablet. Ifitismorethan1houruntilyournextdose:

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


Ifitislessthan1houruntilyournextdose:

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 Levodopa/Carbidopa/Entacapone Orion tablets, to avoid possible side effects.


If you stop taking Levodopa/Carbidopa/Entacapone Orion

Do not stop taking Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion 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.


  1. Possible side effects


    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 Levodopa/Carbidopa/Entacapone Orion 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.


      Verycommon (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.


      Notknown (frequency cannot be estimated from the available data):

      Craving for large doses of Levodopa/Carbidopa/Entacapone Orion 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 Levodopa/Carbidopa/Entacapone Orion.


      Thefollowingsideeffectshavealsobeenreported:

    • hepatitis (inflammation of the liver)

    • itching.


    Youmayexperiencethefollowingsideeffects:

    • 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

    image

    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 thenationalreportingsystem

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


  2. How to store Levodopa/Carbidopa/Entacapone Orion


    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.


  3. Contents of the pack and other information


What Levodopa/Carbidopa/Entacapone Orion contains


What Levodopa/Carbidopa/Entacapone Orion looks like and contents of the pack


Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with “LCE 50” on one side.


Levodopa/Carbidopa/Entacapone Orion 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


Orion Corporation Orion Pharma Orionintie 1

FI-02200 Espoo Finland


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


België/Belgique/Belgien Orion Corporation Tél/Tel: +358 10 4261

Lietuva

Orion Corporation Tel: +358 10 4261


България

Orion Corporation

Тел.: +358 10 4261

Luxembourg/Luxemburg

Orion Corporation

Tél/Tel: +358 10 4261


Česká republika Orion Corporation Tel: +358 10 4261

Magyarország Orion Corporation Tel.: +358 10 4261


Danmark

Orion Pharma A/S Tlf: +45 8614 0000

Malta

Orion Corporation Tel: +358 10 4261


Deutschland

Orion Pharma GmbH

Jürgen-Töpfer-Straße 46

22763 Hamburg

Tel: +49 40 899 689-0

Nederland

Orion Corporation

Tel: +358 10 4261


Eesti

Orion Corporation Tel: +358 10 4261

Norge

Orion Pharma AS Tlf: +47 40 00 42 10

Ελλάδα

Orion Corporation Τηλ: +358 10 4261

Österreich

Orion Corporation Tel: +358 10 4261


España

Orion Corporation Tel: +358 10 4261

Polska

Orion Pharma Poland Sp z.o.o. Tel.: + 48 22 8333177


France

Orion Corporation

Tél: +358 10 4261

Portugal

Orion Corporation

Tel: +358 10 4261


Hrvatska

Orion Corporation Tel.: +358 10 4261

România

Orion Corporation Tel: +358 10 4261


Ireland

Orion Corporation

Tel: +358 10 4261

Slovenija

Orion Corporation

Tel: +358 10 4261


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika Orion Corporation Tel: +358 10 4261


Italia

Orion Corporation

Tel: +358 10 4261

Suomi/Finland

Orion Corporation

Puh./Tel: +358 10 4261


Κύπρος

Orion Corporation

Τηλ: +358 10 4261

Sverige

Orion Pharma AB

Tel: +46 8 623 6440


Latvija

Orion Corporation Tel: +358 10 4261

United Kingdom (Northern Ireland)

Orion Corporation Tel: +358 10 4261


This leaflet was last revised in



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