LEVODOPA 175 mg /43.75 Mg/200 Mg Film-Coated Tablet

Зміст інструкції

1. Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg film-coated tablets
   1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for
   2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
   3. How to take Levodopa/Carbidopa/Entacapone Orion
   4. Possible side effects
   5. How to store Levodopa/Carbidopa/Entacapone Orion
   6. Package contents and other information
2. Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets
   1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for
   2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
   3. How to take Levodopa/Carbidopa/Entacapone Orion
   4. Possible side effects
   5. How to store Levodopa/Carbidopa/Entacapone Orion
   6. Package contents and other information
3. Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets
   1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for
   2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
   3. How to take Levodopa/Carbidopa/Entacapone Orion
   4. Possible side effects
   5. How to store Levodopa/Carbidopa/Entacapone Orion
   6. Package contents and other information
4. Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets
   1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for
   2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
   3. How to take Levodopa/Carbidopa/Entacapone Orion
   4. Possible side effects
   5. How to store Levodopa/Carbidopa/Entacapone Orion
   6. Package contents and other information
5. Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg film-coated tablets
   1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for
   2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
   3. How to take Levodopa/Carbidopa/Entacapone Orion
   4. Possible side effects
   5. How to store Levodopa/Carbidopa/Entacapone Orion
   6. Package Contents and Other Information
6. Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets
   1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for
   2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
   3. How to take Levodopa/Carbidopa/Entacapone Orion
   4. Possible side effects
   5. How to store Levodopa/Carbidopa/Entacapone Orion
   6. Package contents and other information
7. Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets
   1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for
   2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
   3. How to take Levodopa/Carbidopa/Entacapone Orion
   4. Possible side effects
   5. How to store Levodopa/Carbidopa/Entacapone Orion
   6. Contents of the pack and other information

Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone

Read this leaflet carefully before you start taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for

Levodopa/Carbidopa/Entacapone Orion contains three active ingredients (levodopa, carbidopa and
entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone Orion is used
to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and consequently reduces the symptoms of Parkinson's
disease. Carbidopa and entacapone improve the effectiveness of the antiparkinsonian effects of
levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion

Do not take Levodopa/Carbidopa/Entacapone Orion

• if you are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from closed-angle glaucoma (an eye disorder)
• if you have a tumor of the adrenal gland
• if you are taking antidepressants (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
• if you have suffered from the rare reaction to some antipsychotic drugs known as Neuroleptic Malignant Syndrome (NMS)
• if you have suffered from a rare form of muscle disease called non-traumatic rhabdomyolysis
• if you have a severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if
you suffer or have suffered in the past:

• from a heart attack, other heart diseases including arrhythmias, or blood vessel diseases
• from asthma or other lung diseases
• from liver disorders, as the dose may need to be adjusted
• from kidney or hormonal disorders
• from gastric ulcer or convulsions
• if you have prolonged diarrhea, consult your doctor as it may be a sign of colon inflammation
• from severe mental disorders of any kind such as psychoses
• from open-angle chronic glaucoma, as the dose may need to be adjusted and your eye pressure monitored.

Talk to your doctor if you are taking:

• antipsychotic drugs (drugs used to treat psychoses)
• a medicine that may cause a drop in blood pressure when you get up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Orion may worsen these reactions.

Talk to your doctor if during treatment with Levodopa/Carbidopa/Entacapone Orion:

• you notice the onset of muscle rigidity or strong contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or significant fluctuations in blood pressure. In such cases you should seek immediate medical attention
• you feel depressed, have suicidal thoughts, or notice any changes in your behavior
• you experience sudden attacks of sleepiness, or if you feel particularly drowsy. If this occurs, you should not drive or operate other machinery (see also section “Driving and using machines”).
• you notice the onset of uncontrollable movements or if these worsen after taking Levodopa/Carbidopa/Entacapone Orion. In this case, you should consult your doctor as it may be necessary to change the dosage of your anti-Parkinsonian medicines
• you experience diarrhea: it is recommended to monitor your body weight to avoid possible excessive weight loss
• you experience progressive anorexia, asthenia (weakness, fatigue) and weight loss over a relatively short period of time. In this case, a general medical check-up, including liver function tests, should be considered.
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Orion; see section “If you stop taking Levodopa/Carbidopa/Entacapone Orion”.

Tell your doctor if you or a family member/caregiver notice the development of symptoms
similar to addiction that cause a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson’s disease.
Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or
strong urges to behave in unusual ways or cannot resist the urge, drive or temptation to perform activities that may be harmful to you or others. These behaviors
are called impulse control disorder and may include gambling addiction,
excessive spending and eating, abnormally high sexual drive, preoccupation
with increasing sexual thoughts or desires. Your doctor may review your treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
require regular laboratory tests.
If you are going to have surgery, tell your doctor that you are taking
Levodopa/Carbidopa/Entacapone Orion.
The use of Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of
extrapyramidal symptoms (e.g. involuntary movements, tremors, muscle rigidity and muscle contractions
caused by other medicines).

Children and adolescents
Experience in patients under 18 years of age treated with Levodopa/Carbidopa/Entacapone Orion
is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children or
adolescents is not recommended.

Other medicines and Levodopa/Carbidopa/Entacapone Orion
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Orion if you are taking certain antidepressants
(combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective
MAO inhibitors).
Levodopa/Carbidopa/Entacapone Orion may enhance the effects and side effects of some
medicines. These include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterol and isoprenaline, used to treat some respiratory diseases
• adrenaline, used in case of severe allergic reactions
• noradrenaline, dopamine and dobutamine, used to treat some heart diseases and hypotension
• alpha-methyldopa, used to treat hypertension
• apomorphine, used to treat Parkinson’s disease.

The effects of Levodopa/Carbidopa/Entacapone Orion may be decreased by some medicines.
These include:

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

Levodopa/Carbidopa/Entacapone Orion may make it more difficult to absorb iron. Therefore, it is
not recommended to take Levodopa/Carbidopa/Entacapone Orion at the same time as iron supplements.
Levodopa/Carbidopa/Entacapone Orion and medicines containing iron should be
taken at least 2-3 hours apart.

Levodopa/Carbidopa/Entacapone Orion with food and drink
Levodopa/Carbidopa/Entacapone Orion can be taken with or without food. For some patients
Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or immediately
after, protein-rich foods (such as meat, fish, dairy, seeds and nuts). Consult your doctor if you think
this is the case for you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Women should not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Orion.

Driving and using machines
Levodopa/Carbidopa/Entacapone Orion can lower blood pressure and this may cause
a feeling of lightheadedness and dizziness. Be particularly careful when driving and operating
machinery.
If you experience drowsiness or sudden attacks of sleepiness, wait until you have fully recovered before
resuming driving or doing anything else that requires vigilance. Otherwise, you could expose yourself and others to serious risks and even death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.2 mg/tablet). If you have been
diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, which is
essentially “sodium-free”.

3. How to take Levodopa/Carbidopa/Entacapone Orion

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Adults and the elderly:

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone Orion tablets to take each day.
• The tablet is not intended to be divided into smaller parts.
• Take only one tablet at a time.
• Based on your response to therapy, your doctor may recommend a higher or lower dose.
• If you are taking Levodopa/Carbidopa/Entacapone Orion tablets 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.

If you feel that the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too weak or if you experience possible side effects, contact your doctor or pharmacist.
Opening the bottle for the first time: open the
cap and then press with your thumb on the seal
until it breaks. See figure 1.
Figure 1

If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Immediately inform your doctor or pharmacist if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than you should have. In case of an overdose
you may feel confused or agitated, your heartbeat may speed up or slow down, or the
color 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 forgetting to take a tablet.
If more than one hour remains until the next dose:
Take a tablet as soon as you remember and the next one at the scheduled time.
If less than one hour remains until the next dose:
Take a tablet as soon as you remember, wait one hour, then take another tablet. Then
continue as normal.
Always allow at least one hour between successive doses of Levodopa/Carbidopa/Entacapone
Orion, to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Orion
Do not stop treatment with Levodopa/Carbidopa/Entacapone Orion unless your
doctor tells you to. In such cases, your doctor may consider it necessary to adjust the
dose of other anti-Parkinson's medicines you are taking, especially levodopa, to
adequately control your symptoms. A sudden interruption of treatment with
Levodopa/Carbidopa/Entacapone Orion and other anti-Parkinson's medicines can cause
side effects
If you have any further questions about 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 everyone will experience them.
If you experience any of these side effects, contact your doctor as soon as possible. Many of the side
effects can be reduced simply by adjusting the dose. If you experience the following symptoms during
treatment with Levodopa/Carbidopa/Entacapone Orion, contact your doctor immediately:

• Muscle rigidity or severe contractions, tremors, agitation, confusion, fever, increased heart rate or
  severe fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a
  rare and serious reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis
  (a rare and serious muscle condition).
• An allergic reaction, the signs of which may include hives, itching, rash, swelling of the face, lips,
  tongue or throat. The latter can cause difficulty breathing or swallowing.

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

• involuntary movements (dyskinesia)
• feeling unwell (nausea)
• harmless brownish-reddish discoloration of the urine
• muscle pain
• diarrhea.

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

• feeling lightheaded or fainting due to low blood pressure, increased blood pressure
• worsening of Parkinsonian symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
• insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
• mental disorders including memory problems, anxiety and depression (including suicidal thoughts) heart
  problems or arterial problems (e.g. chest pain), irregularities in heart rate or rhythm
• increased frequency of falls
• shortness of breath
• increased sweating, rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infection.

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

• heart attack
• intestinal bleeding
• changes in blood cells that can cause bleeding, abnormalities in liver function tests
• convulsions
• agitation
• psychotic symptoms
• colitis (inflammation of the colon)
• discoloration other than urine (e.g. skin, nails, hair, sweat)
• difficulty swallowing, difficulty urinating.

Not known (frequency cannot be estimated from available data):
A desire for high doses of Levodopa/Carbidopa/Entacapone Orion in excess of what is required to
control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience
severe involuntary abnormal movements (dyskinesias), mood changes or other side effects after taking
high doses of Levodopa/Carbidopa/Entacapone Orion. The following side effects have also been reported:

• hepatitis (inflammation of the liver)
• itching.

You may develop the following side effects:

• An inability to resist the impulse to perform an action that could be harmful, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interests and behaviors, of significant concern to you or others, for
  example an increased sexual drive;
• uncontrollable excessive shopping or spending;
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more
  food than usual and more than is necessary to satisfy hunger).

Inform your doctor if you experience any of these behaviors; they will discuss a way to manage or
reduce these symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system indicated in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. 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 package. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levodopa/Carbidopa/Entacapone Orion contains

• The active ingredients of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
• Each tablet of Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
• The excipients of the tablet core are sodium croscarmellose, magnesium stearate, corn starch, mannitol (E421) and povidone (E1201).
• The excipients of the tablet coating are glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, iron oxide red (E172), sucrose, titanium dioxide (E171) and iron oxide yellow (E172).

Description of the appearance of Levodopa/Carbidopa/Entacapone Orion and package contents
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg: film-coated tablets, non-
divisible, round, convex, brown or reddish-grey in colour, bearing the inscription “LCE 50” on
one side.
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg tablets are available in
six packs (containing 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 further information on this medicinal product, 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 Pharma Corporation
Tel: +358 10 4261

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu.

Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone

Read this leaflet carefully before you start taking this medicine as it contains important information for you.- Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for

Levodopa/Carbidopa/Entacapone Orion contains three active ingredients (levodopa, carbidopa and
entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone Orion is used
to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and consequently reduces the symptoms of Parkinson's
disease. Carbidopa and entacapone improve the effectiveness of the antiparkinsonian effects of
levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion

Do not take Levodopa/Carbidopa/Entacapone Orion

• if you are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from closed-angle glaucoma (an eye disorder)
• if you have a tumour of the adrenal gland
• if you are taking antidepressants (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
• if you have suffered from the rare reaction to some antipsychotic drugs known as Neuroleptic Malignant Syndrome (NMS)
• if you have suffered from a rare form of muscle disease called non-traumatic rhabdomyolysis
• if you have a severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if you suffer
or have suffered in the past:

• from a heart attack, other heart diseases including arrhythmias, or blood vessel diseases
• from asthma or other lung diseases
• from liver disorders, as the dose may need to be adjusted
• from kidney or hormonal disorders
• from gastric ulcer or convulsions
• if you have prolonged diarrhoea consult your doctor as it may be a sign of colon inflammation
• from severe mental disorders of any kind such as psychoses
• from open-angle chronic glaucoma, as the dose may need to be adjusted and your eye pressure controlled.

Talk to your doctor if you are taking:

• antipsychotic drugs (drugs used to treat psychoses)
• a medicine that may cause a drop in blood pressure when you get up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Orion can worsen these reactions.

Talk to your doctor if during treatment with Levodopa/Carbidopa/Entacapone Orion:

• you notice the onset of muscle rigidity or strong contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or strong fluctuations in blood pressure. In such cases it is necessary to consult your doctor immediately
• you feel depressed, have suicidal thoughts, or if you notice any changes in your behaviour
• you have sudden attacks of sleepiness, or if you feel particularly drowsy. If this should occur, you should not drive or operate other machinery (see also section “Driving and using machines”).
• you notice the onset of uncontrolled movements or if these worsen after taking Levodopa/Carbidopa/Entacapone Orion. In such a case you should consult your doctor as it may be necessary to change the dosage of your anti-Parkinsonian medicines
• you experience diarrhoea: it is recommended to monitor your body weight to avoid possible excessive weight loss.
• you experience progressive anorexia, asthenia (weakness, fatigue) and weight loss over a relatively short period of time. In such a case, a general medical check-up, including liver function tests, should be considered.
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Orion; see section “If you stop taking Levodopa/Carbidopa/Entacapone Orion”.

Tell your doctor if you or a family member/caregiver notices the development of symptoms
similar to addiction that cause a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson’s disease.
Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or
strong urges to behave in unusual ways or cannot resist the urge, drive or temptation to perform activities
that may be harmful to you or others. These behaviours are called impulse control disorder and may include
gambling addiction, excessive shopping and eating, abnormally high sexual drive, preoccupation
with increased sexual thoughts or desires. Your doctor may review your treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
regularly request laboratory tests.
If you are to undergo surgery, tell your doctor that you are taking
Levodopa/Carbidopa/Entacapone Orion.
The use of Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of
extrapyramidal symptoms (e.g. involuntary movements, tremors, muscle rigidity and muscle contractions
) caused by other medicines.

Children and adolescents
Experience in patients under 18 years of age treated with Levodopa/Carbidopa/Entacapone Orion
is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children or
adolescents is not recommended.

Other medicines and Levodopa/Carbidopa/Entacapone Orion
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Orion if you are taking certain antidepressants
(combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective
MAO inhibitors).
Levodopa/Carbidopa/Entacapone Orion can enhance the effects and side effects of some
medicines. These include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterol and isoprenaline, used to treat some respiratory diseases
• adrenaline, used in case of severe allergic reactions
• noradrenaline, dopamine and dobutamine, used to treat some heart diseases and hypotension
• alpha-methyldopa, used to treat hypertension
• apomorphine, used to treat Parkinson’s disease.

The effects of Levodopa/Carbidopa/Entacapone Orion may be reduced by some medicines.
These include:

• dopaminergic antagonists used to treat some mental disorders, nausea and vomiting
• phenytoin, used to prevent convulsions
• papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapone Orion can make it more difficult to absorb iron. Therefore it
is not recommended to take Levodopa/Carbidopa/Entacapone Orion at the same time as iron supplements.
Levodopa/Carbidopa/Entacapone Orion and medicines containing iron should be
taken at least 2-3 hours apart.

Levodopa/Carbidopa/Entacapone Orion with food and drink
Levodopa/Carbidopa/Entacapone Orion can be taken with or without food. For some patients
Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or shortly
after, protein-rich foods (such as meat, fish, dairy products, seeds and nuts). Consult your doctor if you think
this is the case.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Women should not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Orion.

Driving and using machines
Levodopa/Carbidopa/Entacapone Orion can lower blood pressure and this can cause
a feeling of lightheadedness and dizziness. Be particularly careful when driving and operating
machinery.
If you experience drowsiness or sudden attacks of sleepiness wait until you have fully recovered before
resuming driving or doing anything else that requires vigilance. Otherwise you could expose yourself and others to serious risks and even death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.4 mg/tablet). If you have been
diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e.
essentially “sodium-free”.

3. How to take Levodopa/Carbidopa/Entacapone Orion

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Adults and the elderly:

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone Orion tablets to take each day.
• The tablet is not intended to be divided into smaller parts.
• Take only one tablet at a time.
• Based on your response to therapy, your doctor may recommend a higher or lower dose.
• If you are taking Levodopa/Carbidopa/Entacapone Orion tablets 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 a day.

If you feel that the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too
weak, or if you experience any possible side effects, contact your doctor or pharmacist.
Opening the bottle for the first time: open the
cap and then press with your thumb on the seal
until it breaks. See figure 1.
Figure 1

If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Immediately notify your doctor or pharmacist if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than you were supposed to take. In case of overdose
you may feel confused or agitated, your heartbeat may speed up or slow down, or the
color 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 forgetting a tablet.
If more than one hour remains until the next dose:
Take a tablet as soon as you remember and the next one at the scheduled time.
If less than one hour remains until the next dose:
Take a tablet as soon as you remember, wait an hour, then take another tablet. Then
continue normally.
Always allow at least one hour between successive doses of Levodopa/Carbidopa/Entacapone
Orion, to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Orion
Do not stop treatment with Levodopa/Carbidopa/Entacapone Orion unless your
doctor decides to do so. In this case, your doctor may consider the need to adjust the
dose of other anti-Parkinson's medications you are taking, especially levodopa, to
adequately control your symptoms. A sudden interruption of treatment with
Levodopa/Carbidopa/Entacapone Orion and other anti-Parkinson's medications can cause
side effects
If you have any questions about 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 everyone will experience them.
If you experience any of these side effects, contact your doctor as soon as possible. Many of the side
effects can be reduced simply by adjusting the dose. If you experience the following symptoms during
treatment with Levodopa/Carbidopa/Entacapone Orion, contact your doctor immediately:

• Muscle rigidity or severe contractions, tremors, agitation, confusion, fever, increased heart rate or
  significant fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome
  (NMS, a rare and serious reaction to medicines used to treat central nervous system disorders) or
  rhabdomyolysis (a rare and serious muscle condition).
• An allergic reaction, the signs of which may include hives, itching, rash, swelling of the face, lips,
  tongue or throat. The latter can cause difficulty breathing or swallowing.

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

• involuntary movements (dyskinesia)
• feeling unwell (nausea)
• harmless brownish-reddish discoloration of the urine
• muscle pain
• diarrhea.

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

• feeling lightheaded or fainting due to low blood pressure, increased blood pressure
• worsening of Parkinsonian symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation,
• insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
• mental disorders including memory problems, anxiety and depression (even with suicidal thoughts)
• heart conditions or problems with the arteries (e.g. chest pain), irregularities in heart rate or rhythm
• increased frequency of falls
• shortness of breath
• increased sweating, skin rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infection.

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

• heart attack
• intestinal bleeding
• changes in blood cells that can cause bleeding, abnormalities in liver function tests
• convulsions
• agitation
• psychotic symptoms
• colitis (inflammation of the colon)
• discoloration other than urinary (e.g. of skin, nails, hair, sweat)
• difficulty swallowing
• difficulty urinating.

Not known (frequency cannot be estimated from available data):
A desire for high doses of Levodopa/Carbidopa/Entacapone Orion in excess of what is required to
control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience
severe involuntary abnormal movements (dyskinesias), mood changes or other side effects after taking
high doses of Levodopa/Carbidopa/Entacapone Orion.
The following side effects have also been reported:

• hepatitis (inflammation of the liver)
• itching.

You may develop the following side effects:

• An inability to resist the impulse to perform an action that could be harmful, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interests and behaviors, of significant concern to you or others, for
  example an increased sexual drive;
• uncontrollable excessive shopping or spending;
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more
  food than usual and more than is needed to satisfy hunger).

Inform your doctor if you experience any of these behaviors; they will discuss a way to manage or
reduce these symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system indicated in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 packaging. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levodopa/Carbidopa/Entacapone Orion contains

• The active ingredients of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
• Each tablet of Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
• The excipients of the tablet core are sodium croscarmellose, magnesium stearate, corn starch, mannitol (E421) and povidone (E1201).
• The excipients of the tablet coating are glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).

Description of the appearance of Levodopa/Carbidopa/Entacapone Orion and package contents
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg: oval tablets of light brown-reddish color
bearing the inscription “LCE 75” embossed on one side.
The tablets of Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg are available in
five packs (containing 10, 30, 100, 130 or 175 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 further information on this medicinal product, 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for

Levodopa/Carbidopa/Entacapone Orion contains three active ingredients (levodopa, carbidopa and
entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone Orion is used
to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and consequently reduces the symptoms of Parkinson's
disease. Carbidopa and entacapone improve the effectiveness of the antiparkinsonian effects of
levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion

Do not take Levodopa/Carbidopa/Entacapone Orion

• if you are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from closed-angle glaucoma (an eye disorder)
• if you have a tumour of the adrenal gland
• if you are taking antidepressants (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
• if you have suffered from the rare reaction to some antipsychotic drugs known as Neuroleptic Malignant Syndrome (NMS)
• if you have suffered from a rare form of muscle disease called non-traumatic rhabdomyolysis
• if you have a severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if
you suffer or have suffered in the past:

• from a heart attack, other heart diseases including arrhythmias, or blood vessel diseases
• from asthma or other lung diseases
• from liver disorders, as the dose may need to be adjusted
• from kidney or hormonal disorders
• from gastric ulcer or convulsions
• if you have prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon
• from severe mental disorders of any kind such as psychoses
• from open-angle chronic glaucoma, as the dose may need to be adjusted and your eye pressure monitored.

Talk to your doctor if you are taking:

• antipsychotic drugs (drugs used to treat psychoses)
• a medicine that may cause a drop in blood pressure when you get up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Orion can worsen these reactions.

Talk to your doctor if during treatment with Levodopa/Carbidopa/Entacapone Orion:

• you notice the onset of muscle rigidity or severe contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or significant fluctuations in blood pressure. In such cases youmust seek immediate medical attention
• you feel depressed, have suicidal thoughts, or notice any changes in your behaviour
• you experience sudden attacks of sleepiness, or if you feel particularly drowsy. If this happens, you should not drive or operate machinery (see also section “Driving and using machines”).
• you notice the onset of uncontrolled movements or if these worsen after taking Levodopa/Carbidopa/Entacapone Orion. In this case you should see your doctor as it may be necessary to change the dosage of your anti-Parkinson's medicines
• you experience diarrhoea: it is recommended to monitor your body weight to avoid possible excessive weight loss
• you experience progressive anorexia, asthenia (weakness, fatigue) and weight loss over a relatively short period of time. In this case, a general medical check-up should be considered, including a check of liver function.
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Orion; see section “If you stop taking Levodopa/Carbidopa/Entacapone Orion”.

Tell your doctor if you or a family member/caregiver notice the development of symptoms
similar to addiction that cause a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson’s disease.
Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or
strong urges to behave in unusual ways or cannot resist the urge, drive or temptation to perform
activities that may be harmful to you or others. These behaviours are called impulse control disorder
and may include gambling addiction, excessive spending and eating, abnormally high sexual drive,
an obsession with an increase in sexual thoughts or desires. Your doctor may review your treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
regularly request laboratory tests.
If you are to undergo surgery, tell your doctor that you are taking
Levodopa/Carbidopa/Entacapone Orion.
The use of Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of
extrapyramidal symptoms (e.g. involuntary movements, tremors, muscle rigidity and muscle contractions
) caused by other medicines.

Children and adolescents
Experience in patients under 18 years of age treated with Levodopa/Carbidopa/Entacapone Orion
is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children
or adolescents is not recommended.

Other medicines and Levodopa/Carbidopa/Entacapone Orion
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Orion if you are taking certain antidepressants
(combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective
MAO inhibitors).
Levodopa/Carbidopa/Entacapone Orion can enhance the effects and side effects of some
medicines. These include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterol and isoprenaline, used to treat some respiratory diseases
• adrenaline, used in case of severe allergic reactions
• noradrenaline, dopamine and dobutamine, used to treat some heart diseases and hypotension
• alpha-methyldopa, used to treat hypertension
• apomorphine, used to treat Parkinson’s disease.

The effects of Levodopa/Carbidopa/Entacapone Orion can be decreased by some medicines.
These include:

• dopaminergic antagonists used to treat some mental disorders, nausea and vomiting
• phenytoin, used to prevent convulsions
• papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapone Orion can make it more difficult to absorb iron. Therefore it
is not recommended to take Levodopa/Carbidopa/Entacapone Orion at the same time as iron supplements.
Levodopa/Carbidopa/Entacapone Orion and medicines containing iron should be
taken at least 2-3 hours apart.

Levodopa/Carbidopa/Entacapone Orion with food and drink
Levodopa/Carbidopa/Entacapone Orion can be taken with or without food. For some patients
Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or shortly
after, protein-rich foods (such as meat, fish, dairy products, seeds and nuts). Consult your doctor if you think
this is the case.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Women should not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Orion.

Driving and using machines
Levodopa/Carbidopa/Entacapone Orion can lower blood pressure and this can cause
a feeling of dizziness and lightheadedness. Be particularly careful when driving and operating
machinery.
If you experience drowsiness or sudden attacks of sleepiness, wait until you have fully recovered before
resuming driving or doing anything else that requires vigilance.
Otherwise you could expose yourself and others to serious risks and even death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.6 mg/tablet). If your doctor has
diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, which is
essentially “sodium-free”.

3. How to take Levodopa/Carbidopa/Entacapone Orion

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Adults and the elderly:

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone Orion tablets to take each day.
• The tablet is not made to be divided into smaller parts.
• Take only one tablet at a time.
• Based on your response to therapy, your doctor may recommend a higher or lower dose.
• If you are taking Levodopa/Carbidopa/Entacapone Orion tablets 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.

If you feel that the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too
weak or if you experience any possible side effects, contact your doctor or pharmacist.
Opening the bottle for the first time: open the
cap and then press with your thumb on the seal
until it breaks. See figure 1.
Figure 1

If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Immediately notify your doctor or pharmacist if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than you should have. In case of overdose
you may feel confused or agitated, your heartbeat may speed up or slow down, or the
color 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 missed tablet.
If more than one hour remains until your next dose:
Take a tablet as soon as you remember and the next one at the scheduled time.
If less than one hour remains until your next dose:
Take a tablet as soon as you remember, wait one hour, then take another tablet. Then
continue normally.
Always allow at least one hour between successive doses of Levodopa/Carbidopa/Entacapone
Orion, to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Orion
Do not stop treatment with Levodopa/Carbidopa/Entacapone Orion unless your
doctor decides to do so. In this case, your doctor may consider the need to adjust the
dose of other antiparkinsonian medicines you are taking, especially levodopa, to
adequately control your symptoms. A sudden interruption of treatment with
Levodopa/Carbidopa/Entacapone Orion and other antiparkinsonian medicines can cause
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 everyone will experience them.
If you experience any of these side effects, contact your doctor as soon as possible. Many of the side
effects can be reduced simply by adjusting the dose. If you experience the following symptoms during
treatment with Levodopa/Carbidopa/Entacapone Orion, contact your doctor immediately:

• Muscle rigidity or severe contractions, tremors, agitation, confusion, fever, increased heart rate or
  significant fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a
  rare and serious reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a
  rare and serious muscle condition).
• An allergic reaction, the signs of which may include hives, itching, rash, swelling of the face, lips, tongue or
  throat. The latter can cause difficulty breathing or swallowing.

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

• involuntary movements (dyskinesia)
• feeling unwell (nausea)
• harmless brownish-reddish discoloration of the urine
• muscle pain
• diarrhea.

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

• feeling lightheaded or fainting due to low blood pressure, increased blood pressure
• worsening of Parkinsonian symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
• insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
• mental disorders including memory problems, anxiety and depression (including suicidal thoughts)
• heart conditions or problems with the arteries (e.g. chest pain), irregular heart rate or rhythm
• increased frequency of falls
• shortness of breath
• increased sweating, skin rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infection.

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

• heart attack
• intestinal bleeding
• changes in blood cells that can cause bleeding, abnormalities in liver function tests
• convulsions
• agitation
• psychotic symptoms
• colitis (inflammation of the colon)
• discoloration other than urinary (e.g. of skin, nails, hair, sweat)
• difficulty swallowing
• difficulty urinating.

Not known (frequency cannot be estimated from available data):
A desire for high doses of Levodopa/Carbidopa/Entacapone Orion in excess of what is required to
control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience
severe involuntary abnormal movements (dyskinesias), mood changes or other side effects after taking
high doses of Levodopa/Carbidopa/Entacapone Orion. The following side effects have also been reported:

• hepatitis (inflammation of the liver)
• itching.

You may develop the following side effects:

• An inability to resist the impulse to perform an action that could be harmful, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interests and behaviors, of significant concern to you or others, for example an
  increased sexual drive;
• uncontrollable excessive shopping or spending;
• binge eating (eating large amounts of food in a short time) or compulsive eating (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 a way to manage or reduce
these symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system indicated in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. 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 medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levodopa/Carbidopa/Entacapone Orion contains

• The active ingredients of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
• Each tablet of Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
• The excipients of the tablet core are sodium croscarmellose, magnesium stearate, corn starch, mannitol (E421) and povidone (E1201).
• The excipients of the tablet coating are glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, iron oxide red (E172), sucrose, titanium dioxide (E171) and iron oxide yellow (E172).

Description of the appearance of Levodopa/Carbidopa/Entacapone Orion and package contents
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg: film-coated tablets, non-
divisible, oval in shape, brown or reddish-grey in colour, bearing the inscription “LCE 100” on one
side.
Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg tablets are available in
six packs (containing 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 further information on this medicinal product, 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 Pharma
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: +371 20028332
Tel: +358 10 4261

United Kingdom (Northern Ireland)
Orion
Corporation
Tel: +358 10 4261

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu

Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for

Levodopa/Carbidopa/Entacapone Orion contains three active ingredients (levodopa, carbidopa and
entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone Orion is used
to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and consequently reduces the symptoms of Parkinson’s
disease. Carbidopa and entacapone improve the effectiveness of the antiparkinsonian effects of
levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion

Do not take Levodopa/Carbidopa/Entacapone Orion

• if you are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from closed-angle glaucoma (an eye disorder)
• if you have a tumor of the adrenal gland
• if you are taking antidepressants (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
• if you have suffered from the rare reaction to some antipsychotic drugs known as Neuroleptic Malignant Syndrome (NMS)
• if you have suffered from a rare form of muscle disease called non-traumatic rhabdomyolysis
• if you have a severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if
you suffer or have suffered in the past:

• from a heart attack, other heart diseases including arrhythmias, or blood vessel diseases
• from asthma or other lung diseases
• from liver disorders, as the dose may need to be adjusted
• from kidney or hormonal disorders
• from gastric ulcer or convulsions
• if you have prolonged diarrhea, consult your doctor as it may be a sign of colon inflammation
• from severe mental disorders of any kind such as psychoses
• from open-angle chronic glaucoma, as the dose may need to be adjusted and your eye pressure monitored.

Talk to your doctor if you are taking:

• antipsychotic drugs (drugs used to treat psychoses)
• a medicine that may cause a drop in blood pressure when you get up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Orion may worsen these reactions.

Talk to your doctor if during treatment with Levodopa/Carbidopa/Entacapone Orion:

• you notice the onset of muscle rigidity or strong contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or significant fluctuations in blood pressure. In such cases youmust seek immediate medical attention
• you feel depressed, have suicidal thoughts, or if you notice any changes in your behavior
• you experience sudden attacks of sleepiness, or if you feel particularly drowsy. If this happens, you should not drive or operate other machinery (see also section “Driving and using machines”).
• you notice the onset of uncontrolled movements or if these worsen after taking Levodopa/Carbidopa/Entacapone Orion. In this case, you should consult your doctor as it may be necessary to change the dosage of your anti-Parkinson's medications
• you experience diarrhea: it is recommended to monitor your body weight to avoid possible excessive weight loss
• you experience progressive anorexia, asthenia (weakness, fatigue) and weight loss over a relatively short period of time. In such cases, a general medical check-up, including liver function tests, should be considered.
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Orion; see section “If you stop taking Levodopa/Carbidopa/Entacapone Orion”.

Tell your doctor if you or a family member/caregiver notice the development of symptoms
similar to addiction that cause a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson’s disease.
Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or
strong urges to behave in unusual ways or cannot resist the urge, drive or temptation to perform activities that may be harmful to you or others. These behaviors
are called impulse control disorder and may include gambling addiction,
excessive spending and eating, abnormally high sexual drive, apprehension
for an increase in sexual thoughts or desires. Your doctor may review the treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
regularly request laboratory tests.
If you are going to have surgery, tell your doctor that you are taking
Levodopa/Carbidopa/Entacapone Orion.
The use of Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of extrapyramidal symptoms (e.g. involuntary movements, tremors, muscle rigidity and contractions
caused by other medicines).

Children and adolescents
Experience in patients under 18 years of age treated with Levodopa/Carbidopa/Entacapone Orion
is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children
or adolescents is not recommended.

Other medicines and Levodopa/Carbidopa/Entacapone Orion
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Orion if you are taking certain antidepressants
(combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors).
Levodopa/Carbidopa/Entacapone Orion may enhance the effects and side effects of some
medicines. These include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterol and isoprenaline, used to treat some respiratory diseases
• adrenaline, used in case of severe allergic reactions
• noradrenaline, dopamine and dobutamine, used to treat some heart diseases and hypotension
• alpha-methyldopa, used to treat hypertension
• apomorphine, used to treat Parkinson's disease.

The effects of Levodopa/Carbidopa/Entacapone Orion may be decreased by some medicines.
These include:

• dopaminergic antagonists used to treat some mental disorders, nausea and vomiting
• phenytoin, used to prevent convulsions
• papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapone Orion may make it more difficult to absorb iron. Therefore, it is
not recommended to take Levodopa/Carbidopa/Entacapone Orion at the same time as iron supplements. Levodopa/Carbidopa/Entacapone Orion and medicines containing iron should be
taken at least 2-3 hours apart.

Levodopa/Carbidopa/Entacapone Orion with food and drink
Levodopa/Carbidopa/Entacapone Orion can be taken with or without food. For some patients
Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or immediately
after, protein-rich foods (such as meat, fish, dairy, seeds and nuts). Consult your doctor if you think
this is the case for you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Women should not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Orion.

Driving and using machines
Levodopa/Carbidopa/Entacapone Orion can lower blood pressure and this may cause
a feeling of lightheadedness and dizziness. Be particularly careful when driving and operating
machinery.
If you feel drowsy or experience sudden attacks of sleepiness, wait until you have fully recovered before
resuming driving or doing anything else that requires vigilance.
Otherwise, you could expose yourself and others to serious risks and even death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.6 mg/tablet). If your doctor has
diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e.
essentially “sodium-free”.

3. How to take Levodopa/Carbidopa/Entacapone Orion

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults and the elderly:

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone Orion tablets to take each day.
• The tablet is not meant to be divided into smaller parts.
• Take only one tablet at a time.
• Based on your response to therapy, your doctor may recommend a higher or lower dose.
• If you are taking Levodopa/Carbidopa/Entacapone Orion tablets 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 a day.

If you feel that the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too
weak or if you experience possible side effects, consult your doctor or pharmacist.
Opening the bottle for the first time: open the
cap and then press with your thumb on the seal
until it breaks. See figure 1.
Figure 1

If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Immediately notify your doctor or pharmacist if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than you were supposed to take. In case of overdose
you may feel confused or agitated, your heartbeat may speed up or slow down, or the
color 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 missed tablet.
If more than one hour remains until the next dose:
Take a tablet as soon as you remember and the next one at the scheduled time.
If less than one hour remains until the next dose:
Take a tablet as soon as you remember, wait one hour, then take another tablet. Then
continue as normal.
Always allow at least one hour between successive doses of Levodopa/Carbidopa/Entacapone
Orion, to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Orion
Do not stop treatment with Levodopa/Carbidopa/Entacapone Orion unless your
doctor decides to do so. In this case, your doctor may deem it necessary to adjust the
dose of other anti-Parkinson's medications you are taking, especially levodopa, to
adequately control your symptoms. A sudden interruption of treatment with
Levodopa/Carbidopa/Entacapone Orion and other anti-Parkinson's medications can cause
side effects.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of these side effects, contact your doctor as soon as possible. Many of the side
effects can be reduced simply by adjusting the dose. If you experience the following symptoms during
treatment with Levodopa/Carbidopa/Entacapone Orion, contact your doctor immediately:

• Muscle rigidity or severe contractions, tremors, agitation, confusion, fever, increased heart rate or
  significant fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome
  (NMS, a rare and serious reaction to medicines used to treat central nervous system disorders) or
  rhabdomyolysis (a rare and serious muscle condition).
• An allergic reaction, the signs of which may include hives, itching, rash, swelling of the face, lips,
  tongue or throat. The latter can cause difficulty breathing or swallowing.

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

• involuntary movements (dyskinesia)
• feeling unwell (nausea)
• harmless brownish-red discoloration of the urine
• muscle pain
• diarrhea.

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

• feeling lightheaded or fainting due to low blood pressure, increased blood pressure
• worsening of Parkinsonian symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
• insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
• mental disorders including memory problems, anxiety and depression (including suicidal thoughts)
• heart problems or artery problems (e.g. chest pain), irregular heart rate or rhythm
• increased frequency of falls
• shortness of breath
• increased sweating, skin rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infection.

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

• heart attack
• intestinal bleeding
• changes in blood cells that can cause bleeding, abnormalities in liver function tests
• convulsions
• agitation
• psychotic symptoms
• colitis (inflammation of the colon)
• discoloration other than urine (e.g. skin, nails, hair, sweat)
• difficulty swallowing
• difficulty urinating.

Not known (frequency cannot be estimated from available data):
A desire for high doses of Levodopa/Carbidopa/Entacapone Orion in excess of what is required to
control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience
severe involuntary abnormal movements (dyskinesias), mood changes or other side effects after taking
high doses of Levodopa/Carbidopa/Entacapone Orion.
The following side effects have also been reported:

• hepatitis (inflammation of the liver)
• itching.

You may develop the following side effects:

• An inability to resist the impulse to perform an action that could be harmful, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interests and behaviors, of significant concern to you or others, for
  example an increased sexual drive;
• uncontrollable excessive shopping or spending;
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more
  food than usual and more than is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; they will discuss a way to manage or reduce
these symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system indicated in
Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.

5. 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 package. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levodopa/Carbidopa/Entacapone Orion contains

• The active ingredients of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
• Each tablet of Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
• The excipients of the tablet core are sodium croscarmellose, magnesium stearate, corn starch, mannitol (E421) and povidone (E1201).
• The excipients of the tablet coating are glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).

Description of the appearance of Levodopa/Carbidopa/Entacapone Orion and package contents
Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg: oval-shaped tablets, of
light brown-reddish color bearing the inscription “LCE125” on one side.
The tablets of Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg are available in
five packs (containing 10, 30, 100, 130 or 175 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 further information on this medicinal product, 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for

Levodopa/Carbidopa/Entacapone Orion contains three active ingredients (levodopa, carbidopa and
entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone Orion is used
to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and consequently reduces the symptoms of Parkinson’s
disease. Carbidopa and entacapone improve the effectiveness of the antiparkinsonian effects of
levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion

Do not take Levodopa/Carbidopa/Entacapone Orion

• if you are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from closed-angle glaucoma (an eye disorder)
• if you have a tumor of the adrenal gland
• if you are taking antidepressants (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
• if you have suffered from the rare reaction to some antipsychotic drugs known as Neuroleptic Malignant Syndrome (NMS)
• if you have suffered from a rare form of muscle disease called non-traumatic rhabdomyolysis
• if you have a severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if
you suffer or have suffered in the past:

• from a heart attack, other heart diseases including arrhythmias, or blood vessel diseases
• from asthma or other lung diseases
• from liver disorders, as the dose may need to be adjusted
• from kidney or hormonal disorders
• from gastric ulcer or convulsions
• if you have prolonged diarrhea consult your doctor as it may be a sign of colon inflammation
• from severe mental disorders such as psychosis
• from open-angle chronic glaucoma, as the dose may need to be adjusted and your eye pressure monitored.

Talk to your doctor if you are taking:

• antipsychotic drugs (drugs used to treat psychosis)
• a medicine that may cause a drop in blood pressure when you get up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Orion may worsen these reactions.

Talk to your doctor if during treatment with Levodopa/Carbidopa/Entacapone Orion:

• you notice the onset of muscle rigidity or severe contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or significant fluctuations in blood pressure. In such cases you should seek immediate medical attention
• you feel depressed, have suicidal thoughts, or notice any changes in your behavior
• you have sudden attacks of sleepiness, or if you feel particularly drowsy. If this happens, you should not drive or operate other machinery (see also the section “Driving and using machines”).
• you notice the onset of uncontrollable movements or if these worsen after taking Levodopa/Carbidopa/Entacapone Orion. In such a case, you should see your doctor as it may be necessary to change the dosage of your anti-Parkinson's medications
• you experience diarrhea: it is recommended to monitor body weight to avoid possible excessive weight loss
• you experience progressive anorexia, asthenia (weakness, fatigue) and weight loss over a relatively short period of time. In such a case, a general medical check-up should be considered, including a check of liver function.
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Orion; see the section “If you stop taking Levodopa/Carbidopa/Entacapone Orion”.

Tell your doctor if you or a family member/caregiver notices the development of symptoms
similar to addiction that cause a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson’s disease.
Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or
strong urges to behave in unusual ways or cannot resist the urge, drive or temptation to perform activities that may be harmful to you or others. These behaviors
are called impulse control disorder and may include gambling addiction,
excessive spending and eating, abnormally high sexual drive, preoccupation
with increased sexual thoughts or desires. Your doctor may review the treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
require regular laboratory tests.
If you are to undergo surgery, tell your doctor that you are taking
Levodopa/Carbidopa/Entacapone Orion.
The use of Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of symptoms
extrapyramidal (e.g. involuntary movements, tremors, muscle rigidity and contractions
muscle) caused by other medicines.

Children and adolescents
Experience in patients under 18 years of age treated with Levodopa/Carbidopa/Entacapone Orion
is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children
or adolescents is not recommended.

Other medicines and Levodopa/Carbidopa/Entacapone Orion
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Orion if you are taking certain antidepressants
(combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective
MAO inhibitors).
Levodopa/Carbidopa/Entacapone Orion may enhance the effects and side effects of some
medicines. These include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterol and isoprenaline, used to treat some respiratory diseases
• adrenaline, used in case of severe allergic reactions
• noradrenaline, dopamine and dobutamine, used to treat some heart diseases and hypotension
• alpha-methyldopa, used to treat hypertension
• apomorphine, used to treat Parkinson's disease.

The effects of Levodopa/Carbidopa/Entacapone Orion may be decreased by some medicines.
These include:

• dopaminergic antagonists used to treat some mental disorders, nausea and vomiting
• phenytoin, used to prevent convulsions
• papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapone Orion may make it more difficult to absorb iron. Therefore, it is
not recommended to take Levodopa/Carbidopa/Entacapone Orion at the same time as iron supplements. Levodopa/Carbidopa/Entacapone Orion and medicines containing iron should be
taken at least 2-3 hours apart.

Levodopa/Carbidopa/Entacapone Orion with food and drink
Levodopa/Carbidopa/Entacapone Orion can be taken with or without food. For some patients
Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or shortly
after, protein-rich foods (such as meat, fish, dairy, seeds and nuts). Consult your doctor if you think
this is the case for you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Women should not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Orion.

Driving and using machines
Levodopa/Carbidopa/Entacapone Orion may lower blood pressure and this may cause
a feeling of dizziness and lightheadedness. Be particularly careful when driving and operating
machinery.
If you experience drowsiness or sudden attacks of sleepiness, wait until you have fully recovered before
resuming driving or doing anything else that requires vigilance. Otherwise, you could expose yourself and others to serious risks and even death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose and sodium
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.9 mg/tablet). If your doctor has
diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains 2.6 mg of sodium (the main component of table salt) per
tablet. The maximum recommended daily dose (10 tablets) contains 26 mg of
sodium. This is equivalent to 1.3% of the recommended maximum daily intake with the diet
of an adult.

3. How to take Levodopa/Carbidopa/Entacapone Orion

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have doubts, consult your doctor or pharmacist.
Adults and the elderly

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone Orion tablets to take each day.
• The tablet is not intended to be divided into smaller parts.
• Take only one tablet at a time.
• Based on your response to therapy, your doctor may recommend a higher or lower dose.
• If you are taking Levodopa/Carbidopa/Entacapone Orion tablets 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.

If you feel that the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too
weak, or if you experience possible side effects, contact your doctor or pharmacist.
Opening the bottle for the first time: open the
closure and then press with your thumb on the seal
until it breaks. See figure 1.
Figure 1

If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Immediately notify your doctor or pharmacist if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than you were supposed to take. In case of overdose
you may feel confused or agitated, your heartbeat may speed up or slow down, or the
color 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 missed tablet.
If more than one hour remains until the next dose:
Take a tablet as soon as you remember and the next one at the scheduled time.
If less than one hour remains until the next dose:
Take a tablet as soon as you remember, wait one hour, then take another tablet. Then
continue as normal.
Always allow at least one hour between successive doses of Levodopa/Carbidopa/Entacapone
Orion, to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Orion
Do not stop treatment with Levodopa/Carbidopa/Entacapone Orion unless your
doctor decides to do so. In this case, your doctor may consider it necessary to adjust the
dose of other antiparkinsonian medicines you are taking, especially levodopa, to
adequately control your symptoms. A sudden interruption of treatment with
Levodopa/Carbidopa/Entacapone Orion and other antiparkinsonian medicines can cause
side effects.
If you have any questions about 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 everyone will experience them.
If you experience any of these side effects, contact your doctor as soon as possible. Many of the side
effects can be reduced simply by adjusting the dose. If you experience the following symptoms during
treatment with Levodopa/Carbidopa/Entacapone Orion, contact your doctor immediately:

• Muscle rigidity or severe contractions, tremors, agitation, confusion, fever, increased heart rate or
  significant fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome
  (NMS, a rare and serious reaction to medicines used to treat central nervous system disorders) or
  rhabdomyolysis (a rare and serious muscle condition).
• An allergic reaction, the signs of which may include hives, itching, rash, swelling of the face, lips,
  tongue or throat. The latter can cause difficulty breathing or swallowing.

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

• involuntary movements (dyskinesia)
• feeling unwell (nausea)
• harmless brownish-red discoloration of the urine
• muscle pain
• diarrhea.

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

• feeling lightheaded or fainting due to low blood pressure, increased blood pressure
• worsening of Parkinsonian symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation,
• insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
• mental disorders including memory problems, anxiety and depression (even with suicidal thoughts)
• heart conditions or artery problems (e.g. chest pain), irregularities in heart rate or rhythm
• increased frequency of falls
• shortness of breath
• increased sweating, rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infection.

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

• heart attack
• intestinal bleeding
• changes in blood cells that can cause bleeding, abnormalities in liver function tests
• convulsions
• agitation
• psychotic symptoms
• colitis (inflammation of the colon)
• discoloration other than urinary (e.g. skin, nails, hair, sweat)
• difficulty swallowing
• difficulty urinating.

Not known (frequency cannot be estimated from available data):
Desire for high doses of Levodopa/Carbidopa/Entacapone Orion in excess of what is required to
control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience
severe involuntary abnormal movements (dyskinesias), mood changes or other side effects after taking
high doses of Levodopa/Carbidopa/Entacapone Orion.
The following side effects have also been reported:

• hepatitis (inflammation of the liver),
• itching.

You may develop the following side effects:

• Inability to resist the impulse to perform an action that could be harmful, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interests and behaviors, of significant concern to you or others, for
  example, an increased sexual drive;
• uncontrollable excessive shopping or spending;
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more
  food than usual and more than is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; they will discuss a way to manage or reduce
these symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system as detailed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. 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 package. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Levodopa/Carbidopa/Entacapone Orion Contains

• The active ingredients of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
• Each tablet of Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
• The excipients of the tablet core are sodium croscarmellose, magnesium stearate, corn starch, mannitol (E421) and povidone (E1201).
• The excipients of the tablet coating are glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171) and yellow iron oxide (E172).

Description of the appearance of Levodopa/Carbidopa/Entacapone Orion and package contents
Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg: film-coated tablets, non-
divisible, elongated elliptical in shape, brown or reddish-gray in color, bearing the inscription “LCE 150”
on one side.
Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg tablets are available in
six packs (containing 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 further information on this medicinal product, 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 Pharma Corporation
Tel: +358 10 4261

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu

Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets

levodopa/carbidopa/entacapone

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for

Levodopa/Carbidopa/Entacapone Orion contains three active ingredients (levodopa, carbidopa and
entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone Orion is used
to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and consequently reduces the symptoms of Parkinson's
disease. Carbidopa and entacapone improve the effectiveness of the antiparkinsonian effects of
levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion

Do not take Levodopa/Carbidopa/Entacapone Orion

• if you are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from closed-angle glaucoma (an eye disorder)
• if you have a tumor of the adrenal gland
• if you are taking antidepressants (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
• if you have suffered from the rare reaction to some antipsychotic drugs known as Neuroleptic Malignant Syndrome (NMS)
• if you have suffered from a rare form of muscle disease called non-traumatic rhabdomyolysis
• if you have a severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if
you suffer or have suffered in the past:

• from a heart attack, other heart diseases including arrhythmias, or blood vessel diseases
• from asthma or other lung diseases
• from liver disorders, as the dose may need to be adjusted
• from kidney or hormonal disorders
• from gastric ulcer or convulsions
• if you have prolonged diarrhea, consult your doctor as it may be a sign of colon inflammation
• from severe mental disorders of any kind such as psychoses
• from open-angle chronic glaucoma, as the dose may need to be adjusted and your eye pressure monitored.

Talk to your doctor if you are taking:

• antipsychotic drugs (drugs used to treat psychoses)
• a medicine that may cause a drop in blood pressure when you get up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Orion can worsen these reactions.

Talk to your doctor if during treatment with Levodopa/Carbidopa/Entacapone Orion:

• you notice the onset of muscle rigidity or severe contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or significant fluctuations in blood pressure. In such cases youmust seek immediate medical attention
• you feel depressed, have suicidal thoughts, or notice any changes in your behavior
• you experience sudden attacks of sleepiness, or if you feel particularly drowsy. If this happens, you should not drive or operate other machinery (see also section “Driving and using machines”).
• you notice the onset of uncontrolled movements or if these worsen after taking Levodopa/Carbidopa/Entacapone Orion. In this case, you should consult your doctor as it may be necessary to change the dosage of your anti-Parkinsonian medicines
• you experience diarrhea: it is recommended to monitor your body weight to avoid possible excessive weight loss
• you experience progressive anorexia, asthenia (weakness, fatigue) and weight loss over a relatively short period of time. In this case, a general medical check-up should be considered, including a check of liver function.
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Orion; see section “If you stop taking Levodopa/Carbidopa/Entacapone Orion”.

Tell your doctor if you or a family member/caregiver notice the development of symptoms
similar to addiction that cause a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson’s disease.
Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or
strong urges to behave in unusual ways or cannot resist the urge, drive or temptation to perform activities that may be harmful to you or others. These behaviors
are called impulse control disorder and may include gambling addiction,
excessive spending and eating, abnormally high sexual drive, preoccupation
with increased sexual thoughts or desires. Your doctor may review your treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
regularly request laboratory tests.
If you are to undergo surgery, tell your doctor that you are taking
Levodopa/Carbidopa/Entacapone Orion.
The use of Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of
extrapyramidal symptoms (e.g. involuntary movements, tremors, muscle rigidity and muscle contractions
) caused by other medicines.

Children and adolescents
Experience in patients under the age of 18 years treated with Levodopa/Carbidopa/Entacapone Orion
is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children
or adolescents is not recommended.

Other medicines and Levodopa/Carbidopa/Entacapone Orion
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Orion if you are taking certain antidepressants
(combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective
MAO inhibitors).
Levodopa/Carbidopa/Entacapone Orion can enhance the effects and side effects of some
medicines. These include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterol and isoprenaline, used to treat some respiratory diseases
• adrenaline, used in case of severe allergic reactions
• noradrenaline, dopamine and dobutamine, used to treat some heart diseases and hypotension
• alpha-methyldopa, used to treat hypertension
• apomorphine, used to treat Parkinson’s disease.

The effects of Levodopa/Carbidopa/Entacapone Orion can be decreased by some medicines.
These include:

• dopaminergic antagonists used to treat some mental disorders, nausea and vomiting
• phenytoin, used to prevent convulsions
• papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapone Orion can make it more difficult to absorb iron. Therefore, it is
not recommended to take Levodopa/Carbidopa/Entacapone Orion at the same time as iron supplements. Levodopa/Carbidopa/Entacapone Orion and medicines containing iron should be
taken at least 2-3 hours apart.

Levodopa/Carbidopa/Entacapone Orion with food and drink
Levodopa/Carbidopa/Entacapone Orion can be taken with or without food. For some patients
Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or shortly
after, protein-rich foods (such as meat, fish, dairy products, seeds and nuts). Consult your doctor if you think
this is the case for you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Women should not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Orion.

Driving and using machines
Levodopa/Carbidopa/Entacapone Orion can lower blood pressure and this can cause
a feeling of lightheadedness and dizziness. Be particularly careful when driving and operating
machinery.
If you feel sleepy or experience sudden attacks of sleepiness, wait until you have fully recovered before
resuming driving or doing anything else that requires vigilance.
Otherwise, you may expose yourself and others to serious risks and even death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.89 mg/tablet). If your doctor has
diagnosed you as having intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, which is
essentially “sodium-free”.

3. How to take Levodopa/Carbidopa/Entacapone Orion

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Adults and the elderly:

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone Orion tablets to take each day.
• The tablet is not made to be divided into smaller parts.
• Take only one tablet at a time.
• Based on your response to therapy, your doctor may recommend a higher or lower dose.
• If you are taking Levodopa/Carbidopa/Entacapone Orion tablets 175 mg/43.75 mg/200 mg, do not take more than 8 tablets per day.

If you feel that the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too
weak, or if you experience any possible side effects, contact your doctor or pharmacist.
Opening the bottle for the first time: open the
cap and then press with your thumb on the seal
until it breaks. See figure 1.
Figure 1

If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Immediately inform your doctor or pharmacist if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than you should have. In case of overdose
you may feel confused or agitated, your heartbeat may speed up or slow down, or the
color 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 forgetting a tablet.
If more than one hour remains until your next dose:
Take a tablet as soon as you remember and the next one at the scheduled time.
If less than one hour remains until your next dose:
Take a tablet as soon as you remember, wait one hour, then take another tablet. Then
continue normally.
Always allow at least one hour between successive doses of Levodopa/Carbidopa/Entacapone
Orion, to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Orion
Do not stop treatment with Levodopa/Carbidopa/Entacapone Orion unless your
doctor decides to do so. In such cases, your doctor may consider the need to adjust the
dose of other antiparkinsonian medicines you are taking, especially levodopa, to
adequately control your symptoms. A sudden interruption of treatment with
Levodopa/Carbidopa/Entacapone Orion and other antiparkinsonian medicines can cause
side effects.
If you have any questions about 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 everyone will experience them.
Many of the side effects can be reduced simply by adjusting the dose.
If you experience the following symptoms during treatment with Levodopa/Carbidopa/Entacapone Orion, seek
immediate medical attention:

• Muscle rigidity or severe contractions, tremors, agitation, confusion, fever, increased heart rate or significant fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare and serious reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare and serious muscle condition).
• An allergic reaction, the signs of which may include hives, itching, rash, swelling of the face, lips, tongue or throat. The latter can cause difficulty breathing or swallowing.

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

• involuntary movements (dyskinesia)
• feeling unwell (nausea)
• harmless discoloration of urine brownish-red
• muscle pain
• diarrhea.

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

• feeling lightheaded or fainting due to low blood pressure, increased blood pressure
• worsening of Parkinsonian symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation,
• insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
• mental disorders including memory problems, anxiety and depression (also with suicidal thoughts)
• heart conditions or problems with the arteries (e.g. chest pain), irregularities in heart rate or rhythm
• increased frequency of falls
• shortness of breath
• increased sweating, rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infection.

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

• heart attack
• intestinal bleeding
• changes in blood cells that can cause bleeding, abnormalities in liver function tests
• convulsions
• agitation
• psychotic symptoms
• colitis (inflammation of the colon)
• discoloration other than urinary (e.g. of skin, nails, hair, sweat)
• difficulty swallowing
• difficulty urinating.

Not known (frequency cannot be estimated from available data):
A desire for high doses of Levodopa/Carbidopa/Entacapone Orion in excess of what is
required to control motor symptoms, known as dopaminergic dysregulation syndrome.
Some patients experience severe involuntary abnormal movements (dyskinesias), mood changes
or other side effects after taking high doses of Levodopa/Carbidopa/Entacapone Orion.
The following side effects have also been reported:

• hepatitis (inflammation of the liver)
• itching.

You may develop the following side effects:

• Inability to resist the urge to perform an action that may be harmful, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interests and behaviors, of significant concern to you or others, for example an increased sexual drive;
• uncontrollable excessive shopping or spending;
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than usual and more than is needed to satisfy hunger).

Inform your doctor if you experience any of these behaviors; they will discuss a way to
manage or reduce these symptoms.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
detailed in Annex V.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. 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 medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levodopa/Carbidopa/Entacapone Orion contains

• The active ingredients of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
• Each tablet of Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
• The excipients of the tablet core are sodium croscarmellose, magnesium stearate, corn starch, mannitol (E421) and povidone (E1201).
• The excipients of the tablet coating are glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).

Description of the appearance of Levodopa/Carbidopa/Entacapone Orion and package contents
Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg: oval-shaped tablets, of
light brown-reddish color bearing the marking “LCE175” engraved on one side.
Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg tablets are available in
five packs (containing 10, 30, 100, 130 or 175 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 further information on this medicinal product, 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

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

levodopa/carbidopa/entacapone

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levodopa/Carbidopa/Entacapone Orion and what is it used for

Levodopa/Carbidopa/Entacapone Orion contains three active ingredients (levodopa, carbidopa and
entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone Orion is used
to treat Parkinson's disease.
Parkinson's disease is caused by low levels of a substance called dopamine in the brain.
Levodopa increases the level of dopamine and consequently reduces the symptoms of Parkinson's
disease. Carbidopa and entacapone improve the effectiveness of the antiparkinsonian effects of
levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Orion

Do not take Levodopa/Carbidopa/Entacapone Orion

• if you are allergic to levodopa, carbidopa or entacapone or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from closed-angle glaucoma (an eye disorder)
• if you have a tumor of the adrenal gland
• if you are taking antidepressants (combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
• if you have suffered from the rare reaction to some antipsychotic drugs known as Neuroleptic Malignant Syndrome (NMS)
• if you have suffered from a rare form of muscle disease called non-traumatic rhabdomyolysis
• if you have a severe liver disease

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if
you suffer or have suffered in the past:

• from a heart attack, other heart diseases including arrhythmias, or blood vessel diseases
• from asthma or other lung diseases
• from liver disorders, as it may be necessary to adjust the dose
• from kidney or hormonal disorders
• from gastric ulcer or convulsions
• if you have prolonged diarrhea, consult your doctor as it may be a sign of colon inflammation
• from severe mental disorders of any kind such as psychoses
• from open-angle chronic glaucoma, as it may be necessary to adjust the dose and check the pressure in your eyes.

Talk to your doctor if you are taking:

• antipsychotic drugs (drugs used to treat psychoses)
• a medicine that may cause a drop in blood pressure when you get up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Orion may worsen these reactions.

Talk to your doctor if during treatment with Levodopa/Carbidopa/Entacapone Orion:

• you notice the onset of muscle rigidity or severe contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate or significant blood pressure fluctuations. In such cases you must seek immediate medical attention
• you feel depressed, have suicidal thoughts, or if you notice any changes in your behavior
• you have sudden attacks of sleepiness, or if you feel particularly drowsy. If this happens, you should not drive or use other machinery (see also section “Driving and using machines”).
• you notice the onset of uncontrolled movements or if these worsen after taking Levodopa/Carbidopa/Entacapone Orion. In this case, you should consult your doctor as it may be necessary to change the dosage of your anti-Parkinson's medications
• you experience diarrhea: it is recommended to monitor body weight to avoid possible excessive weight loss
• you experience progressive anorexia, asthenia (weakness, fatigue) and weight loss over a relatively short period of time. In this case, a general medical check-up, including a check of liver function, should be considered.
• you feel the need to stop taking Levodopa/Carbidopa/Entacapone Orion; see section “If you stop taking Levodopa/Carbidopa/Entacapone Orion”.

Tell your doctor if you or a family member/caregiver notices the development of symptoms
similar to addiction that cause a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson's disease.
Tell your doctor if you notice, or your family members/caregivers notice that you develop impulses or
strong urges to behave in unusual ways or cannot resist the urge, drive or temptation to perform activities that may be harmful to you or others. These behaviors
are called impulse control disorder and may include gambling addiction,
excessive spending and eating, abnormally high sexual drive, preoccupation
with increased sexual thoughts or desires. Your doctor may review the treatment.
During prolonged treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
regularly request laboratory tests.
If you are to undergo surgery, tell your doctor that you are taking
Levodopa/Carbidopa/Entacapone Orion.
The use of Levodopa/Carbidopa/Entacapone Orion is not recommended for the therapy of extrapyramidal symptoms, (for example involuntary movements, tremors, muscle rigidity and contractions
caused by other medicines).

Children and adolescents
Experience in patients under 18 years of age treated with Levodopa/Carbidopa/Entacapone Orion
is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Orion in children
or adolescents is not recommended.

Other medicines and Levodopa/Carbidopa/Entacapone Orion
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Orion if you are taking certain antidepressants
(combinations of MAO-A selective inhibitors and MAO-B inhibitors, or non-selective
MAO inhibitors).
Levodopa/Carbidopa/Entacapone Orion may enhance the effects and side effects of some
medicines. These include:

• medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
• rimiterol and isoprenaline, used to treat some respiratory diseases
• adrenaline, used in case of severe allergic reactions
• noradrenaline, dopamine and dobutamine, used to treat some heart diseases and hypotension
• alpha-methyldopa, used to treat hypertension
• apomorphine, used to treat Parkinson's disease.

The effects of Levodopa/Carbidopa/Entacapone Orion may be decreased by some medicines.
These include:

• dopaminergic antagonists used to treat some mental disorders, nausea and vomiting
• phenytoin, used to prevent convulsions
• papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapone Orion may make it more difficult to absorb iron. Therefore, it
is not recommended to take Levodopa/Carbidopa/Entacapone Orion at the same time as iron supplements. Levodopa/Carbidopa/Entacapone Orion and medicines containing iron should be
taken at least 2-3 hours apart.

Levodopa/Carbidopa/Entacapone Orion with food and drink
Levodopa/Carbidopa/Entacapone Orion can be taken with or without food. For some patients
Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if it is taken with, or shortly
after, protein-rich foods (such as meat, fish, dairy products, seeds and nuts). Consult your doctor if you think
this is the case for you.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Women should not breastfeed during treatment with Levodopa/Carbidopa/Entacapone Orion.

Driving and using machines
Levodopa/Carbidopa/Entacapone Orion may lower blood pressure and this can cause
a feeling of lightheadedness and dizziness. Be particularly careful when driving and using
machinery.
If you feel drowsy or have sudden attacks of sleepiness, wait until you have fully recovered before
resuming driving or doing anything else that requires vigilance.
Otherwise, you could expose yourself and others to serious risks, even death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose
Levodopa/Carbidopa/Entacapone Orion contains sucrose (2.3 mg/tablet). If your doctor has
diagnosed you with intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, which is
essentially “sodium-free”.

3. How to take Levodopa/Carbidopa/Entacapone Orion

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults and the elderly:

• Your doctor will tell you exactly how many Levodopa/Carbidopa/Entacapone Orion tablets to take each day.
• The tablet is not made to be divided into smaller parts.
• Take only one tablet at a time.
• Based on your response to therapy, your doctor may recommend a higher or lower dose.
• If you are taking Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablets, do not take more than 7 tablets of this dosage per day.

If you feel that the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too
weak, or if you experience any possible side effects, contact your doctor or pharmacist.
Opening the bottle for the first time: open the
closure and then press with your thumb on the seal
until it breaks. See figure 1.
Figure 1

If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Immediately notify your doctor or pharmacist if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than you were supposed to take. In case of overdose
you may feel confused or agitated, your heartbeat may speed up or slow down, or the
color 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 missed tablet.
If more than one hour remains until your next dose:
Take a tablet as soon as you remember and the next one at the scheduled time.
If less than one hour remains until your next dose:
Take a tablet as soon as you remember, wait one hour, then take another tablet. Then
continue normally.
Always allow at least one hour between successive doses of Levodopa/Carbidopa/Entacapone
Orion, 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 cases, your doctor may deem it necessary to adjust the
dose of other antiparkinsonian medicines you are taking, especially levodopa, to
adequately control your symptoms. A sudden interruption of treatment with
Levodopa/Carbidopa/Entacapone Orion and other antiparkinsonian medicines can cause
side effects.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of these side effects, contact your doctor as soon as possible. Many of the side
effects can be reduced simply by adjusting the dose. If you experience the following symptoms during
treatment with Levodopa/Carbidopa/Entacapone Orion, contact your doctor immediately:

• Muscle rigidity or severe contractions, tremors, agitation, confusion, fever, increased heart rate or
  severe fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a
  rare and serious reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis
  (a rare and serious muscle disease).
• An allergic reaction, the signs of which may include hives, itching, rash, swelling of the face, lips,
  tongue or throat. The latter can cause difficulty breathing or swallowing.

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

• involuntary movements (dyskinesia)
• feeling unwell (nausea)
• harmless brownish-reddish discoloration of the urine
• muscle pain
• diarrhea.

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

• feeling lightheaded or fainting due to low blood pressure, increased blood pressure
• worsening of Parkinsonian symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn. dry mouth, constipation,
• insomnia, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
• mental disorders including memory problems, anxiety and depression (including suicidal thoughts)
• heart conditions or artery problems (e.g. chest pain), irregularities in heart rate or rhythm
• increased frequency of falls
• shortness of breath
• increased sweating, rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain
• urinary tract infection.

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

• heart attack
• intestinal bleeding
• increased blood pressure
• changes in blood cells that can cause bleeding, abnormalities in liver function tests
• convulsions
• agitation
• psychotic symptoms
• colitis (inflammation of the colon)
• discoloration other than urinary (e.g. skin, nails, hair, sweat)
• difficulty swallowing
• difficulty urinating.

Not known (frequency cannot be estimated based on available data):
A desire for high doses of Levodopa/Carbidopa/Entacapone Orion in excess of what is required to
control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience
severe involuntary abnormal movements (dyskinesias), mood changes or other side effects after taking
high doses of Levodopa/Carbidopa/Entacapone Orion.
The following side effects have also been reported:

• hepatitis (inflammation of the liver)
• itching.

You may develop the following side effects:

• Inability to resist the urge to perform an action that could be harmful, which may include:
• a strong urge to gamble excessively, despite serious personal or family consequences;
• altered or increased sexual interests and behaviors, of significant concern to you or others, for example
  increased sexual drive;
• uncontrollable excessive shopping or spending;
• binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more
  food than usual and more than is needed to satisfy hunger).

Tell your doctor if you experience any of these behaviors; they will discuss a way to manage or reduce
these symptoms.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the national reporting system detailed in Annex V. By reporting
side effects you can help provide more information on the safety of this medicine.

5. 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 medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levodopa/Carbidopa/Entacapone Orion contains

• The active ingredients of Levodopa/Carbidopa/Entacapone Orion are levodopa, carbidopa and entacapone.
• Each tablet of Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
• The excipients of the tablet core are sodium croscarmellose, magnesium stearate, corn starch, mannitol (E421), and povidone (E1201).
• The excipients of the tablet coating are glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).

Description of the appearance of Levodopa/Carbidopa/Entacapone Orion and contents of the pack
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg: film-coated tablets, oval, dark brown-reddish in colour, with the inscription “LCE 200” embossed on one side.
Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablets are available in
five pack sizes (containing 10, 30, 100, 130 or 175 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 further information on this medicinal product, 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
Orion Pharma pārstāvniecība
Tel: +371 20028332

United Kingdom (Northern Ireland)
Orion Corporation
Tel: +358 10 4261

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.