Levodopa/carbidopa/entacapone Orion: detailed information

Package leaflet: Information for the user

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

levodopa/carbidopa/entacapone
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levodopa/Carbidopa/Entacapone Orion is and what it is used for
What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
How to take Levodopa/Carbidopa/Entacapone Orion
Possible side effects
How to store Levodopa/Carbidopa/Entacapone Orion
Contents of the pack and other information

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

Levodopa/Carbidopa/Entacapone Orion contains three active substances (levodopa, carbidopa, and
entacapone) in a single 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 thereby reduces the symptoms of
Parkinson's disease. Carbidopa and entacapone enhance the effectiveness of levodopa's anti-Parkinson effects.

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 have closed-angle glaucoma (an eye disorder)
if you have a tumour of the adrenal gland
if you are taking antidepressants (combinations of selective MAO-A inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
if you have previously experienced the rare reaction to certain antipsychotic medicines known as Neuroleptic Malignant Syndrome (NMS)
if you have previously experienced a rare form of muscle disorder called non-traumatic rhabdomyolysis
if you have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if you
have or have previously had:

a heart attack, other heart conditions including arrhythmias, or blood vessel disorders
asthma or other lung diseases
liver problems, as your dose may need to be adjusted
kidney or hormonal disorders
gastric ulcer or seizures
prolonged diarrhoea – consult your doctor as this may be a sign of inflammation of the colon
severe psychiatric disorders of any kind, such as psychosis
chronic open-angle glaucoma, as your dose may need to be adjusted and your eye pressure monitored.

Talk to your doctor if you are taking:

antipsychotic medicines (medicines used to treat psychosis)
a medicine that may cause low blood pressure when standing up from a sitting or lying position. You should be aware that Levodopa/Carbidopa/Entacapone Orion may worsen such reactions.

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

you develop muscle stiffness or severe muscle contractions, or experience tremors, agitation, confusion, fever, increased heart rate, or severe fluctuations in blood pressure. In such cases, you must contact your doctor immediately
you feel depressed or have thoughts of suicide, or notice any changes in your behaviour
you experience sudden episodes of sleep, or feel unusually sleepy. If this occurs, you must not drive or operate machinery (see also section “Driving and using machines”)
you develop uncontrolled movements or notice that they worsen after taking Levodopa/Carbidopa/Entacapone Orion. In this case, consult your doctor, as it may be necessary to adjust the dosage of your anti-Parkinson’s medicines
you experience diarrhoea: regular monitoring of body weight is recommended to prevent excessive weight loss
you experience progressive loss of appetite, asthenia (weakness, fatigue), and weight loss over a relatively short period of time. In such cases, a general medical evaluation should be considered, including liver function tests
you feel the need to stop taking Levodopa/Carbidopa/Entacapone Orion; see section “If you stop taking Levodopa/Carbidopa/Entacapone Orion”.

Inform your doctor if you or a family member/carer notice the development of symptoms
resembling dependence, leading to a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson’s disease.
Inform your doctor if you, or your family members/carer, notice that you develop impulses or
strong urges to behave in unusual ways, or are unable to resist the impulse, drive, or temptation to carry out activities that could be harmful to yourself or others. These behaviours
are known as impulse control disorders and may include gambling addiction, compulsive spending, compulsive eating, abnormally increased sexual drive, or preoccupation with an increase in sexual thoughts or urges. Your doctor may need to review your treatment.
During long-term treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
request regular laboratory tests.
If you are scheduled for surgery, inform 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 with Levodopa/Carbidopa/Entacapone Orion in patients under 18 years of age is limited. Therefore, use of Levodopa/Carbidopa/Entacapone Orion is not recommended in children or adolescents.

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 selective MAO-A inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors).
Levodopa/Carbidopa/Entacapone Orion may enhance the effects and side effects of certain medicines. These include:

medicines used to treat depression such as moclobemide, amitriptiline, desipramine, maprotiline, venlafaxine, and paroxetine
rimiterol and isoprenaline, used to treat certain respiratory conditions
adrenaline, used in severe allergic reactions
noradrenaline, dopamine, and dobutamine, used to treat certain heart conditions 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 certain medicines.
These include:

dopamine antagonists used to treat certain psychiatric disorders, nausea, and vomiting
phenytoin, used to prevent seizures
papaverine, used to relax muscles.

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

Levodopa/Carbidopa/Entacapone Orion with food and drinks
Levodopa/Carbidopa/Entacapone Orion may be taken with or without food. For some patients, Levodopa/Carbidopa/Entacapone Orion may not be well absorbed if taken with, or immediately after, high-protein meals (such as meat, fish, dairy products, seeds, and nuts). Consult your doctor if you think this may apply to you.

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

Driving and using machines
Levodopa/Carbidopa/Entacapone Orion may lower blood pressure, which can cause dizziness or lightheadedness. Exercise particular caution when driving or operating machinery.
If you experience drowsiness or sudden sleep attacks, wait until you are fully alert before resuming driving or any other activity requiring full attention. Otherwise, you may put yourself and others at serious risk, including risk of death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.2 mg/tablet). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or 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 exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults and elderly:

Your doctor will tell you exactly how many tablets of Levodopa/Carbidopa/Entacapone Orion to take each day.
The tablet is not designed to be divided into smaller parts.
Take only one tablet at a time.
Depending on your response to treatment, 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
Figure 1
cap and then press with your thumb on the seal

Black and white drawing of a hand firmly holding a glass vial with a black arrow pointing downward on the cap

until it breaks. See figure 1.
If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Contact your doctor or pharmacist immediately if you have accidentally taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than prescribed. In case of overdose,
you may feel confused or agitated, your heartbeat may speed up or slow down, or the
colour of your skin, tongue, eyes, or urine may change.
If you forget to take Levodopa/Carbidopa/Entacapone Orion
Do not take a double dose to make up for a forgotten tablet.
If more than one hour remains before the next dose:
Take one tablet as soon as you remember, then take the next one at the scheduled time.
If less than one hour remains before the next dose:
Take one tablet as soon as you remember, wait one hour, then take another tablet. Then
continue as normal.
Always leave at least one hour between consecutive 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 do so. In such a case, your doctor may need to adjust the
dose of other anti-Parkinson’s medicines you are taking, especially levodopa, to properly control your symptoms. Abruptly stopping treatment with
Levodopa/Carbidopa/Entacapone Orion and other anti-Parkinson’s medicines may cause
unwanted side effects.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 any of the following symptoms while taking Levodopa/Carbidopa/Entacapone Orion, contact your doctor immediately:

Muscle rigidity or strong 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 disorders of the central nervous system) or rhabdomyolysis (a rare and serious muscle disorder).
An allergic reaction, which may include signs such as hives, itching, rash, swelling of the face, lips, tongue or throat. Swelling in the throat may cause difficulty breathing or swallowing.

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

involuntary movements (dyskinesia)
feeling unwell (nausea)
harmless reddish-brown discoloration of urine
muscle pain
diarrhoea.

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

light-headedness 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 disease or problems with arteries (e.g. chest pain), irregular heart rhythm or heart rate
increased frequency of falls
shortness of breath
increased sweating, skin rash
muscle cramps, swelling in the legs
blurred vision
anaemia
decreased appetite, weight loss
headache, joint pain
urinary tract infection.

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

heart attack
gastrointestinal bleeding
changes in blood cells which may lead to bleeding, abnormalities in liver function tests
seizures
agitation
psychotic symptoms
colitis (inflammation of the colon)
changes in pigmentation other than urine (e.g. of skin, nails, hair, sweat)
difficulty swallowing, difficulty urinating.

Not known (frequency cannot be estimated from the available data):
A desire for higher-than-needed doses of Levodopa/Carbidopa/Entacapone Orion, beyond what is required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients may experience severe abnormal involuntary 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 carry out 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 behaviours, causing 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 time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger).

Inform your doctor if you experience any of these behaviours; they will discuss ways to manage or reduce these symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed 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 stated on the bottle and the outer carton.
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via 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 substances in 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 in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201).
The excipients in the tablet coating are glycerol (85%) (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, non-divisible, round, convex tablets, brown or greyish-red in colour, marked with "LCE 50" engraved on one side.
Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg tablets are available in six pack sizes (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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

България Luxembourg/Luxemburg
Orion Corporation Orion Corporation
Тел.: +358 10 4261 Tél/Tel: +358 10 4261

Česká republika Magyarország
Orion Corporation Orion Corporation
Tel: +358 10 4261 Tel.: +358 10 4261

Danmark Malta
Orion Pharma A/S Orion Corporation
Tlf: +45 8614 0000 Tel: +358 10 4261

Deutschland Nederland
Orion Pharma GmbH Orion Corporation
Jürgen-Töpfer-Straße 46 Tel: +358 10 4261
22763 Hamburg
Tel: +49 40 899 689-0

Eesti Norge
Orion Corporation Orion Pharma AS
Tel: +358 10 4261 Tlf: +47 40 00 42 10

Ελλάδα Österreich
Orion Corporation Orion Corporation
Τηλ: +358 10 4261 Tel: +358 10 4261

España Polska
Orion Corporation Orion Pharma Poland Sp z.o.o.
Tel: +358 10 4261 Tel.: +48 22 8333177

France Portugal
Orion Corporation Orion Corporation
Tél: +358 10 4261 Tel: +358 10 4261

Hrvatska România
Orion Corporation Orion Corporation
Tel: +358 10 4261 Tel: +358 10 4261

Ireland Slovenija
Orion Corporation Orion Corporation
Tel: +358 10 4261 Tel: +358 10 4261

Ísland Slovenská republika
Vistor hf. Orion Corporation
Sími: +354 535 7000 Tel: +358 10 4261

Italia Suomi/Finland
Orion Corporation Orion Corporation
Tel: +358 10 4261 Puh./Tel: +358 10 4261

Κύπρος Sverige
Orion Corporation Orion Pharma AB
Τηλ: +358 10 4261 Tel: +46 8 623 6440

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

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

Package leaflet: information for the user

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

levodopa/carbidopa/entacapone
Please read this entire 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Levodopa/Carbidopa/Entacapone Orion is and what it is used for
What you need to know before taking Levodopa/Carbidopa/Entacapone Orion
How to take Levodopa/Carbidopa/Entacapone Orion
Possible side effects
How to store Levodopa/Carbidopa/Entacapone Orion
Contents of the pack and other information

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

Levodopa/Carbidopa/Entacapone Orion contains three active substances (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 thereby reduces the symptoms of
Parkinson's disease. Carbidopa and entacapone enhance the effectiveness of levodopa's anti-Parkinsonian effects.

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, entacapone, or any of the other ingredients of this medicine (listed in section 6)
if you have closed-angle glaucoma (an eye condition)
if you have a tumour of the adrenal gland
if you are taking antidepressants (combinations of selective MAO-A inhibitors and MAO-B inhibitors, or non-selective MAO inhibitors)
if you have previously experienced the rare reaction to certain antipsychotic medicines known as Neuroleptic Malignant Syndrome (NMS)
if you have previously experienced a rare muscle disorder called non-traumatic rhabdomyolysis
if you have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Orion if you have
or have previously had:

heart attack, other heart diseases including arrhythmias, or blood vessel disorders
asthma or other lung diseases
liver disorders, as your dose may need to be adjusted
kidney or hormonal disorders
gastric ulcer or seizures
prolonged diarrhoea – consult your doctor as this may be a sign of inflammation of the colon
severe psychiatric disorders of any kind, such as psychosis
chronic open-angle glaucoma, as your dose may need to be adjusted and your eye pressure monitored.

Talk to your doctor if you are taking:

antipsychotic medicines (medicines used to treat psychosis)
any medicine that may cause a drop in blood pressure when standing up from sitting or lying down. You should be aware that Levodopa/Carbidopa/Entacapone Orion may worsen such reactions.

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

you develop muscle stiffness or strong contractions, or if you experience tremors, agitation, confusion, fever, increased heart rate, or severe fluctuations in blood pressure. In such cases, you must seek immediate medical attention
you feel depressed or have thoughts of suicide, or if you notice any changes in your behaviour
you experience sudden attacks of sleep, or feel unusually sleepy. If this occurs, you must not drive or operate machinery (see also section “Driving and use of machines”).
you develop uncontrolled movements or if such movements worsen after taking Levodopa/Carbidopa/Entacapone Orion. In this case, consult your doctor, as it may be necessary to adjust the dosage of your anti-Parkinson’s medicines
you experience diarrhoea: regular monitoring of body weight is recommended to avoid excessive weight loss
you experience progressive loss of appetite, asthenia (weakness, fatigue), and weight loss over a relatively short period. 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”.

Inform your doctor if you or a family member/carer notice the development of symptoms
resembling dependence, leading to a desire for high doses of
Levodopa/Carbidopa/Entacapone Orion and other medicines used to treat Parkinson’s disease.
Inform your doctor if you, or your family members/carers, notice that you develop impulses or
strong urges to behave in unusual ways or are unable to resist impulses, urges, or temptations to carry out activities that could be harmful to you or others. These behaviours
are known as impulse control disorders and may include compulsive gambling, excessive spending and eating, abnormally increased sex drive, or preoccupation with an increase in sexual thoughts or desires. Your doctor may need to review your treatment.
During long-term treatment with Levodopa/Carbidopa/Entacapone Orion, your doctor may
request regular laboratory tests.
If you are scheduled for surgery, inform your doctor that you are taking
Levodopa/Carbidopa/Entacapone Orion.
Levodopa/Carbidopa/Entacapone Orion is not recommended for the treatment of extrapyramidal symptoms (e.g. involuntary movements, tremors, muscle stiffness, and muscle contractions) caused by other medicines.

medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine, and paroxetine
rimiterol and isoprenaline, used to treat certain respiratory conditions
adrenaline, used in severe allergic reactions
noradrenaline, dopamine, and dobutamine, used to treat certain heart conditions 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 certain medicines.
These include:

dopaminergic antagonists used to treat certain psychiatric disorders, nausea, and vomiting
phenytoin, used to prevent seizures
papaverine, used to relax muscles.

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 taken with or immediately after high-protein meals (such as meat, fish, dairy products, seeds, and nuts). Consult your doctor if you think this may apply to you.

Driving and use of machines
Levodopa/Carbidopa/Entacapone Orion may lower blood pressure, which can cause dizziness or lightheadedness. Be especially careful when driving or operating machinery.
If you experience drowsiness or sudden sleep attacks, wait until you are fully alert again before resuming driving or any other activity requiring full attention. Otherwise, you may put yourself and others at serious risk, even death.

Levodopa/Carbidopa/Entacapone Orion contains sucrose
Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.4 mg/tablet). If your doctor has diagnosed you with an 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, i.e. essentially “sodium-free”.

3. How to take Levodopa/Carbidopa/Entacapone Orion

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Adults and elderly:

Your doctor will tell you exactly how many tablets of Levodopa/Carbidopa/Entacapone Orion to take each day.
The tablet is not intended to be divided into smaller parts.
Take only one tablet at a time.
Depending on your response to treatment, 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 think 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
Figure 1
closure and then press with your thumb on the seal

A hand holding a small glass vial with a black arrow pointing toward the upper cap of the container

until it breaks. See figure 1.
If you take more Levodopa/Carbidopa/Entacapone Orion than you should
Contact your doctor or pharmacist immediately if you have taken more tablets of
Levodopa/Carbidopa/Entacapone Orion than you were supposed to. In case of overdose,
you may feel confused or agitated, your heartbeat may speed up or slow down, or the colour of your skin, tongue, eyes or urine may change.
If you forget to take Levodopa/Carbidopa/Entacapone Orion
Do not take a double dose to make up for a forgotten tablet.
If more than one hour remains until the next dose:
Take one tablet as soon as you remember, and take the next one at the scheduled time.
If less than one hour remains until the next dose:
Take one tablet as soon as you remember, wait one hour, then take another tablet. Then
continue as normal.
Always leave at least one hour between consecutive 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 a case, your doctor may need to adjust the dose of other anti-Parkinson's medicines you are taking, especially levodopa, to adequately control your symptoms. Abruptly stopping treatment with
Levodopa/Carbidopa/Entacapone Orion and other anti-Parkinson's medicines may cause
side effects.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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 any of the following symptoms while taking Levodopa/Carbidopa/Entacapone Orion, contact your doctor immediately:

Muscle rigidity or severe muscle contractions, tremors, agitation, confusion, fever, increased heart rate, or severe blood pressure fluctuations. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare and serious reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare and serious muscle disorder).
An allergic reaction, which may include signs such as hives, itching, rash, swelling of the face, lips, tongue, or throat. Swelling of the throat may 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 urine
muscle pain
diarrhoea.

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

light-headedness 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 disease or problems with arteries (e.g. chest pain), irregular heartbeat or heart rate
increased frequency of falls
shortness of breath
increased sweating, skin rash
muscle cramps, swelling in the legs
blurred vision
anaemia
decreased appetite, weight loss
headache, joint pain
urinary tract infection.

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

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

Not known (frequency cannot be estimated from the available data):
A desire to take higher doses of Levodopa/Carbidopa/Entacapone Orion than needed to control motor symptoms, known as dopamine dysregulation syndrome. Some patients may experience severe abnormal involuntary 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 carry out 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 behaviours, causing concern for you or others, for example increased sexual drive;
uncontrolled 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).

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the bottle and the carton. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levodopa/Carbidopa/Entacapone Orion contains

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

Description of the appearance of Levodopa/Carbidopa/Entacapone Orion and contents of the pack
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg: light reddish-brown oval tablets marked with "LCE 75" on one side.
Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 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.