50 mg / 12.5 mg / 200 mg film-coated tablets
levodopa / carbidopa / entacapone
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 due to low levels of the substance dopamine in the brain. Levodopa increases the amount of dopamine and therefore relieves the symptoms of Parkinson’s disease . Carbidopa and entacapone improve the effect of levodopa on Parkinson’s disease .
What you need to know before you take Levodopa / Carbidopa / Entacapone Orion
Do not use Levodopa / Carbidopa / Entacapone Orion if you
- is allergic to levodopa , carbidopa or entacapone or any of the other ingredients of this medicine (listed in section 6).
- have narrow-angle glaucoma (an eye disease)
- has a tumor in the adrenal gland
- taking certain medications to treat depression (combinations of selective MAO-A andMAO-B inhibitors, or non-selective MAO inhibitors )
- previously had neuroleptic malignant syndrome (NMS – this is a rare reaction to drugsused to treat severe mental illness)
- previously had non-traumatic rhabdomyolysis (a rare muscle disease)
- have a serious liver disease.
Warnings and cautions
Talk to your doctor or pharmacist before taking Levodopa / Carbidopa / Entacapone Orion if you have or have had:
- a heart attack or any other heart disease including arrhythmias , or blood vessel disease
- asthma or other lung disease
- liver problems, your dose may then need to be adjusted
- kidney disease or hormone-related disease
- stomach ulcer or seizures
- if you experience prolonged diarrhea, consult a doctor as this may be a sign ofcolon inflammation
- some form of serious mental illness, such as psychosis
- chronic wide-angle glaucoma. Your dose may then need to be adjusted and your eye pressure may need to be monitored.
Consult your doctor if you are taking:
- antipsychotics (drugs for the treatment of psychosis )
- medicines that can cause low blood pressure when you get up from a chair or bed. You should be aware that Levodopa / Carbidopa / Entacapone Orion may aggravate this effect.
Ask your doctor if you are taking Levodopa / Carbidopa / Entacapone Orion during treatment:
- experience that your muscles become very stiff or jerky, or if you suffer from tremors, agitation, confusion, fever, rapid pulse or sharp fluctuations in blood pressure. If any of these happen to you, contact your doctor immediately.
- feeling depressed, having suicidal thoughts, or noticing that your behavior is changing.
- suddenly fall asleep, or feel very sleepy. If this happens, do not drive or use machines (see also the section Driving and using machines)
- get involuntary movements or if they worsen after starting Levodopa / Carbidopa / Entacapone Orion treatment. If this happens, your doctor may need to change your dose of Parkinson’s medication
- get diarrhea: your weight may need to be monitored to avoid any significant weight loss
- experiences loss of appetite that worsens over time, lack of energy (weakness, fatigue) and weight loss within a short period of time. If this happens, a general medical examination including liver function tests should be considered
- feel that you want to stop taking Levodopa / Carbidopa / Entacapone Orion, see the section “If you stop taking Levodopa / Carbidopa / Entacapone Orion”.
Tell your doctor if you or your family / caregiver notice that you are developing addictive symptoms that lead to a craving for higher doses of Levodopa / Carbidopa / Entacapone Orion and other medicines used to treat Parkinson’s disease .
Tell your doctor if you or your family / caregiver finds that you are developing impulses or wanting to behave in ways that are unusual for you, or you can not resist the impulse, the urge or the temptation to engage in certain activity that may harm yourself or others. . This behavior is called impulse control disorder and may include compulsive gambling, excessive food intake or spending, an abnormally high sexual drive, or a preoccupation with an increase in sexual thoughts or feelings.
Your doctor may need to review your treatment.
Your doctor may need to take regular samples of you during long-term treatment with Levodopa / Carbidopa / Entacapone Orion.
If you need surgery, tell your doctor that you are taking Levodopa / Carbidopa / Entacapone Orion.
Levodopa / Carbidopa / Entacapone Orion is not recommended for the treatment of extrapyramidal symptoms (eg involuntary movements, tremors, muscle stiffness and muscle contractions) caused by other medicines.
Children and young people
Experience in the treatment of patients under 18 years of age with Levodopa / Carbidopa / Entacapone Orion is limited. Levodopa / Carbidopa / Entacapone Orion is therefore not recommended for the treatment of 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 medicines to treat depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Levodopa / Carbidopa / Entacapone Orion may potentiate the effects and side effects of certain medicines. This includes:
- antidepressants such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine
- rimiterol and isoprenaline , which are used to treat respiratory diseases
- adrenaline , which is used in severe allergic reactions
- norepinephrine , dopamine and dobutamine , which are used to treat heart disease and low blood pressure
- alpha-methyldopa, which is used to treat high blood pressure
- apomorphine, which is used to treat Parkinson’s disease
Some medicines may weaken the effect of Levodopa / Carbidopa / Entacapone Orion. These are:
- dopamine antagonists used to treat mental illness, nausea and vomiting.
- phenytoin used to prevent convulsions
- papaverine used for muscle relaxation.
Levodopa / Carbidopa / Entacapone Orion may impair the absorption of iron. Therefore, do not take Levodopa / Carbidopa / Entacapone Orion and iron supplements at the same time, but 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. In some patients, Levodopa / Carbidopa / Entacapone Orion may be less well absorbed if taken at the same time as or shortly after eating a high protein diet (such as meat, fish, dairy products, seeds and nuts). Contact your doctor if you think this applies to you.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not breast-feed while being treated with Levodopa / Carbidopa / Entacapone Orion.
Driving and using machines
Levodopa / Carbidopa / Entacapone Orion may lower your blood pressure , which may make you feel dizzy or dizzy. Therefore, be especially careful if you drive or use tools or machines.
If you feel very drowsy or if you sometimes suddenly fall asleep, wait until you feel fully awake before driving or doing anything else that requires your attention. Otherwise, you may expose yourself or others to injury or death.
Levodopa / Carbidopa / Entacapone Orion contains sucrose
Levodopa / Carbidopa / Entacapone Orion contains sucrose (1.2 mg / tablet). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Levodopa / Carbidopa / Entacapone Orion
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
For adults and the elderly:
- Your doctor will tell you exactly how many tablets to take each day.
- The tablets are not meant to be split or broken into small pieces.
- You should only take one tablet at a time.
- Depending on how you respond to treatment, your doctor may suggest an increase or decrease in dose one.
- If you take Levodopa / Carbidopa / Entacapone Orion 50 mg / 12.5 mg / 200 mg, 75 mg / 18.75 mg / 200 mg, 100 mg / 25 mg / 200 mg, 125 mg / 31.25 mg / 200 mg or 150 mg / 37.5 mg / 200 mg tablets, do not take more than 10 tablets per day.
If you have the impression that the effect of Levodopa / Carbidopa / Entacapone Orion is too strong or too weak, or if you experience any side effects, talk to your doctor or pharmacist.
To open the jar for the first time: open the lid and then press with your thumb on the seal until it breaks.
If you take more Levodopa / Carbidopa / Entacapone Orion than you should
If you accidentally take more Levodopa / Carbidopa / Entacapone Orion tablets than you should contact a doctor or pharmacist immediately. In the event of an overdose, you may feel confused or upset, your heart rate may be slower or faster than normal or your skin, tongue, eyes or urine may change color.
If you forget to take Levodopa / Carbidopa / Entacapone Orion
Do not take a double dose to make up for a forgotten tablet.
If it is more than 1 hour until the next dose:
Take one tablet as soon as you remember, and take the next tablet at the usual time.
If it is less than 1 hour until the next dose:
Take one tablet as soon as you remember, wait 1 hour and then take another tablet. After that, you can continue as usual.
Always make sure that there is at least one hour between the Levodopa / Carbidopa / Entacapone Orion doses , to avoid any possible side effects .
If you stop taking Levodopa / Carbidopa / Entacapone Orion
Do not stop taking Levodopa / Carbidopa / Entacapone Orion unless your doctor tells you to. In such a case, your doctor may need to change your other antiparkinsonian medication, especially levodopa , to maintain adequate symptom control. If you suddenly stop taking Levodopa / Carbidopa / Entacapone Orion and other antiparkinsonian drugs, it may lead to unwanted side effects .
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. Many side effects can be alleviated by adjusting the dose .
If you experience the following symptoms during treatment with Levodopa / Carbidopa / Entacapone Orion, contact your doctor immediately:
- Your muscles become stiff or jerky, you suffer from tremors, agitation, confusion, fever, rapid pulse or sharp blood pressure fluctuations. These can be symptoms of malignant neuroleptic syndrome (NMS, a rare severe reaction to drugs used to treat diseases of the central nervous system ) or rhabdomyolysis (a rare severe muscle disease).
- Allergic reaction , symptoms may include hives, itching , rash, swelling of the face, lips, tongue or throat. This may cause difficulty breathing or swallowing.
Very common (may affect more than 1 in 10 people):
- involuntary movements ( dyskinesias )
- reddish-brown discoloration of the urine (harmless)
- muscle pain
Common (may affect up to 1 in 10 people):
- feeling of emptiness or fainting due to low blood pressure , high blood pressure
- aggravated symptoms of Parkinson’s disease , dizziness, drowsiness,
- vomiting, abdominal pain and discomfort, heartburn, dry mouth , constipation
- difficulty sleeping, hallucinations, confusion, abnormal dreams (including nightmares), fatigue
- mental changes – including memory disorders, anxiety and depression (possibly with suicidal thoughts) heart or artery disease (eg chest pain), irregular heart rate or rhythm
- increased tendency to fall
- shortness of breath
- increased sweating, rash
- muscle cramps, swelling of the legs
- decreased appetite, weight loss
- headache, joint pain
- urinary tract infection
Uncommon (may affect up to 1 in 100 people):
- heart attack
- intestinal bleeding
- change in the blood cell picture that can lead to bleeding), abnormal liver function values
- feelings of upset
- psychotic symptoms
- colitis ( inflammation of the colon)
- discoloration of other than urine (eg skin, nails, hair, sweat)
- difficulty swallowing
- inability to urinate
Has been reported (occurs in an unknown number of people):
Request a higher dose of Levodopa / Carbidopa / Entacapone Orion that is greater than that required to control motor symptoms, known as dopaminergic dysregulation syndrome. Some patients experience severe abnormal involuntary movements ( dyskinesias ), mood swings or other side effects after taking larger doses of Levodopa / Carbidopa / Entacapone Orion.
The following side effects have also been reported:
- hepatitis ( inflammation of the liver)
You may experience the following side effects:
- Inability to resist the impulse to perform an action that may be harmful, which may include:
- strong impulse to play extremely much despite serious personal or family consequences:
- altered or increased sexual interest and behavior that significantly affects you or others, such as increased sexual desire;
- uncontrolled excessive shopping or spending;
- binge eating (eating large amounts of food for a short period of time) or compulsive food intake (eating more food than normal and more than is needed to satisfy your hunger).
Tell your doctor if you experience any of these symptoms; one will discuss how to manage or reduce these symptoms.
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By reporting side effects , you can help increase the safety of medicines.
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 label and carton. The expiration date is the last day of the specified month.
No special storage instructions.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
- The active substances of Levodopa / Carbidopa / Entacapone Orion are levodopa , carbidopa and entacapone.
- Each 50 mg / 12.5 mg / 200 mg tablet contains 50 mg levodopa , 12.5 mg carbidopa and 200 mg entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, corn starch, mannitol (E421) and povidone (E1201).
- The film coating contains glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171) and yellow iron oxide (E172).
What the medicine looks like and contents of the pack
Levodopa / Carbidopa / Entacapone Orion 50 mg / 12.5 mg / 200 mg: brown or gray-red round convex (ie top and bottom are rounded) film-coated tablets without a notch marked “LCE 50” on one side.
Levodopa / Carbidopa / Entacapone Orion is available in six different pack sizes (10, 30, 100, 130, 175 and 250 tablets). Not all pack sizes may be marketed.
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