Levodopa / Carbidopa / Entacapone Accord
film-coated tablets
levodopa / carbidopa / entacapone
What Levodopa / Carbidopa / Entacapone Accord is and what it is used for
Levodopa / Carbidopa / Entacapone Accord contains three active substances ( levodopa, carbidopa, and entacapone) in a film-coated tablet. Levodopa / Carbidopa / Entacapone Accord is used for treating 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.
Levodopa/carbidopa/entacapone contained in Levodopa / Carbidopa / Entacapone Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Levodopa / Carbidopa / Entacapone Accord
Do not use Levodopa / Carbidopa / Entacapone Accord
- 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
- take certain medicines to treat depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors )
- previously had neuroleptic malignant syndrome (NMS – this is a rare reaction to drugs used 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 Accord 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 of colitis
- 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 Accord may aggravate this effect.
Ask your doctor if you are taking Levodopa / Carbidopa / Entacapone Accord 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, have suicidal thoughts or notice that your behavior is changing
- suddenly fall asleep, or feel very sleepy. If this happens, do not drive or use machines (see also section “Driving and using machines”).
- get involuntary movements or if they worsen after starting treatment with Levodopa / Carbidopa / Entacapone Accord. If this happens, your doctor may need to change your dose of Parkinson’s medicine .
- 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 using Levodopa / Carbidopa / Entacapone Accord, see the section “If you stop taking Levodopa / Carbidopa / Entacapone Accord”.
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 Accord 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 a 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 sex 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 Accord.
If you need surgery, tell your doctor that you are taking Levodopa / Carbidopa / Entacapone Accord.
Levodopa / Carbidopa / Entacapone Accord is not recommended for the treatment of extrapyramidal symptoms (such as 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 Accord is limited. Levodopa / Carbidopa / Entacapone Accord is therefore not recommended for the treatment of children.
Other medicines and Levodopa / Carbidopa / Entacapone Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Levodopa / Carbidopa / Entacapone Accord 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 Accord may potentiate the effects and side effects of certain medicines. These include:
- 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 Accord. 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 Accord may impair iron absorption. Therefore, do not take Levodopa / Carbidopa / Entacapone Accord and iron supplements at the same time, but at least 2-3 hours apart.
Levodopa / Carbidopa / Entacapone Accord with food and drink
Levodopa / Carbidopa / Entacapone Accord can be taken with or without food. In some patients, Levodopa / Carbidopa / Entacapone Accord may be less well taken if taken concomitantly with or shortly after eating a high-protein diet (such as meat, fish, dairy products, seeds, and nuts). Contact a doctor if you think this applies to you.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 breastfeed while being treated with Levodopa / Carbidopa / Entacapone Accord.
Driving and using machines
Levodopa / Carbidopa / Entacapone Accord 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.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Levodopa / Carbidopa / Entacapone Accord
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 Levodopa / Carbidopa / Entacapone Accord 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 Accord 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 film-coated tablets, do not take more than 10 tablets per day.
- If you are taking Levodopa / Carbidopa / Entacapone Accord 200 mg / 50 mg / 200 mg film-coated tablets, do not take more than 7 tablets of this strength daily.
If you have the impression that the effect of Levodopa / Carbidopa / Entacapone Accord is too strong or too weak, or if you experience any side effects, talk to 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 Accord, contact your doctor immediately :
- your muscles become very stiff or jerky, you suffer from tremors, agitation, confusion, fever, rapid pulse or sharp fluctuations in blood pressure. 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 )
- nausea
- reddish-brown discoloration of the urine (harmless)
- muscle pain
- diarrhea
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 heartbeat or rhythm
- increased tendency to fall
- shortness of breath
- increased sweating, rash
- muscle cramps, swelling of the legs
- dimsyn
- anemia
- 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
- seizures
- 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
The following side effects have also been reported:
- hepatitis ( inflammation of the liver)
- itching
Has been reported (occurs in an unknown number of users):
Request a higher dose of Levodopa / Carbidopa / Entacapone Accord that is greater than that required to control motor systems, 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 Accord.
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, e.g. an increased sex drive
- 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.
How to store Levodopa / Carbidopa / Entacapone Accord
Opened HDPE can be used within 6 months.
Keep this medicine out of sight – and sight of children.
Do not use this medicine after the expiry date which is stated on the can and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines 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
Content declaration
- The active substances of Levodopa / Carbidopa / Entacapone Accord are levodopa , carbidopa and entacapone.
- Each Levodopa / Carbidopa / Entacapone Accord 50 mg / 12.5 mg / 200 mg film-coated tablet contains 50 mg levodopa , 12.5 mg carbidopa and 200 mg entacapone.Each Levodopa / Carbidopa / Entacapone Accord 75 mg / 18.75 mg / 200 mg film-coated tablet contains 75 mg levodopa , 18.75 mg carbidopa and 200 mg entacapone.Each Levodopa / Carbidopa / Entacapone Accord 100 mg / 25 mg / 200 mg film-coated tablet contains 100 mg levodopa , 25 mg carbidopa and 200 mg entacapone.Each Levodopa / Carbidopa / Entacapone Accord 125 mg / 31.25 mg / 200 mg film-coated tablet contains 125 mg levodopa , 31.25 mg carbidopa and 200 mg entacapone.Each Levodopa / Carbidopa / Entacapone Accord 150 mg / 37.5 mg / 200 mg film-coated tablet contains 150 mg levodopa , 37.5 mg carbidopa and 200 mg entacapone.Each Levodopa / Carbidopa / Entacapone Accord 200 mg / 50 mg / 200 mg film-coated tablet contains 200 mg levodopa , 50 mg carbidopa and 200 mg entacapone.The other ingredients in the tablet core are microcrystalline cellulose, crospovidone (type B), povidone K 30, magnesium stearate and sodium citrate.
- The film coating contains hypromellose, macrogol 6000, titanium dioxide (E171), polysorbate 80, red iron oxide (E172) and yellow iron oxide (E172) (50 mg / 12.5 mg / 200 mg, 100 mg / 25 mg / 200 mg and 150 mg / 37.5 mg / 200 mg).
What the medicine looks like and contents of the pack
Levodopa / Carbidopa / Entacapone Accord 50 mg / 12.5 mg / 200 mg film-coated tablets: Light brown to gray-red, round, biconvex film-coated tablets, approximately 11.3 mm in diameter, marked with “50” on one side and no label on the other side.
Levodopa / Carbidopa / Entacapone Accord 75 mg / 18.75 mg / 200 mg film-coated tablets: Light brown to light pink, oval film-coated tablets (length: approximately 15.2 mm, width: approximately 7.2 mm), marked with “75” on one side and no marking on the other side.
Levodopa / Carbidopa / Entacapone Accord 100 mg / 25 mg / 200 mg film-coated tablets: Light brown to gray-red, oval film-coated tablets (length: approximately 16.7 mm, width: approximately 7.7 mm), marked with “100” on one side and no marking on the other side.
Levodopa / Carbidopa / Entacapone Accord 125 mg / 31.25 mg / 200 mg film-coated tablets: Light brown to light pink, oblong / elliptical film-coated tablets (length: approximately 15.2 mm, width: approximately 9.7 mm), marked with “125 ”On one side and no marking on the other side.
Levodopa / Carbidopa / Entacapone Accord 150 mg / 37.5 mg / 200 mg film-coated tablets: Light brown to gray-red, oblong / elliptical film-coated tablets (length: approximately 16.2 mm, width: approximately 10.2 mm), marked with “150 ”On one side and no marking on the other side.
Levodopa / Carbidopa / Entacapone Accord 200 mg / 50 mg / 200 mg film-coated tablets: Dark brown-red, oval film-coated tablets (length: approximately 19.15 mm, width: approximately 9.05 mm), marked with “200” on one side and no marking on the other side.
Levodopa / Carbidopa / Entacapone Accord is available in three different pack sizes (30, 100, and 130 tablets). Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Ltd
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF,
UK
Wessling Hungary Kft.,
Foot out 56., Budapest 1047,
Hungary
Pharmacare Premium Ltd
HHF 003, Hal Far Industrial Estate,
Birzebbugia, BBG 3000,
Malta