Package Leaflet: Information for the User

Levodopa/Carbidopa/Entacapona cinfa 200 mg/50 mg/200 mg Film-Coated Tablets

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication contains three active principles (levodopa, carbidopa and entacapona) in a coated tablet. Levodopa/Carbidopa/Entacapona is used to treat Parkinson's disease.

Parkinson's disease is due to a low concentration in the brain of a substance called dopamine. Levodopa increases the amount of dopamine and thus reduces the symptoms of Parkinson's disease. Carbidopa and entacapona improve the antiparkinsonian effects of levodopa.

Do not take Levodopa/Carbidopa/Entacapona cinfa if

• You are allergic to levodopa, carbidopa, or entacapone, or to any of the other components of this medication (listed in section 6).
• You have narrow-angle glaucoma (a eye disorder).
• You have a tumor of the adrenal glands.
• You are taking certain medications for depression (combinations of MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
• You have ever had a neuroléptico maligno syndrome (NMS – a rare reaction to medications used to treat severe mental disorders).
• You have ever had non-traumatic rhabdomyolysis (a rare muscle disorder).
• You have a severe liver disorder.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levodopa/Carbidopa/Entacapona cinfa.

If you have or have ever had:

• A heart attack or any other heart or blood vessel disease, including arrhythmias, or lung disease.
• Asthma or any other lung disease.
• Any liver problem, as your dose may need to be adjusted.
• Any kidney or hormone-related disease.
• Stomach ulcers or seizures.
• Prolonged diarrhea.Consult your doctor as this may be a sign of colon inflammation.
• Any severe mental disorder, such as psychosis.
• Open-angle glaucoma, as your dose may need to be adjusted and your intraocular pressure monitored.

Consult your doctor if you are taking:

• Antipsychotics (medications for treating psychosis).
• Any medication that can cause a drop in blood pressure when standing up from a chair or bed. You should know that Levodopa/Carbidopa/Entacapona can worsen these reactions.

Consult your doctor if during treatment with Levodopa/Carbidopa/Entacapona:

• You experience great muscle rigidity or muscle contractions, or if you experience tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. If any of these circumstances occur,contact your doctor immediately.
• You feel depressed, have suicidal thoughts, or notice unusual changes in your behavior.
• You fall asleep suddenly, or you feel very drowsy. If this happens, do not drive or operate machinery (see also the section “Driving and operating machines”).
• You start to notice involuntary movements or they worsen. If this occurs, your doctor may need to change your medication dose.
• You experience diarrhea; it is recommended to monitor your weight to avoid excessive weight loss.
• You experience progressive loss of appetite, asthenia (weakness, fatigue), and weight loss over a relatively short period. In these cases, a complete medical evaluation, including a liver function test, may be necessary.
• You consider stopping this medication; see the section "If you interrupt treatment with Levodopa/Carbidopa/Entacapona cinfa".

Inform your doctor if you or your family/caregiver notice that you are developing unusual desires or a tendency to behave in an unusual way in yourself or that you cannot resist the impulse, determination, or temptation to engage in certain activities that may harm you or others. These behaviors are known as impulse control disorders and may include excessive gaming, eating, or spending, and an abnormally elevated or excessive sexual impulse or concern with an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.

Inform your doctor if you, or your family/caregiver, notice that you are developing symptoms similar to addiction, which lead to a desire for large doses of levodopa/carbidopa/entacapone and other medications used to treat Parkinson's disease.

During prolonged treatment with Levodopa/Carbidopa/Entacapona, your doctor may perform regular laboratory tests.

If you need to undergo surgery, inform your doctor that you are taking this medication.

Levodopa/Carbidopa/Entacapona is not recommended for the treatment of extrapyramidal symptoms (e.g., involuntary movements, agitation, muscle rigidity, and muscle contractions) caused by other medications.

Children and adolescents

The experience of using Levodopa/Carbidopa/Entacapona in patients under 18 years old is limited. Therefore, its administration in children or adolescents is not recommended.

Other medications and Levodopa/Carbidopa/Entacapona cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take this medicationif you are taking certain medications for depression (combinations of MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Levodopa/Carbidopa/Entacapona may increase the effect, and also the adverse effects, of certain medications. These include:

• Medications used to treat depression, such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine, and paroxetine.
• Rimiterol and isoprenaline, used to treat respiratory diseases.
• Adrenaline, used to treat severe allergic reactions.
• Noradrenaline, dopamine, and dobutamine, used to treat heart disease and low blood pressure.
• Alpha-metildopa, used to treat high blood pressure.
• Apomorphine, used to treat Parkinson's disease.

Certain medications may reduce the effects of Levodopa/Carbidopa/Entacapona. These medications are:

• Antagonists of dopamine used to treat mental disorders, nausea, and vomiting.
• Phenitoine, used to prevent seizures.
• Papaverine, used to relax muscles.

Levodopa/Carbidopa/Entacapona may interfere with the absorption of iron at the digestive level. Therefore, do not take Levodopa/Carbidopa/Entacapona at the same time as taking iron supplements. If you take one of them, wait at least 2 or 3 hours before taking the other.

Taking Levodopa/Carbidopa/Entacapona cinfa with food and drinks

This medication can be taken with or without food.

In some patients, Levodopa/Carbidopa/Entacapona may not be well absorbed if taken with foods high in protein (meat, fish, dairy products, cereals, and nuts) or shortly after consuming them.

Consult your doctor if you think this occurs in your case.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not breastfeed your child during treatment with this medication.

Driving and operating machines

Levodopa/Carbidopa/Entacapona may cause drowsiness and cause you to experience sudden episodes of sleep. If this happens, do not drive vehicles or perform activities in which a lack of attention may pose a risk, putting you or others in danger of death or serious harm (e.g., operating machines), until these episodes and/or drowsiness have disappeared.

Levodopa/Carbidopa/Entacapona cinfa 200 mg/50 mg/200 mg contains lactose

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and elderly patients:

• Your doctor will tell you the exact number of Levodopa/Carbidopa/Entacapone tablets you should take per day.
• Tablets should not be broken or divided into smaller pieces.
• Take only one tablet at a time.
• Depending on how you respond to treatment, your doctor may indicate that you increase or decrease the dose.
• If you are taking Levodopa/Carbidopa/Entacapone tablets of 200 mg/50 mg/200 mg, do not take more than 7 tablets per day.

Speak with your doctor or pharmacist if you believe the effect of this medication is too intense or too weak, or if you experience any possible side effects.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

You may feel dizzy or agitated, that your heart rate is slower or faster than normal, or that the color of your skin, tongue, eyes, or urine has changed.

If you forgot to take Levodopa/Carbidopa/Entacapone cinfa

Do not take a double dose to compensate for the missed doses.

If more than 1 hour remains until the next dose:

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

If less than 1 hour remains until the next dose:

Take a tablet as soon as you remember, wait 1 hour, and then take another tablet. Continue as usual.

Always allow 1 hour to pass between tablets of this medication to avoid possible side effects.

If you interrupt treatment with Levodopa/Carbidopa/Entacapone cinfa

Do not stop taking this medication unless your doctor tells you to. In that case, your doctor may need to adjust the dose of other Parkinson's medications, especially levodopa, to ensure sufficient control of your symptoms.

If you stop taking Levodopa/Carbidopa/Entacapone and other Parkinson's medications abruptly, you may experience unwanted side effects.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Many can be relieved by adjusting the dose.

If you experience any of these symptoms during treatment with this medicine,contact your doctor immediately:

• Severe stiffness or violent muscle contractions, tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. They may be symptoms of malignant neuroleptic syndrome (SNM, a rare severe reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare and severe muscle alteration).
• Allergic reaction characterized by signs such as hives, itching, rash, and swelling of the face, lips, tongue, or throat. This reaction can cause difficulty breathing or swallowing.

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

• Uncontrolled movements (dyskinesias)
• Unpleasant sensation (nausea)
• Brownish-red discoloration of harmless urine
• Muscle pain
• Diarrhea
• Urinary tract infections

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

• Loss of consciousness or fainting due to decreased blood pressure, hypertension
• Worsening of parkinsonian symptoms, dizziness, somnolence
• Vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation
• Inability to sleep; hallucinations; confusion; abnormal dreams (with nightmares); fatigue
• Mental state changes, including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• Cardiac or arterial problems (e.g., chest pain), irregular heartbeats
• Frequent falls
• Shortness of breath
• Increased sweating, rashes
• Muscle cramps, leg swelling
• Blurred vision
• Anemia
• Decreased appetite, weight loss
• Headache, joint pain
• Urinary tract infections

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

• Myocardial infarction
• Intestinal hemorrhage
• Alterations in blood cell counts that can cause bleeding and abnormalities in liver function tests
• Seizures
• Restlessness
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Different color changes other than urine (e.g., skin, nails, hair, sweat)
• Difficulty swallowing
• Inability to urinate

Frequency not known (cannot be estimated from available data):

Desire for large doses of Levodopa/Carbidopa/Entacapone exceeding those required to control motor symptoms, known as dopamine dysregulation syndrome.

Some patients experience severe abnormal involuntary movements (dyskinesias), mood changes, or other side effects after taking large doses of Levodopa/Carbidopa/Entacapone.

The following adverse effects have also been reported:

• Heptatitis (inflammation of the liver)
• Itching

You may experience the following adverse effects:

Inability to resist the urge to perform an action that could be harmful, and which may include:

• A strong urge to gamble excessively despite severe personal and family consequences
• Increased or altered sexual interest and behavior that is concerning to you or others, such as increased sexual desire
• Excessive or uncontrolled spending
• Eating excessively (eating large amounts of food in short periods) or compulsively (eating more food than usual and more than needed to satisfy hunger)

Inform your doctor if you experience any of these behaviors, and they will discuss how to manage or reduce these symptoms.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Dispose of the product 175 days after opening the packaging.

Medications should not be thrown down the drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Levodopa/Carbidopa/Entacapona cinfa

• The active principles are levodopa, carbidopa, and entacapona. Each coated tablet contains 200 mg of levodopa, 50 mg of carbidopa, and 200 mg of entacapona.
• The other components are: microcrystalline cellulose, anhydrous lactose, hydroxypropyl cellulose, povidone (E-1201), anhydrous colloidal silica, magnesium stearate, titanium dioxide (E-171), hypromellose, glycerol (E-422), yellow iron oxide (E-172), polisorbate 80, red iron oxide (E-172), and black iron oxide (E-172).

Appearance of the product and content of the container

Biconvex, oblong tablets, brown in color, engraved with “200” on one face, smooth on the other.

Levodopa/Carbidopa/Entacapona cinfa 200 mg/50 mg/200 mg is available in HDPE bottles with PP child-resistant closures in containers of 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Teva Pharmaceutical Works Private

Pallagi út 13, 4042 Debrecen

Hungary

O

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: October 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/79649/P_79649.html

QR code to:https://cima.aemps.es/cima/dochtml/p/79649/P_79649.html