Leaflet: information for the user

Levodopa/Carbidopa/Entacapona cinfa 100 mg/25 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, ask 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.

1. Contents of the pack and additional information

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 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 ingredients of this medicine (listed in section 6).
• You have narrow-angle glaucoma (a eye disorder).
• You have a tumor of the adrenal glands.
• You are taking certain medicines 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 medicines 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.
• A liver problem, as your doctor may need to adjust your dose.
• A kidney or hormone-related disease.
• A stomach ulcer or convulsions.
• Prolonged diarrhea. Consult your doctor as it may be a sign of colon inflammation.
• A severe mental disorder, such as psychosis.
• Open-angle glaucoma, as your doctor may need to adjust your dose and monitor your intraocular pressure.

Consult your doctor if you are taking:

• Antipsychotics (medicines for treating psychosis).
• Certain medicines 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 notice great muscle rigidity or they contract violently, 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 using 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, exhaustion), and weight loss in a relatively short time. 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 perform certain activities that may harm you or others. These behaviors are called impulse control disorders and may include excessive gaming, eating, or spending, and an abnormally elevated or concerning sexual impulse. 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 medicines 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 medicine.

Levodopa/Carbidopa/Entacapona cinfa 100 mg/25 mg/200 mg contains lactose.

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

Levodopa/Carbidopa/Entacapona cinfa 100 mg/25 mg/200 mg contains Red 40 (E-129)

This medicine may cause allergic reactions because it contains Red 40 (E129). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

Adults and elderly patients:

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

If you take more Levodopa/Carbidopa/Entacapona 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 the heart rate is slower or faster than normal, or that the color of your skin, tongue, eyes, or urine changes.

If you forgot to take Levodopa/Carbidopa/Entacapona 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 regular 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 the treatment with Levodopa/Carbidopa/Entacapona 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 disease medications, especially levodopa, to ensure sufficient control of your symptoms.

If you stop taking Levodopa/Carbidopa/Entacapona and other Parkinson's disease 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 urticaria, 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 heart rate
• 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
• Sensation of agitation
• 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/Entacapona 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/Entacapona.

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 could 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; 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 Medical Devices Agency: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.

Medicines should not be thrown down the drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. 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 100 mg of levodopa, 25 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), polysorbate 80, red 40 (E-129), and carmine (E-120).

Appearance of the product and content of the container

Biconvex, oblong tablets, pale red in color, engraved with “100” on one face, smooth on the other.

Levodopa/Carbidopa/Entacapona cinfa 100 mg/25 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

Or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: October 2023

Detailed and updated information on 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 on 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/79647/P_79647.html

QR code to:https://cima.aemps.es/cima/dochtml/p/79647/P_79647.html