Product Information for the User

Levodopa/Carbidopa/Entacapona Abdi 75 mg/18.75 mg/200 mg Film-Coated Tablets EFG

Levodopa/carbidopa/entacapona

Read this entire leaflet carefully before you start taking 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. Do 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.

Contents of the Leaflet

1. What Levodopa/Carbidopa/Entacapona Abdi is and what it is used for
2. What you need to know before you start taking Levodopa/Carbidopa/Entacapona Abdi
3. How to take Levodopa/Carbidopa/Entacapona Abdi
4. Possible side effects

5.Storage of Levodopa/Carbidopa/Entacapona Abdi

6.Contents of the pack and additional information

This medication contains three active principles (levodopa, carbidopa, and entacapone) in a film-coated tablet. This medication 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 thereby reduces the symptoms of Parkinson's disease. Carbidopa and entacapone improve the antiparkinsonian effects of levodopa.

Do not take Levodopa/Carbidopa/Entacapona Abdi if:

• You are allergic to levodopa, carbidopa, or entacapone, or to any of the other ingredients of this medication (listed in section 6)
• You have narrow-angle glaucoma (a type of 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 Abdi if you have or have had:any of the following:

• A heart attack or any other heart or blood vessel disease, including arrhythmias
• Asthma or any other lung disease
• A 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 this medication may worsen these reactions.

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

• You notice great muscle rigidity or that your muscles 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 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 comprehensive 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 Abdi."

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 Stalevo and other medications used to treat Parkinson's disease.

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 this medication and other medications used to treat Parkinson's disease.

Inform your doctor if you or your family/caregiver notice that you are developing desires or a propensity to behave in an unusual manner 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 concerning sexual impulse.Your doctor may need to review your treatment.

During prolonged treatment with this medication, your doctor may perform regular analytical tests.

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

This medication is not recommended for treating extrapyramidal symptoms (e.g., involuntary movements, agitation, muscle rigidity, and muscle contractions) caused by other medications.

Children and adolescents

The experience of using this medication in patients under 18 years old is limited. Therefore, its administration in children or adolescents is not recommended.

Taking Levodopa/Carbidopa/Entacapona Abdi with other medications

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

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

This medication 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 diseases 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 this medication. These medications are:

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

This medication may interfere with the absorption of iron at the digestive level. Therefore, do not take this medication at the same time as iron supplements. If you take any of them, wait at least 2 or 3 hours before taking the other.

Taking Levodopa/Carbidopa/Entacapona Abdi with food and drinks

• This medication can be taken with or without food.
• In some patients, this medication may not be well absorbed if taken with high-protein foods (meats, 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

This medication may lower your blood pressure, which may cause dizziness or fainting. Therefore, be especially careful when handling tools or machinery.

If you feel very tired or notice that you fall asleep suddenly, wait until you feel fully awake again before driving or doing anything else that requires you to be alert. If not, you may put yourself and others at risk of a serious or even fatal accident.

Levodopa/Carbidopa/Entacapona Abdi contains lactose and sodium

• This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.
• This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; it is essentially "sodium-free."

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

• Your doctor will tell you the exact number of Levodopa/Carbidopa/Entacapona Abdi tablets you should take per day.
• The 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 instruct you to increase or decrease the dose.
• Do not take more than 10 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 possible side effects.

If you take more Levodopa/Carbidopa/Entacapona Abdi than you should

If you have accidentally taken more tablets of this medication than you should, speak immediately with your doctor or pharmacist. In case of overdose, you may feel dazed or agitated, that the heart rate is slower or faster than normal, or that the color of your skin, tongue, eyes, or urine has changed.

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

If you forget to take Levodopa/Carbidopa/Entacapona Abdi

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/Entacapona Abdi

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 this medication 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 may 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)
• feeling of discomfort (nausea)
• brownish-red discoloration of harmless urine
• muscle pain
• diarrhea
• urinary tract infections

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

• syncope or fainting due to decreased blood pressure, hypertension
• worsening of parkinsonian symptoms, dizziness, somnolence
• vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation
• insomnia; hallucinations; confusion; abnormal dreams (with nightmares); fatigue
• changes in mental state, including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• cardiac or arterial problems (e.g., chest pain), irregular heart rate
• increased falls
• fatiguing breathing
• increased sweating, rashes
• muscle cramps, leg swelling
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain

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)
• changes in color different from 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 this medicine exceeding those required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood changes, or other adverse effects after taking large doses of this medicine.

The following adverse effects have also been reported:

• hepatitis (inflammation of the liver)
• itching

You may experience the following adverse effects:

• Inability to resist the impulse to perform an action that could be harmful, and which could include:
• • a strong impulse to gamble excessively despite severe personal or family consequences
  • an increase or alteration in sexual interest and behavior that is concerning for you or others, such as increased sexual interest
  • excessive or uncontrolled spending
  • excessive eating (eating large amounts of food in short periods of 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 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 System for Pharmacovigilance of Medicines for Human Use www.noticaRAM.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 box after CAD. The expiration date is the last day of the month indicated.

Store at a temperature below 86°F (30°C).

Store in the original packaging and keep the bottle tightly closed to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Levodopa/Carbidopa/Entacapona Abdi

• The active principles of this medication are levodopa, carbidopa, and entacapona.
• Each tablet contains 75 mg of levodopa, 18.75 mg of anhydrous carbidopa (equivalent to 20.24 mg of carbidopa monohydrate) and 200 mg of entacapona.
• The other components of the tablet core are Croscarmelosa sodium E 468, Magnesium stearate E 470b, Microcrystalline cellulose E 460, Poloxamer 188, Hydroxypropylcellulose E 463, Lactose monohydrate.
• The ingredients of the film-coated tablet are

Hydroxypropylmethylcellulose type 2910

Titanium dioxide E 171

Glycerol E 422

Iron oxide red E 172

Iron oxide yellow E 172

Magnesium stearate E 470b

Polysorbate 80 E 433

Hydroxypropylcellulose E 463

Appearance of the product and contents of the package

Biconvex oval tablets, film-coated, light reddish-brown in color with "75" engraved on one face of the tablet and the other face flat. Size: 14.1 mm x 8.2 mm

There are three different package sizes (30, 100, or 175 film-coated tablets) of this medication. The packages consist of HDPE bottles with induction-sealed aluminum caps and a silica gel-filled container as a loose component in the bottle. The HDPE bottle is packed in an external cardboard box.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Abdi Farma GmbH

Donnersbergstraße 4,

64646 Heppenheim

Germany

Responsible for manufacturing

Pharmadox Healthcare Limited

Kkw46 Kordin Industrial Park,

Paola, PLA3000

Malta

For more information about this medication, please contact the local representative of the marketing authorization holder:

Spain:

Xentenel Pharma Europe, S.L.

Camí Can Camps, 17

Vallsolana Garden Business Park

08174 Sant Cugat del Vallés (Barcelona)

Spain

Last review date of this leaflet:August 2024

Other sources of information

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