Package Leaflet: Information for the User

Levodopa/Carbidopa/Entacapona Stada125 mg/31.25 mg/200 mg Film-Coated Tablets

Read this 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 pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. Check the full list of side effects in section 4.

1.What Levodopa/Carbidopa/Entacapona Stada is and what it is used for

2.What you need to know before you start taking Levodopa/Carbidopa/Entacapona Stada

3.How to take Levodopa/Carbidopa/Entacapona Stada

4.Possible side effects

5.Storage of Levodopa/Carbidopa/Entacapona Stada

6.Contents of the pack and additional information

Levodopa/Carbidopa/Entacapona Stada 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 Stada if

• You are allergic to levodopa, carbidopa, or entacapone, soy, peanuts, or 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 if you have or have had:

• 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 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 tools or 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: monitor your weight to avoid excessive weight loss.
• You experience progressive loss of appetite, weakness, and weight loss over a relatively short period. In these cases, a complete medical evaluation, including liver function testing, may be necessary.
• You consider stopping levodopa/carbidopa/entacapona; see the section “If you interrupt treatment with levodopa/carbidopa/entacapona”.

Inform your doctor if you or your family/caregiver notice that you are developing unusual desires or propensities to behave in an unusual way in you 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 sensations.Your doctor may need to review your treatment.

Inform your doctor if you or your family/caregiver observe that you are developing symptoms similar to addiction that lead to a desire for high doses oflevodopa/carbidopa/entacapona 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 levodopa/carbidopa/entacapona.

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.

If you are unsure whether any of the above circumstances affect you, consult your doctor or pharmacist before taking levodopa/carbidopa/entacapona.

Children and adolescents

The experience of using levodopa/carbidopa/entacapona in patients under 18 years is limited. Therefore, its administration is not recommended in children.

Levodopa/Carbidopa/Entacapona Stada 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 levodopa/carbidopa/entacapona if 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 for severe allergic reactions.
• Noradrenaline, dopamine, and dobutamine, used to treat heart disease and low blood pressure.
• Alpha-methyldopa, 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:

• Antidopaminergic medications used to treat mental disorders, nausea, and vomiting.
• Phenytoin, used to prevent seizures.
• Papaverine, used to relax muscles.

Levodopa/carbidopa/entacapona may interfere with iron absorption in the digestive tract. Therefore, do not take levodopa/carbidopa/entacapona at the same time as taking iron supplements. If you take either of them, wait at least 2 to 3 hours before taking the other.

Levodopa/Carbidopa/Entacapona Stada with food and drinks

Levodopa/carbidopa/entacapona can be taken with or without food. In some patients, levodopa/carbidopa/entacapona 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 levodopa/carbidopa/entacapona.

Driving and operating machines

Levodopa/carbidopa/entacapona may lower your blood pressure, which can cause dizziness or fainting. Therefore, be especially careful when operating 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 operating tools or machinery (see also the section “Driving and operating machines”).

Levodopa/Carbidopa/Entacapona Stada contains lecithin (soy) and sodium

If you are allergic to peanuts or soy, do not take this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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:

• Your doctor will indicate the exact number of tablets oflevodopa/carbidopa/entacaponayou 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 tablets oflevodopa/carbidopa/entacapona125 mg/31.25 mg/200 mg, do not take more than 10 tablets per day.

Speak with your doctor or pharmacist if you believe the effect oflevodopa/carbidopa/entacaponais too intense or too weak, or if you experience possible side effects.

Use in children and adolescents

Levodopa/carbidopa/entacaponashould not be used in children and adolescents under 18 years of age.

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

If you have accidentally taken more tablets oflevodopa/carbidopa/entacaponathan you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service,phone91.562.04.20 indicating the medication and the amount ingested.

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 changes.

If you forgot to take Levodopa/Carbidopa/Entacapona Stada

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. Then, follow your usual routine.

Always allow 1 hour to pass betweenlevodopa/carbidopa/entacaponatablets, to avoid possible side effects.

If you interrupt treatment with Levodopa/Carbidopa/Entacapona Stada

Do not stop takinglevodopa/carbidopa/entacaponaunless 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 takinglevodopa/carbidopa/entacaponaand other Parkinson's medications abruptly, you may experience unwanted side effects.

If you have any other doubts 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 levodopa/carbidopa/entacapona,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)
• nausea
• brownish-red urine discoloration
• 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
• mental state changes - including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• cardiac or arterial discomfort (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
• blood cell count alterations that can cause bleeding and liver function test abnormalities
• seizures
• restlessness
• psychotic symptoms
• colitis (inflammation of the colon)
• color changes other than urine (e.g., skin, nails, hair, sweat)
• difficulty swallowing
• inability to urinate

Adverse effects have also been reported:

Unknown frequency(cannot be estimated from available data)

• hepatitis (inflammation of the liver)
• itching
• desire for high doses of levodopa/carbidopa/entacapona that exceed the required dose 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 high doses of levodopa/carbidopa/entacapona.

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 desire;
• 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 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 through the Spanish System for Pharmacovigilance of Medicines for Human Use. 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 box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

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

Composition of Levodopa/Carbidopa/Entacapona Stada

• The active principles are levodopa, carbidopa, and entacapona.

Each film-coated tablet contains125 mg of levodopa, 31.25 mg of carbidopa (as monohydrate) and 200 mg of entacapona.

• The other components of thetablet coreare croscarmellose sodium, hydroxypropylcellulose, dihydrate of trehalose, powdered cellulose, anhydrous sodium sulfate, microcrystalline cellulose, and magnesium stearate.

Film coating: partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, red iron oxide (E172), soy lecithin (E322), and yellow iron oxide (E172).

Appearance of the product and content of the container

Levodopa/Carbidopa/Entacapona Stada125 mg/31.25 mg/200 mg: film-coated tablets, reddish-brown, oval, biconvex, 7.5 x 15.8 mm, with "125" on one side and "LEC" on the opposite side.

Container sizes:

30, 100, and 175 film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitza 2600

Bulgaria

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel,

Germany

Last review date of this leaflet: March 2020

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