LEVODOPA/CARBIDOPA/ENTACAPONA STADA 75 mg/18.75 mg/200 mg FILM-COATED TABLETS

2. What you need to know before you take Levodopa/Carbidopa/Entacapone Stada

Do not take Levodopa/Carbidopa/Entacapone Stada if

• you are allergic to levodopa, carbidopa, or entacapone, soy, peanut, or any of the other ingredients of this medicine (listed in section 6).
• you have narrow-angle glaucoma (a condition of the eye).
• you have a tumor of the adrenal gland.
• you are taking certain medicines for depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
• you have ever had neuroleptic malignant syndrome (NMS - a rare reaction to medicines used to treat severe mental disorders).
• you have ever had non-traumatic rhabdomyolysis (a rare and severe muscle disorder).
• you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take levodopa/carbidopa/entacapone if you suffer or have ever suffered from:

• a heart attack or any other heart disease, including arrhythmias, or blood vessel disease.
• asthma or any other lung disease.
• a liver problem, as your dose may need to be adjusted.
• any kidney disease or hormone-related disease.
• stomach ulcers or convulsions.
• prolonged diarrhea. Consult your doctor as it 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 (medicines for treating psychosis).
• any medicine that may cause a drop in blood pressure when standing up from a chair or bed. You should be aware that levodopa/carbidopa/entacapone may worsen these reactions.

Consult your doctor if during treatment with levodopa/carbidopa/entacapone:

• you notice great muscle stiffness or violent contractions, or if you suffer from 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 suddenly fall asleep or feel very drowsy. If this happens to you, do not drive or operate tools or machinery (see also the section "Driving and using machines").
• you start to notice uncontrolled movements or if they worsen. If this occurs, your doctor may need to adjust your medication dose.
• you suffer from diarrhea: it is recommended to monitor your weight to avoid excessive weight loss.
• you suffer from progressive loss of appetite, asthenia (weakness, exhaustion), and weight loss over a relatively short period. In these cases, a complete medical evaluation, including a liver function test, should be considered.
• you consider stopping treatment with levodopa/carbidopa/entacapone; consult the section "If you stop taking Levodopa/Carbidopa/Entacapone Stada".

Tell your doctor if you or your family member/caregiver notice that you are developing desires or tendencies to behave in an unusual way for you 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 addiction to gambling, eating, or excessive spending, and an abnormally high sexual drive or concern with an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.

Tell your doctor if you or your family member/caregiver observe that you are developing symptoms similar to addiction that lead to a desire for high doses of levodopa/carbidopa/entacapone and other medicines used to treat Parkinson's disease.

During prolonged treatment with levodopa/carbidopa/entacapone, your doctor may perform regular blood tests.

If you need to undergo surgery, you must inform your doctor that you are taking levodopa/carbidopa/entacapone.

It is not recommended to use levodopa/carbidopa/entacapone for the treatment of extrapyramidal symptoms (e.g., involuntary movements, agitation, muscle stiffness, and muscle contractions) caused by other medicines.

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

Children and adolescents

Experience with the use of levodopa/carbidopa/entacapone in patients under 18 years of age is limited. Therefore, it is not recommended for use in children.

Taking Levodopa/Carbidopa/Entacapone Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take levodopa/carbidopa/entacapone if you are taking certain medicines for depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Levodopa/carbidopa/entacapone may increase the effect and also the side effects of certain medicines. These include:

• medicines 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 diseases and low blood pressure.
• alpha-methyldopa, used to treat high blood pressure.
• apomorphine, used to treat Parkinson's disease.

Certain medicines may reduce the effects of levodopa/carbidopa/entacapone. These medicines are:

• Dopamine antagonists used to treat mental disorders, nausea, and vomiting.
• Phenytoin, used to prevent convulsions.
• Papaverine, used to relax muscles.

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

Taking Levodopa/Carbidopa/Entacapone Stada with food and drinks

Levodopa/carbidopa/entacapone can be taken with or without food. However, in some patients, levodopa/carbidopa/entacapone may not be absorbed well if taken with food rich in protein (meat, fish, dairy products, cereals, and nuts) or shortly after eating them. Consult your doctor if you think this is happening 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 taking levodopa/carbidopa/entacapone.

Driving and using machines

Levodopa/carbidopa/entacapone may lower your blood pressure, which can cause dizziness or fainting. Therefore, be careful when using tools or machines.

If you feel very tired or notice that you suddenly fall asleep, wait until you feel fully awake before driving or doing anything that requires you to be alert. Otherwise, you may put yourself and others at risk of a serious or even fatal accident.

Levodopa/Carbidopa/Entacapone Stada contains soy lecithin and sodium

If you are allergic to peanut or soy, do not take this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Levodopa/Carbidopa/Entacapone Stada

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Adults and elderly patients:

• Your doctor will tell you exactly how many tablets of levodopa/carbidopa/entacapone to take each day.
• Do not break or divide the tablets into smaller pieces.
• Take only one tablet at a time.
• Depending on how you respond to treatment, your doctor may adjust your dose.
• If you are taking 75 mg/18.75 mg/200 mg tablets of levodopa/carbidopa/entacapone, do not take more than 10 tablets per day.

Talk to your doctor or pharmacist if you think the effect of levodopa/carbidopa/entacapone is too strong or too weak, or if you experience any side effects.

Use in children and adolescents

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

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

If you accidentally take more tablets of levodopa/carbidopa/entacapone than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91.562.04.20, indicating the medicine and the amount taken.

In case of overdose, you may feel dizzy or agitated, your heart rate may be slower or faster than normal, or your skin, tongue, eyes, or urine may change color.

If you forget to take Levodopa/Carbidopa/Entacapone Stada

Do not take a double dose to make up for forgotten doses.

If it is more than 1 hour until your next dose:

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

If it is less than 1 hour until your next dose:

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

There should always be an interval of 1 hour between levodopa/carbidopa/entacapone tablets to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Stada

Do not stop taking levodopa/carbidopa/entacapone unless your doctor tells you to. In that case, your doctor may need to adjust the dose of your other Parkinson's medicines, especially levodopa, to ensure sufficient control of your symptoms. If you stop taking levodopa/carbidopa/entacapone and other Parkinson's medicines abruptly, you may experience unwanted side effects.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many can be alleviated by adjusting the dose.

If you experience any of these symptoms during treatment with levodopa/carbidopa/entacapone, contact your doctor immediately:

• great muscle stiffness or violent contractions, tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS - a rare and severe reaction to medicines used to treat central nervous system disorders) or rhabdomyolysis (a rare and severe muscle disorder).
• 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 sick (nausea)
• brown-red discoloration of urine (harmless)
• muscle pain
• diarrhea
• urinary tract infections

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

• fainting or fainting due to low blood pressure, high blood pressure
• worsening of parkinsonian symptoms, dizziness, drowsiness
• vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
• difficulty sleeping, hallucinations, confusion, abnormal dreams (with nightmares), fatigue
• changes in mental state - including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• heart or blood vessel disorders (e.g., chest pain), irregular heartbeats
• more frequent falls
• breathlessness
• increased sweating, rash
• muscle cramps, swelling of the legs
• blurred vision
• anemia
• decreased appetite, weight loss
• headache, joint pain

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

• heart attack
• intestinal bleeding
• changes in blood cell counts that can cause bleeding and abnormalities in liver function tests
• seizures
• feeling agitated
• psychotic symptoms
• colitis (inflammation of the colon)
• color changes different from those of urine (e.g., skin, nails, hair, sweat)
• difficulty swallowing
• inability to urinate

The following side effects have also been reported:

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

• hepatitis (inflammation of the liver)
• itching
• craving for high doses of levodopa/carbidopa/entacapone that exceed 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 high doses of levodopa/carbidopa/entacapone.

You may experience the following side effects:

• Inability to resist the impulse to perform an action that could be harmful, and that could include:
  • a strong impulse to gamble excessively despite serious personal or family consequences;
  • an increased or altered interest in sex and a disturbing behavior for you or others, such as an increased sexual drive;
  • excessive and uncontrolled shopping or 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).

Tell your doctor if you experience any of these behaviors; they will discuss how to manage or reduce these symptoms.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Levodopa/Carbidopa/Entacapone Stada

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you have any further questions on the use of this product, ask your pharmacist. By doing so, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Levodopa/Carbidopa/Entacapona Stada

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

Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa (as monohydrate) and 200 mg of entacapona.

• The other components of the tablet coreare sodium croscarmellose, hydroxypropylcellulose, trehalose dihydrate, 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), soybean lecithin (E322), and yellow iron oxide (E172).

Appearance of the Product and Packaging Content

Levodopa/Carbidopa/Entacapona Stada 75 mg/18.75 mg/200 mg: film-coated tablets, reddish-brown, oval, biconvex, 7.04 x 14.7 mm, with "75" on one face and "LEC" on the opposite side.

Packaging Sizes:

30, 100, and 175 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Stada Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitza 2600

Bulgaria

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel,

Germany

or

Vetprom AD

Ulitsa Otets Paisiy 26,

Radomir, 2403

Bulgaria

Date of the Last Review of this Prospectus: March 2020

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