Prospect: Information for the user

Levodopa/Carbidopa/Entacapona Kern Pharma 125 mg/31.25 mg/200 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Levodopa/Carbidopa/Entacapona Kern Pharma

3.How to take Levodopa/Carbidopa/Entacapona Kern Pharma

4.Possible adverse effects

5.Storage of Levodopa/Carbidopa/Entacapona Kern Pharma

6.Contents of the package and additional information

This medicationcontains three active principles (levodopa, carbidopa and entacapona) in a coated tablet. Levodopa/Carbidopa/Entacapona Kern Pharma 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, in this way, reduces the symptoms of Parkinson's disease. Carbidopa and entacapona improve the antiparkinsonian effects of levodopa.

Do not take Levodopa/Carbidopa/Entacapona Kern Pharma 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 this medication if you suffer or have sufferedanytime:

• A heart attack or any other heart or blood vessel disease, including arrhythmias.
• Asthma or any other lung disease.
• A liver problem, as it may be necessary to adjust the dose you receive.
• Any kidney or hormone-related disease.
• Stomach ulcers or seizures.
• 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 it may be necessary to adjust the dose and monitor your intraocular pressure.

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 this medication:

• 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; 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 Kern Pharma".

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 perform 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.

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/Entacapona Kern Pharma 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 is not recommended in children.

Taking Levodopa/Carbidopa/Entacapona Kern Pharma 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 takethis 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:

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

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

Taking Levodopa/Carbidopa/Entacapona Kern Pharma with food and drinks

This medicationcan 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 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 you 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”). If not, you may put yourself and others at risk of a serious or even fatal accident.

Levodopa/Carbidopa/Entacapona Kern Pharma 125 mg/31.25 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and elderly:

• Your doctor will indicate the exact number of Levodopa/Carbidopa/Entacapona 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/Entacapona tablets of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, or 150 mg/37.5 mg/200 mg, 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 Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 915 620 420, 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 Kern Pharma

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

If more than 1 hour 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 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 Kern Pharma

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 medicinecan 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 urine discoloration
• Muscle pain
• Diarrhea

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

• Fainting or dizziness 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 discomfort (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
• Restlessness
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Changes in skin color other than urine discoloration (e.g., skin, nails, hair, sweat)
• Difficulty swallowing
• Inability to urinate

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

• A strong urge to gamble excessively despite severe personal or 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 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.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.

No special storage conditions are required.

Dispose of the product 175 days after opening the packaging.

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

Composition of Levodopa/Carbidopa/EntacaponaKern Pharma

The active principles are levodopa, carbidopa, and entacapona. Each coated tablet contains 125 mg of levodopa, 31.25 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), yellow iron oxide (E-172), polysorbate 80, and red iron oxide (E-172).

Appearance of the product and content of the container

Biconvex, round, brownish-yellow tablets, engraved with “125” on one face, smooth on the other.

Levodopa/Carbidopa/Entacapona Kern Pharma 125mg/31.25 mg/200 mg is available in containers of 100 tablets. Not all container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

Teva Pharmaceutical Works Private

Pallagi út 13, 4042 Debrecen

Hungary

or

Teva UK Limited

Brampton Road, Hampden Park,

Eastbourne, East Sussex, BN22 9AG,

United Kingdom

Last review date of this leaflet: September 2019.

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