Package Leaflet: Information for the User

Levodopa/Carbidopa/EntacaponaTeva-ratiopharm100 mg/25 mg/200 mg Film-Coated Tablets

Levodopa/Carbidopa/Entacapona

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 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. What Levodopa/Carbidopa/Entacapona Teva-ratiopharm is and what it is used for
2. What you need to know before you start taking Levodopa/Carbidopa/Entacapona Teva-ratiopharm

3. How to take Levodopa/Carbidopa/Entacapona Teva-ratiopharm

4. Possible side effects

5. Storage of Levodopa/Carbidopa/Entacapona Teva-ratiopharm

6. Contents of the pack and additional information

Levodopa/Carbidopa/EntacaponaTeva-ratiopharmcontains three active ingredients (levodopa, carbidopa and entacapona) in a coated tablet. Levodopa/Carbidopa/EntacaponaTeva-ratiopharmis used to treat Parkinson's disease.

Parkinson's disease is caused by 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 entacapona improve the antiparkinsonian effects of levodopa.

Do not take Levodopa/Carbidopa/EntacaponaTeva-ratiopharm

• if you are allergic to levodopa, carbidopa, or entacapona, or to any of the other ingredients of this medicine (listed in section 6)

this medicine

• if you have narrow-angle glaucoma (a type of eye disorder)
• if you have a tumor of the adrenal glands
• if you are taking certain medications for depression (combinations of MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors)
• if you have ever had a neuroléptico maligno syndrome (NMS – a rare reaction to certain medications used to treat severe mental disorders)
• if you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
• if you have a severe liver disorder

Warnings and precautions

Consult your doctor or pharmacist before starting to take Levodopa/Carbidopa/EntacaponaTeva-ratiopharmif you have or have had:

• a heart attack or any other heart or blood vessel disease, including arrhythmias, or respiratory disease
• asthma or any other lung disease
• a liver problem, as your doctor may need to adjust your dose
• any kidney or hormone-related disease
• stomach ulcers or convulsions
• 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 doctor may need to adjust your dose and monitor your intraocular pressure

Consult your doctor if you are taking:

• antipsychotics (medications for treating psychosis)
• any medication that may cause a drop in blood pressure when standing up from a chair or bed. You should know that Levodopa/Carbidopa/EntacaponaTeva-ratiopharmmay worsen these reactions.

Consult your doctor if during treatment with Levodopa/Carbidopa/EntacaponaTeva-ratiopharmyou:

• notice great rigidity in your muscles 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.
• feel depressed, have suicidal thoughts, or notice unusual changes in your behavior
• fall asleep suddenly, or feel very drowsy. If this happens, do not drive or operate tools or machinery (see also the section “Driving and operating machines”)
• start to notice involuntary movements or they worsen. If this occurs, your doctor may need to change your medication dose
• experience diarrhea; it is recommended to monitor your weight to avoid excessive weight loss
• experience progressive loss of appetite, asthenia (weakness, fatigue), and weight loss over a relatively short period. In these cases, a complete medical evaluation, including liver function tests, may be necessary
• consider stopping Levodopa/Carbidopa/Entacapona Teva-ratiopharm; see the section "If you stop taking Levodopa/Carbidopa/Entacapona Teva-ratiopharm "

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 ofLevodopa/Carbidopa/Entacapona Tevaand 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 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 addiction to gaming, food, or excessive spending, and an abnormally elevated or concerning sexual impulse.Your doctor may need to review your treatment.

During prolonged treatment with Levodopa/Carbidopa/EntacaponaTeva-ratiopharm, your doctor may perform regular laboratory tests.

If you need to undergo surgery, inform your doctor that you are taking Levodopa/Carbidopa/EntacaponaTeva-ratiopharm.

Levodopa/Carbidopa/EntacaponaTeva-ratiopharmis 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/EntacaponaTeva-ratiopharmin patients under 18 years is limited. Therefore, the administration of Levodopa/Carbidopa/EntacaponaTeva-ratiopharmin children is not recommended.

Levodopa/Carbidopa/EntacaponaTeva-ratiopharmwith 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/EntacaponaTeva-ratiopharmif you are taking certain medications for depression (combinations of MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).

Levodopa/Carbidopa/EntacaponaTeva-ratiopharmmay increase the effect, and also the adverse effects, of certain medications. These include:

• medications used to treat depression, such as moclobemida, amitriptilina,
• desipramina, maprotilina, venlafaxina, and paroxetina
• zimiterol and isoprenalina, used to treat respiratory diseases
• adrenaline, used to treat severe allergic reactions
• noradrenaline, dopamine, and dobutamina, used to treat heart disease and low blood pressure
• alpha-metildopa, used to treat high blood pressure
• apomorfina, used to treat Parkinson's disease.

Certain medications may reduce the effects of Levodopa/Carbidopa/Entacapona Teva-ratiopharm.

These medications are:

• antagonists of dopamine used to treat mental disorders, nausea, and vomiting
• phenitoína, used to prevent convulsions
• papaverina, used to relax muscles.

Levodopa/Carbidopa/EntacaponaTeva may make it difficult for the body to absorb iron at the digestive level. Therefore, do not take Levodopa/Carbidopa/EntacaponaTeva at the same time as taking iron supplements. If you take one of them, wait at least 2 or 3 hours before taking the other.

Levodopa/Carbidopa/EntacaponaTeva-ratiopharmwith food and drinks

Levodopa/Carbidopa/EntacaponaTeva-ratiopharmcan be taken with or without food.

In some patients, Levodopa/Carbidopa/EntacaponaTeva-ratiopharmmay 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 taking this medicine.

Do not breastfeed your baby during treatment with Levodopa/Carbidopa/Entacapona Teva-ratiopharm.

Driving and operating machines

Levodopa/Carbidopa/EntacaponaTeva-ratiopharmmay 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/EntacaponaTeva-ratiopharmcontains lactoseand Red Allura AC (E129)

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

This medicinealso contains Red Allura AC (E129), which may cause allergic reactions.

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 people:

• Your doctor will indicate the exact number of Levodopa / Carbidopa / EntacaponaTeva-ratiopharmtablets 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 indicate that you increase or decrease the dose.
• If you are taking Levodopa/Carbidopa/EntacaponaTeva-ratiopharmtablets 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 Levodopa/Carbidopa/EntacaponaTeva-ratiopharmis too intense or too weak, or if you experience possible side effects.

If you take more Levodopa/Carbidopa/EntacaponaTeva-ratiopharm

If you have accidentally taken more Levodopa/Carbidopa/EntacaponaTeva-ratiopharmtablets than you should, speak immediately with your doctor or pharmacist or call the Toxicological Information Service (phone 915 620 420)indicatingthemedicationandtheamountingested. In case of overdose, 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/EntacaponaTeva-ratiopharm

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 take another tablet then. Then, follow your usual routine.

Always allow 1 hour to pass between Levodopa/Carbidopa/Entacapona Teva-ratiopharm tablets to avoid possible side effects.

If you interrupt treatment with Levodopa/Carbidopa/EntacaponaTeva-ratiopharm

Do not stop taking Levodopa/Carbidopa/EntacaponaTeva-ratiopharmunless your doctor tells you to. In that case, your doctor may need to adjust the dose of other Parkinson's medications, especially levodopa, so that your symptoms are adequately controlled. If you stop taking Levodopa / Carbidopa / EntacaponaTeva-ratiopharmand 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, Levodopa/Carbidopa/Entacapona Teva-ratiopharm 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 Levodopa/Carbidopa/Entacapona Teva-ratiopharm ,contact your doctor immediately:

• Severe stiffness or violent muscle contractions, tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. These 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 disorder).
• Allergic reaction characterized by signs such as hives, itching, rash, and swelling of the face, lips, tongue, or throat. This reaction may 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):

• 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 withsuicidal thoughts)
• Cardiac or arterial disorders (e.g., chest pain), irregular heart rate
• Increased falls
• Shortness of breath
• Increased sweating, rashes
• Muscle cramps, leg swelling
• Blurred vision
• Anemia
• Decreased appetite, weight loss
• Headache, joint pain
• Urinary tract infections

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

• Myocardial infarction
• Intestinal hemorrhage
• Blood cell abnormalities that may cause bleeding; liver function test abnormalities
• Seizures
• Restlessness
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Changes in skin color other than urine discoloration (e.g., skin, nails, hair, sweat)
• Dysphagia
• Inability to urinate

Unknown (cannot be estimated from available data):

Overdose on 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.

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 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 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 Healthcare Products Agency website: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.

No special storage conditions are required.

Take the tablets within the first 175 days after the first opening of the bottle.

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

Composition of Levodopa/Carbidopa/Entacapona Teva-ratiopharm

The active principles of Levodopa/Carbidopa/Entacapona Teva-ratiopharm are levodopa, carbidopa, and entacapona.

• Each Levodopa/Carbidopa/Entacapona Teva-ratiopharm 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa, and 200 mg of entacapona.
• The other components of the tablet core are microcrystalline cellulose, lactose, hydroxypropyl cellulose, povidone (K-30), anhydrous colloidal silica, and magnesium stearate.
• The coating components are titanium dioxide (E171), hypromellose, glycerol (E422), polisorbate 80, red Allura AC (E129), cochineal (E120), and magnesium stearate.

Appearance of the product and contents of the package

Levodopa/Carbidopa/Entacapona Teva-ratiopharm 100 mg/25 mg/200 mg: oblong, biconvex, pale red tablets, engraved on one face with “100”, smooth on the other face. Dimensions: approximately 17x9 mm.

Levodopa/Carbidopa/Entacapona Teva-ratiopharm is available in the following package sizes, bottles containing 10, 28, 30, 50, 60, 90, 98, 100, 130, 150, 175, 200, or 250 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma S.L.U.

C/ Anabel Segura 11.Edificio Albatros B. planta 1ª.

28108, Alcobendas. Madrid

Spain

Responsible manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

or

Teva Pharma B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

or

Merckle GmbH
Ludwig-Merckle-Strasse 3,

89143 Blaubeuren

Germany

This medicinal product is authorized in the Member States with the following names:

Last review date of this leaflet:November 2019

Other sources of information

The detailed information on this medicinal product 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 medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79022/P_79022.html