LEVODOPA/CARBIDOPA/ENTACAPONA TEVA-RATIOPHARM 100/25/200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levodopa/Carbidopa/EntacaponeTeva-ratiopharm100 mg/25 mg/200 mg film-coated tablets EFG

Levodopa/Carbidopa/Entacapone

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Levodopa/Carbidopa/Entacapone Teva-ratiopharm and what is it used for 2. What you need to know before taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm
2. How to take Levodopa/Carbidopa/Entacapone Teva-ratiopharm
3. Possible side effects
4. Storage of Levodopa/Carbidopa/Entacapone Teva-ratiopharm
5. Package contents and further information

1. What is Levodopa/Carbidopa/Entacapone Teva-ratiopharm and what is it used for

Levodopa/Carbidopa/Entacapone Teva-ratiopharm contains three active substances (levodopa, carbidopa, and entacapone) in one film-coated tablet. Levodopa/Carbidopa/Entacapone Teva-ratiopharm 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 thus reduces the symptoms of Parkinson's disease. Carbidopa and entacapone improve the antiparkinsonian effects of levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm

Do not take Levodopa/Carbidopa/EntacaponeTeva-ratiopharm

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

of this medicine (including those listed in section 6)

• if you have narrow-angle glaucoma (a condition of the eye).
• if you have a tumor of the adrenal gland.
• if you are taking certain medicines for depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
• if you have ever had neuroleptic malignant syndrome (NMS - a rare reaction to medicines used to treat severe mental disorders).
• if you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder).
• if you have severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Levodopa/Carbidopa/Entacapone Teva-ratiopharm if you have or have had:

• A heart attack or any other heart disease, including arrhythmias, or blood vessel disease.
• Asthma or any other lung disease.
• A liver problem, as you may need to have your dose adjusted.
• Any kidney disease or hormone-related disease.
• Stomach ulcers or seizures
• Prolonged diarrhea. Talk to 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.

Talk to 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 Teva-ratiopharm may worsen these reactions.

Talk to your doctor if, during treatment with Levodopa/Carbidopa/Entacapone Teva-ratiopharm, you:

• Notice great stiffness in the muscles or violent contractions, 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.
• Feel suddenly sleepy, 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").
• Start to notice uncontrolled movements or if they worsen. If this happens, your doctor may need to adjust your medication dose.
• Suffer from diarrhea; it is recommended to monitor your weight to avoid excessive weight loss.
• 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.
• Consider stopping treatment with Levodopa/Carbidopa/Entacapone Teva-ratiopharm; consult the section "If you stop taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm".

Tell your doctor if you, or your family member/caregiver, notice that you are developing symptoms similar to addiction, leading to a desire for high doses of Levodopa/Carbidopa/Entacapone and other medicines used to treat Parkinson's disease.

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, food, or excessive spending, and abnormally increased sexual drive or concern with an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.

During prolonged treatment with Levodopa/Carbidopa/Entacapone Teva-ratiopharm, your doctor may perform regular blood tests.

If you need to undergo surgery, tell your doctor that you are taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm.

Levodopa/Carbidopa/Entacapone Teva-ratiopharm is not recommended for the treatment of extrapyramidal symptoms (e.g., involuntary movements, agitation, muscle stiffness, and muscle contractions) caused by other medicines.

Children and adolescents

Experience with the use of Levodopa/Carbidopa/Entacapone Teva-ratiopharm in patients under 18 years of age is limited. Therefore, the administration of Levodopa/Carbidopa/Entacapone Teva-ratiopharm is not recommended in children.

Taking Levodopa/Carbidopa/EntacaponeTeva-ratiopharm 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 Teva-ratiopharm 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 Teva-ratiopharm 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
• Zimiterol 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 Teva-ratiopharm.

These medicines are:

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

Levodopa/Carbidopa/Entacapone Teva-ratiopharm may interfere with the absorption of iron in the gut. Therefore, do not take Levodopa/Carbidopa/Entacapone Teva-ratiopharm at the same time as taking iron supplements. If you take any of them, you should wait at least 2 or 3 hours before taking the other.

Taking Levodopa/Carbidopa/EntacaponeTeva-ratiopharm with food and drinks

Levodopa/Carbidopa/Entacapone Teva-ratiopharm can be taken with or without food.

It is possible that in some patients Levodopa/Carbidopa/Entacapone Teva-ratiopharm may not be absorbed well if taken with protein-rich foods (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 Teva-ratiopharm.

Driving and using machines

Levodopa/Carbidopa/Entacapone Teva-ratiopharm 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/EntacaponeTeva-ratiopharm contains lactoseand Red Allura AC (E129)

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

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

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults and elderly:

• Your doctor will tell you the exact number of Levodopa/Carbidopa/Entacapone Teva-ratiopharm tablets to take each 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 tell you to increase or decrease the dose.
• If you are taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm 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 tablets, do not take more than 10 tablets per day.

Talk to your doctor or pharmacist if you think the effect of Levodopa/Carbidopa/Entacapone Teva-ratiopharm is too strong or too weak, or if you experience any side effects.

If you take more Levodopa/Carbidopa/EntacaponeTeva-ratiopharm than you should

If you have accidentally taken more Levodopa/Carbidopa/Entacapone Teva-ratiopharm tablets than you should, talk to your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 915 620 420) 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/EntacaponeTeva-ratiopharm

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

If it is more than 1 hour until the 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 the 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 Teva-ratiopharm tablets to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/EntacaponeTeva-ratiopharm

Do not stop taking Levodopa/Carbidopa/Entacapone Teva-ratiopharm 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 Teva-ratiopharm and other Parkinson's medicines abruptly, you may experience unwanted side effects.

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

4. Possible side effects

Like all medicines, Levodopa/Carbidopa/Entacapone Teva-ratiopharm can cause side effects, although not everybody gets them. Many can be relieved by adjusting the dose.

If you experience any of these symptoms during treatment with Levodopa/Carbidopa/Entacapone Teva-ratiopharm, contact your doctor immediately:

• Great stiffness or violent contractions of the muscles, 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).
• An 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

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

• Fainting or fainting due to low blood pressure, high blood pressure
• Worsening of Parkinson's symptoms, dizziness, drowsiness
• 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)
• Heart or blood vessel disorders (e.g., chest pain), irregular heartbeats
• Frequent falls
• Shortness of breath
• Increased sweating, rash
• Muscle cramps, swelling of the legs
• Blurred vision
• Anemia
• Decreased appetite, weight loss
• Headache, joint pain
• Urinary tract infections

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

• Heart attack
• Intestinal bleeding
• Changes in blood cell counts that can cause bleeding; abnormalities in liver function tests
• Seizures
• Feeling agitated
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Color changes other than those of urine (e.g., skin, nails, hair, sweat)
• Difficulty swallowing
• Urination problems

Rare (cannot be estimated from the available data):

Dopamine dysregulation syndrome, characterized by an intense desire to take high doses of levodopa/carbidopa/entacapone that exceed those required to control motor symptoms. Some patients experience severe abnormal involuntary movements (dyskinesias), mood changes, or other side effects after taking high doses of levodopa/carbidopa/entacapone.

The following side effects have also been reported:

• Hepatitis (inflammation of the liver)
• Itching

You may experience the following side effects:

• Failure to resist the impulse to perform an action that could be harmful, which may include:

• A strong impulse to gamble excessively despite severe personal or family consequences;
• An increase or alteration in sexual interest and behavior that is bothersome to you or others, such as 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 side effects

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

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

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 CAD. The expiry 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 via wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levodopa/Carbidopa/Entacapona Teva-ratiopharm

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

• 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 entacapone.
• The other ingredients of the tablet core are microcrystalline cellulose, lactose, hydroxypropylcellulose, povidone (K-30), colloidal anhydrous silica, and magnesium stearate.
• The coating ingredients are titanium dioxide (E171), hypromellose, glycerol (E422), polysorbate 80, Allura Red AC (E129), cochineal (E120), and magnesium stearate.

Appearance of the Product and Package Contents

Levodopa/Carbidopa/Entacapona Teva-ratiopharm 100 mg/25 mg/200 mg: oblong, biconvex tablets, pale red in color, engraved on one side with "100", smooth on the other side. Dimensions: approx. 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 Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura 11. Edificio Albatros B. 1st floor.

28108, Alcobendas. Madrid

Spain

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 medicine is authorized in the Member States under the following names:

Date of the Last Revision of this Leaflet:November 2019

Other Sources of Information

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79022/P_79022.html