Levodopa/carbidopa/entacapone CINFA 125 mg/31.25 mg/200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levodopa/Carbidopa/Entacapone cinfa 125 mg/31.25 mg/200 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Levodopa/Carbidopa/Entacapone cinfa is and what it is used for
2. What you need to know before taking Levodopa/Carbidopa/Entacapone cinfa
3. How to take Levodopa/Carbidopa/Entacapone cinfa
4. Possible side effects
5. How to store Levodopa/Carbidopa/Entacapone cinfa
6. Contents of the pack and other information

1. What Levodopa/Carbidopa/Entacapone cinfa is and what it is used for

This medicine contains three active substances (levodopa, carbidopa and entacapone) in a film-coated tablet. Levodopa/Carbidopa/Entacapone is used to treat Parkinson's disease.

Parkinson's disease is caused by low brain levels of a substance called dopamine. Levodopa increases the amount of dopamine and thereby reduces the symptoms of Parkinson's disease. Carbidopa and entacapone enhance the anti-Parkinson effects of levodopa.

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

Do not take Levodopa/Carbidopa/Entacapona cinfa if

• you are allergic to levodopa, carbidopa or entacapone, or to any of the other ingredients of this medicine (listed in section 6).
• you have narrow-angle glaucoma (an eye disorder).
• you have a tumour of the adrenal glands.
• 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 serious mental disorders).
• you have ever had non-traumatic rhabdomyolysis (a rare muscle disorder).
• you have severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Levodopa/Carbidopa/Entacapona cinfa.

If you have or have ever had:

• a heart attack or any other heart or blood vessel disease, including arrhythmias.
• asthma or any other lung disease.
• any liver problems, as your dose may need to be adjusted.
• any kidney disease or hormone-related disorder.
• stomach ulcer or seizures.
• prolonged diarrhoea. Consult your doctor, as this may be a sign of inflammation of the colon.
• any form of serious 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 sitting or lying down. Be aware that Levodopa/Carbidopa/Entacapona may worsen these reactions.

Talk to your doctor if, during treatment with Levodopa/Carbidopa/Entacapona:

• you notice severe muscle stiffness or violent muscle contractions, or if you develop tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. If any of these occur, contact your doctor immediately.
• you feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour.
• you suddenly fall asleep or feel very sleepy. If this happens, you must not drive or operate tools or machinery (see also section “Driving and use of machines”).
• you start to notice uncontrolled movements or they worsen. If this occurs, your doctor may need to change your dose.
• you experience diarrhoea; weight should be monitored to avoid excessive weight loss.
• you experience progressive loss of appetite, asthenia (weakness, exhaustion), and weight loss over a relatively short period. In such cases, a full medical evaluation including liver function tests should be considered.
• you are considering stopping this medicine; refer to the section "If you stop taking Levodopa/Carbidopa/Entacapona cinfa".

Inform your doctor if you or your family/carer notice that you are developing urges or a tendency to behave in a way that is unusual for you or that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm you or others. These behaviours are called impulse control disorders and may include gambling addiction, binge eating, compulsive spending, or abnormally increased sexual drive or preoccupation with increased sexual thoughts or feelings. Your doctor may need to review your treatment.

Inform your doctor if you or your family/carer notice that you are developing addiction-like symptoms, leading to a desire for high doses of levodopa/carbidopa/entacapone and other medicines used to treat Parkinson's disease.

During long-term treatment with Levodopa/Carbidopa/Entacapona, your doctor may carry out regular blood tests.

If you are undergoing surgery, you must inform your doctor that you are taking this medicine.

Levodopa/Carbidopa/Entacapona is not recommended for the treatment of extrapyramidal symptoms (e.g. involuntary movements, restlessness, muscle rigidity, and muscle contractions) caused by other medicines.

Children and adolescents

Experience with the use of Levodopa/Carbidopa/Entacapona in patients under 18 years of age is limited. Therefore, administration in children or adolescents is not recommended.

Other medicines and Levodopa/Carbidopa/Entacapona cinfa

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

Do not take this medicine if you are taking certain medicines for depression (combinations of selective 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 medicines. These include:

• medicines used to treat depression, such as moclobemide, amitriptiline, 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 conditions 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/Entacapona. 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/Entacapona may interfere with the gastrointestinal absorption of iron. Therefore, you should not take Levodopa/Carbidopa/Entacapona at the same time as iron supplements. If you take either, you should wait at least 2 to 3 hours between taking them.

Taking Levodopa/Carbidopa/Entacapona cinfa with food and drink

This medicine 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 eating them.

Consult your doctor if you think this applies to you.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not breastfeed while taking this medicine.

Driving and use of machines

Levodopa/Carbidopa/Entacapona may cause drowsiness and sudden episodes of sleep. If this happens, you must not drive or perform activities where lack of attention could result in death or serious harm to yourself or others (e.g. operating machinery), until these episodes and/or drowsiness have resolved.

Levodopa/Carbidopa/Entacapona cinfa 125 mg/31.25 mg/200 mg contains lactose

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

3. How to take Levodopa/Carbidopa/Entacapone cinfa

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults and elderly patients:

• Your doctor will tell you the exact number of Levodopa/Carbidopa/Entacapone tablets you should take each day.
• The tablets must not be split or divided into smaller pieces.
• Take only one tablet at a time.
• Depending on your response to treatment, your doctor may instruct you to increase or decrease the dose.
• If you are taking Levodopa/Carbidopa/Entacapone 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.

Talk to your doctor or pharmacist if you think the effect of this medicine is too strong or too weak, or if you experience possible adverse effects.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

You may feel dizzy or agitated, your heart rate may be slower or faster than normal, or you may notice changes in the color of your skin, tongue, eyes, or urine.

If you forget to take Levodopa/Carbidopa/Entacapone cinfa

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

If more than 1 hour remains until the next dose:

Take one tablet as soon as you remember, then take the next one at the usual time.

If less than 1 hour remains until the next dose:

Take one tablet as soon as you remember, wait 1 hour, and then take another tablet. After that, continue as usual.

There must always be at least 1 hour between doses of this medicine to avoid possible adverse effects.

If you stop taking Levodopa/Carbidopa/Entacapone cinfa

Do not stop taking this medicine unless your doctor tells you to. In that case, your doctor may need to adjust the dose of your other Parkinson's medications, especially levodopa, to ensure adequate symptom control.

If you abruptly stop taking Levodopa/Carbidopa/Entacapone and other Parkinson's medications, you may experience unwanted adverse effects.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Many of these can be relieved by adjusting the dose.

If you experience any of the following symptoms during treatment with this medicine, contact your doctor immediately:

• Severe muscle stiffness or violent muscle contractions, tremors, agitation, confusion, fever, rapid pulse, or large fluctuations in blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS, a rare, serious reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare and serious muscle disorder).
• Allergic reaction characterized by signs such as hives, itching, rash, or 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):

• Uncontrollable movements (dyskinesias)
• Feeling unwell (nausea)
• Harmless brownish-red discoloration of the urine
• Muscle pain
• Diarrhea
• Urinary tract infections

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

• Fainting or collapse due to low blood pressure, hypertension
• Worsening of parkinsonism symptoms, dizziness, drowsiness
• Vomiting; abdominal pain and discomfort; heartburn; dry mouth; constipation
• Inability to sleep; hallucinations; confusion; abnormal dreams (including nightmares); fatigue
• Changes in mental state, including memory problems, anxiety, and depression (possibly with suicidal thoughts)
• Heart or artery problems (e.g., chest pain), irregular heartbeat
• More frequent falls
• Labored breathing
• Increased sweating, rashes
• Muscle cramps, swelling of the legs
• Blurred vision
• Anaemia
• 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 may lead to bleeding and abnormalities in liver function tests
• Seizures
• Feeling of restlessness
• Psychotic symptoms
• Colitis (inflammation of the colon)
• Changes in pigmentation other than in urine (e.g., skin, nails, hair, sweat)
• Difficulty swallowing
• Inability to urinate

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

A desire for high doses of Levodopa/Carbidopa/Entacapone exceeding those required to control motor symptoms, known as dopamine dysregulation syndrome.

Some patients experience severe abnormal involuntary movements (dyskinesias), mood changes, or other adverse 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 carry out an action that could be harmful, which may include:

• A strong urge to gamble excessively despite serious personal or family consequences
• Increased or altered interest in sex and behaviour that is concerning to you or others, such as increased sexual urges
• Excessive or uncontrolled shopping or spending
• Overeating (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 behaviours; they will discuss how to manage or reduce these symptoms.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levodopa/Carbidopa/Entacapone cinfa

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Discard the product 175 days after opening the container.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levodopa/Carbidopa/Entacapone cinfa

• The active substances are levodopa, carbidopa and entacapone. Each coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
• The other components are: microcrystalline cellulose, anhydrous lactose, hydroxypropylcellulose, povidone (E-1201), colloidal anhydrous 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 medicinal product and contents of the pack

Round, biconvex tablets, yellowish-brown in colour, without a breakline.

Levodopa/Carbidopa/Entacapone cinfa 125 mg/31.25 mg/200 mg is available in HDPE bottles with a child-resistant PP closure, in pack sizes of 100 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Teva Pharmaceutical

Works Private

Pallagi út 13, 4042

Debrecen

Hungary

Or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: October 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79646/P_79646.html

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