LEVODOPA/CARBIDOPA/ENTACAPONA ABDI 200 mg/50 mg/200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levodopa/Carbidopa/Entacapone Abdi 200 mg/50 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, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Levodopa/Carbidopa/Entacapone Abdi and what is it used for
2. What you need to know before taking Levodopa/Carbidopa/Entacapone Abdi
3. How to take Levodopa/Carbidopa/Entacapone Abdi
4. Possible side effects

1. Storage of Levodopa/Carbidopa/Entacapone Abdi
2. Contents of the pack and further information

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

This medicine contains three active substances (levodopa, carbidopa, and entacapone) in one film-coated tablet. This medicine 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 anti-Parkinsonian effects of levodopa.

2. What you need to know before taking Levodopa/Carbidopa/Entacapone Abdi

Do not take Levodopa/Carbidopa/Entacapone Abdi 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 (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 muscle disorder)
• you have severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Levodopa/Carbidopa/Entacapone Abdi 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 your dose may need to be adjusted
• any kidney disease or hormone-related disease
• stomach ulcers or convulsions
• 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 this medicine may worsen these reactions.

Talk to your doctor if, during treatment with Levodopa/Carbidopa/Entacapone Abdi, you:

• notice great stiffness in the muscles or violent muscle 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
• notice that you fall asleep suddenly, or feel very drowsy. If this happens to you, do not drive or operate 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
• experience diarrhea; it is recommended to monitor your weight to avoid excessive weight loss
• experience 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 this medication; consult the section "If you stop taking Levodopa/Carbidopa/Entacapone Abdi".

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 Stalevo and other medicines used to treat Parkinson's disease.

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 this medicine 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, 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.

During prolonged treatment with this medicine, your doctor may perform regular blood tests.

If you need to undergo surgery, tell your doctor that you are taking this medicine.

This medicine 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 this medicine in patients under 18 years of age is limited. Therefore, its administration is not recommended in children or adolescents.

Taking Levodopa/Carbidopa/Entacapone Abdi with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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).

This medicine 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 this medicine. These medicines are:

• dopamine antagonists used to treat mental disorders, nausea, and vomiting
• phenytoin, used to prevent convulsions
• papaverine, used to relax muscles.

This medicine may interfere with the absorption of iron in the gut. Therefore, do not take this medicine at 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/Entacapone Abdi with food and drinks

• This medicine can be taken with or without food.
• It is possible that in some patients this medicine may not be absorbed well if taken with protein-rich foods (meat, fish, dairy products, cereals, and nuts) or shortly after eating them.

Talk to 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not breastfeed your child during treatment with this medicine.

Driving and using machines

This medicine may lower your blood pressure, which can cause dizziness or fainting. Therefore, be careful when operating tools or machinery.

If you feel very tired or notice that you fall asleep suddenly, 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 Abdi contains lactose and sodium

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

3. How to take Levodopa/Carbidopa/Entacapone Abdi

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 the elderly

• Your doctor will tell you the exact number of Levodopa/Carbidopa/Entacapone Abdi tablets to take each day.
• The tablets must 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.
• 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 any side effects.

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

If you have accidentally taken more tablets of this medicine than you should, talk to your doctor or pharmacist immediately. 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Levodopa/Carbidopa/Entacapone Abdi

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 tablets of this medicine to avoid possible side effects.

If you stop taking Levodopa/Carbidopa/Entacapone Abdi

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 medicines, especially levodopa, to ensure sufficient control of your symptoms. If you stop taking this medicine 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, 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 this medicine, contact your doctor immediately:

• great 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 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)
• brownish 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 Parkinson's disease 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 other than those of urine (e.g., skin, nails, hair, sweat)
• difficulty swallowing
• inability to urinate

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

Dopamine dysregulation syndrome, characterized by an excessive desire for high doses of this medicine beyond what is required to control motor symptoms. Some patients experience severe abnormal involuntary movements (dyskinesias), mood changes, or other side effects after taking high doses of this medicine.

The following side effects have also been reported:

• hepatitis (inflammation of the liver)
• itching

You may experience the following side effects:

• Inability to resist the impulse to perform an action that could be harmful, and which could include:
• • a strong impulse to gamble excessively despite severe personal or family consequences
  • an increased or altered sexual interest and behavior that is troubling to 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, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levodopa/Carbidopa/Entacapone Abdi

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

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

Store at a temperature below 30°C.

Store in the original package and keep the bottle tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Levodopa/Carbidopa/Entacapone Abdi

• The active substances of this medicine are levodopa, carbidopa, and entacapone.
• Each tablet contains 200 mg of levodopa, 50 mg of carbidopa anhydrous (equivalent to 54 mg of carbidopa monohydrate) and 200 mg of entacapone.
• The other ingredients of the tablet core are Croscarmellose sodium E 468, Magnesium stearate E 470b, Microcrystalline cellulose E 460, Poloxamer 188, Hydroxypropylcellulose E 463, Lactose monohydrate.
• The ingredients of the film coating of the tablets are

Hypromellose type 2910

Titanium dioxide E 171

Glycerol E 422

Red iron oxide E 172

Yellow iron oxide E 172

Magnesium stearate E 470b

Polysorbate 80 E 433

Hydroxypropylcellulose E 463

Appearance of the product and packaging contents

Oval biconvex film-coated tablets, dark reddish-brown in color with "200" engraved on one face of the tablet and the other face flat. Size: 14.6 mm x 9.7 mm

There are three different packaging sizes (of 30, 100, or 175 film-coated tablets) for this medication. The packages consist of HDPE bottles with an aluminum induction seal and a container as a loose component in the bottle containing silica gel. The HDPE bottle is packed in an external cardboard box.

Only some packaging sizes may be marketed.

Marketing authorization holder

Abdi Farma GmbH

Donnersbergstraße 4,

64646 Heppenheim

Germany

Manufacturer

Pharmadox Healthcare Limited

Kkw46 Kordin Industrial Park,

Paola, PLA 3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Spain:

Xentenel Pharma Europe, S.L.

Camí Can Camps, 17

Vallsolana Garden Business Park

08174 Sant Cugat del Vallés (Barcelona)

Spain

Date of the last revision of this prospectus:August 2024

Other sources of information

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