MADOPAR RETARD 100/25 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Madopar Retard 100 mg/25 mg prolonged-release hard capsulesLevodopa / Benserazide

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 further questions, ask your doctor or pharmacist.-This medicine has been prescribed for you only. Do not pass it on to others. 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 leaflet. See section 4.

1. What is Madopar Retard and what is it used for

Madopar Retard is indicated for the treatment of Parkinson's disease

Madopar Retard contains two active substances, levodopa and benserazide.

Madopar Retard works as follows:

• In your body, levodopa is converted into dopamine. Dopamine is the active substance that your brain needs to treat Parkinson's disease.
• Benserazide allows more of the administered levodopa to reach your brain before it is converted into dopamine.

2. What you need to know before you take Madopar Retard

Do not take Madopar Retard:

• if you are allergic (hypersensitive) to levodopa or benserazide or any of the other components of this medicine (listed in section 6).

• if you are taking non-selective monoamine oxidase (MAO) inhibitors (medicines for treating depression) or combinations of selective MAO-A and MAO-B inhibitors.

• if you have narrow-angle glaucoma (a disease that affects the eyes), high pressure in the eye.

• if you have severe endocrine disorders: pheochromocytoma (a tumor of the adrenal gland that causes hypertension), hyperthyroidism (overactive thyroid gland), Cushing's syndrome (excess cortisol hormone).

• if you have severe kidney, liver, or heart disorders.

• if you have severe psychiatric disorders with a psychotic component (alteration of personality and loss of contact with reality).

• if you are under 25 years old.

• if you are pregnant or breastfeeding.

• if you become pregnant during treatment with Madopar Retard, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Madopar Retard:

• if you have mild or moderate liver or kidney disorders
• if you have diabetes (a disease in which blood glucose levels are very high), as you may need more frequent glucose checks
• if you have open-angle glaucoma (a disease that affects the eyes), your doctor may perform periodic checks on your intraocular pressure
• if you have orthostatic hypotension (low blood pressure associated with changes in posture, which makes you feel dizzy)
• if you have ever had a heart attack or heart problems, your cardiac function will be monitored at the start of treatment and periodically throughout treatment
• when you notice that you sometimes fall asleep suddenly during the day or feel very sleepy (see also section "Driving and using machines").
• if you have any other illness before starting treatment with Madopar Retard
• when you are going to undergo surgery soon, as your doctor may interrupt treatment with Madopar Retard.

When you start treatment, you may be asked to have blood tests to check liver function and other blood disorders.

It is possible that at the start of treatment, you may experience a transient worsening of symptoms, which improves with the correct adjustment of the dose.

This medicine may alter the results of certain laboratory tests.

Before starting treatment and during treatment, periodic skin examinations should be performed.

After prolonged treatment, involuntary movements may occur, episodes of blockage that can be eliminated or reduced by reducing the dose.

Depression and suicidal thoughts may appear during treatment with Madopar Retard, although they can also be due to your illness. If you feel depressed while being treated, you should contact your doctor.

In some patients treated with medicines for Parkinson's disease, cases of pathological gambling, increased sexual desire, and excessive sexual desire, compulsive shopping, overeating, or compulsive eating have been reported, all attributable to taking larger amounts of the medication.

You should continue your treatment, as long as your doctor indicates. Stopping suddenly could cause potentially life-threatening side effects (see section 3).

Children and adolescents:

Madopar Retard should not be administered to children or adolescents under 25 years old.

Using Madopar Retard with other medicines

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

This is extremely important because when taking more than one medicine at the same time, the effect of Madopar Retard may be enhanced or weakened. Therefore, you should not take Madopar Retard with any other medicine unless your doctor has prescribed it.

Madopar Retard should be used with caution in combination with certain medicines such as:

• monoamine oxidase (MAO) inhibitors (used to treat depression), the combination of these medicines with Madopar Retard may cause excessively high blood pressure. This could also occur if you have taken an MAO inhibitor in the last 2 weeks (see 'Do not take Madopar Retard', mentioned above).
• other medicines used to treat Parkinson's disease, as they may increase adverse effects.
• iron sulfate (used to treat iron deficiency)
• antacids
• metoclopramide and domperidone (used to treat digestive disorders).
• medicines belonging to a group called opiates (used to relieve pain).
• medicines for high blood pressure that contain reserpine.

• neuroleptic medicines (used to treat some psychiatric disorders, including anxiety and severe schizophrenia, nausea, dizziness, and hypotension).
• antipsychotic medicines
• it is recommended to adjust the dose of levodopa when administered with antidepressant medicines.
• medicines for the treatment of high blood pressure: your blood pressure may become too low. Your doctor may need to adjust the dose of your high blood pressure treatment.
• medicines belonging to a group called sympathomimetics, such as epinephrine, norepinephrine, isoproterenol, amphetamines, should not be used at the same time as Madopar Retard: the effect of these medicines may be enhanced. Your doctor may need to adjust the dose of your sympathomimetic treatment.

Madopar Retard may interfere with the results of tests for certain chemical levels in the blood. Urine analysis results may give false positives for ketone bodies.

Taking Madopar Retard with food and drinks:

The absorption of levodopa may be delayed due to foods with high protein content. It is recommended to take the medicine at least 30 minutes before or 1 hour after meals. Gastrointestinal adverse effects, which may occur mainly at the start of treatment, can be controlled by taking Madopar Retard with a low-protein food (e.g., a cookie) or with liquid.

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.

Madopar Retard should not be taken during pregnancy. There is a possibility of producing skeletal malformations in the fetus.

A pregnancy test is recommended before treatment to rule out pregnancy.

If you are of childbearing age, you should use reliable contraceptive methods. If you become pregnant while taking this medicine, you should stop treatment immediately.

You should not breastfeed during treatment with Madopar Retard. There is a possibility of producing skeletal malformations in the child.

Driving and using machines

Depending on your response to treatment, Madopar Retard may affect your ability to drive or operate machinery. Therefore, it should be used with caution until you know how you react to this treatment.

Madopar Retard may cause drowsiness (excessive sleepiness) and sudden episodes of sleep. Therefore, if you feel very sleepy or notice that you sometimes fall asleep suddenly, wait until you feel fully awake again before driving or doing anything that requires you to be alert. If you do not, you may put yourself and others at risk of serious injury or even death.

3. How to take Madopar Retard

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Remember to take your medicine.

Treatment with Madopar Retard will be carried out only under the control and recommendations of your doctor.

The recommended dose varies from person to person, as it depends on the symptoms of each patient and their individual response to treatment. Treatment with Madopar Retard usually replaces previous treatment with levodopa, which the doctor will change and gradually increase as they check the evolution of your response. The substitution ratio is as follows:

For every 100 mg of levodopa you were taking, you will now take one Madopar Retard 100mg/25mg capsule.

It is possible that at the start of treatment, you may experience a transient worsening of symptoms, which improves with the correct adjustment of the dose.

The Madopar Retard capsules should be swallowed whole and not chewed. Madopar Retard can be taken with or without food.

It is recommended to take Madopar Retard 30 minutes before or 1 hour after meals. In case of gastrointestinal disorders, it is recommended to take the capsules with some food or liquid.

Your doctor will indicate the duration of treatment with Madopar Retard.If you take more Madopar Retard than you should:

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562.04.20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

In case of overdose, involuntary movements, confusion, and insomnia may appear. Less frequently, nausea, vomiting, or cardiac arrhythmias (disorder of the heartbeat rhythm) may occur.If you forget to take Madopar Retard:

Do not take a double dose to make up for forgotten doses. Take the next dose as usual.

If you stop taking Madopar Retard:

Treatment with Madopar Retard should not be stopped abruptly, as it may cause serious adverse effects.

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

4. Possible side effects

Like all medicines, Madopar Retard can cause side effects, although not everybody gets them.

Side effects of unknown frequency (cannot be estimated from the available data) that may occur during treatment with Madopar Retard:

• fluctuations in response such as "blockage" (sudden difficulty moving), "end of dose" (return of symptoms before the next dose), and "on-off" phenomena (sudden changes from periods of good control of symptoms to periods where symptoms are less controlled) *
• distorted or affected voluntary movements (dyskinesia)
• involuntary movements *
• hallucinations, especially in the elderly
• disorientation in time, especially in the elderly
• allergic skin reactions such as itching and rash
• orthostatic hypotension
• decrease in red blood cell, white blood cell, or platelet count (hemolytic anemia, leucopenia, or thrombocytopenia)
• liver enzyme alterations (increased transaminases and alkaline phosphatase)
• agitation, especially in the elderly
• anxiety, especially in the elderly
• sleep disorders, especially in the elderly
• delirium, especially in the elderly
• loss of appetite
• excessive daytime sleepiness (sleep)
• sudden episodes of sleep
• abnormal heart rhythm
• decrease in blood pressure, which improves with dose reduction
• restless legs syndrome
• depression **
• taste alterations or loss **
• nausea **
• vomiting **
• diarrhea **
• urine discoloration, usually reddish in color. Other body fluids may also be discolored, such as saliva, tongue, teeth, or oral mucosa.
• mild euphoria
• aggression
• dopamine dysregulation syndrome: cognitive and behavioral disorders, pathological gambling (ludopathy), increased sexual desire, compulsive shopping, overeating
• digestive disorders: discoloration in saliva, tongue, teeth, and oral mucosa
• increased blood urea levels
• flushing and sweating
• eating disorders, anorexia

• In the later stages of treatment, and in many cases after the medicine has been taken for many years, unusual, uncontrollable movements of the arms, legs, face, and tongue or fluctuations in response may occur. This may disappear if the daily dose is changed or if the extension of the doses throughout the day is improved.

** These side effects usually occur at the start of treatment and can usually be controlled by taking Madopar Retard with food or drink and increasing the dose more slowly.

In patients treated with dopaminergic agonists for the treatment of Parkinson's disease, including levodopa, especially at high doses, cases with signs of pathological gambling, increased sexual desire, and excessive sexual desire, compulsive shopping, overeating, have been reported, usually reversible after dose reduction or treatment discontinuation.

If you experience any side effect that you think is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Madopar Retard

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

Do not store above 30°C.

Store in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Madopar Retard:

The active substances are: levodopa and benserazide (as hydrochloride). Each capsule contains 100 mg of levodopa and 25 mg of benserazide (as hydrochloride).

The other ingredients are:

Capsule content: hypromellose, hydrogenated vegetable oil, calcium phosphate dibasic anhydrous, mannitol (E-421), povidone, talc, and magnesium stearate.

Capsule shell: gelatin, carmine indigo (E-132), yellow iron oxide (E-172), titanium dioxide (E-171)

Appearance and packaging of the product:

Madopar Retard is available in packs of 100 prolonged-release hard capsules

Marketing authorisation holder and manufacturer:

Marketing authorisation holder: ROCHE FARMA, S.A., C/ Ribera del Loira, 50, 28042 Madrid

Manufacturer: Roche Farma, S.A., C/ Eratóstenes, 19, Getafe, 28906 Madrid

Date of last revision of this leaflet:

September 2023

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