MADOPAR 200mg/50mg TABLETS

Introduction

Package Leaflet: Information for theuser

Madopar 200 mg/50 mg tablets

Levodopa / 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 signs of illness 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.

Contents of the package leaflet

1. What is Madopar and what is it used for
2. What you need to know before you take Madopar
3. How to take Madopar
4. Possible side effects
5. Storage of Madopar
6. Contents of the pack and further information

1. What is Madopar and what is it used for

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

Madopar contains two active substances, levodopa and benserazide.

Madopar 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

Do not take Madopar

• if you are allergic (hypersensitive) to levodopa or benserazide or any of the other ingredients of this medicine (listed in section 6).
• if you are taking certain medicines known as MAO inhibitors (medicines for treating depression), except for selegiline, rasagiline, and moclobemide.
• if you have narrow-angle glaucoma, 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 (personality disorder 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, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Madopar:

• if you have mild or moderate liver or kidney disorders, if you have diabetes, as you may need more frequent blood sugar checks.
• if you have open-angle glaucoma, your doctor may perform periodic checks on your intraocular pressure.
• if you have orthostatic hypotension (low blood pressure associated with changes in posture, making 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 or feel very sleepy during the day (see also section "Driving and using machines").
• if you have any other illness before starting treatment with Madopar.
• when you are going to undergo surgery soon, as it is possible that your doctor will interrupt treatment with Madopar.

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 temporary worsening of symptoms, which improve 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, which can be eliminated or reduced by reducing the dose.

Depression and suicidal thoughts may appear during treatment with Madopar, although they may also be due to your illness. If you feel depressed while taking this treatment, 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 of which are attributable to taking larger amounts of the medication.

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

Use in children

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

Use of Madopar with other medicines

Tell your doctor or pharmacist that 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 may be enhanced or weakened. Therefore, you should not take Madopar with any other medicine unless your doctor has prescribed it.

Madopar should be administered with caution with certain medicines such as:

• monoamine oxidase inhibitors (MAOIs) (used to treat depression), the combination of these medicines with Madopar may cause excessively high blood pressure. This may also occur if you have taken an MAOI in the last 2 weeks (see 'Do not take Madopar', mentioned above).
• other medicines used to treat Parkinson's disease, as they may increase side effects.
• iron sulfate (used to treat iron deficiency).
• metoclopramide and domperidone (used to treat digestive disorders).
• medicines belonging to a group called opioids (used to relieve pain), medicines for high blood pressure that contain reserpine.
• neuroleptic medicines (used to treat certain 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: the effect of these medicines may be enhanced. Your doctor may need to adjust the dose of your sympathomimetic treatment.

Madopar 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 with food and drinks

The absorption of levodopa may be delayed due to protein-rich foods.

It is recommended to take the medicine at least 30 minutes before or 1 hour after meals. Gastrointestinal side effects, which may occur mainly at the start of treatment, can be controlled by taking Madopar with a low-protein food (e.g., a biscuit) or with liquid.

Pregnancy and breastfeeding

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.

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

A pregnancy test should be performed 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.

Driving and using machines

Depending on your response to treatment, Madopar 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 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 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.

Madopar contains sodium

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

3. How to take Madopar

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

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Madopar. Do not stop treatment prematurely or abruptly, as this may cause serious side effects. Therefore, strictly follow your doctor's instructions for discontinuing treatment. Treatment with Madopar will only be carried out under the control and recommendations of your doctor.

The normal dose varies from person to person, as it depends on the symptoms of each patient and their individual response to treatment.

Treatment with Madopar usually starts with low doses, for example, a quarter of a tablet two to four times a day.

After three to seven days, your doctor may, if necessary, start increasing your dose until adequate control of your symptoms is achieved.

The maximum dose is generally no more than four tablets per day.

If you have already taken levodopa with another decarboxylase inhibitor, you should stop taking it 12 hours before starting to take Madopar.

The change from levodopa to Madopar can be made from one day to the next according to the following scheme: Madopar 200 mg/50 mg will be prescribed, ½ tablet less than half of the tablets or capsules of 500 mg of levodopa that the patient was taking per day.

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

It may take several weeks for the full effect of your medicine to become apparent.

It is recommended to take Madopar half an hour before or one hour after meals. In case of gastrointestinal discomfort, it is recommended to take it with some food or liquid.

If you take more Madopar than you should

If you have taken more Madopar than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone: 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 may occur.

If you forget to take Madopar

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

Take the next dose as usual.

If you stop taking Madopar

Treatment with Madopar should not be stopped abruptly, as this may cause serious side effects. Therefore, strictly follow your doctor's instructions for discontinuing treatment.

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 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:

• 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 (sleepiness),
• 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 can disappear if the daily dose is changed or if the duration of the doses is improved throughout the day.

** These side effects usually occur at the start of treatment and can normally be controlled by taking Madopar 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 of pathological gambling, increased sexual desire, and excessive sexual desire, compulsive shopping, eating compulsively, have been reported, which are generally 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 via 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

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

Do not store above 30°C. Keep the container tightly closed to protect it from moisture.

Store in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Madopar 200 mg/50 mg tablets

• The active substances are levodopa and benserazide (as hydrochloride). Each tablet contains 200 mg of levodopa and 50 mg of benserazide (as hydrochloride).
• The other ingredients are mannitol, calcium phosphate dibasic, microcrystalline cellulose, pregelatinized starch (from corn), povidone, magnesium stearate, ethylcellulose, red iron oxide (E-172), silicic acid, dioctyl sulfosuccinate, and sodium.

Appearance of the product and pack contents

Madopar is available in a bottle of 100 tablets.

The tablets are pale red, slightly speckled, cylindrical, and biconvex, with the inscription "ROCHE" and a hexagon on one side and with break lines on both sides (scored).

Marketing authorization holder and manufacturer

Marketing authorization holder

ROCHE FARMA, S.A.

Ribera del Loira, 50

28042 Madrid

Manufacturer:

Roche Farma, S.A.

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/