Prospect: information for theuser

Madopar 200 mg/50 mg tablets

Levodopa / Benserazida

Read this prospect carefully before starting to take this medication, because it contains important information for you.

-Keep this prospect, as you may need to read it again.
-If you have any doubts, consult your doctor, or pharmacist.

-This medication has been prescribed only to you, and you should not give it to other peopleeven if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor, or pharmacist, even if they do not appear in this prospect. See section 4.

1.What isMadopar and for what it is used

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

3.How to take Madopar

4.Possible adverse effects

5.Storage of Madopar

6.Contents of the package and additional information

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

Madopar contains two active principles, levodopa and benserazide.

Madopar acts as follows:

• In your body, levodopa is transformed into dopamine. Dopamine is the active principle that your brain needs to treat Parkinson's disease.
• Benserazide allows more levodopa to reach your brain than the amount administered, before levodopa is transformed into dopamine.

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 monoamine oxidase inhibitors (MAOIs), except for selegiline, rasagiline, and moclobemide.
• if you have closed-angle glaucoma, high eye pressure.
• if you have severe endocrine disorders: phaeochromocytoma (a tumor of the adrenal gland that causes high blood pressure), hyperthyroidism (an overactive thyroid gland), Cushing's syndrome (excess cortisol hormone).
• if you have severe kidney, liver, or heart problems.
• 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, 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 problemsif you have diabetes, as you may need more frequent blood sugar checks
• if you have open-angle glaucoma, your doctor may perform regular eye pressure checks
• 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 heart function will be monitored at the start of treatment and periodically during treatment.
• if you notice that you fall asleep suddenly or feel very drowsy during the day (see also section "Driving and operating machinery").
• if you have any other illnessbefore starting treatment with Madopar
• if you are about to undergo surgery, as your doctor may interrupt treatment with Madopar.

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

You may experience a temporary worsening of symptoms at the start of treatment, which improves with the correct adjustment of the dose.

This medicine may affect the results of certain blood tests.

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

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

Depression and suicidal thoughts may occur during treatment with Madopar, although they may also be due to your illness. If you feel depressed while on treatment, contact your doctor.

In some patients treated with Parkinson's disease medicines, cases of pathological gambling, increased sex drive, and excessive sex drive have been reported, all attributed to taking higher doses of the medication.

You should continue your treatment as long as your doctor tells you to. Stopping suddenly may cause potentially life-threatening side effects (see section 3).

Use in children

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

Use of Madopar with other medicines

Inform your doctor or pharmacist that you are taking or have recently taken or may need to take any other medicine.

This is extremely important as taking more than one medicine at the same time may enhance or reduce the effect of Madopar. Therefore, do not take Madopar with any other medicine unless your doctor has prescribed it.

Madopar should be taken 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 past two weeks (see 'Do not take Madopar', above).
• other medicines used to treat Parkinson's disease, as they may increase the risk of side effects.
• iron sulfate (used to treat iron deficiency)
• metoclopramide and domperidone (used to treat digestive disorders).
• opioids (used to relieve pain).
• antihypertensive medicines that contain reserpine.
• neuroleptic medicines (used to treat certain psychiatric disorders, including anxiety and severe schizophrenia, nausea, dizziness, and hypotension).
• antipsychotic medicines
• the dose of levodopa should be adjusted when taken with antidepressant medicines.
• antihypertensive medicines: your blood pressure may become too low. Your doctor may need to adjust the dose of your antihypertensive treatment.
• sympathomimetic medicines, 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 blood tests for certain substances. Urine test results may give false positives for ketones.

Taking Madopar with food and drink

The absorption of levodopa may be delayed by foods high in protein.

It is recommended to take the medicine at least 30 minutes before or 1 hour after meals.The gastrointestinal side effects that 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 a liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

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

A pregnancy test should be performed before treatment to rule out pregnancy.

If you are fertile, you should use reliable contraceptive methods.

If you become pregnant while taking this medicine, stop treatment immediately.

You should not breastfeed during treatment with Madopar.

Driving and operating machinery

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

Madopar may cause drowsiness (excessive drowsiness) and sudden episodes of sleep. Therefore, if you feel very drowsy or notice that you fall asleep suddenly, wait until you feel fully awake again before driving or doing anything else that requires you to be alert. If you do not do this, 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; it is essentially "sodium-free".

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

Remember to take your medication.

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

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

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

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

The maximum dose is generally not more than four tablets per day.

If you have already taken levodopa with another decarboxylase inhibitor, you must 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 schedule: Madopar 200 mg/ 50mg will be prescribed ½ tablet less than half of the tablets or capsules of 500 mg of levodopa that the patient had been taking per day.

It is possible that at the beginning of treatment, there may be 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 medication to become apparent.

It is recommended to take Madopar half an hour before or one hour after meals. If gastrointestinal discomfort appears, it is recommended to take them with something to eat or drink.

If you take more Madopar than you should

If you have taken more Madopar than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet 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 forgot to take Madopar

Do not take a double dose to compensate for the missed doses.

Take the next dose as usual.

If you interrupt treatment with Madopar

Treatment with Madopar should not be discontinued abruptly, as this could cause serious reactions. Therefore, follow your doctor's instructions strictly for discontinuing treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Madopar can cause side effects, although not everyone will experience them.

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

• fluctuations in response such as “blockade” (suddenly movement becomes difficult), “end of dose” (return of symptoms before the next dose) and “on-off” phenomena (sudden changes in periods of good symptom control 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
• skin allergic reactions such as itching and skin rash
• orthostatic hypotension
• decrease in the count of red, white or platelet blood cells (hemolytic anemia, leukopenia or thrombocytopenia)
• liver enzyme alterations (increase in 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 **
• alterations or loss of taste **
• nausea **
• vomiting **
• diarrhea **
• urine discoloration, usually a reddish color. Other bodily fluids may also discolor, such as saliva, tongue, teeth or oral mucosa.
• mild euphoria
• aggression
• dopamine dysregulation syndrome: cognitive and behavioral alterations, pathological gambling (ludopathy), increased sexual desire, compulsive buying, excessive eating
• digestive disorders: discoloration in saliva, tongue, teeth and oral mucosa
• increased urea levels in the blood
• flushing and sweating
• feeding disorders, anorexia

* In the final stages of treatment, and in many cases after taking the medication 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 dose extension is improved throughout the day.

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

In patients treated with dopamine agonists for the treatment of Parkinson's disease, including levodopa, especially at high doses, cases have been reported with signs of pathological gambling (ludopathy), increased sexual desire and excessive sexual desire, compulsive buying, excessive eating, usually reversible after dose reduction or suspension of treatment.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do notstoreattemperatureabove30ºC.Keep the container perfectly closed to protect it from moisture.

Store in the original packaging.

Do not use this medication after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, please ask your pharmacist how to dispose of containers and medications you no longer need.By doing so, you will help protect the environment.

Composition of Madopar 200 mg/50 mg tablets

• The active principles are levodopa and benserazide (as hydrochloride). Each tablet contains 200 mg of levodopa and 50 mg of benserazide (as hydrochloride).
• The other componentsare mannitol, calcium phosphate dibasic, microcrystalline cellulose, pregelatinized cornstarch, polyvinylpyrrolidone, magnesium stearate, ethylcellulose, iron oxide red (E-172), silicon dioxide, dioctyl sulfosuccinate and sodium.

Appearance of the product and contents of the packaging

Madopar is presented in a bottle of 100 tablets

The tablets are pale red, slightly speckled, cylindrical biconvex, with the inscription “ROCHE” and a hexagon on one face and with breaking lines on both faces (scored).

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

ROCHE FARMA, S.A.

C/ Ribera del Loira, 50

28042 Madrid

Manufacturer:

Roche Farma, S.A.

C/ Eratóstenes, 19

Getafe

28906 Madrid

Last review date of this leaflet: September 2023

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