Madopar Retard 100/25 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Madopar Retard 100 mg/25 mg prolonged-release hard capsules Levodopa / Benserazide

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.- Keep this leaflet, as you may need to read it again.- If you have any questions, consult your doctor or pharmacist.- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Madopar Retard is and what it is used for
2. What you need to know before taking Madopar Retard
3. How to take Madopar Retard
4. Possible adverse effects
5. How to store Madopar Retard
6. Contents of the pack and other information

1. What Madopar Retard is and what it is 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 your brain needs to treat Parkinson's disease.
• Benserazide allows more of the administered levodopa to reach your brain before levodopa is converted into dopamine.

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

Do not take Madopar Retard: • if you are allergic (hypersensitive) to levodopa or benserazide or to any of the other ingredients of this medicine (listed in section 6). • if you are taking medicines known as non-selective MAO inhibitors (medicines used to treat depression) or combinations of selective MAO-A and MAO-B inhibitors. • if you have closed-angle glaucoma (a disease affecting the eyes), or high pressure in the eye. • if you have severe endocrine disorders: phaeochromocytoma (a tumour of the adrenal gland causing high blood pressure), hyperthyroidism (overactive thyroid gland), Cushing's syndrome (excess of the hormone cortisol). • if you have severe kidney, liver, or heart problems. • if you have severe psychiatric disorders with psychotic features (personality disturbances and loss of contact with reality).

• if you are under 25 years of age.

• 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 impairment
• if you have diabetes (a condition in which blood glucose (sugar) levels are very high), as you may need more frequent blood sugar monitoring
• if you have open-angle glaucoma (a disease affecting the eyes), your doctor may perform periodic checks of your intraocular pressure
• if you have orthostatic hypotension (low blood pressure associated with changes in posture, causing dizziness)
• if you have ever had a heart attack or heart problems, your cardiac function will be monitored at the start of treatment and periodically thereafter
• if you notice that you fall asleep suddenly during the day or feel very drowsy (see also section “Driving and use of machines”)
• if you have any other illness before starting treatment with Madopar Retard
• if you are scheduled to undergo surgery soon, as your doctor may need to discontinue Madopar Retard treatment.

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

It is possible that at the beginning of treatment, you may experience a temporary worsening of symptoms, which improves with proper dose adjustment.

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 and episodes of freezing may occur, which can be eliminated or reduced by lowering the dose.

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

In some patients treated with medicines for Parkinson's disease, cases of pathological gambling, increased sexual desire and hypersexuality, compulsive spending or shopping, compulsive overeating or binge eating have been reported, all of which may be attributable to taking higher than recommended doses of medication.

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

Children and adolescents:

Madopar Retard must not be given to children or to individuals under 25 years of age.

Using Madopar Retard with other medicines

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

This is extremely important because taking more than one medicine at the same time may increase or reduce the effect of Madopar Retard. Therefore, you should not take Madopar Retard with any other medicine unless specifically prescribed by your doctor.

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

• monoamine oxidase inhibitors (MAO inhibitors) (used to treat depression); combining these medicines with Madopar Retard could cause excessively high blood pressure. This could also occur if you have taken an MAO inhibitor within the last 2 weeks (see 'Do not take Madopar Retard', above).

• other medicines used to treat Parkinson's disease, as they may increase adverse effects.

• ferrous sulphate (used to treat iron deficiency)

• antacids

• metoclopramide and domperidone (used to treat digestive disorders)

• medicines belonging to a group called opioids (used to relieve pain)

  • antihypertensive medicines containing reserpine

• neuroleptic medicines (used to treat certain psychiatric disorders including anxiety and severe schizophrenia, nausea, dizziness, and hiccups)

• antipsychotic medicines

• dose adjustment of levodopa is recommended when administered with antidepressant drugs

• medicines for high blood pressure: your blood pressure could become too low. Your doctor may need to adjust the dose of your antihypertensive treatment

• medicines belonging to a group called sympathomimetics, such as epinephrine, norepinephrine, isoproterenol, and amphetamines, should not be used at the same time as Madopar Retard: the effect of these medicines could be enhanced. Your doctor may need to adjust the dose of your sympathomimetic treatment.

Madopar Retard may interfere with laboratory test results for certain chemical substances in the blood. Urine tests may give false positive results for ketone bodies.

Taking Madopar Retard 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. Gastrointestinal side effects, which may occur mainly at the beginning of treatment, can be managed by taking Madopar with a low-protein food (e.g., a biscuit) 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 must not be taken during pregnancy. There is a risk of causing skeletal malformations in the fetus.

A pregnancy test is recommended before starting 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 must stop treatment immediately.

You must not breastfeed during treatment with Madopar Retard. There is a risk of causing skeletal malformations in the infant.

Driving and use of 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 falling asleep. Therefore, if you feel very drowsy or notice that you fall asleep suddenly at times, wait until you are fully awake again before driving or doing any other activity requiring alertness. If you do not follow this advice, you may put yourself and others at risk of serious injury or even death.

3. How to take Madopar Retard

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

Remember to take your medicine.

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

The recommended dose varies from individual to individual, as it depends on each patient's symptoms and their individual response to treatment. Treatment with Madopar Retard normally replaces a previous levodopa treatment, which your doctor will gradually change and increase as they monitor your response. The substitution ratio is as follows:

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

At the beginning of treatment, a temporary worsening of symptoms may occur, which improves with proper dose adjustment.

Madopar Retard capsules must be swallowed whole and not chewed. Madopar Retard may be taken with or without food.

It is recommended to take Madopar Retard half an hour before or one hour after meals. If gastrointestinal discomfort occurs, it is recommended to take the capsules with some food or liquid.

Your doctor will advise you on how long to continue treatment with Madopar Retard.

If you take more Madopar Retard than you should: In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562.04.20, indicating the medicine and the amount taken. It is advisable to bring the medicine container and package leaflet to the healthcare professional.

In case of overdose, symptoms such as involuntary movements, confusion, and insomnia may occur. Less commonly, nausea, vomiting, or cardiac arrhythmias (disturbances in the heartbeat rhythm) may occur.

If you forget to take Madopar Retard: Do not take a double dose to make up for missed doses. Take the next dose as usual.

If you stop taking Madopar Retard: Treatment with Madopar Retard must not be stopped abruptly, as this could cause serious 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, Madopar Retard can cause adverse effects, although not everyone will experience them.

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

• fluctuations in response such as "on-off" phenomena (sudden changes between periods of good symptom control and periods of poor control), "wearing-off" (return of symptoms before the next dose), and "freezing" (sudden difficulty in movement) *

• distorted or impaired voluntary movements (dyskinesia)

• involuntary movements *

• hallucinations, especially in the elderly

• disorientation in time, especially in the elderly

• skin allergic reactions such as itching and rash

• orthostatic hypotension

• decreased counts of red blood cells, white blood cells, or platelets (hemolytic anemia, leukopenia, or thrombocytopenia)

• changes in liver enzymes (elevated transaminases and alkaline phosphatase)

• agitation, especially in the elderly

• anxiety, particularly in the elderly

• sleep disturbances, especially in the elderly

• delirium, particularly in the elderly

• loss of appetite

• excessive daytime sleepiness (drowsiness)

• sudden episodes of sleep

• abnormal heart rhythm

• decrease in blood pressure, which improves with dose reduction

• restless legs syndrome

• depression **

• disturbances or loss of taste **

• nausea **

• vomiting **

• diarrhea **

• discoloration of urine, usually reddish in color. Other body fluids may also become discolored, such as saliva, tongue, teeth, or oral mucosa.

• mild euphoria

• aggression

• dopamine dysregulation syndrome: cognitive and behavioral disturbances, pathological gambling, increased libido, compulsive shopping, binge eating

• gastrointestinal disturbances: discoloration of 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. These may resolve if the daily dose is adjusted or if the dosing schedule is better distributed throughout the day.

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

In patients treated with dopaminergic agonists for Parkinson's disease, including levodopa, especially at high doses, cases have been reported with signs of pathological gambling, increased libido, hypersexuality, compulsive spending, and compulsive eating, which are generally reversible upon dose reduction or discontinuation of treatment.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es/. By reporting adverse 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 at temperatures above 30°C.

Store in the original packaging. 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.

6. Package contents and other 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 components are:

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

Capsule coating: Gelatin, indigo carmine (E-132), yellow iron oxide (E-172), titanium dioxide (E-171).

Appearance of the product and pack contents: Madopar Retard is available in packs of 100 prolonged-release hard capsules.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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 the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/