Madopar 125 mg

Leaflet attached to the packaging: patient information

Madopar 62.5mg, 50 mg + 12.5 mg, capsules

Madopar 125 mg, 100 mg + 25 mg, capsules

Madopar, 200 mg + 50 mg, capsules

Madopar HBS, 100 mg + 25 mg, capsules

Madopar 250 mg, 200 mg + 50 mg, tablets Madopar 62.5 mg, 50 mg + 12.5 mg, tablets for oral suspension

Madopar 125 mg, 100 mg + 25 mg, tablets for oral suspension

Levodopa + Benserazide

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be re-read.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Madopar and what is it used for
• 2. Important information before using Madopar
• 3. How to use Madopar
• 4. Possible side effects
• 5. How to store Madopar
• 6. Package contents and other information

1. What is Madopar and what is it used for

Madopar is a combination medicine containing two active substances: levodopa and benserazide (in the form of hydrochloride).
Madopar is indicated for the treatment of Parkinson's disease.
Madopar 125 mg, 100 mg + 25 mg, capsules; Madopar, 200 mg + 50 mg, capsules; and Madopar HBS, 100 mg + 25 mg, capsules are also indicated for the symptomatic treatment of idiopathic (primary) or renal failure-related restless legs syndrome (RLS).

• 1. Parkinson's diseaseParkinson's disease is characterized by slowed movements, muscle stiffness, and tremors. These symptoms are caused by insufficient dopamine in certain brain centers. The symptoms occur in individual patients with varying severity. The goal of treating Parkinson's disease is to supplement the dopamine deficiency in the brain. The difficulty in treatment lies in the fact that dopamine does not pass from the blood into the brain. However, its chemical precursor, levodopa, passes through without obstacles. Unfortunately, most of the levodopa is converted to dopamine before entering the brain. The dopamine produced outside the brain causes unpleasant side effects. Madopar contains two substances: levodopa and benserazide, which inhibits the conversion of levodopa to dopamine outside the brain. After administering the medicine, the following processes occur in the body: levodopa (the first component of Madopar) cannot be converted to dopamine outside the brain - due to benserazide (the second component of Madopar). Thanks to benserazide, more levodopa enters the brain and is converted to dopamine, and there is no conversion of levodopa to dopamine in extracerebral tissues, which results in fewer side effects. Madopar can thus have a beneficial effect on symptoms related to Parkinson's disease. However, it does not cure the disease, as it does not eliminate the cause of dopamine deficiency in the brain. Causal treatment of the disease is currently impossible.

In larger quantities, levodopa penetrates the brain and is converted to dopamine, and there is no conversion of levodopa to dopamine in extracerebral tissues, which results in fewer side effects. Madopar can thus have a beneficial effect on symptoms related to Parkinson's disease. However, it does not cure the disease, as it does not eliminate the cause of dopamine deficiency in the brain. Causal treatment of the disease is currently impossible.

• 2. Restless Legs Syndrome (RLS)This is a common condition characterized by an urge to move the limbs with sensory disturbances (paresthesias), restlessness, worsening of symptoms at rest, temporary improvement in the patient's condition related to their activity, and worsening of symptoms in the evening and at night. The cause of RLS, like Parkinson's disease, is a dopamine deficiency.

2. Important information before using Madopar

When not to use Madopar:

• if the patient is allergic to levodopa, benserazide, or any of the other ingredients of this medicine (listed in section 6);
• in patients treated with non-selective monoamine oxidase inhibitors (MAOIs), due to the risk of hypertensive crisis. Concurrent use of Madopar with selective MAO-B inhibitors, such as selegiline or rasagiline, or selective MAO-A inhibitors, such as moclobemide, is not contraindicated; however, it should be noted that concurrent use of both selective MAO-A and MAO-B inhibitors with Madopar is equivalent to non-selective MAO inhibition and should be avoided;
• in patients with uncontrolled endocrine, renal, or hepatic disorders, heart diseases (e.g., severe arrhythmias and heart failure), psychiatric disorders with psychotic symptoms, and glaucoma with closed-angle filtration;
• in patients under 25 years of age (bone growth must be completed);
• in pregnant or breastfeeding women, or women of childbearing age who do not use effective contraception. If a woman taking Madopar becomes pregnant, the medicine should be discontinued (after consulting a doctor).
• Additionally, Madopar HBS should not be used in case of known hypersensitivity to peanuts or soy (see section 2 Madopar HBS contains soybean oil).

Warnings and precautions

Before starting to take Madopar, the patient should discuss with their doctor or pharmacist if:

• the patient has diabetes- blood glucose levels should be checked more frequently and the dosage of antidiabetic drugs should be adjusted accordingly;
• the patient has open-angle glaucoma- intraocular pressure should be regularly measured;
• the patient is scheduled for general anesthesia. In such a case, Madopar should be taken for as long as possible before the operation, except for anesthesia using halothane. When using halothane for general anesthesia, Madopar should be discontinued 12-48 hours before the procedure, due to the risk of blood pressure fluctuations and/or cardiac arrhythmias. After the procedure, treatment can be resumed, gradually increasing the doses to the previously used dose;
• the patient has a history of coronary artery disease, arrhythmias, or heart failure - cardiac function should be carefully monitored, especially during the initial treatment period and regularly during therapy;
• the patient is elderly and taking antihypertensive drugs and other medications that may cause orthostatic hypotension or has a history of hypotension;
• the patient is taking sympathomimetic drugs, as their effect may be enhanced;
• the patient is taking a catechol-O-methyltransferase (COMT) inhibitor;
• the patient is taking anticholinergic drugs, such as amantadine, selegiline, bromocriptine, dopamine agonists; concurrent use of these drugs with Madopar may enhance both the therapeutic and adverse effects.

During the dose titration phase, it is recommended to periodically monitor liver, kidney, and cardiovascular function
and monitor blood counts.
During treatment with Madopar, depressionmay occur, which may be related to the underlying disease. Patients taking Madopar should be closely monitored for psychological changes and depression: with or without suicidal thoughts.
Patients taking Madopar may experience cognitive and behavioral disorders.
In rare cases, duringlevodopa treatment, drowsiness and/or sudden sleepmay occur. Very rarely, reports of sleep attacks that may occur during daily activities, sometimes without warning or prior drowsiness, have been received. Therefore, during treatment with Madopar, caution should be exercised when driving or operating machinery. Patients who have already experienced drowsiness and/or sleep attacks should not drive or operate machinery. If drowsiness or sleep attacks occur, the doctor should consider reducing the dose or discontinuing treatment.
In susceptible individuals, hypersensitivity reactionsmay occur.
Patients should inform their doctor if they or their relatives notice unusual behaviors resulting from irresistible impulses, compulsions, or urges to perform certain actions that may be harmful to the patient or others. Such behaviors are called impulse control disordersand may include addiction to gambling, compulsive or binge eating, excessive sexual drive, or intensified sexual thoughts and feelings. It may be necessary to re-evaluate the treatment being used by the doctor.
In patients with Parkinson's disease, there is an increased risk of developing malignant melanoma. It is not clear whether the observed increased risk is due to Parkinson's disease or other factors, such as levodopa used to treat Parkinson's disease. During treatment with Madopar for any indication, regular skin examinations for melanoma should be performed.
Madopar should not be discontinued abruptly.
Sudden discontinuation of the medicine may lead to the development of a potentially life-threatening condition resembling malignant neuroleptic syndrome (high fever, muscle stiffness, possible mental changes). If such symptoms occur, the patient should be under medical supervision, if necessary in a hospital, and receive prompt symptomatic treatment.

Possibility of dependence on the medicine or its abuse

In a small number of patients, cognitive and behavioral disorders may occur, which may be directly related to taking a higher dose of the medicine than recommended (a dose significantly exceeding the dose of the medicine required for the treatment of motor impairment).

Madopar and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If a patient taking a non-selective MAOI is prescribed Madopar by their doctor, at least two weeks should elapse between the end of non-selective MAOI treatment and the start of Madopar treatment.
Concomitant use of Madopar with selective MAO-B inhibitors, such as selegiline and rasagiline, or selective MAO-A inhibitors, such as moclobemide, is allowed. However, concurrent administration of a selective MAO-A inhibitor and a selective MAO-B inhibitor is equivalent to non-selective MAO inhibition and should not be used with Madopar.
Taking antacids and Madopar HBSreduces the absorption of levodopa and may lead to a weaker effect of the medicine.
Concomitant use of iron sulfate reduces the maximum plasma concentration of levodopa.
Metoclopramide increases the absorption rate of levodopa. Domperidone may affect increased absorption of levodopa in the intestine.
When using antihypertensive drugsand Madopar, blood pressure should be regularly monitored to allow for dose adjustments.
Neuroleptic drugs, opioids, and antihypertensive drugs containing reserpineinhibit the effect of Madopar.
Concomitant use of Madopar with anti-Parkinsonian drugs(amantadine, selegiline, bromocriptine, dopamine agonists, anticholinergic drugs, such as trihexyphenidyl) is allowed, but it should be noted that both the desired and undesired effects of the medicine may be enhanced. It is recommended not to abruptly discontinue anticholinergic drugswhen starting treatment with Madopar, as the effect of levodopa occurs after some time.
Concomitant administration of antipsychotic drugs with drugs having dopamine receptor blocking properties may counteract the effect of Madopar on Parkinson's disease. Levodopa may counteract the effect of antipsychotic drugs. Caution should be exercised when concomitantly administering these drugs, and the patient should be closely monitored for decreased effectiveness of anti-Parkinsonian drugs and worsening of Parkinson's disease symptoms.
Levodopa contained in Madopar may affect the results of laboratory tests for catecholamines, creatinine, uric acid, and glucosuria.
In patients taking Madopar, false-positive Coombs test resultsand false-positive results for ketone bodies in urine may occur.
In the case of general anesthesia using halothane, Madopar should be discontinued 12-48 hours before the procedure, as concomitant administration of Madopar and halothane may cause blood pressure fluctuations and/or cardiac arrhythmias.

Using Madopar with food and drink

Concomitant consumption of protein-rich meals may weaken the effect of the medicine in immediate-release forms, i.e., capsules and standard-release tablets, as well as oral suspension tablets. There are no data available on the effect of food on the efficacy of Madopar in other pharmaceutical forms.

Pregnancy and breastfeeding

Madopar should not be used during pregnancy or in women of childbearing age who do not use effective contraception.
Before starting treatment, a pregnancy test is recommended to rule out pregnancy.
If a woman taking Madopar becomes pregnant, the medicine should be discontinued (after consulting a doctor).
Madopar should not be used during breastfeeding, as the active substances of the medicine may pass into breast milk and harm the baby.

Driving and operating machinery

During treatment with Madopar, drowsinessmay occur, and in rare cases, sudden sleep attacksmay occur. Therefore, when taking Madopar, caution should be exercised when driving or operating machinery. Patients who have already experienced drowsiness or sleep attacks during treatment with Madopar should refrain from driving or operating machinery, as their impaired concentration may pose a risk of serious injury or death to themselves or others.

Madopar 250 mg tablets contain sodium

Madopar 250 mg tablets contain less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Madopar HBS contains soybean oil

Madopar HBS contains soybean oil (a component of hydrogenated vegetable oil). Madopar HBS should not be used in case of known hypersensitivity to peanuts or soy.

3. How to use Madopar

This medicine should always be used exactly as prescribed by a doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
Dosing in Parkinson's disease:

The patient with Parkinson's disease must be under strict medical supervision and must not undergo any other treatment for this disease without consulting a doctor. If it is necessary to change doctors or visit another doctor, they should be immediately informed about the treatment with Madopar.

Madopar should never be taken without a doctor's prescription. Under no circumstances should the dosage be changed without the doctor's consent.

Madopar in the form of capsules, tablets, and oral suspension tablets should be taken preferably 30 minutes before a meal or 1 hour after a meal.

Undesirable gastrointestinal symptoms that occur mainly in the initial phase of treatment can usually be avoided by taking Madopar with a small, protein-poor meal or drink, or by gradually increasing the dose. Madopar HBS can be taken independently of meals.
For the treatment to be effective, it is essential to take the correct amount of medicine at the right time.
The doctor determines the appropriate amount and frequency of taking the medicine individually and, in close cooperation with the patient, determines the best treatment schedule for them. Therefore, the patient should strictly follow the doctor's instructions. Generally, at the beginning of treatment, the doctor prescribes Madopar in smaller doses and gradually increases the dose. This is done so that the patient's body can adapt to the medicine, thus limiting side effects as much as possible.
Typically, the recommended dose of Madopar is:
In the early stages of Parkinson's disease, treatment usually starts with one capsule of Madopar 62.5 mg (50 mg levodopa + 12.5 mg benserazide) three to four times a day.
Optimal therapeutic effectis usually achieved with a daily dose of Madopar equivalent to 300-800 mg levodopa + 75-200 mg benserazide, taken in at least 3 divided doses over a period of 4 to 6 weeks.
Average maintenance dosecorresponds to 1 capsule of Madopar 125 mg, taken 3 to 6 times a day. The number of divided doses and their distribution throughout the day should be determined individually by the doctor for each patient, depending on their clinical condition. Madopar HBS and Madopar in the form of oral suspension tablets can be administered instead of the standard-release form of Madopar (capsules and tablets) to achieve optimal therapeutic effect.
Dosing in restless legs syndrome
In restless legs syndrome, the dosage depends on the severity of the disease, with optimal efficacy achieved through careful individual dose titration. Madopar is usually taken for a longer period. The dosage and duration of treatment are determined by the doctor. The medicine should be taken 1 hour before bedtime, preferably with a small amount of liquid and a snack. Taking capsules during a meal containing a lot of protein may reduce the absorption of Madopar and limit its effectiveness.

Maximum daily dose of Madopar should not exceed 500 mg.

Typically, the recommended dose of Madopar is:
Idiopathic restless legs syndrome
Madopar is taken orally 1 hour before bedtime. To avoid gastrointestinal side effects, it is best to take the medicine with a small meal.
RLS with sleep disturbances
In patients with RLS who complain of sleep disturbances, the recommended dose of Madopar is 62.5 mg - 125 mg. If symptoms persist, the dose of Madopar can be increased to 250 mg.
RLS with sleep disturbances and nocturnal sleep disturbances
In patients with RLS who experience both sleep disturbances and nocturnal sleep disturbances, 1 capsule of Madopar HBS should be taken with 1 capsule of Madopar 125 mg 1 hour before bedtime. If this does not lead to sufficient alleviation of symptoms in the second part of the night, the dose can be increased to 2 capsules of Madopar HBS.
RLS with sleep disturbances, nocturnal sleep disturbances, and additional daytime disturbances
In such patients, an additional dose of 125 mg Madopar standard-release form can be administered, taking care not to exceed the maximum daily dose of 500 mg Madopar.
Restless legs syndrome associated with renal failure requiring dialysis
In patients with RLS undergoing dialysis, a dose of 125 mg Madopar standard-release form or oral suspension tablets should be taken 30 minutes before dialysis.

Special dosing instructions

Parkinson's disease:
All patients should have their dose carefully determined. Patients treated with other anti-Parkinsonian drugs may receive Madopar. As the patient's condition improves with Madopar treatment, the doses of these drugs can be reduced or gradually discontinued.
Madopar in the form of oral suspension tabletsis particularly recommended for patients with dysphagia (swallowing disorders) or when rapid onset of action is desired.
Patients who experience large fluctuations in the effect of the medicine throughout the dayshould receive smaller doses more frequently throughout the day or have the standard-release form of Madopar replaced with Madopar HBS.
Switching from standard-release form to Madopar HBSshould be done from day to day, starting with the first morning dose. The same daily dose and distribution of doses should be maintained as with the standard-release form. After 2-3 days, the dose can be gradually increased by about 50%. There is a possibility of temporary worsening of the condition.
Properties of Madopar HBScause the onset of its action to occur later than with standard-release preparations. The intended effect can be achieved faster by administering Madopar HBS together with the standard-release form or oral suspension tablets of Madopar. This method may be particularly useful when administering the first morning dose, which usually should be larger than subsequent doses taken throughout the day. The dosing regimen for Madopar HBS is determined individually by the doctor, slowly and with special caution, with intervals of at least 2-3 days between each dose change.
In patients with reduced motor function at night, positive effects are achieved by gradually increasing the last evening dose of Madopar HBS to 250 mg, taken directly before bedtime.
Excessive response (dyskinesia)after administration of Madopar HBS is more effectively reduced by prolonging the interval between individual doses rather than reducing single doses.
In case of insufficient clinical response to Madopar HBS, it is recommended to return to the previous treatment with standard-release forms of Madopar or Madopar oral suspension tablets.
Restless legs syndrome (RLS)
To avoid exacerbation of symptoms (i.e., early occurrence of RLS symptoms during the day, increased severity of symptoms, and involvement of other body parts), the maximum recommended daily dose of Madopar should not be exceeded.
If exacerbation or rebound effect occurs, it is essential not to exceed the maximum daily dose. If exacerbation or rebound effect occurs, consideration should be given to adjunctive treatment with reduced levodopa dose or gradual withdrawal of levodopa and replacement with another drug.
Taking Madopar in the form of tablets, capsules, or HBS capsules
Madopar capsules and Madopar HBS capsules should be swallowed whole, without chewing, washed down with a non-alcoholic beverage, and taken with a small amount of food. If the doctor has prescribed Madopar in the form of tablets, the prescribed amount can be crushed if necessary to facilitate swallowing.
Taking Madopar in the form of oral suspension tablets
Oral suspension tablets should be dissolved in a small amount of water (about 25-50 ml). The tablets should not be dissolved in fruit juices, milk, or hot beverages, as this reduces the effectiveness of Madopar. Within a few minutes, the tablet will completely disintegrate and form a white suspension. The suspension should be used within 30 minutes of preparation.
Before drinking the suspension, it should be well mixed.
If the patient feels that the effect of Madopar is too strong or too weak, they should consult their doctor.

Taking a higher dose of Madopar than recommended

In case of taking a higher dose of Madopar than recommended, the patient should immediately consult a doctor or pharmacist.
The most common symptoms of overdose may include cardiovascular symptoms (arrhythmias), psychiatric disorders (e.g., disorientation and insomnia), gastrointestinal symptoms (e.g., nausea and vomiting), and involuntary movements. If the patient has overdosed on Madopar prolonged-release form (i.e., HBS capsules), the onset of symptoms may be delayed due to the slower absorption of active substances from the gastrointestinal tract.
Overdose of Madopar requires immediate medical attention, if necessary in a hospital or intensive care unit. It is recommended to monitor the patient's vital functions and other parameters according to their clinical condition.
Patients may require treatment for cardiovascular symptoms (e.g., arrhythmias) or central nervous system disorders. It may be necessary to administer anti-arrhythmic drugs and/or respiratory stimulants or neuroleptics.

Missing a dose of Madopar

A double dose should not be taken to make up for a missed dose. Subsequent doses of the medicine should be taken according to the schedule established by the doctor.

Discontinuing Madopar

Madopar should not be discontinued abruptly. See section 2 Warnings and precautions.
In case of any further doubts regarding the use of this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Madopar can cause side effects, although not everybody gets them.
The following side effects have been reported in clinical trials with Madopar in restless legs syndrome:
Common:may affect up to 1 in 10 people

• headache,
• worsening of symptoms in restless legs syndrome,
• dizziness,
• infection with fever,
• common cold,
• bronchitis,
• dry mouth,
• diarrhea,
• nausea,
• ECG changes: arrhythmias,
• increased blood pressure.

The following side effects have been reported during post-marketing use of Madopar:
Frequency not known:cannot be estimated from the available data

• blood and lymphatic system disorders: hemolytic anemia (a small number of red blood cells due to their abnormal breakdown), leukopenia (a small number of white blood cells), thrombocytopenia (a small number of platelets); therefore, as with long-term levodopa treatment, it is recommended to periodically monitor blood morphology and liver and kidney function,
• metabolic and nutritional disorders: decreased appetite,
• psychiatric disorders: dopamine dysregulation syndrome (cognitive and behavioral disorders that may be directly related to taking a higher dose of the medicine than recommended), confusion, depression, agitation, anxiety, insomnia, hallucinations, delusions, disorientation, pathological gambling, increased libido, increased sexual drive, compulsive spending or shopping, binge eating, or eating disorders (a description of the symptoms accompanying these side effects is provided below),
• nervous system disorders: loss of taste, taste disorders, involuntary movements (e.g., movements that disrupt normal coordination; these can usually be eliminated or reduced by reducing the dose of the medicine), changes in treatment response during the day (can be eliminated or reduced by adjusting the dose of the medicine or by administering smaller single doses at shorter intervals), drowsiness, sudden sleep attacks, freezing (sudden immobility),
• cardiovascular disorders: arrhythmias,
• vascular disorders: orthostatic hypotension (blood pressure change related to changing position from lying or sitting to standing); these can usually be reduced by reducing the dose of Madopar,
• gastrointestinal disorders: nausea, vomiting, diarrhea, change in saliva color, change in tongue color, change in tooth color, change in oral mucosa color; these occur mainly in the initial treatment phase and can be largely limited by taking Madopar with a small, protein-poor meal or drink, or by gradually increasing the dose,
• hepatic and biliary disorders: increased activity of liver enzymes (increased transaminase activity, increased alkaline phosphatase activity, increased gamma-glutamyltransferase activity),
• skin and subcutaneous tissue disorders: itching, rash,
• musculoskeletal and connective tissue disorders: in restless legs syndrome, exacerbation of symptoms may occur (shift of symptoms from the evening/night period to the early afternoon and evening before the next nocturnal dose),
• investigations: increased blood urea levels, chromaturia (change in urine color; urine usually turns red and darkens after settling); color change or discoloration may also affect other body fluids and tissues, including saliva, tongue, teeth, and oral mucosa,
• it should be noted that the following side effects may also occur due to the psychiatric disorders mentioned above:
• dopamine dysregulation syndrome (cognitive and behavioral disorders that may be directly related to taking a higher dose of the medicine than recommended);
• inability to resist impulses, temptations, or urges to perform actions that may be harmful to the patient or others; this includes:
• strong impulse to gamble excessively, despite significant personal or family consequences,
• altered or increased sexual interests and behaviors of great importance to the patient or others, e.g., activities related to increased sexual drive,
• compulsive, uncontrolled spending or shopping,
• binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger).

Patients should inform their doctor if they exhibit any of the above behaviors to discuss ways to control or limit these symptoms.
If any side effects worsen or any side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the "national reporting system" (detailed information below). By reporting side effects, more information can be collected on the safety of the medicine.
Department of Post-Marketing Drug Surveillance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.

5. How to store Madopar

The medicine should be stored out of sight and reach of children.
Madopar HBS should be stored at a temperature not exceeding 30°C. The bottle should be kept tightly closed to protect it from moisture.
Madopar 62.5 mg, 50 mg + 12.5 mg, oral suspension tablets, and Madopar 125 mg, 100 mg + 25 mg, oral suspension tablets should be stored at a temperature below 30°C. The bottle should be kept tightly closed to protect it from moisture.
Madopar 250 mg, 200 mg + 50 mg, tablets should be stored at a temperature below 25°C. The bottle should be kept tightly closed to protect it from moisture.
Madopar 62.5 mg, 50 mg + 12.5 mg, capsules; Madopar 125 mg, 100 mg + 25 mg, capsules; Madopar, 200 mg + 50 mg, capsules: The bottle should be kept tightly closed to protect it from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Madopar contains

• The active substances of Madopar are levodopa and benserazide. Each tablet, oral suspension tablet, or capsule of Madopar contains levodopa and benserazide (in the form of hydrochloride) in a 4:1 ratio.
• Other ingredients of the medicine are: Madopar 62.5 mg, 50 mg + 12.5 mg, capsules: mannitol, microcrystalline cellulose, talc, povidone K90, magnesium stearate, gelatin, titanium dioxide (E171), black iron oxide (E172), indigo carmine (E132); Madopar 125 mg, 100 mg + 25 mg, capsules: microcrystalline cellulose, talc, povidone K90, magnesium stearate, gelatin, titanium dioxide (E171), red iron oxide (E172), indigo carmine (E132); Madopar, 200 mg + 50 mg, capsules: microcrystalline cellulose, talc, povidone K90, magnesium stearate, gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132); Madopar HBS, 100 mg + 25 mg, capsules: hypromellose, hydrogenated vegetable oil, calcium phosphate, mannitol, povidone, talc, magnesium stearate, gelatin, yellow iron oxide (E172), titanium dioxide (E171), indigo carmine (E132); Madopar 250 mg, 200 mg + 50 mg, tablets: mannitol, anhydrous calcium phosphate, microcrystalline cellulose, pre-gelatinized corn starch, crospovidone, ethyl cellulose, red iron oxide (E172), colloidal silicon dioxide, sodium docusate, magnesium stearate; Madopar 62.5 mg, 50 mg + 12.5 mg, oral suspension tablets: anhydrous citric acid, pre-gelatinized corn starch, microcrystalline cellulose, magnesium stearate; Madopar 125 mg, 100 mg + 25 mg, oral suspension tablets: anhydrous citric acid, pre-gelatinized corn starch, microcrystalline cellulose, magnesium stearate.

What Madopar looks like and contents of the pack

The pack contains: 100 tablets, 100 oral suspension tablets, or 100 capsules of Madopar, or 30 or 100 capsules of Madopar HBS.
Madopar 62.5 mg, 50 mg + 12.5 mg, capsules; light blue-gray capsules containing 50 mg levodopa and 12.5 mg benserazide (in the form of hydrochloride).
Madopar 125 mg, 100 mg + 25 mg, capsules; light blue-pink capsules containing 100 mg levodopa and 25 mg benserazide (in the form of hydrochloride).
Madopar, 200 mg + 50 mg, capsules; light blue-brown capsules containing 200 mg levodopa and 50 mg benserazide (in the form of hydrochloride).
Madopar HBS, 100 mg + 25 mg, capsules; (Hydrodynamically Balanced System) green-light blue capsules with prolonged release containing 100 mg levodopa and 25 mg benserazide (in the form of hydrochloride).
Madopar 250 mg, 200 mg + 50 mg, tablets; pink tablets containing 200 mg levodopa and 50 mg benserazide (in the form of hydrochloride).
Madopar 62.5 mg, 50 mg + 12.5 mg, oral suspension tablets; divisible, white, with a gray or creamy tint, containing 50 mg levodopa and 12.5 mg benserazide (in the form of hydrochloride).
Madopar 125 mg, 100 mg + 25 mg, oral suspension tablets; divisible, white, with a gray or creamy tint, containing 100 mg levodopa and 25 mg benserazide (in the form of hydrochloride).
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:
Roche Polska Sp. z o.o.
ul. Domaniewska 28
02-672 Warsaw
Phone: 022 345 18 88
fax: 022 345 18 74
Importer:
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Date of last revision of the leaflet: