Madopar 62.5 mg: detailed information

Package leaflet: Information for the patient

Madopar 62.5 mg, 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, oral suspension tablets
Madopar 125 mg, 100 mg + 25 mg, oral suspension tablets
Levodopa + Benserazide
Please read this leaflet carefully before 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, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Madopar is and what it is used for
Important information before taking Madopar
How to take Madopar
Possible side effects
How to store Madopar
Contents of the pack and other information

1. What Madopar is and what it is used for

Madopar is a combination medicine containing two active substances: levodopa and benserazide (as hydrochloride).
Madopar is indicated in 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-associated restless legs syndrome (RLS) requiring dialysis therapy.

Parkinson's disease
Parkinson's disease is characterized by slowness of movement, muscle stiffness, and tremor. These symptoms result from insufficient dopamine levels in specific areas of the brain. The severity and combination of symptoms vary among individual patients. The goal of Parkinson's disease treatment is to compensate for the dopamine deficiency in the brain. The main challenge in treatment is that dopamine itself does not cross the blood-brain barrier. However, its chemical precursor, levodopa, readily enters the brain. Unfortunately, a large portion of levodopa is converted into dopamine outside the brain before it can reach its target. Dopamine formed outside the brain causes unpleasant side effects. Madopar contains two substances: levodopa and benserazide, the latter of which inhibits the conversion of levodopa to dopamine outside the brain. After administration, the following processes occur: levodopa (the first component of Madopar) is prevented from converting into dopamine outside the brain due to benserazide (the second component of Madopar). Thanks to benserazide, more levodopa reaches the brain, where it is converted into dopamine, while conversion of levodopa to dopamine in peripheral (non-brain) tissues is minimized, thereby reducing the occurrence of side effects. Thus, Madopar can exert beneficial effects on the symptoms of Parkinson's disease. However, it does not cure the disease, as it does not address the underlying cause of dopamine deficiency in the brain. Etiological treatment of the disease remains impossible to date.
Restless Legs Syndrome (RLS)
This is a common disorder characterized by an urge to move the limbs, associated with sensory disturbances (paresthesia), motor restlessness, worsening of symptoms at rest, temporary relief through movement, and a distinct worsening of symptoms in the evening and at night. The cause of restless legs syndrome, as in Parkinson's disease, is 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 (MAO), due to the risk of hypertensive crisis. Concomitant 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, care should be taken not to use both selective MAO-A and MAO-B inhibitors simultaneously with Madopar;
in patients with uncontrolled disorders: endocrine (pheochromocytoma, hyperthyroidism, Cushing's syndrome), renal function (except for patients undergoing dialysis for RLS), or liver function, heart disease (e.g. severe cardiac arrhythmias and heart failure), psychiatric disorders with psychotic symptoms, and closed-angle glaucoma;
in patients under 25 years of age (skeletal development must be complete);
in pregnant women or women of childbearing potential who are not using effective contraceptive methods. If pregnancy occurs in a woman being treated with Madopar, the drug should be discontinued immediately;
additionally, Madopar HBS should not be used in cases of known hypersensitivity to peanuts or soya (see section 2: Madopar HBS contains soya oil).

Warnings and precautions
Before starting treatment with Madopar, discuss with your doctor or pharmacist if:

the patient has diabetes – blood glucose levels should be monitored more frequently and antidiabetic medication doses adjusted accordingly;
the patient has open-angle glaucoma – intraocular pressure should then be measured regularly;
the patient is scheduled for surgery under general anaesthesia. In such cases, Madopar should be continued for as long as possible up to the time of surgery, except when anaesthesia involves halothane. When general anaesthesia with halothane is planned, Madopar should be discontinued 12–48 hours before the procedure due to the risk of blood pressure fluctuations and/or cardiac arrhythmias. After surgery, treatment may be resumed gradually, increasing the dose until the previously used dose is reached;
the patient has previously had coronary artery disease, cardiac arrhythmias, or heart failure – cardiac function should be carefully monitored, especially at the beginning of treatment and then regularly throughout therapy;
the patient is elderly and concurrently taking antihypertensive drugs or other medications that may cause orthostatic hypotension, or if the patient has previously experienced hypotension;
the patient is taking sympathomimetic drugs (stimulating the sympathetic nervous system), as this may enhance their effects;
the patient is taking a catechol-O-methyltransferase (COMT) inhibitor;
the patient is taking anticholinergic drugs such as amantadine, selegiline, bromocriptine, or dopamine agonists; concomitant use of these drugs with Madopar may enhance both therapeutic and adverse effects.

During the dose adjustment phase, liver function, kidney function, and cardiovascular function should be periodically monitored,
and blood counts should be checked.
Depression may occur during treatment with Madopar, although it may also be related to the
underlying disease. Patients taking Madopar should be closely monitored for psychological
changes and depression, with or without suicidal thoughts.
Cognitive and behavioural disturbances may occur in patients taking Madopar.
Rarely, during levodopa treatment, drowsiness and/or sudden sleep attacks may occur.
Very rarely, cases of sudden sleep attacks have been reported, which may occur even during
routine daily activities, sometimes without warning or preceding drowsiness. Therefore, caution
should be exercised when driving or operating machinery while taking Madopar. Patients who
have previously experienced drowsiness and/or sleep attacks must not drive or operate machinery.
If drowsiness or sleep attacks occur, the doctor should consider reducing the dose or discontinuing treatment.
Hypersensitivity reactions may occur in predisposed individuals.
Inform your doctor if the patient or their family notice unusual behaviours resulting from an
irresistible impulse, compulsion, or obsessive performance of certain actions harmful to the patient
or others. These behaviours are known as impulse control disorders and may include gambling
addiction, compulsive or episodic binge eating, increased sexual drive, or intense sexual thoughts
and feelings. The treating physician may need to re-evaluate the ongoing treatment.
Patients with Parkinson's disease have an increased risk of developing melanoma. It is unclear
whether this increased risk is due to Parkinson's disease itself or other factors, such as levodopa used
in its treatment. During treatment with Madopar for any indication, regular periodic skin examinations
for melanoma should be performed.
Madopar must not be stopped abruptly.
Sudden discontinuation of the drug may lead to a potentially life-threatening condition resembling
neuroleptic malignant syndrome (high fever, muscle rigidity, possible psychiatric changes). If such
symptoms occur, the patient should be placed under medical supervision, possibly in hospital, and
prompt symptomatic treatment initiated.
Possibility of drug dependence or misuse
In a small number of patients, cognitive and behavioural disturbances may occur, which may be
directly related to taking higher than recommended doses of the drug (doses significantly exceeding
the amount required to treat motor impairment).

Madopar and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans to take.
If a patient taking a non-selective MAO inhibitor is prescribed Madopar, at least two weeks should
elapse between stopping the non-selective MAO inhibitor and starting Madopar. Concomitant use
of Madopar with selective MAO-B inhibitors such as selegiline and rasagiline, or selective
MAO-A inhibitors such as moclobemide, is permitted. However, simultaneous administration
of a selective MAO-A inhibitor and a selective MAO-B inhibitor is equivalent to non-selective MAO
inhibition and therefore should not be used concomitantly with Madopar.
Taking antacids and Madopar HBS reduces the absorption of levodopa and may result in reduced
therapeutic effect.
Concomitant administration of iron sulfate reduces the maximum plasma concentration of levodopa.
Metoclopramide increases the rate of levodopa absorption. Domperidone may affect increased
intestinal absorption of levodopa.
When antihypertensive drugs and Madopar are used together, blood pressure should be monitored
regularly to allow for dose adjustments.
Neuroleptics, opioids, and antihypertensive preparations containing reserpine inhibit the effect of Madopar.
Concomitant use of Madopar with anti-Parkinson drugs (amantadine, selegiline, bromocriptine,
dopamine agonists, anticholinergics such as trihexyphenidyl) is allowed, but it should be noted that
both desired and undesired effects may be enhanced. Care should be taken not to discontinue
anticholinergic drugs abruptly at the start of Madopar treatment, as the effect of levodopa may take
some time to manifest.
Concomitant administration of antipsychotics with drugs that block dopamine receptors may
antagonize the anti-Parkinson effect of Madopar. Levodopa may reduce the effectiveness of
antipsychotic drugs. Caution is required when administering these drugs together, and patients should
be closely observed for reduced anti-Parkinson effects and worsening of Parkinson's symptoms.
Levodopa contained in Madopar may affect laboratory test results for catecholamines, creatinine,
uric acid, and glucosuria.
Patients taking Madopar may have false-positive Coombs test results and false-positive urine
ketone tests.
During general anaesthesia with halothane, Madopar should be discontinued 12–48 hours before
the procedure, as concomitant use of Madopar and halothane may cause blood pressure fluctuations
and/or cardiac arrhythmias.

Taking Madopar with food and drink
Concomitant intake of high-protein meals may reduce the effect of immediate-release formulations,
i.e. capsules, standard-release tablets, and oral suspension tablets. No data are available on the effect
of food on the efficacy of Madopar in other pharmaceutical forms.

Pregnancy and breastfeeding
Madopar must not be used during pregnancy or in women of childbearing potential who are not
using effective contraceptive methods.
A pregnancy test should be performed before starting treatment to exclude pregnancy.
If a woman taking Madopar becomes pregnant, the drug should be discontinued (after consultation
with her physician).
Breastfeeding must not be undertaken during treatment with Madopar, as the active substances may
pass into breast milk and harm the infant.

Driving and operating machinery
Drowsiness may occur during treatment with Madopar, and in rare cases sudden sleep attacks may
occur. Therefore, caution should always be exercised when driving or operating machinery while
taking Madopar. Patients who experience drowsiness or sleep attacks during Madopar therapy must
refrain from driving motor vehicles or performing certain other activities (such as operating machinery),
as 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, meaning the medicine is considered "sodium-free".

Madopar HBS contains soya oil
Madopar HBS contains soya oil (a component of hydrogenated vegetable oil). Do not use Madopar HBS if hypersensitivity to peanuts or soya has been diagnosed.

3. How to take Madopar

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Dosing in Parkinson's disease:
A patient with Parkinson's disease must remain under strict medical supervision and must not
initiate any other treatment for this condition without prior agreement with the doctor. If a change
of doctor or a visit to another doctor becomes necessary, the treating physician must be promptly
informed about the therapy with Madopar.
Never take Madopar without a doctor's prescription. Under no circumstances should the dosage
be changed without the doctor's consent.
Madopar capsules, tablets, and dispersible tablets for oral suspension should be taken preferably
30 minutes before a meal or one hour after a meal. Undesirable gastrointestinal effects, which occur
mainly during the initial phase of treatment, can usually be avoided by taking Madopar with a small,
low-protein meal or with a drink, or by gradually increasing the dose. Madopar HBS may be taken
independently of meals.
For effective treatment, it is important to take the correct amount of medicine at the correct time.
Your doctor will individually determine the appropriate dose and frequency of administration and,
in close cooperation with the patient, establish the optimal treatment regimen. Therefore, strictly
follow the doctor's instructions. Generally, at the beginning of treatment, the doctor prescribes
Madopar in lower doses and gradually increases the dose. This approach allows the patient's body
to adapt to the medicine, thereby minimizing adverse effects as much as possible.
Typical dosage:
In early-stage Parkinson's disease, treatment usually starts with one capsule of Madopar 62.5 mg
(50 mg levodopa + 12.5 mg benserazide) taken three to four times daily.
The optimal therapeutic effect is usually achieved with a daily dose of Madopar corresponding
to 300–800 mg levodopa + 75–200 mg benserazide, administered in at least three divided doses
over a period of 4 to 6 weeks.
The average maintenance dose corresponds to one capsule of Madopar 125 mg taken three to
six times daily. The number of divided doses and their distribution throughout the day should be
individually determined by the doctor for each patient, depending on the clinical condition.
Madopar HBS and Madopar dispersible tablets may be used instead of standard-release formulations
(capsules and tablets) to achieve optimal therapeutic effect.
Dosing in restless legs syndrome (RLS)
In restless legs syndrome, dosing depends on the severity of the disease, and optimal efficacy is
achieved through careful individual dose adjustment. Madopar is usually taken over a prolonged
period. The dosage and duration of treatment are determined by the doctor. The medicine should be
taken one hour before bedtime, preferably with a small amount of fluid and bread. Taking capsules
during a meal rich in protein reduces the absorption of Madopar and may limit its effectiveness.
The maximum daily dose of Madopar should not exceed 500 mg.
Typical dosage:
Idiopathic restless legs syndrome
Madopar is taken orally one hour before going to sleep. To avoid gastrointestinal adverse effects,
it is best to take the medicine with a small meal.
RLS with difficulty falling asleep
In patients with RLS who experience difficulty falling asleep, the recommended dose of Madopar is
62.5 mg – 125 mg. If symptoms do not improve, the dose may be increased to 250 mg.
RLS with difficulty falling asleep and nocturnal sleep disturbances
In patients with RLS who experience both difficulty falling asleep and nocturnal sleep disturbances,
one capsule of Madopar HBS should be taken together with one capsule of Madopar 125 mg one
hour before bedtime. If this does not provide sufficient relief of symptoms during the second half
of the night, the dose may be increased to two capsules of Madopar HBS.
RLS with difficulty falling asleep, nocturnal sleep disturbances, and additional daytime symptoms
In such patients, an additional dose of 125 mg of standard-release Madopar is recommended, taking
care that the total daily dose administered over 24 hours does not exceed 500 mg of Madopar.
Restless legs syndrome associated with renal failure requiring dialysis
In patients with RLS undergoing dialysis, a dose of 125 mg of standard-release Madopar or
dispersible tablets should be administered 30 minutes before dialysis.
Special dosing instructions
Parkinson's disease:
The dose should be carefully determined for all patients. Patients treated with other anti- parkinsonian drugs may receive Madopar. As the condition of a patient treated with Madopar
improves, the doses of these drugs may be reduced or gradually discontinued.
Madopar dispersible tablets are particularly indicated in patients with dysphagia (swallowing
difficulties) or when a faster onset of action is desired.
Patients who experience large fluctuations in drug effect during the day should receive smaller
doses more frequently throughout the day, or a switch from standard-release formulations to
Madopar HBS is recommended.
Switching from standard-release formulations to Madopar HBS should occur day by day, starting
with the first morning dose. The same total daily dose and dose distribution as with standard-release
formulations should be maintained.
After 2–3 days, the dose should be gradually increased by approximately 50%. A temporary
worsening of health may occur.
The properties of Madopar HBS result in a later onset of action compared to standard-release
formulations. The desired effect may be achieved more quickly by administering Madopar HBS
together with a standard-release formulation or with Madopar dispersible tablets. This approach
may be particularly useful for the first morning dose, which is usually larger than subsequent doses
taken during the day. The dosing regimen for Madopar HBS is individually determined by the doctor,
slowly and with special caution, with intervals of at least 2–3 days between each dose adjustment.
Positive effects in patients with reduced motor function at night can be achieved by gradually
increasing the last evening dose of Madopar HBS to 250 mg, administered immediately before
sleep.
Excessive response (dyskinesias) after administration of Madopar HBS is preferably managed by
increasing the interval between doses rather than by reducing individual doses.
If a satisfactory clinical response is not achieved with Madopar HBS, it is recommended to return
to previous treatment with standard-release Madopar formulations or Madopar dispersible tablets.
Restless legs syndrome (RLS)
To avoid symptom augmentation (earlier onset of RLS symptoms during the day, increased
severity, and spread to other body parts), the maximum recommended daily dose of Madopar should
not be exceeded.
If symptom augmentation occurs, it is important not to exceed the maximum daily dose. If
augmentation or rebound effects occur, consider adjunctive therapy with reduced levodopa dose or
gradual withdrawal of levodopa and replacement with another medicine.
Taking Madopar in the form of tablets, capsules, or HBS capsules
Madopar capsules and Madopar HBS capsules should always be swallowed whole, without
chewing, with a non-alcoholic drink and some food. If your doctor has prescribed Madopar tablets,
the prescribed amount may be crushed if necessary to facilitate swallowing.
Taking Madopar in the form of dispersible tablets for oral suspension
Dispersible tablets should be poured over a small amount of water (approx. 25–50 ml). Do not use
fruit juices, milk, or hot drinks, as this reduces the effectiveness of Madopar. Within a few minutes,
the tablet completely disintegrates, forming a white suspension. The suspension should be used no
later than 30 minutes after preparation. Immediately before drinking, the suspension should be
thoroughly mixed.
If you feel that the effect of Madopar is too strong or too weak, consult your doctor.
Taking a higher than recommended dose of Madopar
If a higher than recommended dose is taken, contact your doctor or pharmacist immediately.
The most common symptoms of overdose may include cardiovascular effects (e.g., cardiac
arrhythmias), psychiatric disturbances (e.g., disorientation and insomnia), gastrointestinal symptoms
(e.g., nausea and vomiting), and involuntary abnormal movements. If a patient overdoses on the
extended-release formulation (i.e., HBS capsules), symptoms may be delayed due to the later release
and absorption of active substances from the gastrointestinal tract.
Overdose of Madopar requires immediate medical attention, possibly in a hospital setting or in an
intensive care unit. Monitoring of vital functions and other parameters according to the clinical
condition is indicated. Patients may require treatment for cardiovascular symptoms (e.g., cardiac
arrhythmias) or central nervous system dysfunction. Administration of antiarrhythmic drugs and/or
respiratory stimulants or neuroleptics may be necessary.
Missed dose of Madopar
Do not take a double dose to make up for a missed dose. Continue taking the medicine according to
the schedule prescribed by your doctor.
Stopping Madopar treatment
Do not stop taking Madopar abruptly. See section 2 Warnings and precautions.
If you have any further doubts regarding the use of this medicine, consult your doctor or
pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience
them.
The following side effects were reported in clinical trials using Madopar in restless legs syndrome:
Common: may affect up to 1 in 10 patients

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

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

blood and lymphatic system disorders: low number of red blood cells due to their abnormal breakdown (hemolytic anemia), low white blood cell count (leukopenia), low platelet count (thrombocytopenia); for this reason – as always during long-term treatment with levodopa – periodic monitoring of blood count, liver function, and kidney function is recommended,
metabolism and nutrition disorders: decreased appetite,
psychiatric disorders: dopamine dysregulation syndrome (cognitive and behavioral disturbances that may be directly related to taking more than the recommended dose of the medicine), confusion, depression, restlessness, anxiety, insomnia, hallucinations, delusions, disorientation, pathological gambling, increased libido, increased sexual arousal, compulsive spending or shopping, binge eating, eating disorders (a description of symptoms accompanying these adverse effects is provided below),
nervous system disorders: loss of taste, taste disturbances, involuntary movements (e.g., movements impairing normal motor coordination; these can usually be eliminated or reduced by decreasing the dose of the medicine), fluctuations in response to treatment during the day (can be eliminated or reduced by appropriate dose adjustment or by administering smaller doses at shorter intervals), somnolence, sudden sleep attacks, freezing (sudden immobility),
cardiac disorders: cardiac arrhythmias,
vascular disorders: changes in blood pressure related to changing from lying or sitting to standing position (orthostatic hypotension); these can usually be reduced by decreasing the dose of Madopar,
gastrointestinal disorders: nausea, vomiting, diarrhoea, change in saliva color, change in tongue color, change in tooth color, change in color of oral mucosa; these occur mainly in the early phase of treatment and can be significantly reduced by taking Madopar with a small, low-protein meal, taking the medicine with a drink, or gradually increasing the dose,
liver and biliary disorders: increased activity of liver function 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, symptom augmentation may occur (shifting of symptoms from evening/night to early afternoon and evening before taking the next nightly dose),
effects on diagnostic tests: increased blood urea concentration, chromaturia (change in urine color; urine usually becomes reddish and darkens upon standing); color changes may also affect other body fluids and tissues, including saliva, tongue, teeth, and oral mucosa,
it should be noted that the following adverse effects related to psychiatric disorders listed above may also occur:
dopamine dysregulation syndrome (cognitive and behavioral disturbances that may be directly related to taking more than the recommended dose of the medicine);
inability to resist impulses, urges, or compulsions to perform actions that may be harmful to the patient or others; this includes:
strong impulse to engage in uncontrolled gambling, despite serious personal or family consequences,
altered or increased sexual interests and behaviors of significant concern 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).

Inform your doctor if the patient exhibits any of the above behaviors, so that ways to control or
reduce these symptoms can be discussed.
If any of the listed side effects worsen or if any unlisted side effects occur, inform your doctor or
pharmacist.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or
nurse.
Side effects can be reported directly to the "national reporting system" (detailed information below).
Reporting side effects helps to provide more information on the safety of the medicine.
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.

5. How to store Madopar

Keep this medicine out of the sight and reach of children.
Madopar HBS should be stored at a temperature not exceeding 30°C. Keep the bottle tightly closed to protect from moisture.
Madopar 62.5 mg, 50 mg + 12.5 mg tablets for oral suspension and Madopar 125 mg, 100 mg + 25 mg tablets for oral suspension should be stored below 30°C. Keep the bottle tightly closed to protect from moisture.
Madopar 250 mg, 200 mg + 50 mg tablets should be stored below 25°C. Keep the bottle tightly closed to protect 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: Keep the bottle tightly closed to protect 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Madopar contains

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

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

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Roche Polska Sp. z o.o.
ul. Domaniewska 28
02-672 Warszawa
Poland
Tel.: 022 345 18 88
Fax: 022 345 18 74

Importer:
Roche Pharma AG
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany