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Madopar^®

Madopar^® is registered for use in the following countries

Albania
Andorra,
Austria
Belgium (Prolopa^®)
Bosnia-Herzegovina
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France (Modopar^®)
Germany
Gibraltar
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Lithuania
Luxembourg (Prolopa^®)
Malta
Monaco
Netherlands
Norway
Poland
Portugal
Romania
Russia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Turkey
United Kingdom
Yugoslavia

Madopar^®, which is available in more than 130 countries, is also available in most Latin-American countries, as well as Middle-East, Australia and Asia & Pacific

Madopar^® is also known under the trade mark:

• Madopark^®: Sweden
• Modopar^®: France, Guinea Republic, Ivory Coast, Mauritania, Morocco, Senegal, Tunisia, and Vietnam
• Prolopa^® : Aruba, Belgium, Brazil, Canada, Chile, Costa Rica, Dominican Rep., Ecuador, El Salvador, Guatemala, Honduras, Jamaica, Luxembourg, Nicaragua, Panama, Uruguay

Availability - Formulation

Madopar^® is supplied as tablet or capsule for oral administration. Each tablet contains levodopa and benserazide in a ratio of 4:1.

Please note that the availability of the different formulations may be different from country to country. For full information about which formulation is available in your country please ask your doctor or contact the local Roche affiliate.

Standard formulations

Madopar^® capsules

• 62,5 (levodopa 50 mg + benserazide 12,5 mg)
• 125 (levodopa 100 mg + benserazide 25 mg)
• 250 (levodopa 200 mg + benserazide 50 mg)

Madopar^® cross-scored tablets

• 125 (levodopa 100 mg + benserazide 25 mg)
• 250 (levodopa 200 mg + benserazide 50 mg)

Dispersible formulation

Madopar^® single-scored dispersible tablets

• 52,5 (levodopa 50 mg + benserazide 12,5 mg)
• 125 (levodopa 100 mg + benserazide 25 mg)

Controlled release formulations

Madopar^® HBS capsule - 125 (levodopa 100 mg + benserazide 25 mg)

Madopar^® dual-release tablet (Switzerland only) - 125 (levodopa 100 mg + benserazide 25 mg)

Therapeutic Indications

• Madopar^® is indicated for the treatment of parkinsonian patients.
• Madopar^® Dispersible is special indicated for patients with dysphagia (difficulties in swallowing) or who require a formulation with a more rapid onset of action than the ‘standard’ formulations.
• Madopar^® HBS is special indicated for patients presenting with all types of fluctuations.

Contra-indications (When Not To Use)

• If you are allergic to Madopar^® or any ingredients it contains
• If you suffer from a hormonal disorder, e.g. an overactive thyroid gland
• If you have a kidney, liver or heart condition
• If you suffer from certain nervous or psychiatric disorders
• If you have narrow angle glaucoma (High pressure in the eye)
• If you have or have had, a cancer of the skin (Malignant melanoma)
• If you are taking or have taken medicines known as monoamine oxidase inhibitors in the past 14 days.
• If you are pregnant or breast feeding
• If you are under 25 years old (since treatment may affect bone growth)

How To Take Madopar^®

• Always take Madopar^® exactly as your doctor tells you. He/she will prescribe a suitable dose for you. The dose depends on your individual symptoms and your response to Madopar^®.
• Treatment is usually started with low doses three or four times daily but in some patients the doctor may start with a high dose.
• After three to seven days your doctor will, if necessary, increase your dose. As a rule, the average maintenance dose is one capsule of Madopar^® 125 four to eight times daily; the maximum dose necessary is generally no more than six capsules of Madopar^® 125 daily. The size of individual doses and the way they are spread throughout the day must be adjusted to suit the needs of each individual patient.
• If you forget to take one dose, you should never make up the missing dose by doubling the dose next time. Instead you should simply continue with the next dose when it is due, however you may experience some return of Parkinson’s disability in the meantime.

How to take Madopar^® Dispersible Tablet

• The tablets may be swallowed whole together with a drink of water or dispersed in a glass of cold water or squash and taken as a drink.
• The tablets must not be dispersed in pure fruit juice or hot drinks as this will reduce the effectiveness of your medicine. Once the tablets have been dissolved in water, drink the Madopar solution as soon as possible.

Instructions for dispersing tablets

• Add each Madopar^® tablet to at least a quarter of a tumbler ( 25ml) of cold water or squash
• The tablet will disperse completely within a few minutes giving a cloudy liquid. Some sediment may appear at the bottom of the glass. Do not worry about this, it is quite normal and will not reduce the effectiveness of your medicine. Stir or swirl the liquid immediately before taking a drink.

Special Warning & Precautions For Use

No data available.

Interactions With Other Medicinal Products & Other Forms of Interaction

No data available.

Pregnancy and Lactation

See contra-indications

Effects on Ability to Drive & Use Machines

No data available.

Possible Undesirable Effects of Madopar ^®

These are the most commonly reported undesirable effects with Madopar^® in clinical studies, however it does not necessarily mean that you will experience some or all of them.

For full information about possible undesirable effects you should read the package information or talk to your doctor.

Gastrointestinal

At the beginning of treatment, loss of appetite, nausea, vomiting and diarrhoea can occur. These symptoms can usually be bought under control by taking the medicine during, or immediately after meals or with sufficient food or liquid and by increasing the dose slowly.

Cardiovascular

Occasional reports of cardiac arrhythmias and orthostatic hypotension.

Skin

Rarely allergic reactions such as pruritus and rash

Neuropsychiatric

Psychiatric problems are common in Parkinsonian patients, including those being treated with levodopa. They include feeling in high spirits, anxiety, agitation, insomnia, drowsiness, depression, aggression, delusions, hallucinations, temporal disorientation. Sleep disturbances, feelings of unrest, anxiety, depressed mood, somnolence (excessive drowsiness), sudden sleep onset, and other psychiatric reactions may occur.

Involuntary movements are common, particularly on long-term administration. These are usually dose-dependent and may disappear or become tolerable after dose adjustment.

Others

Occasionally, intestinal bleeding, hot flushes, sweating and drowsiness have been reported by patients taking levodopa.

Sometimes your urine may be coloured red and turn dark if left to stand. The changes are the result of the action of the drug and are no cause for concern.

Tolerance to Madopar varies widely between patients and is often related to the rate of dosage increases. With long-term administration fluctuations in the therapeutic response may be encountered. They include “freezing” episodes, end-of-dose deterioration and the so-called “on-off” effect. Patients may be helped by dosage reduction or by giving smaller and more frequent doses.

Overdose

No data available

Pharmacological Properties of Madopar^®

No data available

Product Information Downloads

No downloads available

Useful Links & References

• Roche website : www.roche.com

Further Information

F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124
CH-4070 Basel
Switzerland

t:  +41-61-688 1111
f:  +41-61-691 9391