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Madopar® (levodopa + benserazide)

Roche

Information courtesy of F. Hoffmann-La Roche Ltd

 

Last reviewed October 2013

This section provides a summary of the drug information for Madopar® (levodopa + benserazide). It is still important that you read the full package leaflet that accompanies the product carefully before you start to take any medication. If you have any further questions about your PD medication, or other aspects of your PD treatment, you should discuss these with your doctor or other healthcare professional. 

Always check with your healthcare professional before altering any of your medications and always ask your pharmacist first if you are considering taking over-the counter medications as they can interfere with your Parkinson’s medications and may have unwanted side effects.  Remember to tell your doctor too if you take over-the counter drugs that can be bought without a prescription.

Madopar® is currently available in the following European 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
  • Kosovo
  • Latvia 
  • Lithuania 
  • Luxembourg (Prolopa®
  • Malta 
  • Monaco 
  • Netherlands
  • Norway 
  • Poland 
  • Portugal 
  • Romania 
  • Russia
  • Serbia & Montenegro
  • Slovakia 
  • Slovenia 
  • Spain 
  • Sweden 
  • Switzerland 
  • Turkey 
  • United Kingdom

Madopar®, which is available in more than 107 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

  • Restex®: Germany


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 (UK)

The appearance and strengths of Madopar outside of the UK may be different to those described below.

  • Madopar® 50mg/12.5mg Hard Capsules

  • Madopar® 100mg/25mg Hard Capsules

  • Madopar® 200mg/50mg Hard Capsules


Dispersible formulation

  • Madopar® 50mg/12.5mg Dispersible tablets

  • Madopar® 100mg/25mg Dispersible tablets


Controlled release formulations

  • Madopar® CR 100mg/25mg Prolonged Release Hard Capsules


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® prolonged release 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® 100mg/25mg four to eight times daily; the maximum dose necessary is generally no more than six capsules of Madopar®100mg/25mg 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.


Interactions With Other Medicinal Products & Other Forms of Interaction

Please refer to the Summary of Product Characteristics.


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.

Occasional intestinal bleeding.

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 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.


Product Information Downloads

The information on this page is a general summary of the Madopar® medication product in the UK.

Please click on the links below to download more detailed information on the specific Neupro® medication, its handling and use. Links go to the electronic Medicines Compendium (eMC) website.

UK Patient Information Leaflets (PIL)


UK Summary of Product Characteristics (SPC)

Please note that SPCs are designed for healthcare professionals.