Madopar CR 100mg/25mg Prolonged Release Hard Capsules

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

BENSERAZIDE, LEVODOPA

Commercializzato da:

Roche Products Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

Codice ATC:

N04BA02

INN (Nome Internazionale):

BENSERAZIDE 25 mg LEVODOPA 100 mg

Forma farmaceutica:

PROLONGED-RELEASE CAPSULE

Composizione:

BENSERAZIDE 25 mg LEVODOPA 100 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTI-PARKINSON DRUGS

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2005-08-09

Foglio illustrativo

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mt-pl-tracked-ma060-00601
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MADOPAR CR 100 MG/25 MG PROLONGED RELEASE HARD CAPSULES
ROCHE
levodopa and benserazide (as hydrochloride)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Madopar CR is and what it is used for
2. What you need to know before you take Madopar CR
3. How to take Madopar CR
4. Possible side effects
5. How to store Madopar CR
6. Contents of the pack and other information
1.
WHAT MADOPAR CR IS AND WHAT IT IS USED FOR
Madopar CR capsules contain two medicines called levodopa and
benserazide. They are used to treat
Parkinson’s disease.
People with Parkinson’s disease do not have enough dopamine in
certain parts of their brains. This can
result in slow movements, stiff muscles and tremor.
Madopar CR works like this:

In your body the LEVODOPA is changed into dopamine. Dopamine is the
active medicine that is needed in
your brain to help Parkinson’s disease.

The BENSERAZIDE allows more of the levodopa you take to get into your
brain, before it is changed into
dopamine.
The capsules are designed to release the medicines into your body
slowly. This is why they are called ‘CR’
which stands for ‘controlled release’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MADOPAR CR
DO NOT TAKE MADOPAR CR IF:

You are allergic (hypersensitive) to levodopa, benserazide or any of
the other ingredients of Madopar CR
(listed in Section 6: Contents of the pack and other information).

You have a problem with the pressure in your eyes

Scheda tecnica

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Madopar CR 100 mg/25 mg Prolonged Release Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
capsule
contains
100.0
mg
Levodopa
and
25
mg
Benserazide
(as
benserazide
hydrochloride)
For excipients see section 6.1
3
PHARMACEUTICAL FORM
Prolonged-release capsules, hard.
Light blue opaque body and dark green opaque cap imprinted with ROCHE
in red.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of all stages of Parkinson’s disease. Patients with
fluctuations related to levodopa
plasma concentrations or timing of dose, e.g. end of dose
deterioration or wearing-off effects,
are more likely to benefit from switching to Madopar CR.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS, INCLUDING THE ELDERLY _
Dosage and administration are very variable and must be titrated to
the needs of the individual
patient.
Madopar CR capsules must always be swallowed whole, preferably with a
little water. They
may be taken with or without food but antacid preparations should be
avoided.
In patients with nocturnal immobility, positive effects have been
reported after gradually
increasing the last evening dose to two Madopar CR 100 mg/25 mg
capsules on retiring.
_PATIENTS NOT CURRENTLY TREATED WITH LEVODOPA _
In patients with mild to moderate disease, the initial recommended
dose is one capsule of
Madopar CR three times daily with meals. Higher doses, in general, of
Madopar CR will be
required than with conventional levodopa-decarboxylase inhibitor
combinations as a result of
the reduced bioavailability. The initial dosages should not exceed 600
mg per day of levodopa.
Page 2 of 12
Some patients may require a supplementary dose of conventional
Madopar, or Madopar
Dispersible, together with the first morning dose of Madopar CR to
compensate for the more
gradual onset of the CR formulation.
In cases of poor response to Madopar CR at total daily doses of
Madopar CR plus any
supplementary conventional Madopar corresponding to 1200 mg lev