Madopar 100 mg/25 mg dispersible tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Levodopa; Benserazide

Disponible desde:

Roche Products (Ireland) Ltd

Código ATC:

N04BA; N04BA02

Designación común internacional (DCI):

Levodopa; Benserazide

Dosis:

100 mg/25 milligram(s)

formulario farmacéutico:

Dispersible tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Dopa and dopa derivatives; levodopa and decarboxylase inhibitor

Estado de Autorización:

Marketed

Fecha de autorización:

1987-04-08

Información para el usuario

1
ie-pil-madopar-clean-210111-62.5-125-disp-tabs
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MADOPAR 50 MG/12.5 MG
ROCHE
MADOPAR 100 MG/25 MG
DISPERSIBLE TABLETS
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 is and what it is used for
2. What you need to know before you take Madopar
3. How to take Madopar
4. Possible side effects
5. How to store Madopar
6. Contents of the pack and other information
1.
WHAT MADOPAR IS AND WHAT IT IS USED FOR
Madopar dispersible tablets 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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MADOPAR
DO NOT TAKE MADOPAR IF:

You are allergic (hypersensitive) to levodopa, benserazide or any of
the other ingredients of Madopar
(listed in Section 6: Further information).

You have a problem with the pressure in your eyes called
‘narrow-angle glaucoma’.

You have serious problems with your kidneys, liver or heart.

You have a serious problem with your hormones, such as an over

Ficha técnica

Health Products Regulatory Authority
01 February 2021
CRN009488
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Madopar 100 mg/25 mg dispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg levodopa and 25 mg benserazide (as
hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dispersible Tablet
Round, white to tablets with Roche 125 imprinted on one face and a
single break bar on the other.
The break bar does not allow division of the tablet into equal parts.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Parkinsonism - idiopathic, post-encephalitic. Previous neurosurgery is
not a contra-indication to Madopar. Patients requiring a
more rapid onset of action, e.g. patients suffering from early morning
or afternoon akinesia, or who exhibit delayed on or
wearing off phenomena are more likely to benefit from Madopar
Dispersible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and administration are variable and no more than a guide can be
given.
Posology
_ADULTS_
_PATIENTS NOT PREVIOUSLY TREATED WITH LEVODOPA_
The recommended initial dose is one dispersible tablet of Madopar
50mg/12.5 mg three or four times daily. If the disease is at
an advanced stage, the starting dose should be one dispersible tablet
of Madopar 100mg/25mg three times daily.
The daily dosage should then be increased by one dispersible tablet of
Madopar 100mg/25mg, or their equivalent, once or
twice weekly until a full therapeutic effect is obtained, or
side-effects supervene.
In some elderly patients, it may suffice to initiate treatment with
one dispersible tablet of Madopar 50mg/12.5mg once or twice
daily, increasing by one dispersible tablet every third or fourth day.
The effective dose usually lies within the range of four to eight
dispersible tablets of Madopar 100mg/25mg (two to four
capsules of Madopar 200mg/50mg) daily in divided doses, most patients
requiring no more than six dispersible tablets of
Madopar 100mg/25mg daily.
Optimal impr