MADOPAR 100/25 Milligram Tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

LEVODOPA, BENSERAZIDE HYDROCHLORIDE

Tilgængelig fra:

Roche Products Limited

ATC-kode:

N04BA02

INN (International Name):

LEVODOPA, BENSERAZIDE HYDROCHLORIDE

Dosering:

100/25 Milligram

Lægemiddelform:

Tablets

Recept type:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Dopa and dopa derivatives

Autorisation status:

Authorised

Autorisation dato:

1987-04-08

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MADOPAR
®
50 MG/12.5 MG
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 overactive thyroid
gland.
● You have a severe menta

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Madopar 100mg/25mg 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.
_ADULTS_
_PATIENTS NOT PREVIOUSLY TREATED WITH LEVODOPA_
The recommended initial
dose is one dispersible tablet
of Madopar 50mg/12.5mg 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 50/mg/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
improvement
is usually seen in one to three weeks but
the full
therapeutic effect
of Mad