Madopar 100mg/25mg 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:

HARD 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Withdrawn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-ma060-00602-00603-00604
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MADOPAR 50 MG/12.5 MG
ROCHE
MADOPAR 100 MG/25 MG
MADOPAR 200 MG/50 MG
HARD CAPSULES
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 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 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: Contents of the pack and other 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 hormone

Scheda tecnica

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mt-madopar-spc-tracked-150818-125-caps
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Madopar 100 mg/25 mg 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
Capsules, hard.
Pale pink opaque body and a powder blue opaque cap, imprinted with the
name
‘Roche’ in black ink on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Parkinsonism - idiopathic post-encephalitic.
Previous neurosurgery is not a contra-indication to Madopar.
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 capsule or dispersible tablet of
Madopar 50
mg/12.5 mg three or four times daily. If the disease is at an advanced
stage, the starting
dose should be one capsule or dispersible tablet of Madopar 100 mg/25
mg three times
daily.
The daily dosage should then be increased by one capsule or
dispersible tablet of
Madopar
100
mg/25
mg,
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 capsule or
dispersible tablet of Madopar 50 mg/12.5 mg once or twice daily,
increasing by one
capsule or dispersible tablet every third or fourth day.
2
mt-madopar-spc-tracked-150818-125-caps
The effective dose usually lies within the range of four to eight
capsules or dispersible
tablets of Madopar 100 mg/25 mg (two to four capsules of Madopar 200
mg/50 mg)
daily in divided doses, most patients requiring no more than six
capsules or dispersible
tablets of Madopar 100 mg/25 mg daily.
Optimal improvement is usually seen in one to three weeks but the full
therapeutic effect
of Madopar may not be apparent for some time. It is advisable,
therefore, to allow
several weeks to elapse before c