Madopar 200 mg/50 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levodopa; Benserazide

Available from:

Roche Products (Ireland) Ltd

ATC code:

N04BA; N04BA02

INN (International Name):

Levodopa; Benserazide

Dosage:

200 mg/50 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopa and dopa derivatives; levodopa and decarboxylase inhibitor

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

1
ie-pil-madopar-clean-210111-250-hard-caps
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROCHE
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: 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

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2021
CRN009488
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Madopar 200 mg/50 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200.0 mg levodopa and 50 mg benserazide (as
benserazide hydrochloride).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard (Capsules)
Light brown, opaque body and a powder blue, opaque cap, imprinted with
the name ‘ROCHE’ in black ink on both sections.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of Parkinsonism of idiopathic, post-encephalitic or
arteriosclerotic type.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULTS OVER THE AGE OF 25 YEARS ONLY:_
_ _
Madopar 200mg/50mg capsules are only for maintenance therapy once the
optimal dosage has been determined using
Madopar 100mg/25mg dispersible tablets.
_ _
_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 the 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 capsule 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 Madopar may not be apparent for
some time. It is advisable, therefore, to all