MADOPAR 200/50 Milligram Capsules Hard

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

LEVODOPA, BENSERAZIDE HYDROCHLORIDE

제공처:

Roche Products Limited

ATC 코드:

N04BA02

INN (국제 이름):

LEVODOPA, BENSERAZIDE HYDROCHLORIDE

복용량:

200/50 Milligram

약제 형태:

Capsules Hard

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Dopa and dopa derivatives

승인 상태:

Authorised

승인 날짜:

1979-04-01

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 mental problem
which may make you distressed an

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Madopar 200mg/50mg 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
_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/25mgdispersible 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 allow several
weeks to elapse before contemplating dosage
increments above the average dose range.