Madopar 50mg/12.5mg capsules

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Benserazide hydrochloride; Levodopa

から入手可能:

Roche Products Ltd

ATCコード:

N04BA02

INN（国際名）:

Benserazide hydrochloride; Levodopa

投薬量:

12.5mg ; 50mg

医薬品形態:

Oral capsule

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04090100; GTIN: 5000471002027

情報リーフレット

1
uk-madopar-pl-clean-150817-62.5-125-250-hard capsules
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
UK
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 proble

製品の特徴

OBJECT 1
MADOPAR 50 MG/12.5 MG HARD CAPSULES
Summary of Product Characteristics Updated 17-Mar-2016 | Roche
Products Limited
1. Name of the medicinal product
Madopar 50 mg/12.5 mg Hard Capsules
2. Qualitative and quantitative composition
Each capsule contains 50.0 mg Levodopa and 12.5 mg Benserazide (as
benserazide hydrochloride).
For excipients, see section 6.1
3. Pharmaceutical form
Capsules, hard.
Light grey 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.
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 elaps