Madopar CR capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Benserazide hydrochloride; Levodopa

Available from:

Lexon (UK) Ltd

ATC code:

N04BA02

INN (International Name):

Benserazide hydrochloride; Levodopa

Dosage:

25mg ; 100mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100

Patient Information leaflet

MADOPAR
® CR 125 CAPSULES
(levodopa/benserazide)
PATIENT INFORMATION LEAFLET
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.
Your medicine is available using the above name but will be referred
to as
Madopar CR throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Madopar CR is and what it is used for
2. What you need to know before you take Madopar CR
3. How to take Madopar CR
4. Possible side effects
5. How to store Madopar CR
6. Contents of the pack and other information
1. WHAT MADOPAR CR IS AND WHAT IT IS USED FOR
Madopar CR 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 CR 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.
The capsules are designed to release the medicines into your body
slowly.
This is why they are called ‘CR’ which stands for ‘controlled
release’.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MADOPAR CR
DO NOT TAKE MADOPAR CR IF:
-
You are allergic (hypersensitive) to levodopa, benserazide or any of
the
other ingredients of Madopar CR (listed in Section 6: Contents of the
pack and other information).
-
You have a problem with the pressure in your eyes call

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Madopar CR 100 mg/25 mg Prolonged Release Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
capsule
contains
100.0mg
Levodopa
and
25mg
Benserazide
(as
benserazide hydrochloride)
For excipients see section 6.1
3
PHARMACEUTICAL FORM
Prolonged-release capsules, hard
Light blue opaque body and dark green opaque cap imprinted with ROCHE
in
red.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of all stages of Parkinson’s disease. Patients with
fluctuations
related to levodopa plasma concentrations or timing of dose, e.g. end
of dose
deterioration or wearing-off effects, are more likely to benefit from
switching
to Madopar CR.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS, INCLUDING THE ELDERLY
Dosage and frequency of administration are very variable and must be
titrated to
the needs of the individual patient.
Madopar CR capsules must always be swallowed whole, preferably with a
little
water. They may be taken 30 min before or one hour after meals but
antacid
preparations should be avoided.
In patients with nocturnal immobility, positive effects have been
reported after
gradually increasing the last evening dose to two Madopar CR 100 mg/25
mg
capsules on retiring.
_PATIENTS NOT CURRENTLY TREATED WITH LEVODOPA _
In patients with mild to moderate disease, the initial recommended
dose is one
capsule of Madopar CR three times daily with meals. Higher doses, in
general,
of Madopar CR will be required than with conventional
levodopa-decarboxylase
inhibitor combinations as a result of the reduced bioavailability. The
initial
dosages should not exceed 600 mg per day of levodopa.
Some patients may require a supplementary dose of conventional
Madopar, or
Madopar Dispersible, together with the first morning dose of Madopar
CR to
compensate for the more gradual onset of the CR formulation.
In cases of poor response to Madopar CR at total daily doses of
Madopar CR
plus any
supplementary conventional Madopar corresponding to 1200 mg
levod