Carbidopa/Levodopa Fair-Med Tablets 10mg/100mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CARBIDOPA, LEVODOPA

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

N04BA02

INN (International Name):

CARBIDOPA 10.8 mg LEVODOPA 100 mg

Pharmaceutical form:

TABLET

Composition:

CARBIDOPA 10.8 mg LEVODOPA 100 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Authorization status:

Withdrawn

Authorization date:

2016-02-18

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBIDOPA/LEVODOPA FAIR-MED 12.5 MG/50 MG
TABLETS CARBIDOPA/LEVODOPA FAIR-MED 10 MG/100
MG TABLETS CARBIDOPA/LEVODOPA FAIR-MED 25
MG/100 MG TABLETS CARBIDOPA/LEVODOPA FAIR-MED
25 MG/250 MG TABLETS CARBIDOPA/LEVODOPA
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Carbidopa/Levodopa Fair-Med is and what it is used for
2.
What you need to know before you take Carbidopa/Levodopa Fair-Med
3.
How to take Carbidopa/Levodopa Fair-Med
4.
Possible side effects
5.
How to store Carbidopa/Levodopa Fair-Med
6.
Contents of the pack and other information
1.
WHAT CARBIDOPA/LEVODOPA FAIR-MED IS AND WHAT IT IS USED FOR
Carbidopa/Levodopa Fair-Med improves the signs of Parkinson’s
disease. Parkinson's disease is a long-
term illness where:
•
you become slow and unsteady
•
your muscles feel stiff
•
you may develop shaking or trembling (called ‘tremor’).
If not treated, Parkinson's disease can make it hard for you to
continue your normal daily activities.
Carbidopa/Levodopa Fair-Med contains two different medicines called:
levodopa and carbidopa.
•
levodopa turns into a material called ‘dopamine’ in your brain.
The dopamine helps to improve
the signs of your Parkinson’s disease.
•
carbidopa
belongs
to
a
group
of
medicines
called
‘aromatic
amino
acid
decarboxylase
inhibitors’. It helps levodopa work more effectively by slowing the
speed at which levodopa is
broken down in your body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBIDOPA/LEVOD

Summary of Product characteristics

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Carbidopa/Levodopa Fair-Med 12.5 mg/50 mg tablets
Carbidopa/Levodopa Fair-Med 10 mg/100 mg tablets
Carbidopa/Levodopa Fair-Med 25 mg/100 mg tablets
Carbidopa/Levodopa Fair-Med 25 mg/250 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Carbidopa/Levodopa Fair-Med contains 13.5 mg carbidopa
monohydrate
(equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa.
Each tablet of Carbidopa/Levodopa Fair-Med contains 10.8 mg carbidopa
monohydrate
(equivalent to 10 mg of anhydrous carbidopa) and 100 mg levodopa.
Each tablet of Carbidopa/Levodopa Fair-Med contains 27.0 mg carbidopa
monohydrate
(equivalent to 25 mg of anhydrous carbidopa) and 100 mg levodopa.
Each tablet of Carbidopa/Levodopa Fair-Med contains 27.0 mg carbidopa
monohydrate
(equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Carbidopa/Levodopa Fair-Med 12.5 mg/50 mg tablets are light yellow
colored, oval shaped,
with dimensions of 9.65 mm x 5.00 mm, with “C” on one side and
“17” on other side of tablet.
Carbidopa/Levodopa Fair-Med 10 mg/100 mg tablets are light blue
colored, round shaped,
with a diameter of 8 mm, with “C” on one side and “18” on
other side of tablet.
Carbidopa/Levodopa Fair-Med 25 mg/100 mg tablets are light yellow
colored, round shaped,
with a diameter of 8 mm, with “C” on one side and “19” on
other side of tablet.
Carbidopa/Levodopa Fair-Med 25 mg/250 mg tablets are light blue
colored, round shaped,
with a diameter of 10.40 mm, with “C” on one side and “20” on
other side of tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antiparkinsonian agent.
For treatment of Parkinson's disease and syndrome.
Page 2 of 12
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The optimum daily dosage of carbidopa/levodopa must be determined by
careful titration in
each patient.
Carbidopa/Levodopa Fair-Med are avai