Carbidopa/Levodopa Fair-Med 12.5mg/50mg Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Levodopa; Carbidopa

Tilgjengelig fra:

Fairmed Healthcare GmbH

ATC-kode:

N04BA; N04BA02

INN (International Name):

Levodopa; Carbidopa

Dosering :

12.5/50 milligram(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Dopa and dopa derivatives; levodopa and decarboxylase inhibitor

Autorisasjon status:

Not marketed

Autorisasjon dato:

2016-03-04

Informasjon til brukeren

1
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/LEVODOPA FAIR-ME

Preparatomtale

Health Products Regulatory Authority
13 February 2024
CRN00F1QC
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbidopa/Levodopa Fair-Med 12.5mg/50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Carbidopa/Levodopa Fair-Medcontains 13.5 mg carbidopa
monohydrate (equivalent to 12.5 mg of anhydrous
carbidopa) and 50 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, round shaped, with a diameter of 6 mm, with
"C" on one side and "17" on other side of tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antiparkinsonian agent.
For treatment of Parkinson's disease and syndrome.
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 available in a ratio of 1:4 or 1:10 of
carbidopa to levodopa to provide facility for fine dosage
titration for each patient.
For doses not realisable/practicable with this medicinal product,
other medicinal products are available.
GENERAL CONSIDERATIONS
Studies show that the peripheral dopa-decarboxylase is fully inhibited
(saturated) by carbidopa at doses between 70 and 100
mg a day. Patients receiving less than this amount of carbidopa are
more likely to experience nausea and vomiting.
Standard antiparkinsonian drugs, other than levodopa alone, may be
continued while carbidopa/levodopa is being
administered, although their dosage may have to be adjusted.
Patients should be carefully monitored during the dosage adjustment
period. Involuntary movements, particularly
blepharospasm, are a useful early sign of excess dosage in some
patients.
Dosage may be best initiated with one tablet of Carbidopa/Levodopa
Fair-Med 25 mg/100 mg three times a day. This dosage
schedule provides 75 mg of carbidopa per day. Dosage may be increased
by one tablet of Carbidopa/Levodopa Fair-Med 12.5
mg/50 mg or