Co-Careldopa 12.5mg/50mg Tablets

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

CARBIDOPA, LEVODOPA

Disponível em:

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland

Código ATC:

N04BA02

DCI (Denominação Comum Internacional):

CARBIDOPA 12.5 mg LEVODOPA 50 mg

Forma farmacêutica:

TABLET

Composição:

CARBIDOPA 12.5 mg LEVODOPA 50 mg

Tipo de prescrição:

POM

Área terapêutica:

ANTI-PARKINSON DRUGS

Status de autorização:

Withdrawn

Data de autorização:

2014-11-17

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CO-CARELDOPA 10 MG/100 MG TABLETS
CO-CARELDOPA 12.5 MG/50 MG TABLETS
CO-CARELDOPA 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 Co-Careldopa tablets is and what it is used for
2. What you need to know before you take Co-Careldopa tablets
3. How to take Co-Careldopa tablets
4. Possible side effects
5.
How to store Co-Careldopa tablets
6.
Contents of the pack and other information
1.
WHAT CO-CARELDOPA TABLETS IS AND WHAT IT IS USED FOR
The
name
of
your
medicine
is
Co-Careldopa
tablets.
It
contains
two
different
active
ingredients Carbidopa and Levodopa.
Co-Careldopa tablets 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.
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 CO-CARELDOPA TABLETS
DO NOT TAKE CO-CARELDOPA TABLETS IF:
•
you are allergic (hypersensitive) to carbidopa or levodopa or any o

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Co-Careldopa 10 mg/100 mg Tablets
Co-Careldopa 12.5 mg/50 mg Tablets
Co-Careldopa 25 mg/250 mg
Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10.8 mg carbidopa monohydrate(equivalent to 10 mg
of anhydrous
carbidopa) and 100 mg levodopa.
Each tablet contains 13.5 mg carbidopa monohydrate (equivalent to 12.5
mg of anhydrous
carbidopa) and 50 mg levodopa.
Each tablet 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
Round shaped, light blue coloured tablet, with “C” on one side and
“18” on other side of
tablet. The tablet dimensions are 8.00 ± 0.2 mm.
Light yellow coloured, oval shaped tablet with “C” on one side and
“17” on other side. The
tablet dimensions are 9.65 mm x 5.00 mm ± 0.20 mm.
Round shaped, light blue coloured tablet, with “C” on one side and
“20” on other side of
tablet. The tablet dimensions are 10.40 ± 0.2 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For treatment of Parkinson's disease
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The optimum daily dosage of Co-Careldopa tablets must be determined by
careful titration
in each patient.
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Co-Careldopa tablets 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.
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 of Co-
Careldopa tablets is being administered, although their dosage may
have to be adjusted.
Because both therapeutic and adverse effects are seen more rapidly
with of Co-Careldopa
tablets