Co-Careldopa

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

CARBIDOPA, LEVODOPA

Beszerezhető a:

Bristol Laboratories Limited

ATC-kód:

N04BA02

INN (nemzetközi neve):

CARBIDOPA, LEVODOPA

Gyógyszerészeti forma:

TABLET

Összetétel:

CARBIDOPA 10.8 milligram(s) ; LEVODOPA 100 milligram(s)

Recept típusa:

POM

Terápiás terület:

ANTI-PARKINSON DRUGS

Engedélyezési státusz:

Authorised

Engedély dátuma:

2014-11-17

Betegtájékoztató

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 of
the other

Termékjellemzők

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of
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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
Light blue coloured, oval shaped scored tablet with C and break line
on one
side and 18 on other side. The tablet dimensions are 12.90 mm x 7.30
mm ±
0.20 mm
Light yellow coloured, oval shaped scored tablet with C and break line
on one
side and 17 on other side. The tablet dimensions are 9.65 mm x 5.00 mm
±
0.20 mm.
Yellow coloured, oval shaped scored tablet with C and break line on
one side
and 19 on other side. The tablet dimensions are 12.90 mm x 7.30 mm ±
0.20
mm.
Light blue coloured, oval shaped scored tablet with C and break line
on one
side and 20 on other side. The tablet dimensions are 14.90 mm x 8.30
mm ±
0.20 mm.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For treatment of Parkinson's disease
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13
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.
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