Carbidopa/Levodopa Orion 25 mg/100 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Carbidopa monohydrate; Levodopa

Available from:

Orion Corporation

ATC code:

N04BA02

INN (International Name):

Carbidopa monohydrate; Levodopa

Pharmaceutical form:

Tablet

Therapeutic area:

levodopa and decarboxylase inhibitor

Authorization status:

Marketed

Authorization date:

2022-12-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARBIDOPA/LEVODOPA ORION 25 MG/100 MG TABLETS
CARBIDOPA/LEVODOPA ORION 12.5 MG/50 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 Orion is and what it is used for
2.
What you need to know before you take Carbidopa/Levodopa Orion
3.
How to take Carbidopa/Levodopa Orion
4.
Possible side effects
5.
How to store Carbidopa/Levodopa Orion
6.
Contents of the pack and other information
1.
WHAT CARBIDOPA/LEVODOPA ORION IS AND WHAT IT IS USED FOR
Carbidopa/Levodopa Orion improves the signs of Parkinson’s disease
in adults. 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 Orion 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 ORION
DO NOT TAKE CARBIDOPA/LEVODOPA ORION
-
if you are allergic to levodopa, carbidopa or any of the other
ingredients of this medici

Summary of Product characteristics

Health Products Regulatory Authority
17 October 2023
CRN00DTLC
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Carbidopa/Levodopa Orion 25 mg/100 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains carbidopa monohydrate equivalent to 25 mg
carbidopa and 100 mg levodopa.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White or off-white, round tablet, 10 mm in diameter which is scored
and marked "LC 100" on one side. The tablet can be
divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Carbidopa/Levodopa Orion is indicated for the treatment of Parkinson's
disease in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The optimal Carbidopa/Levodopa Orion dosage should be determined
individually by careful titration. The ratio of carbidopa
and
levodopa
in
Carbidopa/Levodopa
Orion
tablets
is
1:4
(Carbidopa/Levodopa
Orion
25
mg/100
mg
and
Carbidopa/Levodopa Orion 12.5 mg/50 mg).
_General considerations: _The dosage should be adjusted to individual
patient needs. This may require adjusting both the
individual dose and the frequency of administration.
Studies show that carbidopa inhibits the function of peripheral
dopadecarboxylase at daily doses of about 70–100 mg. Patients
receiving smaller carbidopa doses than this are more likely to
experience nausea and vomiting.
Standard antiparkinsonian drugs, other than levodopa alone, may be
continued while Carbidopa/Levodopa Orion is being
administered, although their dosage may have to be adjusted.
_The usual initial dose: _
The recommended initial dose is one Carbidopa/Levodopa Orion 25 mg/100
mg tablet three times daily.
The daily dose of carbidopa is then 75 mg. The dosage may be increased
by adding one tablet to the regimen every day or
every other day as necessary, until the total daily dose is equivalent
to eight Carbidopa/Levodopa Orion 25 mg/100 mg tablets.
Carbidopa/Levodopa Orion 12.5 mg/50 mg tablets may be used to
facilitate adjusting the dose t