Levodopa/Carbidopa retard 100/25, tabletten met verlengde afgifte 100/25 mg

Nchi: Uholanzi

Lugha: Kiholanzi

Chanzo: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Viambatanisho vya kazi:

CARBIDOPA 1-WATER 25 SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER mg/stuk ; LEVODOPA 100 mg/stuk

Inapatikana kutoka:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC kanuni:

N04BA02

INN (Jina la Kimataifa):

CARBIDOPA 1-WATER 25 SAMENSTELLING overeenkomend met ; CARBIDOPA 0-WATER mg/stuk ; LEVODOPA 100 mg/stuk

Dawa fomu:

Tablet met verlengde afgifte

Tungo:

CHINOLINEGEEL (E 104) ; FUMAARZUUR (E 297) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; NATRIUMSTEARYLFUMARAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Njia ya uendeshaji:

Oraal gebruik

Eneo la matibabu:

Levodopa And Decarboxylase Inhibitor

Bidhaa muhtasari:

Hulpstoffen: CHINOLINEGEEL (E 104); FUMAARZUUR (E 297); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); NATRIUMSTEARYLFUMARAAT; POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Idhini ya tarehe:

2002-07-15

Taarifa za kipeperushi

Sandoz B.V.
Page 1/10
Levodopa/Carbidopa retard 100/25 – 200/50
RVG 28127-8
V13
1.3.1.3 Package Leaflet
Augustus 2023
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVODOPA/CARBIDOPA RETARD 100/25, TABLETTEN MET VERLENGDE AFGIFTE
100/25 MG
LEVODOPA/CARBIDOPA RETARD 200/50, TABLETTEN MET VERLENGDE AFGIFTE
200/50 MG
LEVODOPA/CARBIDOPA
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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[NATIONALLY COMPLETED NAME] IS USED IN THE TREATMENT OF PARKINSON’S
DISEASE
. It reduces the “off” time (a
sudden onset of muscle stiffness that can last for minutes or even
hours) if you are being treated with
levodopa alone, levodopa/decarboxylase inhibitor tablets with an
immediate-release formulation (e.g.
carbidopa) and if you suffer from sudden uncontrolled movements.
[nationally completed name] belongs to a class of drugs used to treat
Parkinson’s disease.
The symptoms of this disease are probably caused by a lack of
dopamine, a substance that is normally
produced by the brain. Dopamine plays a role in controlling muscle
movement. A lack of it causes problems
in muscle movement. Levodopa compensates for the lack of dopamine,
whilst carbidopa ensures that e

Tabia za bidhaa

Sandoz B.V.
Page 1/13
Levodopa/Carbidopa retard 100/25 – 200/50 mg
RVG 28127-8
V13
1.3.1.1 Summary of Product Characteristics
Augustus 2023
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levodopa/Carbidopa retard 100/25, tabletten met verlengde afgifte
100/25 mg
Levodopa/Carbidopa retard 200/50, tabletten met verlengde afgifte
200/50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 100 mg levodopa and 25 mg
carbidopa (as carbidopa
monohydrate).
Each prolonged-release tablet contains 200 mg levodopa and 50 mg
carbidopa (as carbidopa
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
[nationally completed name] 100/25 mg prolonged-release tablets:
Orange-brown, round tablets
[nationally completed name] 200/50 mg prolonged-release tablets:
Orange-brown, round tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Idiopathic Parkinson’s disease, in particular to shorten the
“off” period in patients who have
previously been treated with immediate-release levodopa/decarboxylase
inhibitors or with just
levodopa and who showed motor fluctuations.
Experience with Levodopa/Carbidopa retard is limited in patients, who
have not been
previously treated with levodopa.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily dose of Levodopa/Carbidopa should be carefully determined.
Patients should be
monitored closely during the period of dose adjustment, especially
with regard to the occurrence
or exacerbation of nausea and abnormal involuntary movements, such as
dyskinesia, chorea and
dystonia. Blepharospasm could be an early sign of overdosing.
•
Starting dose
Patients who have never before received Levodopa therapy
Levodopa/Carbidopa retard 100/25 mg is designed for use in patients,
who have not
previously had levodopa treatment or to aid titration in patients who
receive
Sandoz B.V.
Page 2/13
Levodopa/Carbidopa retard 100/25 – 200/50 mg
RVG 28127-8
V13
1.3.1.1 Summary of Product Cha