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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
TRIVASTAL
® RETARD 50
_Piribedil, 50 mg _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What TRIVASTAL® Retard
50 is and what it is used for
2.
How TRIVASTAL® Retard
50 works
3.
Before
you
use
TRIVASTAL® Retard 50
4.
How to use TRIVASTAL®
Retard 50
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
TRIVASTAL® Retard 50
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT
TRIVASTAL®
RETARD
50 IS AND WHAT IT IS USED FOR
Pharmacotherapeutic
group
-
ATC Code: N04BC08
TRIVASTAL®
Retard
50
is
a
dopamine agonist (that acts in the
brain to stimulate the receptors of
a substance called dopamine).
THIS MEDICINE IS INDICATED:
For the treatment of Parkinson’s
disease alone or in combination
with dopatherapy from the outset
or secondarily.
HOW TRIVASTAL® RETARD 50
WORKS
Piribedil:
dopaminergic
agonist
(stimulates
dopamine
receptors
and
the
cerebral
dopaminergic
pathways).
In
humans,
the
mechanism
of
action
is
demonstrated
by
the
clinical pharmacology studies:
•
stimulation
of
cortical
electrogenesis
of
the
"dopaminergic"
type
both
while awake and during sleep,
•
clinical
activity
on
the
different functions controlled
by
dopamine,
with
this
activity
being
demonstrated
via the use of behavioural or
psychometric scales.
In addition, piribedil results in an
increase
in
femoral
blood
flow
(the
existence
of
dopaminergic
receptors in the femoral vascular
bed
explains
the
action
of
piribedil
on
peripheral
circulation).
BEFORE YOU USE TRIVASTAL®
RETARD 50
- _When you must not use it _
_ _
DO
NOT
USE
TRIVASTAL®
RETARD
50
IN
THE
FOLLOWING
SITUATIONS:
•
a history of allergy to piribedil
or any of the other ingredients
in
this
medicine
listed
in
section 8.
•
myocardial infarction or any
other
serious
cardiovascular
disease,
•
in
combination
with
antiemetic
neuroleptics
(see
Taking other medicines).
If you are in any doubt, you must
ask your doctor or pharmacist for
advice.
PREGNANCY AND BREAST-FEEDING
In the absen
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1
Final PI_Trivastal_17.05.2022
TRIVASTAL
®
RETARD 50 MG
1.
NAME OF THE MEDICINAL PRODUCT
TRIVASTAL
®
RETARD 50 MG, SUSTAINED RELEASE COATED TABLETS.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Piribedil
....................................................................................................................
50.00 mg
For one sustained release coated tablet
.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Sustained release coated tablets.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of Parkinson's disease:
•
either as monotherapy,
•
or combined with dopatherapy from the outset, or secondarily.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Treatment of Parkinson's disease:
•
as monotherapy : 150 mg to 250 mg, i.e. 3 to 5 tablets daily, to be
divided into 3 to
5
administrations per day.
•
as a supplement to dopatherapy: 1 to 3 tablets daily (approximately 50
mg of piribedil per
250mg of L.Dopa).
These doses must be attained gradually: increase by one tablet every
three days.
_Discontinuation of treatment _
Sudden discontinuation of dopamine agents may result in neuroleptic
malignant syndrome. To avoid this
risk the dose of piribedil must be reduced gradually until complete
discontinuation of treatment.
_Impulse control disorders_
To avoid the risk of impulse control disorders, prescription of the
minimum effective dose is
recommended. Dose reduction or gradual discontinuation of treatment
should be considered if such
symptoms occur (see section 4.4).
_Kidney or liver failure_
Piribedil has not been studied in these groups of patients. It is
recommended to treat these patients with
caution.
_Paediatric population _
The safety and efficacy of piribedil in children under the age of 18
years have not been established.
There is no available data. There is no justified use of piribedil in
the paediatric population for this
indication.
_Method of administration _
Oral route.
The tablets should be swallowed, without chewing, with half a glass of
water at
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