Trivastal Retard 50, sustained-release coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PIRIBEDIL

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

N04BC08

INN (International Name):

PIRIBEDIL 50 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

PIRIBEDIL 50 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Authorization status:

Authorised

Authorization date:

2005-09-23

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIVASTAL
 RETARD 50 MG, SUSTAINED-RELEASE COATED TABLET
PIRIBEDIL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What TRIVASTAL RETARD 50 is and what it is used for
2.
Before you take TRIVASTAL RETARD 50
3.
How to take TRIVASTAL RETARD 50
4.
Possible side effects
5.
How to store TRIVASTAL RETARD 50
6.
Further information
1.
WHAT TRIVASTAL RETARD 50 IS AND WHAT IT IS USED FOR
This medicine is indicated in
certain forms of Parkinson's disease.
2.
BEFORE YOU TAKE TRIVASTAL RETARD 50
DO NOT TAKE TRIVASTAL RETARD 50
-
if you are allergic (hypersensitive) to piribedil, or any of the other
ingredients of TRIVASTAL RETARD
50,
-
if you suffer from cardiovascular shock,
-
if you are in the acute phase of myocardial infarction,
-
if you are taking medications known as neuroleptics (except
clozapine).
WARNING AND PRECAUTIONS
Somnolence and sudden sleeping fits have been reported during the
treatment with
piribedil, especially in patients with Parkinson's disease. Suddenly
falling asleep during daily activities, in
certain cases without awareness or warning signs, has been very rarely
reported. Patients must be informed of
this and advised to exercise caution while driving or operating
machines during treatment with piribedil.
Patients who have experienced somnolence and/or an episode of sudden
sleep onset must refrain from driving
or operating machines. The physician can recommend a reduction of the
dosage or termination of therapy with
the medicine TRIVASTAL RETARD 50.
Tell your doctor if you or your family/carer notic

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
TRIVASTAL RETARD 50
mg, sustained-release coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Piribedil
............................................................................
50.00 mg per sustained-release coated tablet.
For a full list of excipients, see section 6.1.
Excipients with known effects: sucrose, ponceau 4R (E124).
3. PHARMACEUTICAL FORM
Sustained-release coated tablet.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS

Treatment of Parkinson's disease:
•
either as single-agent therapy (treatment of essential forms with
tremor),
•
or in combination with levo-dopa, from the outset or secondarily, in
particular in forms with
tremor.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Treatment of Parkinson's disease:

Single-agent therapy: 150 to 250 mg, i.e. 3 to 5 tablets daily to be
divided into 3 to 5 intakes daily.

In combination with levo-dopa: 80 to 140 mg (about 20 mg of piribedil
per 100 mg of levo-dopa).
_ _
_Treatment discontinuation _
A sudden withdrawal of dopaminergics exposes to a risk of neuroleptic
malignant syndrome. To avoid
this risk the dose of piribedil should be decreased gradually until
full withdrawal
_. _
_ _
_Impulse control disorder _
To avoid the risk of impulse control disorders the prescription of the
lowest effective dose is
recommended. Dose reduction/tapered discontinuation should be
considered if such
symptoms develop (see section 4.4).
_ _
_Patients with hepatic and/or renal impairment _
Piribedil has not been investigated in these patient groups. Caution
is advised when treating patients
with hepatic and/or renal impairment.
_ _
_Paediatric population _
The safety and efficacy of Piribedil in children and adolescents aged
below 18 years have not been
established. No data are available. There is no relevant use of
Piribedil in the paediatric population for the
indication.
Method of administration
Oral route.
The tablets are to be swallowed with half a glass of water,