TRIVASTAL Sustained release coated tablet (2013)
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Περιεχόμενα
Name of the medicinal product
TRIVASTAL 50 mg L.P, prolonged-release coated tablet.
Qualitative and quantitative composition
Piribedil 50.00 mg. For one sustained release coated tablet. For the full list of excipients, see section 6.1.
Pharmaceutical form
Sustained release coated tablets.
Therapeutic indications
Treatment of Parkinsons disease: either as monotherapy, or combined with dopatherapy from the onset, or secondarily.
Posology and method of administration
Oral route. Treatment of Parkinsons disease: as monotherapy: 150 mg to 250 mg, i.e. 3 to 5 tablets per day, to be divided into 3 to 5 administrations per day. as a supplement to dopatherapy: 80 to 140 ...
Contraindications
This medicine is contra-indicated in the following situations: hypersensitivity to piribedil, or to any of the excipients, cardiovascular shock, acute phase of myocardial infarction, in association with ...
Special warnings and precautions for use
Piribedil has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinsons disease. Sudden onset of sleep during daily activities, in some cases without ...
Interaction with other medicinal products and other forms of interaction
Contra-indicated associations Antiemetic neuroleptics Reciprocal antagonism between dopaminergic agonist and neuroleptics. Use an anti-emetic devoid of extrapyramidal effects. Unadvisable associations ...
Pregnancy and lactation
This medicine is restricted to elderly subjects, for whom the risk of pregnancy does not exist. In the absence of relevant data, the use of this drug during pregnancy or breastfeeding is not recommended. ...
Effects on ability to drive and use machines
Patients treated with piribedil presenting somnolence and/or sudden sleeping fits, must be told not to drive vehicles or perform an activity in which an alteration of alertness could expose them or other ...
Undesirable effects
The following undesirable effects have been observed during treatment with piribedil and ranked under the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare ...
Overdose
Given the emetic effect of piribedil at very high doses, overdosage is unlikely with the tablet form. The signs of overdose are: blood pressure instability (arterial hypertension or hypotension), digestive ...
Pharmacodynamic properties
<b>Pharmacotherapeutic class:</b> DOPAMINERGIC AGONISTS <b>ATC code:</b> N04BC08 Piribedil: dopaminergic agonist (stimulates dopamine receptors and the cerebral dopaminergic pathways). In humans, the mechanism ...
Pharmacokinetic properties
Piribedil is absorbed rapidly. The maximum concentration is reached one hour after oral administration of piribedil. Plasma elimination is biphasic and is composed of a first phase characterised by a half-life ...
List of excipients
Povidone Magnesium stearate Talc Sodium hydrogen carbonate Carmellose sodium White beeswax Titanium dioxide (E171) Cochineal red A aluminium lake (E124) Polysorbate 80 Sucrose Colloidal anhydrous silica ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 30°C.
Nature and contents of container
10, 20, 30, 40, 50, 60 or 100 tablets in blisters (PVC/Aluminium).
Special precautions for disposal and other handling
LES LABORATOIRES SERVIER
Marketing authorization holder
Les Laboratoires Servier
Date of revision of the text
August 2013
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