VASTAREL (2014)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Name of the medicinal product
VASTAREL 20 mg Film-coated Tablets.
Qualitative and quantitative composition
Each tablet contains 20mg trimetazidine dihydrochloride. Excipients: Ponceau 4R (E124): 0.369 mg per tablet. Sunset yellow (E110): 0.042 mg per tablet. For full list of excipients, see section 6.1.
Therapeutic indications
Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies. ...
Posology and method of administration
Oral administration The dose is one tablet of 20mg of trimetazidine three times a day during meals. Special populations Patients with renal impairment: In patients with moderate renal impairment (creatinine ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders, ...
Special warnings and precautions for use
This drug is not a curative treatment for angina attacks, nor is indicated as an initial treatment for unstable angina, or myocardial infarction. It should not be used in the prehospital phase nor during ...
Interaction with other medicinal products and other forms of interaction
No drug interactions have been identified.
Pregnancy and lactation
Pregnancy Studies in animals have not demonstrated a teratogenic effect; however, in the absence of clinical data, the risk of malformation cannot be excluded. Therefore, for safety reasons, prescription ...
Effects on ability to drive and use machines
Trimetazidine does not have haemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience (see section 4.8), which may affect ability ...
Undesirable effects
Trimetazidine may cause the following undesirable effects ranked under the following frequency: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare ...
Overdose
Very limited information is available on Trimetazidine overdose. Treatment should be symptomatic.
Pharmacodynamic properties
Pharmacotherapeutic group: Other cardiovascular antianginal drug. ATC code: C01EB15 (C: cardiovascular system). Mechanism of action Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain ...
Pharmacokinetic properties
It is well absorbed and metabolised in the liver to inactive metabolites, then excreted in urine with a T ½ of 5-6 hours.
Preclinical safety data
Not applicable.
List of excipients
Maize starch Mannitol Povidone Magnesium stearate Talc Film coating Glycerol Hypromellose Macrogol 6000 Magnesium stearate Ponceau 4R aluminium lake (E124) Sunset yellow FCF aluminium lake (E110) Titanium ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C.
Special precautions for storage
No special requirements.
Nature and contents of container
Cartons of 30, 60 and 90 tablets in PVC/Aluminium blisters. Not all pack sizes may be marketed.
Marketing authorization holder
Servier Laboratories (Ireland) Limited Block 2 West Pier Business Campus Old Dunleary Road Dun Laoghaire Co. Dublin.
Marketing authorization number(s)
PA 68/10/1
Date of first authorization / renewal of the authorization
Date of first authorisation: 8th April 1987 Date of last renewal: 8th April 2007
Date of revision of the text
August 2014