VASTAREL (2014)
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Marketing authorization number(s)
PA 68/10/1
Date of revision of the text
August 2014
Special precautions for storage
Do not store above 30°C.
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 ...
Preclinical safety data
Not applicable.
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.
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 ...
Incompatibilities
Not applicable.
Special precautions for storage
No special requirements.
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 ...
Nature and contents of container
Cartons of 30, 60 and 90 tablets in PVC/Aluminium blisters. Not all pack sizes may be marketed.
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 ...
Name of the medicinal product
VASTAREL 20 mg Film-coated Tablets.
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 ...
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 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 8th April 1987 Date of last renewal: 8th April 2007
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, ...
Overdose
Very limited information is available on Trimetazidine overdose. Treatment should be symptomatic.
Interaction with other medicinal products and other forms of interaction
No drug interactions have been identified.
Marketing authorization holder
Servier Laboratories (Ireland) Limited Block 2 West Pier Business Campus Old Dunleary Road Dun Laoghaire Co. Dublin.
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 ...
Shelf life
Shelf life: 3 years.