Trimetazidine dihydrochloride 20 mg.
For one film-coated tablet.
Excipients with known effect: Sunset yellow FCF (E110) and cochineal red A (E124).
Pharmacology: Pharmacodynamics: In patients with ischemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant hemodynamic effects.
Pharmacokinetics: Absorption: After oral administration, absorption of trimetazidine is rapid and the plasma peak is reached in less than 2 hours. After a single oral dose of 20 mg of trimetazidine, the peak plasma concentration is approximately 55 ng.ml-1. During repeated administration, the steady state is reached after 24 to 36 hours and remains very stable throughout treatment.
Distribution: The apparent distribution volume is 4.8 l/kg, which suggests good tissue diffusion. Protein binding is low: in vitro measurements give a value of 16%.
Elimination: Trimetazidine is eliminated primarily in the urine, mainly in the unchanged form. The mean elimination half-life is 6 hours.
Linearity: Trimetazidine pharmacokinetics is linear following single dose administration up to 100 mg. Repeated doses showed a time-linear pharmacokinetic response.
Elderly: Trimetazidine exposure may be increased in elderly patients due to an age-related decrease in renal function. A pharmacokinetics study performed specifically in elderly (75-84 years) and very elderly (≥85 years) participants showed that in the event of moderate renal impairment (creatinine clearance between 30 and 60 ml/min) trimetazidine exposure was increased by a factor of 1.0 and 1.3, respectively in comparison with younger participants (30-65 years) with moderate renal impairment. No safety concerns were observed in the elderly subjects as compared with the general population.
Renal impairment: On average, trimetazidine exposure is multiplied by 1.7 in patients with moderate renal impairment (creatinine clearance between 30 and 60 ml/min) and by 3.1 in patients with severe renal impairment (creatinine clearance below 30 ml/min) compared with healthy young volunteers with normal renal function. No safety concerns were observed in this population as compared with the general population.
Pediatric population: The pharmacokinetics of trimetazidine have not been studied in the pediatric population (<18 years).
Preventive treatment of episodes of angina pectoris.
Adjuvant symptomatic treatment of vertigo and tinnitus.
Adjuvant treatment of visual disorders of circulatory origin.
3 tablets/day to be taken in 3 divided doses with meals.
Limited information is available on trimetazidine overdose. Treatment should be symptomatic.
Hypersensitivity to trimetazidine or to any of the other ingredients of Vastarel 20.
Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Severe renal impairment (creatinine clearance <30 mL/min).
This medicinal product is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris or myocardial infarction, nor in the pre-hospital phase or during the first days of hospitalization.
In the event of an angina attack, the coronaropathy should be reevaluated and an adaptation of the treatment considered (medicinal treatment and possibly revascularization).
This medicinal product can aggravate or cause symptoms similar to those of Parkinson's disease (tremor, difficulty in making movements, rigidity of limbs), which should be investigated and reported to the doctor, especially in elderly patients. In doubtful cases, patients should be referred to a neurologist for appropriate investigations.
The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of Trimetazidine (Vastarel 20).
These cases have a low incidence and are usually reversible after treatment discontinuation. The majority of the patients recovered within 4 months after Trimetazidine (Vastarel 20) withdrawal. If parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist's opinion should be sought.
Falls may occur following a drop in blood pressure or a loss of balance, in particular in patients taking antihypertensive treatment.
Caution should be exercised in patients with moderate renal impairment and elderly (>75 years old).
This medicine contains sunset yellow FCF S (E 110) and cochineal red A (E 124) and may cause allergic reactions.
Driving and using machines: Trimetazidine (Vastarel 20) does not have hemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience, which may affect ability to drive and use machines.
Pregnancy: There are no data from the use of trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine (Vastarel 20) during pregnancy.
Breastfeeding: It is unknown whether trimetazidine/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine (Vastarel 20) should not be used during breastfeeding.
As with all medicines, Trimetazidine (Vastarel 20) is likely to have side effects, although not everyone may be prone to them.
The table as follows includes the adverse reactions from spontaneous notifications and scientific literature.
Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data). (See table.)
Click on icon to see table/diagram/image
No drug interaction has been reported.
Store at temperatures not exceeding 30°C.
C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.
Tab 20 mg (red, lenticular) x 100's.