VASTAREL TABLET 20 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TRIMETAZIDINE

Available from:

SERVIER (S) PTE LTD

ATC code:

C01EB15

Dosage:

20 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

TRIMETAZIDINE 20 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE

Authorization status:

ACTIVE

Authorization date:

1988-06-08

Patient Information leaflet

VASTAREL film-coated tablet 

PACKAGE INSERT 

VASTAREL 20 MG 

Film-coated tablet 

INN: Trimetazidine 

PRESENTATION AND COMPOSITION 
Box of 60 film-coated tablets, each containing 20 mg of trimetazidine dihydrochloride. 
Excipients: q.s.f. one tablet 

PROPERTIES 

_PHARMACODYNAMIC PROPERTIES _

OTHER CARDIOVASCULAR ANTIANGINAL DRUG 
ATC CODE: C01EB15 
(C: CARDIOVASCULAR SYSTEM) 

Mechanism of action 
By preserving energy metabolism in cells exposed to hypoxia or ischaemia, trimetazidine 
prevents a decrease in intracellular ATP levels, thereby ensuring the proper functioning of 
ionic pumps and transmembrane sodium-potassium flow whilst maintaining cellular 
homeostasis. 

Trimetazidine  inhibits 
β-oxidation  of  fatty  acids  by  blocking  long-chain  3-ketoacyl-CoA 
thiolase,  which  enhances  glucose  oxidation.  In  an  ischaemic  cell,  energy  obtained  during 
glucose  oxidation  requires  less  oxygen  consumption  than  in  the 
β-oxidation  process. 
Potentiation  of  glucose  oxidation  optimizes  cellular  energy  processes,  thereby  maintaining 
proper energy metabolism during ischaemia.  
Pharmacodynamic effects 
In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving 
the myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved 
without concomitant haemodynamic effects. 
Clinical efficacy and safety 
Clinical studies have demonstrated the efficacy and safety of trimetazidine in the treatment of 
patients  with  chronic  angina,  either  alone  or  when  the  benefit  from  other  antianginal 
medicinal products was insufficient.   
In  a  426-patients  randomized,  double  blind,  placebo-controlled  study  (TRIMPOL-II), 
trimetazidine  (60�

Summary of Product characteristics

1
PACKAGE INSERT
1. NAME OF THE MEDICINAL PRODUCT
VASTAREL, film-coated tablets
2. QUALITATIVE AND QUANTITIVE COMPOSITION
Trimetazidine
dihydrochloride……………………………………………….20
mg
Excipients q.s. for one film-coated tablet
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Film-coated tablet
_ _
4. CLINICAL PARTICULARS
4.1 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Oral use.
Method of administration
The dose is one tablet of 20 mg of trimetazidine three times a day
during meals.
The benefit of the treatment should be assessed after three months and
trimetazidine should
be discontinued if there is no treatment response.
Special populations
_ _
_Patients with renal impairment_
In patients with moderate renal impairment (creatinine clearance
[30-60] ml/min) (see
sections 4.4 and 5.2), the recommended dose is 1 tablet of 20 mg twice
daily, i.e., one in the
morning and one in the evening during meals.
_ _
_Elderly patients_
Elderly patients may have increased trimetazidine exposure due to
age-related decrease in
renal function (see section 5.2). In patients with moderate renal
impairment (creatinine
clearance [30-60] ml/min), the recommended dose is 1 tablet of 20 mg
twice daily, i.e., one in
the morning and one in the evening during meals.
Dose titration in elderly patients should be exercised with caution
(see section 4.4).
2
_Paediatric population: _
The safety and efficacy of trimetazidine in children aged below 18
years have not been
established. No data are available.
4.3 CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients;
-
Parkinson disease, parkinsonian symptoms, tremors, restless leg
syndrome, and other
related movement disorders;
-
Severe renal impairment (creatinine clearance < 3