VASTAREL MR TABLET 35 mg

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

TRIMETAZIDINE DIHYDROCHLORIDE

Prieinama:

SERVIER (S) PTE LTD

ATC kodas:

Pending

Dozė:

35MG

Vaisto forma:

TABLET, FILM COATED

Sudėtis:

TRIMETAZIDINE DIHYDROCHLORIDE 35 mg

Vartojimo būdas:

ORAL

Recepto tipas:

Prescription Only

Pagaminta:

LES LABORATOIRES SERVIER INDUSTRIE

Autorizacija statusas:

ACTIVE

Leidimo data:

2003-04-25

Pakuotės lapelis

Vastarel MR 

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PACKAGE INSERT 

VASTAREL MR 
INN: Trimetazidine 

PRESENTATION AND COMPOSITION 

Boxes  of  60  modified  release  film-coated  tablets,  each  containing  35mg  of 
trimetazidine dihydrochloride._ _
Excipients:  calcium  hydrogen  phosphate,  hypromellose,  povidone,  magnesium 
stearate, silica colloidal anhydrous. 
Coating:  glycerol,  macrogol,  magnesium  stearate,  hypromellose,  red  iron  oxide, 
titanium dioxide. 

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  effica

Prekės savybės

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PACKAGE INSERT
1. NAME OF THE MEDICINAL PRODUCT
VASTAREL MR TABLET 35 mg, modified release film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Trimetazidine
dihydrochloride…………………………………….35 mg_ _
Excipients q.s. for one modified release film-coated tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release 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.
The dose is one tablet of 35 mg of trimetazidine twice daily i.e. once
in the morning and
once in the evening 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 35 mg in
the morning during
breakfast. _ _
_ _
_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 35 mg
in the morning during
breakfast._ _
Dose titration in elderly patients should be exercised with caution
(see section 4.4)._ _
_ _
_Paediatric population: _
The safety and efficacy of trimetazidine in children aged below 18
years have not been
established. No data are available.
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4.3 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