VASTAREL 35mg Modified-Release Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

TRIMETAZIDINE DIHYDROCHLORIDE

제공처:

Les Laboratoires Servier

ATC 코드:

C01EB; C01EB15

INN (International Name):

TRIMETAZIDINE DIHYDROCHLORIDE

복용량:

35 milligram(s)

약제 형태:

Modified-release tablet

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Other cardiac preparations; trimetazidine

승인 상태:

Not marketed

승인 날짜:

2005-11-04

제품 특성 요약

Health Products Regulatory Authority
12 November 2019
CRN009G48
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
VASTAREL 35mg Modified-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 35 mg trimetazidine
dihydrochloride.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Modified-release tablet.
Pink round biconvex 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
Oral administration.
Posology
The dose is one tablet of 35mg of trimetazidine twice daily during
meals.
Special populations
_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 35mg in the morning during breakfast.
_Elderly _
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 35mg 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.
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 disorders,
-Severe renal impairment (creatinine clearance < 30ml/min).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should be used with caution in patients who are
predisposed to closed-angle glaucoma.
This medicine is not a curative trea