VASTAREL XR EXTENDED-RELEASE HARD CAPSULE 80 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Trimetazidine dihydrochloride

Available from:

SERVIER (S) PTE LTD

ATC code:

C01EB15

Pharmaceutical form:

CAPSULE, EXTENDED RELEASE

Composition:

Trimetazidine dihydrochloride 80 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Egis Pharmaceuticals PLC (Production site of Körmend)

Authorization status:

ACTIVE

Authorization date:

2020-01-20

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
VASTAREL
®
XR 80 mg, extended-release hard capsule.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One extended-release hard capsule contains 80 mg of trimetazidine
dihydrochloride
Excipient with known effect:
Sucrose 33.75mg per capsule
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Extended-release hard capsules.
Hard capsule with a white body and an orange red cap with a printed
white Servier logo
and “80”
on it.
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
The dose is one capsule of 80mg of trimetazidine once daily during
breakfast.
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 Vastarel MR 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 Vastarel MR 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.
Method of administration
Capsule must be taken orally without opening it, once daily
_i.e_
. one in the morning during breakfast
2
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients
listed