Vastarel 20 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trimetazidine dihydrochloride

Available from:

Les Laboratoires Servier

ATC code:

C01EB; C01EB15

INN (International Name):

Trimetazidine dihydrochloride

Dosage:

20 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other cardiac preparations; trimetazidine

Authorization status:

Marketed

Authorization date:

1987-04-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VASTAREL
®
20 mg Film-coated Tablets
Trimetazidine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Vastarel 20 mg is and what it is used for
2.
What you need to know before you take Vastarel 20 mg
3.
How to take Vastarel 20 mg
4.
Possible side effects
5.
How to store Vastarel 20 mg
6.
Contents of the pack and other information
1.
WHAT VASTAREL 20 MG IS AND WHAT IT IS USED FOR
This medicine is intended for use in adult patient, in combination
with other medicines to treat
angina pectoris (chest pain caused by coronary disease).
It protects the heart cells from the effects of a reduced oxygen
supply during an episode of angina.
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VASTAREL 20 MG
DO NOT TAKE VASTAREL
20 MG
-
if you are allergic to trimetazidine or any of the other ingredients
of this medicine (listed in
section 6),
-
if you have a Parkinson disease: disease of the brain affecting
movement (trembling, rigid
posture, slow movements and a shuffling, unbalanced walk),
-
if you have severe kidney problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Vastarel 20 mg.
This drug is not a cure for angina attacks and should not be used as a
treatment for unstable angina
or heart attack.
In the event of an angina attack, tell your doctor. Your treatment
should be re-evaluated.
This medicine can cause or worsen symptoms such as trembling, rigid
posture, slow movements
and a shuffling, unbalanced walk, especially

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2021
CRN009Y8R
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vastarel 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg trimetazidine dihydrochloride.
Excipients with known effect:
Ponceau 4R aluminium lake (E124): 0.369 mg per tablet.
Sunset yellow FCFS(E110): 0.042 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Red, film-coated tablets.
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 20mg of trimetazidine three times a day
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 20mg twice daily, i.e., one in the morning and one
in the evening during meals.
_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 20mg
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).
_Paediatric population:_
The safety and efficacy of trimetazidine in children aged below 18
years have not been established. No data are available.
Health Products Regulatory Authority
23 February 2021
CRN009Y8R
Page 2 of 6
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 ot