VASTAREL 20 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-01-2018
Summary of Product characteristics
(SPC)
24-01-2018
Active ingredient:
TRIMETAZIDINE DIHYDROCHLORIDE
Available from:
Servier Laboratories (Ireland) Ltd
ATC code:
C01EB15
INN (International Name):
TRIMETAZIDINE DIHYDROCHLORIDE
Dosage:
20 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other cardiac preparations
Authorization status:
Authorised
Authorization date:
1987-04-08
Patient Information leaflet
0214_08.02.indd 1
12/09/2017 10:43
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Rare (may affect up to 1 in 1,000 people):
Fast or irregular heartbeats (also called palpitations), extra
heartbeats, faster heartbeat, fall in blood pressure on
standing-up which causes dizziness, light headiness or fainting,
malaise (generally feeling unwell), dizziness, fall, flushing.
Not known (frequency cannot be estimated from the available data):
Extrapyramidal symptoms (unusual movements, including trembling and
shaking of the hands and fingers, twisting
movements of the body, shuffling walk and stiffness of the arms and
legs), usually reversible after treatment
discontinuation.
Sleep disorders (difficulty in sleeping, drowsiness), spinning
sensation (vertigo), constipation, serious generalised
red skin rash with blistering, swelling of the face, lips, mouth,
tongue or throat which may cause difficulty in
swallowing or breathing.
Severe reduction in number of white blood cells which makes infections
more likely, reduction in blood platelets,
which increases risk of bleeding or bruising.
A liver disease (nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itching, yellowing of the skin
and eyes, light coloured bowel motions, dark coloured urine).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Vastarel 20 mg
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
If your doctor decides to stop your treatment, return any tablets left
over to the pharmacist.
Only keep them if your doctor tells you to.
Do not use this medicine after the expiry date which is stated on the
bliste
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vastarel 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg trimetazidine dihydrochloride.
Excipients with known effect:
Ponceau 4R aluminium lake (E124): 0.369 mg per tablet.
Sunset yellow FCF S (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.
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