VASTAREL 35 Milligram Modified-release Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
10-08-2017
Summary of Product characteristics
(SPC)
11-08-2017
Active ingredient:
TRIMETAZIDINE DIHYDROCHLORIDE
Available from:
Servier Laboratories (Ireland) Ltd
ATC code:
C01EB15
INN (International Name):
TRIMETAZIDINE DIHYDROCHLORIDE
Dosage:
35 Milligram
Pharmaceutical form:
Modified-release Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Other cardiac preparations
Authorization status:
Authorised
Authorization date:
2005-11-04
Patient Information leaflet
_ _
11
PACKAGE LEAFLET: INFORMATION FOR THE USER
VASTAREL 35 MG MODIFIED-RELEASE 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 toyour 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 35 mg Modified-Release Tablets is and what it is used
for
2.
What you need to know before you take Vastarel 35 mg Modified-Release
Tablets
3.
How to take Vastarel 35 mg Modified-Release Tablets
4.
Possible side effects
5.
How to store Vastarel 35 mg Modified-Release Tablets
6.
Contents of the pack and other information
1.
WHAT VASTAREL 35 MG MODIFIED-RELEASE TABLETS 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 35 MG MODIFIED-RELEASE
TABLETS
DO NOT TAKE VASTAREL 35 MG MODIFIED-RELEASE TABLETS
-
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 35 mg
Modified-Release Tablets
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
Read the complete document
Summary of Product characteristics
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.
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