TRIMETAZIDINE 35 Milligram Tablet Prolonged Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
TRIMETAZIDINE DIHYDROCHLORIDE
Available from:
Servier Laboratories (Ireland) Ltd
INN (International Name):
TRIMETAZIDINE DIHYDROCHLORIDE
Dosage:
35 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2014-09-23
Patient Information leaflet
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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIMETAZIDINE 35MG PROLONGED-RELEASE TABLETS
TRIMETAZIDINE DIHYDROCHLORIDE
This medicine is subject to additional monitoring. This will allow quick identification of new
safety information. You can help by reporting any side effects you may get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Trimetazidine 35mg Prolonged-Release Tablets is and what it
is used for
2.
What you need to know before you
take Trimetazidine 35mg Prolonged-Release Tablets
3.
How to take Trimetazidine 35mg Prolonged-Release Tablets
4.
Possible side effects
5.
How to store Trimetazidine 35mg Prolonged-Release Tablets
6.
Further information
1. WHAT TRIMETAZIDINE 35MG
PROLONGED-RELEASE TABLETSIS 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 TRIMETAZIDINE 35MG PROLONGED-RELEASE TABLETS
DO NOT TAKE TRIMETAZIDINE 35MG PROLONGED-RELEASE TABLETS
- if you are allergic to trimetazidine or any of
the other ingredients of this medicine (listed in
section 6
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Trimetazidine 35 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 35mg trimetazidine dihydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-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.
The dose is one tablet of 35mg of trimetazidine twice daily during meals.
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 35mg 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 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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