Vastarel MR modified release film-coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TRIMETAZIDINE DIHYDROCHLORIDE

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

C01EB15

INN (International Name):

TRIMETAZIDINE DIHYDROCHLORIDE 35 mg

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

TRIMETAZIDINE DIHYDROCHLORIDE 35 mg

Prescription type:

POM

Therapeutic area:

CARDIAC THERAPY

Authorization status:

Authorised

Authorization date:

2005-10-06

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
VASTAREL MR 35 MG, MODIFIED RELEASE FILM-COATED TABLETS
Trimetazidine dihydrochloride
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 VASTAREL MR is and what it is used for
2.
Before you take VASTAREL MR
3.
How to take VASTAREL MR
4.
Possible side effects
5.
How to store VASTAREL MR
6.
Further information
1.
WHAT VASTAREL MR 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).
2.
BEFORE YOU TAKE VASTAREL MR
DO NOT TAKE VASTAREL MR
-
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 MR.
This drug is not a curative treatment for angina attacks, nor is it
indicated as an initial treatment for unstable
angina, or myocardial infarction. In case of a myocardial infarction,
it should not be used in the pre-hospital
phase, or during the first days of hospitalization.
In the event of an angina attack, the coronary artery disease should
be reevaluated and an adaptation of the
treatment considered (drug treatment and possibly revascularisation).
This medicine can cause or worsen symptoms such as trembling, rigid
posture, slow movements and a
shuffling, unbalanced walk

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
VASTAREL MR
35 mg, modified release film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 35 mg trimetazidine dihydrochloride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release 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 use.
The dose is one tablet of 35 mg 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 35 mg 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 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.
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 other related
movement disorders,
-
Severe renal impairment (creatinine clearance < 30ml/min).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Page 2 of 6
This drug is not a curative treatment for angina attacks, nor is it
indicated as an initial treatment for
unstable angina or myocardial infarction. It should not be used in the
pre-hospital phase nor during
the first days of hospitalization.
In the even