Vastarel 20mg 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 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TRIMETAZIDINE DIHYDROCHLORIDE 20 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 20 MG, FILM-COATED TABLET
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 20 mg is and what it is used for
2.
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.
Further 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).
2.
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 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 w

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 8
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: sunset yellow FCF (E110), ponceau 4R (E124).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
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 20 mg of trimetazidine three times a day
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 20 mg twice daily, i.e.,
one in the morning and one in
the evening during meals.
_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 20 mg 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.
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).
Page 3 of 8
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This drug is not a curative treatment for angina attacks, nor is it
i