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VASTAREL

Main information

  • Trade name:
  • VASTAREL Tablet Prolonged Release 35 Milligram
  • Available from:
  • Servier Laboratories (Ireland) Ltd
  • Dosage:
  • 35 Milligram
  • Pharmaceutical form:
  • Tablet Prolonged Release
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • VASTAREL Tablet Prolonged Release 35 Milligram
    Ireland
  • Language:
  • English

Other information

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Status

  • Source:
  • IMB
  • Authorization date:
  • 04-11-2005
  • Last update:
  • 09-08-2016

Summary of Product characteristics

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

VASTAREL 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

It is intended for use in the management of angina pectoris. It has been shown in a few studies to be useful in

the management of certain disorders of ischaemic origin affecting the cochleovestibular structures or the

chorioretinal tissues.

4.2 Posology and method of administration

Oral administration.

One tablet at mealtimes in the morning and evening.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use

This product should be used with caution in patients who are predisposed to closed angle glaucoma.

The drug is not a curative treatment for angina attacks, nor is 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 hospitalisation.

In the event of an angina attack, angina pectoris disease should be re-evaluated and an adaptation of the treatment

considered.

4.5 Interaction with other medicinal products and other forms of interaction

No drug interactions have been identified.

4.6 Fertility, pregnancy and lactation

Pregnancy:

Studies in animals have not demonstrated a teratogenic effect; however, in the absence of clinical data, the risk of

Irish Medicines Board

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Date Printed 14/02/2012 CRN 2082569 page number: 1

Lactation:

In the absence of data on excretion in breast milk, breastfeeding is not recommended during treatment.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Very limited information is available on Trimetazidine overdose. Treatment should be symptomatic.

4.9 Overdose

Very limited information is available on Trimetazidine overdose. Treatment should be symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Other cardiovascular antianginal drug.

ATC code : CO1E B15 (Cardiovascular system).

The drug has some anti-anoxic and vasodilator properties.

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet Core:

Calcium hydrogen phosphate dihydrate

Hypromellose

Povidone

- After oral administration, maximum concentration is found, on average, 5 hours after taking the tablet. Over 24

hours the plasma concentration remains at levels above or equal to 75% of the maximum concentration for 11

hours. Steady state is reached by the 60th hour, at the latest.

- The pharmacokinetic characteristics of Vastarel Prolonged Release 35 mg Tablets are not influenced by meals.

- The apparent distribution volume is 4.8 l/kg; protein binding is low: in vitro measurements give value of 16%.

- Trimetazidine is eliminated primarily in the urine, mainly in the unchanged form.

- The elimination half-life of Vastarel Prolonged Release 35 mg Tablets is an average of 7 hours in healthy young

volunteers and 12 hours in subjects aged more than 65 years. Total clearance of trimetazidine is the result of major

renal clearance which is directly correlated to creatinine clearance and, to a lesser extent, to liver clearance which

is reduced with age.

- A specific clinical study carried out in an elderly population using a dosage of 2 tablets per day taken in 2 doses,

analysed by a kinetic population method, showed an increase in plasma exposure which does not justify a dosage

Irish Medicines Board

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Date Printed 14/02/2012 CRN 2082569 page number: 2

Magnesium stearate

Tablet Coating:

Macrogol

Titanium dioxide (E171)

Glycerol

Hypromellose

Red iron oxide (E172)

Magnesium Stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Cartons of 10, 30, 60 and 90 tablets in PVC/Aluminium blisters.

Not all of these pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Servier Laboratories (Ireland) Ltd

First Floor, Block Two

West Pier Business Campus

Old Dunleary Rd

Dun Laoghaire

Co. Dublin

8 MARKETING AUTHORISATION NUMBER

PA 68/10/2

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 04 November 2005

Irish Medicines Board

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Date Printed 14/02/2012 CRN 2082569 page number: 3

10 DATE OF REVISION OF THE TEXT

Irish Medicines Board

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Date Printed 14/02/2012 CRN 2082569 page number: 4

There are no safety alerts related to this product.

There are no news related to this product.

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