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VASTAREL

Information leaflet

                                                     Irish Medicines Board




                                  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
 malformation cannot be excluded. Therefore, for safety reasons, prescription should be avoided during pregnancy.




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




 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

  - 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
    alteration.

 5.3 Preclinical safety data

 Not applicable.

 6 PHARMACEUTICAL PARTICULARS

 6.1 List of excipients

 Tablet Core:

 Calcium hydrogen phosphate dihydrate
 Hypromellose
 Povidone
 Anhydrous colloidal silica




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