TRIMETAZIDINE Prolonged-release tablets

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Trimetazidine 35 mg prolonged-release tablets.

Qualitative and quantitative composition

Each prolonged-release tablet contains 35 mg trimetazidine dihydrochloride. For the full list of excipients, see section 6.1.

Pharmaceutical form

Prolonged-release tablet. Pink, round, biconvex film-coated tablets (diameter approx. 9.0 mm).

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. ...

Posology and method of 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) ...

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. ...

Special warnings and precautions for use

Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients. In doubtful cases, patients should be referred ...

Interaction with other medicinal products and other forms of interaction

Occurrence of interactions with other medicinal products or foodstuffs has not been found. Trimetazidine can be used with heparin, calciparine, oral anticoagulants, medicinal products used in disturbances ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of Trimetazidine in pregnant women. Animal studies are insufficient (see section 5.3). The potential risk for humans is unknown. Trimetazidine should not ...

Effects on ability to drive and use machines

Trimetazidine does not have haemodynamic effects in clinical studies, however cases of dizziness and drowsiness have been observed in post-marketing experience (see section 4.8), which may affect ability ...

Undesirable effects

Classification of expected frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated ...

Overdose

No cases of occurrence of poisoning by trimetazidine owing to its overdose have been reported.

Pharmacodynamic properties

Pharmacotherapeutic group: Other cardiac preparation ATC code: C01EB15 (C01E: Other cardiac preparations) Trimetazidine inhibits -oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, ...

Pharmacokinetic properties

Absorption Trimetazidine after oral administration and absorption from the digestive tract reaches the maximum concentration in the serum after about 5 hours from administration of the drug. The steady ...

Preclinical safety data

The acute toxicity of trimetazidine in mice, rats and guinea pigs is low. Repeated-dose toxicity studies with trimetazidine have been performed in rats and in dogs and no toxicological target organ was ...

List of excipients

Hydroxypropyl methylcellulose Calcium hydrogen phosphate Magnesium stearate Colloidal anhydrous silica Stearic acid Macrogol 6000 Glycerine Titanium dioxide (E171) Iron oxide red (E172)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 18 months.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Blisters (PVC/PVDC/aluminium) in packs of 20, 60 and 120 prolonged release tablets. Not all pack sizes may be marketed.

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