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Cardiovascular Agents

Trimetazidin STADA® 20 mg

 

Pack size:

Box of 2 blisters x 30 film-coated tablets.

 

Composition: 

Each film-coated tablet contains trimetazidine dihydrochloride 20 mg.

 

Shelf-lfe:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place.

Protect from light. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • 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.
     
  • Usual dose: One tablet, three times a day during meals.
     
  • Patients with moderate renal impairment (creatinine clearance [30-60] ml/min):
    The recommended dose is one tablet, twice daily, one in the morning and one in the evening during meals.
    Elderly:
    Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function. In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is one tablet, twice daily, one in the morning and one in the evening during meals.
    Dose titration in elderly patients should be exercised with caution.
    Children:
    The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.
     

Or as prescribed by physicians.

 

  • Hypersensitivity to the active substance or to any ingredient of the drug.
  • Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
  • Severe renal impairment (creatinine clearance < 30 ml/min).

     

Common

  •  Dizziness, headache.
  •  Abdominal pain, diarrhoea, dyspepsia, nausea and vomiting.
  •  Asthenia.
  •  Rash, pruritus, urticaria.

Rare

  • Palpitations, extrasystoles, tachycardia. Arterial hypotension, orthostatic hypotension that may be associated with malaise, dizziness or fall, in particular in patients taking antihypertensive treatment, flushing.

Not known

  •  Parkinsonian symptoms (tremor, akinesia, hypertonia), gait instability, restless leg syndrome, other related movement disorders, usually reversible after treatment discontinuation.
  •  Sleep disorders (insomnia, drowsiness).
  •  Constipation.
  •  Acute generalized exanthematus pustulosis, angioedema.
  •  Agranulocytosis thrombocytopenia, thrombocytopenic purpura.
  • Hepatitis.

     

  • 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 to a neurologist for appropriate investigations.
  • The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
  • These cases have a low incidence and are usually reversible after treatment discontinuation. The majority of the patients recovered within 4 months after trimetazidine withdrawal. If parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist opinion should be sought.
  • Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment.
  • Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected:
  • Moderate renal impairment.
  • Elderly patients older than 75 years old.
  • Trimetazidine should not be prescribed to pregnancy and nursing women.
  • Trimetazidine may cause symptoms, such as dizziness and drowsiness which may affect ability to drive and use machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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