VASTEC 35 MR

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COMPOSITION:
Trimetazidine dihydrochloride ...... 35 mg
Excipients q.s ............................ 1 tablet
(Calcium hydrogen phosphate dihydrate, povidone K30, hypromellose, colloidal silicon dioxide,
magnesium stearate, polyethylene glycol 6000, talc, titanium dioxide, red ferric oxide).
DOSAGE FORM: Modified release film coated tablet.
PRESENTATION: Box of 5 blisters x 10 tablets.
PHARMACODYNAMICS: Mechanism of action: Trimetazidine inhibits beta oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase.  In an ischaemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the beta-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia.
Pharmacodynamic effects: In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant haemodynamic effects.
PHARMACOKINETICS: 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 Vastec 35 MR 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 Vastec 35 MR 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.
INDICATIONS:
Vastec 35 MR 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.
CONTRAINDICATIONS: - Hypersensitivity to the active ingredient or to any of the excipients listed in the composition.
- Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
- Severe renal impairment (creatinine clearance < 30 ml/min).
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 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 (see Adverse effects).
Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected (see Dosage & administration):
- Patients with moderate renal impairment.
- Elderly patients older than 75 years old.
Trimetazidine is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina or myocardial infarction, nor in the pre-hospital phase or during the first days of hospitalization.
PREGNANCY AND LACTATION: Pregnancy: In the absence of clinical data, the risk of malformation cannot be excluded. Therefore, for safety reasons, prescription should be avoided during pregnancy.
Lactation: In the absence of data on excretion in breast milk, breastfeeding is not recommended during treatment.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Trimetazidine may cause dizziness and drowsiness, which may affect ability to drive and use machine.
INTERACTIONS: No drug interactions have been identified. However, concomitant administration of Vastec 35 MR and other drugs should be monitored.
ADVERSE EFFECTS:
Nervous system disorders:
Common: Dizziness, headache.
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).
Cardiac disorders: Rare: Palpitations, extrasystoles, tachycardia.
Vascular disorders: Rare: Arterial hypotension, orthostatic hypotension that may be associated with malaise, dizziness or fall, in particular in patients taking antihypertensive treatment, flushing.
Gastrointestinal disorders:
Common: Abdominal pain, diarrhoea, dyspepsia, nausea and vomiting.
Not known: Constipation.
Skin and subcutaneous tissue disorders:
Common: Rash, pruritus, urticaria.
Not known: Acute generalized exanthematus pustulosis (AGEP), angioedema.
General disorders and administration conditions: Common: Asthenia.
Blood and lymphatic system disorders: Not known: Agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
Hepatobiliary disorders: Not known: Hepatitis.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: No documents have been reported.
DOSAGE & ADMINISTRATION: The dose is one tablet of Vastec 35 MR twice daily during meals.
The benefit of the treatment should be assessed after three months and trimetazidine should be discontinued if there is no treatment response.
Special populations:
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of Vastec 35 MR in the morning during meals. (See more in Contraindications, special warnings and precautions for use)
Elderly patients: Elderly patients may have increased trimetadizine 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 1 tablet of Vastec 35 MR in the morning during meals.
Dose titration in elderly patients should be exercised with caution. (See more in Contraindications, special warnings and precautions for use)
Paediatric population: The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.
Or as prescribed by the physician.
Keep out of reach of children.
Read the directions carefully before use.   Shelf-life: 36 months from the manufacturing date.
Consult the physician for more information.   Storage conditions: Store in dry places, not exceeding 300C, protect from light.
This drug is for prescriptions only.    Specifications: Manufacturer's.

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