Angimed

Trimetazidine hydrochloride 35 mg Modified Release Tablet is a light pink to reddish pink modified release tablet, circular, biconvex, plain on both sides.
Each modified release tablet contains: Trimetazidine hydrochloride 35 mg.

Pharmacology: Pharmacodynamics: Finding from in vitro and ex vivo studies of myocardial ischemia have demonstrated that trimetazidine (1) limits intracellular acidosis, (2) limits sodium and calcium accumulation, (3) maintains intracellular ATP levels and reduces creatine phosphokinase release, (4) preserves mitochondrial function, (5) reduces myocardial fatty acid metabolism and increases myocardial glucose metabolism, (6) protects against oxygen free radical-induced membrane damage, and (7) inhibits neutrophil infiltration.
By inhibiting fatty acid metabolism and secondarily stimulating glucose metabolism, trimetazidine optimizes cardiac metabolism and thus protects the heart against the harmful effects of ischemia. However, the definitive mechanism of action of trimetazidine has yet to be determined.
Pharmacokinetics: Trimetazidine is rapidly absorbed from the intestinal mucosa after oral administration.
After multiple oral administration of a 35 mg MR tablet twice daily for four days to fasted normal adults, mean peak trimetazidine plasma concentration (C_max) at steady (8^th dosing interval of 0.1±0.01 μg/mL was achieved in 4.78 ± 1.52 hours (T_max). The area under the plasma concentration-time curve (AUC_0-∞) at steady state was 1.07 ± 0.24 μg·hr/mL. The elimination half-life was 9.75 ± 10.89 hours.
Trimetazidine is only weakly protein bound in plasma (~16%) and therefore is widely distributed throughout the body. In 11 healthy volunteers, the volume of distributed (V_d) of trimetazidine was 318.6 L after a 40 mg intravenous dose.
The elimination half-life of immediate release trimetazidine 20 mg is about 6 hours after single or repeated oral administration. More than 80% of an administered dose of trimetazidine is excreted in urine within 48 hours, with 62% of the drug eliminated unchanged. Eight metabolites have been detected in urine, however, little is known of their properties.
The Trimetazidine MR 35 mg twice daily regimen is likely to result in improved patient compliance and better patient anti-ischemic protection in the early morning.

Preventive treatment of episodes of angina pectoris.
Adjuvant symptomatic treatment of vertigo and tinnitus.
Adjuvant treatment of visual disorders of circulatory origin.

Oral route: The usual dosage is 1 tablet in the morning and evening. Tablets should be swallowed with glass of water at meal times.
If the patient thinks that the effect of Trimetazidine hydrochloride is too strong or too weak, talk to a doctor or pharmacist.

Consult a doctor or pharmacist immediately.

If the patient is hypersensitive to trimetazidine or to any of the other ingredient. Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorder. Severe renal impairment (creatinine clearance <30 mL/min). This product is generally not recommended during breastfeeding.

This medicinal product is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris or myocardial infarction, nor in the pre-hospital phase or during the first days of hospitalization.
In the event of an angina attack, the coronaropathy should be reevaluated and an adaptation of the treatment considered (medicinal treatment and possibly revascularization). This medicinal product can aggravate or cause symptoms similar to those of Parkinson's disease (tremor, difficulty in making movements, rigidity of limbs) which should be investigated and reported to the doctor, especially in elderly patients. In doubtful case, patients should be referred to a neurologist for appropriate investigations. The occurrence of movement disorder such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine hydrochloride. These cases have a low incidence and are usually reversible after treatment discontinuation. The majority of the patients recovered within months after trimetazidine hydrochloride withdrawal. If parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist's opinion should be sought.
Falls may occur following a drop in blood pressure or a loss of balance, in particular in patients taking antihypertensive treatment. Caution should be exercised in patients with moderate renal impairment and elderly (>75 years old).

Pregnancy: It is preferable not to take this medicine during pregnancy. If the patient discovers that she is pregnant, while taking this medicine, consult a doctor as he alone can judge the necessity of continuing the treatment.
Lactation: In the absence of data on excretion in breast milk, breastfeeding is not recommended during treatment. Ask a doctor's or pharmacist's advice before taking any medicine.

As with all medicines, Trimetazidine hydrochloride is likely to have side effects, although not everyone may be prone to them.
Listed as follows are the side effects which have been reported using the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); not known (cannot be estimated from the available data).
Common: Dizziness, headache, abdominal pain, diarrhea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria, asthenia.
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, difficulty in making movements, and rigidity of limbs), gait instability, restless leg syndrome, other related movement disorder, usually reversible after treatment discontinuation, sleep disorder (insomnia, drowsiness), constipation, acute generalized exanthematous pustulosis (AGEP), angioedema, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, hepatitis.

Monoamine oxidase inhibitors (MAOIs): Trimetazidine hydrochloride should not be co-administered with these drugs since non interaction has not been established.
Digoxin, phenazone, theophylline: No effect on the pharmacokinetics of Trimetazidine hydrochloride.

Store at temperatures not exceeding 30°C.

Anti-Anginal Drugs

C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.

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