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Preductal® OD (Trimetazidine) 80 mg, 30 capsules

$38.00

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Description

Other brand names: Vastarel, Moduxin, Matenol, Tacirel LM, Angiozil Retard, Trimet, Cardimax


Composition

One tablet contains the active ingredient: Trimetazidine dihydrochloride – 80 mg

 

Indications for use

Preductal® OD 80 mg is indicated in adults as adjunctive therapy for the symptomatic treatment of patients with stable angina that is not well controlled or who cannot tolerate first-line antianginal drugs

 

Dosage and administration

Preductal® OD 80 mg capsules should be taken orally, without opening them, once a day, one capsule in the morning during breakfast. After three months of treatment, the benefit of therapy should be evaluated, and if the effect of treatment is not observed, trimetazidine should be discontinued.

Special patient groups

Patients with renal insufficiency

With moderate renal failure (creatinine clearance 30-60 ml / min)

the recommended dose should be reduced to one 35 mg tablet in the morning with food.

Elderly patients

In elderly patients, due to the age-related decrease in kidney function, the elimination period of the drug is extended, so select the dose with caution. In patients with moderate renal insufficiency (CC 30-60 ml / min), the recommended dose is 1 tablet of 35 mg in the morning during breakfast. Caution should be exercised when titrating doses in elderly patients.

Children:

The safety and efficacy of Preductal® OD 80 mg in children under 18 years of age have not been established.

 

Side effects

Adverse reactions, defined as adverse events that are at least possibly related to trimetazidine therapy, are listed below and correspond to the following gradation:

Very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10000, <1/1000); very rarely (<1/10000); unspecified frequency (cannot be estimated from the available data).

Often

– dizziness, headache

– abdominal pain, diarrhea, dyspepsia, nausea, vomiting

– rash, pruritus, urticaria

– asthenia

Seldom

– palpitations, extrasystole, tachycardia

– arterial hypotension; orthostatic hypotension, which may be associated with malaise, dizziness, or a fall in the patient, especially in those patients receiving antihypertensive drugs

– hyperemia

Frequency unknown

– symptoms of parkinsonism (tremor, akinesia, hypertension), unsteady gait, restless legs syndrome, other movement disorders, usually reversible after discontinuation of the drug

– constipation

– acute generalized exanthematous pustulosis (AGEP), angioedema

– agranulocytosis, thrombocytopenia, thrombocytopenic purpura

– hepatitis

– sleep disorders (insomnia, drowsiness)

– vertigo

 

Contraindications

– hypersensitivity to the active substance or to any of the excipients

– Parkinson’s disease, parkinsonian symptoms, tremors, restless leg syndrome and other movement disorders

– severe renal dysfunction (creatinine clearance<30 ml/min)

– children and adolescents under 18 years of age (efficacy and safety have not been established)

 

Drug Interactions

There are no data on interactions with other drugs.

 

Special instructions

Preductal® OD 80 mg is not intended for the relief of angina attacks, as well as for the initial course of therapy for unstable angina or myocardial infarction, before hospitalization or in the first days of hospitalization.

In the event of an angina attack, coronary disease should be re-evaluated and the therapy prescribed (medical treatment and possibly revascularization) should be reviewed.

Trimetazidine may cause or worsen symptoms of parkinsonism (tremor, akinesia, hypertension) which should be monitored regularly, especially in elderly patients. In cases of doubt, patients should be referred to a neurologist for appropriate investigations.

With the appearance of movement disorders, such as parkinsonism, restless legs syndrome, tremor, unsteady gait, it is necessary to stop taking the drug.

These cases have a low frequency and are usually reversible upon discontinuation of the drug. In most patients, recovery occurs within 4 months after trimetazidine is discontinued. If the symptoms of parkinsonism persist for more than 4 months after stopping the drug, you should contact a neurologist.

Patient falls associated with unsteady gait or hypotension may occur, particularly in patients taking antihypertensive drugs.

Caution should be exercised when taking the drug in patients who have an increased time to remove trimetazidine from the body:

– moderate impairment of kidney function;

– Elderly patients over 75 years of age.

The composition of the drug includes sucrose, so the drug is not recommended for patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome and sucrase-isomaltase deficiency.

USE IN PREGNANCY AND DURING BREASTFEEDING
PREGNANCY

THERE ARE NO DATA ON THE USE OF TRIMETAZIDINE IN PREGNANT WOMEN. ANIMAL STUDIES DIRECT OR INDIRECT TOXIC EFFECTS ON REPRODUCTIVE FUNCTION HAVE NOT BEEN DETECTED. THEREFORE, FOR SAFETY, TRIMETAZIDINE SHOULD BE AVOIDED DURING PREGNANCY.

LACTATION

IT IS UNKNOWN WHETHER TRIMETAZIDINE IS EXCLUDED IN HUMAN MILK, SO A RISK TO THE NEWBORN / INFANT CANNOT BE EXCLUDED. DO NOT USE PREDUCTAL® OD DURING BREASTFEEDING.

FERTILITY

NO REPRODUCTIVE TOXICITY EFFECTS ON FELTILITY IN MALE AND FEMALE RATS (SEE NON-CLINICAL SAFETY DATA SECTION).

FEATURES OF THE DRUG INFLUENCE ON THE ABILITY TO DRIVE A VEHICLE OR POTENTIALLY DANGEROUS MECHANISMS.

TRIMETAZIDINE HAS NOT SHOWED A HEMODYNAMIC EFFECT ON THE ORGANISM IN CLINICAL STUDIES. HOWEVER, VERTIGO AND Drowsiness HAS BEEN REPORTED IN POST-MARKET STUDIES WHICH MAY AFFECT THE ABILITY TO DRIVE AND OPERATE MECHANISMS.

 

OVERDOSE

SYMPTOMS: ARTERIAL HYPOTENSION, FLUSHES.
TREATMENT: SYMPTOMATIC.

 

STORAGE CONDITIONS

STORE AT A TEMPERATURE NOT ABOVE 30°C.
KEEP OUT OF THE REACH OF CHILDREN!
SHELF LIFE 3 YEARS

Additional information

Ingredient

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