Amtaz

White, circular, biconvex tablet plain on both sides.
Each modified-release tablet contains: Trimetazidine Hydrochloride 35 mg.

Pharmacologic category: Anti-angina.
Pharmacology: Pharmacodynamics: Trimetazidine inhibits oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation. In an ischemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischemia.
Pharmacodynamic effects: In patients with ischemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Anti-ischemic effects are achieved without concomitant hemodynamic effects.
Pharmacokinetics: 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 concentration of the drug in the serum is reached after 60 hours and is stable throughout the period of treatment. No interactions with foodstuffs have been found.
Distribution: The drug binds to plasma proteins at about 16%. The volume of distribution is 4.8 L/kg, which means good penetration of the drug into the tissues.
Elimination: Trimetazidine is eliminated mainly in the urine, in unchanged form. The average half-life is 7 hours, in patients over age 65 years it increases to 12 hours.
Pharmacokinetics in special populations: No pharmacokinetic data are available for the use of trimetazidine in hepatically impaired patients.

Used in adult patient, in combination with other medicines to treat angina pectoris (chest pain caused by coronary disease).

The dose is one tablet of 35 mg of Trimetazidine 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: Patients with renal impairment: In patients with moderate renal impairment (creatinine clearance [30-60] mL/min), the recommended dose is 1 tablet of 35 mg in morning during breakfast.
Elderly patients: 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 1 tablet of 35 mg in the morning during breakfast. Dose titration in elderly patients should be exercised with caution.
Pediatric population: The safety and efficacy of trimetazidine in children aged below 18 years have not been established.
Mode of Administration: For oral use. Tablets must be taken orally twice daily, i.e., one in the morning and one in the evening during meals.

If the patient takes more Trimetazidine Hydrochloride tablet than they should, inform the doctor or pharmacist.
If they forget to take Trimetazidine Hydrochloride tablet: Resume treatment normally. Do not double the dose the day after missed dose.

Do not take if patient is: Hypersensitive to the active substance or to any of the excipients of this formulation.
If the patient has Parkinson's disease: disease of the brain affecting movement (trembling, rigid posture, slow movements and a shuffling, unbalanced walk).

Talk to a doctor or pharmacist before taking Trimetazidine Hydrochloride tablet. This medicinal product is generally not recommended during breast-feeding.
This medicinal product is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris. It is not a treatment for myocardial infarction. In the event of an angina attack, inform a doctor. Tests may be required and treatment may possibly be modified. This medicine can cause or worsen symptoms such as trembling, rigid posture, slow movements and a shuffling, unbalanced walk, especially in elderly patients, which should be investigated and reported to a doctor who could reassess the treatment. Falls may occur following a drop in blood pressure or a loss of balance.
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.
Driving and using machines: This medicine may make the patient feel dizzy and drowsy that may affect the ability to drive or use machinery.
Use in Children: Children and adolescents: Trimetazidine Hydrochloride tablet is not recommended in children aged below 18 years.

Pregnancy: It is preferable not to take this medicine during pregnancy. If the patient discovers that they are pregnant while taking this medicine, consult the doctor as he alone can judge the necessity of continuing treatment.
Breast-feeding: In the absence of data on excretion in breast milk, breast-feeding is not recommended during treatment. If the patient is pregnant or breast-feeding, thinking that they may be pregnant or are planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.

As with all medicines, Trimetazidine Hydrochloride tablet is likely to have side effects, although not everyone may be prone to them. The frequency of possible side effects listed as follows is defined using the following convention: Very common (affects more than 1 user in 10), Common (affects 1 to 10 users in 100), Uncommon (affects 1 to 10 users in 1000), Rare (affects 1 to 10 users in 10000), Very rare (affects less than 1 user in 10000), Not known (frequency cannot be estimated from the available data).
Common: Dizziness, headache, abdominal pain, diarrhea, indigestion, feeling sick, vomiting, rash, itching, hives and feeling of weakness.
Rare: Fast or irregular heartbeats (also called palpitations), extra heartbeats, faster heartbeat, fall in blood pressure on standing-up which causes dizziness, lightheadedness or fainting, malaise (generally feeling unwell), dizziness, fall, flushing.
Not known: Extrapyramidal symptoms (unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs), usually reversible after treatment discontinuation. Sleep disorders (difficulty in sleeping, drowsiness), constipation, serious generalised red skin rash with blistering, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. Severe reduction in number of white blood cells which makes infections more likely, reduction in blood platelets, which increases risk of bleeding or bruising. A liver disease (nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine).

Patient must inform doctor or pharmacist if they are taking, or have recently taken any other medicines, even if it is a medicine that they can buy without a prescription.

Instructions and special precautions for handling and disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Store at temperatures not exceeding 30°C.

Anti-Anginal Drugs

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

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