NEOTAZIN^® MR

COMPOSITION: Each modified-release film-coated tablet contains:

Trimetazidinehydrochloride……................... 35 mg

Excipients:Copovidone, Lactose, Hypromellose, Colloidal anhydrous silica, Magnesium stearate, OpadryII white, Red iron oxide, Yellow iron oxide.

INDICATIONS:

Trimetazidine 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 anti-anginal therapies. 

DOSAGE AND ADMINISTRATION

Take one tablet of 35mg of trimetazidine twice daily during meals.

Special populations:

• Patients with moderaterenal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast. (see Contraindications and Warnings and precautions)
• 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 35mg in the morning during breakfast. Dose titration in elderly patients should be exercised with caution (see Contraindications and Warnings and precautions)
• Paediatric population:The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available.

CONTRAINDICATIONS

• Hypersensitivity to the active substance 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 < 30ml/min).

WARNINGS AND PRECAUTIONS

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 Undesirable effects).

Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected (see Dosage and administration):

• Moderate renal impairment
• Elderly patients older than 75 years old

USE IN PREGNANCY

None of the animal studies have shown any teratogenicity.However, in the absence of clinical data, risk of fetal deformity cannot be eliminated. As a precautionary measure, it is preferable to avoid the use of trimetazidine during pregnancy.

USE IN LACTATION

In the absence of data on excretion in breast milk, breastfeeding is not recommended during treatment.

PRESENTATION: Blister of 10 tablets; box of 3 blisters.                                                         

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and Distributed by: AMPHARCO U.S.A PHARMACEUTICAL JOINT-STOCK COMPANY

NhonTrach 3 Industrial Park, HiepPhuoc Ward, NhonTrach District, Dong Nai Province

Tel: 02513 566 202    -     Fax: 02513 566 203