Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRIMETAZIDINE DIHYDROCHLORIDE
SERVIER MALAYSIA SDN BHD
TRIMETAZIDINE DIHYDROCHLORIDE
60Tablet Tablets
LES LABS SERVIER INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 VASTAREL MR_ _ _Trimetazidine dihydrochloride, 35mg _ _ _ WHAT IS IN THIS LEAFLET 1. What VASTAREL MR is used for 2. How VASTAREL MR works 3. Before you use VASTAREL MR, 4. How to use VASTAREL MR, 5. While you are using it 6. Side effects 7. Storage and Disposal of VASTAREL MR 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VASTAREL MR IS USED FOR OTHER CARDIAC PREPARATIONS - ATC code: C01EB15 This medicine is intended for use in adult patients, in combination with other medicines to treat angina pectoris (chest pain caused by coronary disease). BEFORE YOU USE VASTAREL MR - _When you must not use it_ _DO NOT TAKE VASTAREL MR: _ • if you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section 8), • if you have a Parkinson disease: disease of the brain affecting movement (trembling, rigid posture, slow movements and a shuffling, unbalanced walk), • if you have severe kidney problems. - _Before you start to use it _ Talk to your doctor or pharmacist before taking VASTAREL MR. This medicinal product is not a curative treatment for angina attacks, nor an initial treatment for unstable angina. It is not a treatment for myocardial infarction. In the event of an chest pain angina attack, inform your doctor. Tests may be required and your 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 your doctor who could reassess the treatment. This medicinal product is generally not recommended during breastfeeding. Falls may occur following a drop in blood pressure or a loss of balance (see description of side effects). ATHLETES VASTAREL MR contains an active substance that may give a positive result in anti-doping tests. CHILDREN AND ADOLESCENTS VASTAREL MR is not recommended in children aged below Perskaitykite visą dokumentą
Final PI_Vastarel MR_Gidy_17.05.2022 1/6 VASTAREL MR INN: Trimetazidine 1. NAME OF THE MEDICINAL PRODUCT VASTAREL MR, MODIFIED RELEASE FILM-COATED TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Trimetazidine dihydrochloride………………………………………………………….35 mg _ _ Excipients q.s. for one modified release film-coated tablet. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified release film-coated tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC 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 antianginal therapies. 4.2 DOSAGE AND METHOD OF ADMINISTRATION DOSAGE Oral route. The dose is one tablet of trimetazidine 35 mg twice daily, i.e. once in the morning and once in the evening, 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) (see sections 4.4 and 5.2), the recommended dose is 1 tablet of 35mg in the morning during breakfast. _Elderly patients_ Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function (see section 5.2). 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 section 4.4). Final PI_Vastarel MR_Gidy_17.05.2022 2/6 _Paediatric population: _ The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Parkinson disease, parkinsonian symptoms, tremors, Perskaitykite visą dokumentą