Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRIMETAZIDINE HYDROCHLORIDE
SERVIER MALAYSIA SDN BHD
TRIMETAZIDINE HYDROCHLORIDE
60Tablet Tablets
LES LABS SERVIER INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ VASTAREL 20 MG _Trimetazidine dihydrochloride (20mg) _ WHAT IS IN THIS LEAFLET 1. What VASTAREL 20 mg is used for 2. How VASTAREL 20 mg works 3. Before you use VASTAREL 20 mg 4. How to use VASTAREL 20 mg 5. While you are using it 6. Side effects 7. Storage and Disposal of VASTAREL 20 mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT VASTAREL 20 MG IS USED FOR OTHER CARDIOVASCULAR ANTIANGINAL DRUG - 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). HOW VASTAREL 20 MG WORKS Trimetazidine acts by inhibiting the break down of fatty acids which enhances glucose oxidation. Energy obtained during glucose oxidation requires less oxygen consumption thus optimises the heart’s energy producing function, protecting vulnerable heart muscle tissue from further oxygen-deprived damage. BEFORE YOU TAKE VASTAREL 20 MG _- When you must not use it_ Do not take VASTAREL 20 mg: • 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 20 mg. • This medicinal product is not a curative treatment for chest pain, nor an initial treatment for unstable angina pectoris (a type of chest pain). It is not a treatment for heart attack. • In the event of chest pain, 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 t Прочитайте повний документ
VASTAREL 20 mg Film- coated tablet INN : Trimetazidine 1. NAME OF THE MEDICINAL PRODUCT VASTAREL 20 mg, film -coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Trimetazidine dihydrochloride................................................................................................. 20.00 mg For one film -co ated tablet. Excipients with known effect: Sunset yellow FCF (E110) and cochineal red A (E124). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 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 Posology and method of administration Posology Oral route. The dose is one tablet of 20 mg of trimetazidine three times a day 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 po pulations 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 20 mg twice daily, i.e. one in the morning and one in the evening , during meals . 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 20 mg twice daily, i.e. one in the morning and one in the evening , during meals. Dose titration in elderly patients should be exercised with caution (see section 4.4). Paediatric population The safety and efficacy of trimetazidine in children aged below 18 years have not been established. No data are available. Final _PI_Vastarel 20mg_15.02.2018 1 Прочитайте повний документ