Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRIMETAZIDINE DIHYDROCHLORIDE
SERVIER MALAYSIA SDN BHD
TRIMETAZIDINE DIHYDROCHLORIDE
30 Capsules; 10 Capsules
Egis Pharmaceuticals PLC
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 VASTAREL ® XR 80MG_ _ _Trimetazidine dihydrochloride 80mg, prolonged-release hard capsule _ WHAT IS IN THIS LEAFLET 1. What VASTAREL XR is used for 2. How VASTAREL XR works 3. Before you use VASTAREL XR 4. How to use VASTAREL XR 5. While you are using it 6. Side effects 7. Storage and disposal of VASTAREL XR 8. Product description 9. Manufacturer and Product registration holder 10. Date of revision WHAT VASTAREL XR IS USED FOR VASTAREL XR is intended for use in adults, in combination with other medicines to treat angina pectoris (chest pain caused by coronary disease). HOW VASTAREL XR WORKS VASTAREL XR contains an active ingredient, trimetazidine dihydrochloride. It acts by inhibiting the breakdown of fatty acids which enhances glucose oxidation. Glucose oxidation requires less oxygen consumption thus, optimises the heart's energy producing function, protecting vulnerable heart muscle tissues from further oxygen-deprived damage. BEFORE YOU USE VASTAREL XR _When you must not use it_ _DO NOT TAKE VASTAREL XR IF _ _YOU: _ • are allergic to trimetazidine or any of the other ingredients of this medicine (listed in ingredients section), • have a Parkinson disease: disease of the brain affecting movement (trembling, rigid posture, slow movements and a shuffling, unbalanced walk), • have severe kidney problems. _Before you start to use it _ _WARNINGS AND PRECAUTIONS _ Talk to your doctor or pharmacist before taking VASTAREL XR. This drug is not a curative treatment for angina attacks, nor an initial treatment for unstable angina or heart attack (myocardial infarction). In the event of an angina attack, inform your doctor. Tests may be required and your treatment may possibly be modified. This medicine can cause or worsen symptoms Parkinsonian 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. Falls ma Leggi il documento completo
1 1. NAME OF THE MEDICINAL PRODUCT Vastarel ® XR 80 mg, prolonged-release hard capsule. _ _ _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ One prolonged-release hard capsule contains 80 mg of trimetazidine dihydrochloride _ _ _ _ Excipient with known effect: Sucrose 33.75mg per capsule For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release hard capsules. Hard capsule with a white body and an orange red cap with a printed white Servier logo and “80” on it. 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 The dose is one capsule of 80mg of trimetazidine once daily during breakfast. This dosage regimen with Vastarel 80mg is equivalent to the following regimen with Vastarel 20mg or Vastarel 35mg. Vastarel 20mg: one tablet of 20 mg of trimetazidine three times a day during meals. Vastarel 35mg: one tablet of 35mg of trimetazidine 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 reduced by half _ie_ , 1 tablet of 20mg twice daily, one in the morning and one in the evening during meals or 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 reduced by half _ie_ , 1 tablet of 20mg twice daily, one in the morning and one Leggi il documento completo