국가: 몰타
언어: 영어
출처: Medicines Authority
TRIMETAZIDINE DIHYDROCHLORIDE
Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France
C01EB15
TRIMETAZIDINE DIHYDROCHLORIDE 35 mg
MODIFIED-RELEASE TABLET
TRIMETAZIDINE DIHYDROCHLORIDE 35 mg
POM
CARDIAC THERAPY
Authorised
2005-10-06
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER VASTAREL MR 35 MG, MODIFIED RELEASE FILM-COATED TABLETS Trimetazidine dihydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What VASTAREL MR is and what it is used for 2. Before you take VASTAREL MR 3. How to take VASTAREL MR 4. Possible side effects 5. How to store VASTAREL MR 6. Further information 1. WHAT VASTAREL MR IS AND WHAT IT IS USED FOR This medicine is intended for use in adult patient, in combination with other medicines to treat angina pectoris (chest pain caused by coronary disease). 2. BEFORE YOU TAKE VASTAREL MR DO NOT TAKE VASTAREL MR - if you are allergic to trimetazidine or any of the other ingredients of this medicine (listed in section 6), - 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. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking VASTAREL MR. This drug is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina, or myocardial infarction. In case of a myocardial infarction, it should not be used in the pre-hospital phase, or during the first days of hospitalization. In the event of an angina attack, the coronary artery disease should be reevaluated and an adaptation of the treatment considered (drug treatment and possibly revascularisation). This medicine can cause or worsen symptoms such as trembling, rigid posture, slow movements and a shuffling, unbalanced walk 전체 문서 읽기
1 1. NAME OF THE MEDICINAL PRODUCT VASTAREL MR 35 mg, modified release film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 35 mg trimetazidine dihydrochloride. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified release film-coated tablets. 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 Oral use. The dose is one tablet of 35 mg of trimetazidine twice daily during meals. Special populations: _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 35 mg in the morning during breakfast. _Elderly: _ 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 35 mg in the morning during breakfast. 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. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders, - Severe renal impairment (creatinine clearance < 30ml/min). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Page 2 of 6 This drug is not a curative treatment for angina attacks, nor is it indicated as an initial treatment for unstable angina or myocardial infarction. It should not be used in the pre-hospital phase nor during the first days of hospitalization. In the even 전체 문서 읽기