Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
TRIMETAZIDINE DIHYDROCHLORIDE
Servier Laboratories (Ireland) Ltd
C01EB15
TRIMETAZIDINE DIHYDROCHLORIDE
20 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Other cardiac preparations
Authorised
1987-04-08
0214_08.02.indd 1 12/09/2017 10:43 0214_08.02.indd 2 12/09/2017 10:43 Rare (may affect up to 1 in 1,000 people): Fast or irregular heartbeats (also called palpitations), extra heartbeats, faster heartbeat, fall in blood pressure on standing-up which causes dizziness, light headiness or fainting, malaise (generally feeling unwell), dizziness, fall, flushing. Not known (frequency cannot be estimated from the available data): Extrapyramidal symptoms (unusual movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs), usually reversible after treatment discontinuation. Sleep disorders (difficulty in sleeping, drowsiness), spinning sensation (vertigo), constipation, serious generalised red skin rash with blistering, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. Severe reduction in number of white blood cells which makes infections more likely, reduction in blood platelets, which increases risk of bleeding or bruising. A liver disease (nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Vastarel 20 mg Keep this medicine out of the sight and reach of children. Do not store above 30°C. If your doctor decides to stop your treatment, return any tablets left over to the pharmacist. Only keep them if your doctor tells you to. Do not use this medicine after the expiry date which is stated on the bliste Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vastarel 20 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20mg trimetazidine dihydrochloride. Excipients with known effect: Ponceau 4R aluminium lake (E124): 0.369 mg per tablet. Sunset yellow FCF S (E110): 0.042 mg per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Red, 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 administration. Posology The dose is one tablet of 20mg of trimetazidine three times a day 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 20mg twice daily, i.e., one in the morning and one in the evening during meals. _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 20mg 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Leggi il documento completo