Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIRIBEDIL
SERVIER MALAYSIA SDN BHD
PIRIBEDIL
30Tablet Tablets
LES LABS SERVIER INDUSTRIE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 TRIVASTAL ® RETARD 50 _Piribedil, 50 mg _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What TRIVASTAL® Retard 50 is and what it is used for 2. How TRIVASTAL® Retard 50 works 3. Before you use TRIVASTAL® Retard 50 4. How to use TRIVASTAL® Retard 50 5. While you are using it 6. Side effects 7. Storage and Disposal of TRIVASTAL® Retard 50 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TRIVASTAL® RETARD 50 IS AND WHAT IT IS USED FOR Pharmacotherapeutic group - ATC Code: N04BC08 TRIVASTAL® Retard 50 is a dopamine agonist (that acts in the brain to stimulate the receptors of a substance called dopamine). THIS MEDICINE IS INDICATED: For the treatment of Parkinson’s disease alone or in combination with dopatherapy from the outset or secondarily. HOW TRIVASTAL® RETARD 50 WORKS Piribedil: dopaminergic agonist (stimulates dopamine receptors and the cerebral dopaminergic pathways). In humans, the mechanism of action is demonstrated by the clinical pharmacology studies: • stimulation of cortical electrogenesis of the "dopaminergic" type both while awake and during sleep, • clinical activity on the different functions controlled by dopamine, with this activity being demonstrated via the use of behavioural or psychometric scales. In addition, piribedil results in an increase in femoral blood flow (the existence of dopaminergic receptors in the femoral vascular bed explains the action of piribedil on peripheral circulation). BEFORE YOU USE TRIVASTAL® RETARD 50 - _When you must not use it _ _ _ DO NOT USE TRIVASTAL® RETARD 50 IN THE FOLLOWING SITUATIONS: • a history of allergy to piribedil or any of the other ingredients in this medicine listed in section 8. • myocardial infarction or any other serious cardiovascular disease, • in combination with antiemetic neuroleptics (see Taking other medicines). If you are in any doubt, you must ask your doctor or pharmacist for advice. PREGNANCY AND BREAST-FEEDING In the absen Læs hele dokumentet
1 Final PI_Trivastal_17.05.2022 TRIVASTAL ® RETARD 50 MG 1. NAME OF THE MEDICINAL PRODUCT TRIVASTAL ® RETARD 50 MG, SUSTAINED RELEASE COATED TABLETS. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Piribedil .................................................................................................................... 50.00 mg For one sustained release coated tablet . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sustained release coated tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of Parkinson's disease: • either as monotherapy, • or combined with dopatherapy from the outset, or secondarily. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Treatment of Parkinson's disease: • as monotherapy : 150 mg to 250 mg, i.e. 3 to 5 tablets daily, to be divided into 3 to 5 administrations per day. • as a supplement to dopatherapy: 1 to 3 tablets daily (approximately 50 mg of piribedil per 250mg of L.Dopa). These doses must be attained gradually: increase by one tablet every three days. _Discontinuation of treatment _ Sudden discontinuation of dopamine agents may result in neuroleptic malignant syndrome. To avoid this risk the dose of piribedil must be reduced gradually until complete discontinuation of treatment. _Impulse control disorders_ To avoid the risk of impulse control disorders, prescription of the minimum effective dose is recommended. Dose reduction or gradual discontinuation of treatment should be considered if such symptoms occur (see section 4.4). _Kidney or liver failure_ Piribedil has not been studied in these groups of patients. It is recommended to treat these patients with caution. _Paediatric population _ The safety and efficacy of piribedil in children under the age of 18 years have not been established. There is no available data. There is no justified use of piribedil in the paediatric population for this indication. _Method of administration _ Oral route. The tablets should be swallowed, without chewing, with half a glass of water at Læs hele dokumentet