Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Sodium valproate; Valproic acid
Sanofi-Aventis Ireland Limited T/A SANOFI
N03AG; N03AG01
Sodium valproate; Valproic acid
100 milligram(s)
Prolonged-release granules
Product subject to prescription which may be renewed (B)
Fatty acid derivatives; valproic acid
Marketed
2007-03-02
PACKAGE LEAFLET: INFORMATION FOR THE USER EPILIM® CHRONOSPHERE® 100 MG PROLONGED RELEASE GRANULES EPILIM® CHRONOSPHERE® 250 MG PROLONGED RELEASE GRANULES EPILIM® CHRONOSPHERE® 500 MG PROLONGED RELEASE GRANULES Sodium valproate and Valproic acid ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 4035600 FOR HELP WARNING Epilim, sodium valproate can seriously harm an unborn child when taken during pregnancy. If you are a female able to have a baby you must use effective method of birth control (contraception) without interruptions during your entire treatment with Epilim. Your doctor will discuss this with you but you must also follow the advice in section 2 of this leaflet. Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant. Do not stop taking Epilim unless your doctor tells you to as your condition may become worse._ _ OTHER SOURCES OF INFORMATION For the most up to date patient information leaflet and important safety information on this product for girls and women of childbearing potential scan the QR code included in this leaflet and on the carton label with a smartphone. The same information is also available on the following URL: qr.epilimandme.ie Patients should select the electronic patient information leaflet which matches the name of their medicine, the name of this medicine is stated in full at the beginning of this leaflet. qr.epilimandme.ie 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 only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours. • If you get any side ef Прочитайте повний документ
Health Products Regulatory Authority 11 March 2024 CRN00F60S Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Epilim Chronosphere 100mg prolonged-release granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of prolonged-release granules contains: Sodium valproate 66.66mg Valproic acid 29.03mg Equivalent to 100mg sodium valproate Excipients with known effect: Sodium 9.22 mg (see section 4.4). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release granules. Sachets containing small, off-white to slightly yellow, waxy microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of generalised, partial or other epilepsy. Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated. The continuation of treatment after manic episode could be considered in patients who have responded to Epilim Chronosphere for acute mania. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Epilim Chronosphere is a pharmaceutical form particularly suitable for children (when they are able to swallow soft food) and adults with swallowing difficulties. Epilim Chronosphere is a controlled release formulation of Epilim, which reduces peak concentration and ensures more regular plasma concentration throughout the day. Epilim Chronosphere may be given once or twice daily. In patients where adequate control has been achieved, Epilim Chronosphere formulations are interchangeable with other conventional or prolonged-release formulations of Epilim on an equivalent daily dosage basis. Daily dosage should be established according to age and body weight and should be given to the nearest whole 50mg sachet. Partial sachets should not be used. However, the wide individual sensi Прочитайте повний документ