البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Selegiline hydrochloride
PCO Manufacturing Ltd.
N04BD; N04BD01
Selegiline hydrochloride
5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Monoamine oxidase B inhibitors; selegiline
Authorised
2013-02-22
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER ELDEPRYL ® 5 MG TABLETS selegiline hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. – 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 effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Eldepryl is and what it is used for 2. What you need to know before you take Eldepryl 3. How to take Eldepryl 4. Possible side effects 5. How to store Eldepryl 6. Contents of the pack and other information 1. WHAT ELDEPRYL IS AND WHAT IT IS USED FOR Eldepryl contains the active substance selegiline hydrochloride. Eldepryl is a monoamine oxidase-B inhibitor, and is used in the treatment of Parkinson’s disease. Eldepryl may be taken alone in the early stages of your condition, delaying the need for the addition of other medicines. Eldepryl however can also be used in conjunction with other treatments such as levodopa to reduce the on-off symptoms or uncontrolled movements you may experience. This happens especially when the effects of the other treatments are wearing-off. Your doctor will explain why this medicine has been chosen for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELDEPRYL DO NOT TAKE ELDEPRYL if you are allergic (hypersensitive) to selegiline hydrochloride or any of the other ingredients of Eldepryl (listed in section 6) if you are taking any antidepressants (see Other medicines and Eldepryl). Antidepressants should be stopped a number of weeks before taking Eldepryl, speak to your doctor for further advice if you are taking a group of medicines known as sympathomimetics which are used to treat for example asthma, اقرأ الوثيقة كاملة
Health Products Regulatory Authority 15 November 2018 CRN008LXK Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eldepryl 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of selegiline hydrochloride. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet _Product imported from The UK:_ A white or almost white, round, convex uncoated tablet having a single scoreline on one face. 4 CLINICAL PARTICULARS As per PA1327/003/001 5 PHARMACOLOGICAL PROPERTIES As per PA1327/003/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Mannitol (E421) Maize starch Microcrystalline cellulose Povidone Magnesium stearate 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE Health Products Regulatory Authority 15 November 2018 CRN008LXK Page 2 of 2 The shelf life expiry date for this product shall be the date shown on the bottle and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. Keep the container tightly closed. Store in the original container. 6.5 NATURE AND CONTENTS OF CONTAINER White HDPE bottle with HDPE closure placed in cardboard outer carton. Pack size: 100 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 MARKETING AUTHORISATION NUMBER PPA0465/304/001 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/304/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 nd February 2013 Last updated: May 2015 10 DATE OF REVISION OF THE TEXT November 2018 اقرأ الوثيقة كاملة