देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Fenofibrate
PCO Manufacturing Ltd.
C10AB; C10AB05
Fenofibrate
Capsule, hard
Fibrates; fenofibrate
2022-02-18
PACKAGE LEAFLET: INFORMATION FOR THE USER LIPANTIL ® MICRO 200 MG HARD CAPSULES fenofibrate 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. WHAT IS IN THIS LEAFLET: 1. What Lipantil Micro is and what it is used for 2. What you need to know before you take Lipantil Micro 3. How to take Lipantil Micro 4. Possible side effects 5. How to store Lipantil Micro 6. Contents of the pack and other information 1. WHAT LIPANTIL MICRO IS AND WHAT IT IS USED FOR Lipantil Micro belongs to a group of medicines, commonly known as ‘fibrates’. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as ‘triglycerides’. Lipantil Micro is used, alongside a low fat diet and other non- medical treatments such as exercise and weight loss, to lower levels of fats in the blood. Lipantil Micro can be used in addition to other medicines (called ‘statins’) in some circumstances when levels of fats in the blood are not controlled with a statin alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIPANTIL MICRO DO NOT TAKE LIPANTIL MICRO IF: • you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in Section 6, Contents of the pack and other information) • while taking other medicines (such as other fibrates or an anti- inflammatory medicine called ‘ketoprofen’) you have had an allergic reaction or skin damage from sunlight or UV light. • you have severe liver, kidney or gallbladder problems • you have pancreatitis (an inflamed pancreas which causes abdominal pain), पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 21 February 2022 CRN00CS5R Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Micro 200 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg fenofibrate. Excipient(s) with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. _Product imported from Poland:_ Ochre hard gelatin capsule. 4 CLINICAL PARTICULARS As per PA2010/015/002 5 PHARMACOLOGICAL PROPERTIES As per PA2010/015/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Excipients: Lactose monohydrate Magnesium stearate Pregelatinised maize starch Sodium laurilsulfate Crospovidone. Capsule shell: Gelatin Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the blister and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original package in order to protect from moisture. Do not store above 25°C. Health Products Regulatory Authority 21 February 2022 CRN00CS5R Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips in a pack of 30 capsules. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/471/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 th February 2022 10 DATE OF REVISION OF THE TEXT पूरा दस्तावेज़ पढ़ें