Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Fenofibrate
Primecrown 2010 Limited
C10AB; C10AB05
Fenofibrate
200 milligram(s)
Capsule, hard
Oral use
Blister packs of 30
Product subject to prescription which may be renewed (B)
Recipharm Fontaine
Serum Lipid Reducing Agents/Cholesterol and Triglyceride Reducers/Fibrates
Fibrates; fenofibrate
It is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: severe hypertriglyceridaemia with or without low HDL cholesterol, mixed hyperlipidaemia when a statin is contraindicated or not tolerated, mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
Authorised
2015-04-17
PACKAGE LEAFLET: INFORMATION FOR THE USER LIPANTIL MICRO 200MG CAPSULES, HARD Fenofibrate PILLIPM200/2 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 Preberite celoten dokument
Health Products Regulatory Authority 06 November 2018 CRN008QDP Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipantil Micro 200mg capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200mg fenofibrate. Excipients with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. _Product imported from Spain:_ 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 (E 171) Red iron oxide (E 172) Yellow iron oxide (E172) Health Products Regulatory Authority 06 November 2018 CRN008QDP Page 2 of 3 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf –life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 06 November 2018 CRN008QDP Page 3 of 3 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store in the original package in order to protect from moisture. Do not store above 30°C. 6.5 NATURE AND CONTENTS OF CONTAINER Pack size: 30 capsules in blister (PVC/aluminium) contained in a repackaged outer cardboard box. 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 Primecrown 2010 Limited 4/5 Northolt Trading Estate Belvue Road Northolt Middlesex UB5 5QS United Kingdom 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1633/036/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 th April 2015 10 DATE OF REVISION OF THE TEXT November 2018 Preberite celoten dokument