Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Ezetimibe; Rosuvastatin
PCO Manufacturing Ltd.
C10BA06
Ezetimibe; Rosuvastatin
10 mg/10 milligram(s)
Capsule, hard
rosuvastatin and ezetimibe
2021-03-05
_ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LIPOCOMB ® 10 MG/10 MG HARD CAPSULES LIPOCOMB ® 20 MG/10 MG HARD CAPSULES rosuvastatin/ezetimibe 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 Lipocomb is and what it is used for 2. What you need to know before you take Lipocomb 3. How to take Lipocomb 4. Possible side effects 5. How to store Lipocomb 6. Contents of the pack and other information 1. WHAT LIPOCOMB IS AND WHAT IT IS USED FOR Lipocomb contains two different active substances in one capsule. One of the active substances is rosuvastatin, belonging to the group of so-called statins, the other active substance is ezetimibe. Lipocomb is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in your blood. In addition, it also raises levels of “good” cholesterol (HDL cholesterol). This medicine works to reduce your cholesterol in two ways: it reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. For most people, high cholesterol does not affect the way they feel because it does not produce any symptoms. However, if it is left untreated, fatty deposits can build up in the walls of your blood vessels causing them to narrow. Sometimes, these narrowed blood vessels can get blocked which can cut off the blood supply to the heart or brain leading to a heart attack or a stroke. By lowering your cholesterol levels, you can reduce your risk of having Прочитать полный документ
Health Products Regulatory Authority 17 January 2024 CRN00F1HP Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipocomb 10 mg/10 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 10 mg rosuvastatin (as zinc) and 10 mg of ezetimibe. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard. _Product imported from Poland_ Unmarked self-closing Coni Snap type, hard gelatin capsule with yellow coloured cap and yellow coloured body. 4 CLINICAL PARTICULARS As per PA1470/004/001 5 PHARMACOLOGICAL PROPERTIES As per PA1470/004/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Core: Silicified microcrystalline cellulose (microcrystalline cellulose (E460) and Colloidal anhydrous silica (E551)) Colloidal anhydrous silica (E551) Magnesium stearate (E572) Povidone (E 1201) Croscarmellose sodium (E468) Microcrystalline cellulose (E460) Mannitol (E421) Sodium laurilsulfate (E514) Low-substituted hydroxypropyl cellulose (E463) Capsule shell: Cap and body: Yellow iron oxide (E172) Titanium dioxide (E171) Gelatine 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the container and outer package of the product as marketed in the country of origin. Health Products Regulatory Authority 17 January 2024 CRN00F1HP Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Store below 30 °C. Store in the original package in order to protect from light and moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Pack of 30 hard capsules in cold-formed foil blister (OPA/Al/PVC//Al) 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/460/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 th March 2021 10 DATE OF REVISION OF THE TEXT January 2024 Прочитать полный документ