Country: Malta
Language: English
Source: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
C10BA06
ROSUVASTATIN 10 mg EZETIMIBE 10 mg
FILM-COATED TABLET
ROSUVASTATIN 10 mg EZETIMIBE 10 mg
POM
LIPID MODIFYING AGENTS
Authorised
2018-10-26
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER TWICOR 10 MG / 10 MG FILM-COATED TABLETS TWICOR 20 MG / 10 MG FILM-COATED TABLETS rosuvastatin and 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 TWICOR is and what it is used for 2. What you need to know before you take TWICOR 3. How to take TWICOR 4. Possible side effects 5. How to store TWICOR 6. Contents of the pack and other information 1. WHAT TWICOR IS AND WHAT IT IS USED FOR TWICOR contains two different active substances in one film-coated tablet. One of the active substances is rosuvastatin, belonging to the group of so called statins, the other active substance is ezetimibe. TWICOR is a medicine used in adult patients to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fatty substances called triglycerides in the 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, y Read the complete document
1 1. NAME OF THE MEDICINAL PRODUCT TWICOR 10 mg/10 mg film-coated tablets TWICOR 20 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TWICOR 10 mg/10 mg film-coated tablets: Each film-coated tablet contains 10 mg of rosuvastatin (as calcium) and 10 mg of ezetimibe. TWICOR 20 mg/10 mg film-coated tablets: Each film-coated tablet contains 20 mg of rosuvastatin (as calcium) and 10 mg of ezetimibe. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. TWICOR 10 mg/10 mg film-coated tablets: Pink coloured round shaped film-coated tablet with a diameter of 10.1 mm embossed with “AL” on one side. TWICOR 20 mg/10 mg film-coated tablets: Pink coloured round shaped film-coated tablet with a diameter of 10.7 mm, plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia TWICOR is indicated as adjunct to diet for treatment of primary hypercholesterolemia as substitution therapy in adult patients adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with TWICOR. TWICOR can be administered within the dose range of 10/10 mg to 20/10 mg. The recommended dose is one film-coated tablet of the given strength per day, with or without food. TWICOR is not suitable for initial therapy. Treatment initiation should only be done with the mono- components and after setting the appropriate doses the switch to the fixed dose combination of the ap- propriate strength is possible. Treatment should be individualised according to the target lipid levels, the recommended goal of ther- apy, and the patient's response. A dose adjustment can be made after 4 weeks where necessary. TWICOR 10 mg/10 mg is not suitable for the treatment of patients requiring 20 mg dose of rosuvas- tatin. Page 2 of Read the complete document