Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Lomitapide
Amryt Pharmaceuticals DAC
C10AX12
lomitapide
Lipid modifying agents
Hypercholesterolemia
Lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinaemia and secondary causes of hypercholesterolaemia (e.g. nephrotic syndrome, hypothyroidism) must be excluded.,
Revision: 18
Authorised
2013-07-31
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET: INFORMATION FOR THE USER_ _ LOJUXTA 5 MG HARD CAPSULES LOJUXTA 10 MG HARD CAPSULES LOJUXTA 20 MG HARD CAPSULES lomitapide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Lojuxta is and what it is used for 2. What you need to know before you take Lojuxta 3. How to take Lojuxta 4. Possible side effects 5. How to store Lojuxta 6. Contents of the pack and other information 1. WHAT LOJUXTA IS AND WHAT IT IS USED FOR Lojuxta contains the active substance called lomitapide. Lomitapide is a “lipid-modifying agent” which works by blocking the action of “microsomal triglyceride transfer protein.” This protein is located within the liver and the gut cells, where it is involved in assembling fatty substances into larger particles that are then released into the blood stream. By blocking this protein, the medicine decreases the level of fats and cholesterol (lipids) in the blood. Lojuxta is used to treat adult patients with very high cholesterol because of a condition that runs in their families (homozygous familial hypercholesterolaemia or HoFH). It is typically passed down by both father and mother, who also have high cholesterol passed down from their parents. The patient’s “bad” cholesterol level is very high from a v Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lojuxta 5 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide. _Excipient with known effect _ Each hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4). Lojuxta 10 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide. _Excipient with known effect _ Each hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4). Lojuxta 20 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide. _Excipient with known effect _ Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4). Lojuxta 30 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide. _Excipient with known effect _ Each hard capsule contains 194.84 mg of lactose (as monohydrate) (see section 4.4). Lojuxta 40 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide. _Excipient with known effect _ Each hard capsule contains 259.79 mg of lactose (as monohydrate) (see section 4.4). Lojuxta 60 mg hard capsules Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide. 3 _Excipient with known effect _ Each hard capsule contains 389.68 mg of lactose (as monohydrate) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Lojuxta 5 m g hard capsules The capsule is an orange cap/orange body hard capsule of Aqra d-dokument sħiħ