Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lomitapide
Amryt Pharma
C10AX12
Lomitapide
10mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5060345160017
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 very early age. The “ Прочетете целия документ
LOJUXTA HARD CAPSULES Summary of Product Characteristics Updated 12-Dec-2016 | Aegerion Pharmaceuticals Limited 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 2. Qualitative and quantitative composition Each 5 mg hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide. Each 10 mg hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide. Each 20 mg hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide. Excipient with known effect Each 5 mg hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4). Each 10 mg hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4). Each 20 mg hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsule, hard. The 5 mg capsule is an orange cap/orange body hard capsule of 19.4 mm, printed with black ink imprinted with “5 mg” on body and “A733” on cap. The 10 mg capsule is an orange cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “10 mg” on body and “A733” on cap. The 20 mg capsule is a white cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “20 mg” on body and “A733” on cap. 4. Clinical particulars 4.1 Therapeutic indications 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 hypercholesterola Прочетете целия документ