البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
hydroxycarbamide
Theravia
L01XX05
hydroxycarbamide
Antineoplastic agents
Anemia, Sickle Cell
Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.
Revision: 24
Authorised
2007-06-29
25 B. PACKAGE LEAFLET _ _ 26 PACKAGE LEAFLET: INFORMATION FOR THE USER SIKLOS 100 MG FILM-COATED TABLET SIKLOS 1 000 MG FILM-COATED TABLET hydroxycarbamide 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 or nurse. - 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Siklos is and what it is used for 2. What you need to know before you take Siklos 3. How to take Siklos 4. Possible side effects 5 How to store Siklos 6. Contents of the pack and other information 1. WHAT SIKLOS IS AND WHAT IT IS USED FOR Siklos is used to prevent painful crises, including sudden chest pain, caused by sickle cell disease, in adults, adolescents and children older than 2 years. Sickle cell disease is an inherited blood disorder that affects the disc shaped red cells of the blood. Some cells become abnormal, rigid and take a crescent or sickle shape which leads to anemia. The sickle cells also get stuck in blood vessels, blocking blood flow. This can cause acute pain crises and organ damage. For severe painful crises, most patients require hospitalisation. Siklos will decrease the number of painful crises as well as the need for hospitalisation linked with the disease. The active substance of Siklos, hydroxycarbamide, is a substance which inhibits growth and proliferation of some cells, such as blood cells. These effects lead to a reduction of circulating red, white and coagulation blood cells (myelosuppressive effect). In sickle cell disease, hydroxycarbamide helps also to prevent red blood cells from taking abnormal shape. 2. WHAT YOU NEED TO KNOW BEFORE YOU اقرأ الوثيقة كاملة
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Siklos 100 mg film-coated tablet. Siklos 1 000 mg film-coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Siklos 100 mg film-coated tablet Each film-coated tablet contains 100 mg of hydroxycarbamide. Siklos 1 000 mg film-coated tablet Each film-coated tablet contains 1 000 mg of hydroxycarbamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Siklos 100 mg film-coated tablet Off-white oblong-shaped, film-coated tablet with half-scoring on both sides. The tablet can be divided into two equal parts. Each half of tablet is embossed “H” on one side. Siklos 1 000 mg film-coated tablet Off-white, capsule-shaped, film-coated tablet with triple scoring on both sides. The tablet can be divided into four equal parts. Each quarter of tablet is embossed “T” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic sickle cell syndrome (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Siklos should be initiated by a physician experienced in the management of patients with sickle cell syndrome. Posology _In adults, adolescents and children older than 2 years _ The posology should be based on the patient’s body weight (b.w.). The starting dose of hydroxycarbamide is 15 mg/kg b.w. and the usual dose is between 15 and 30 mg/kg b.w./day. As long as the patient responds to therapy either clinically or haematologically (e.g. increase in haemoglobin F (HbF), Mean Corpuscular Volume (MCV), decrease in neutrophil count), the dose of Siklos should be maintained. In case of non-response (re-occurrence of crises or lack of reduction in crisis rate), the daily dose may be increased by steps of 2.5 to 5 mg/kg b.w./day using the most appropriate strength. Under ex اقرأ الوثيقة كاملة