Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Fingolimod
Tillomed Pharma GmbH
L04AA27
Fingolimod
0.5 milligram(s)
Capsule, hard
fingolimod
Not marketed
2021-04-01
2 PACKAGE LEAFLET: INFORMATION FOR THE USER FINGOLIMOD TILLOMED 0.5 MG HARD CAPSULES fingolimod 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 Fingolimod Tillomed is and what it is used for 2. What you need to know before you take Fingolimod Tillomed 3. How to take Fingolimod Tillomed 4. Possible side effects 5. How to store Fingolimod Tillomed 6. Contents of the pack and other information 1. WHAT FINGOLIMOD TILLOMED IS AND WHAT IT IS USED FOR WHAT FINGOLIMOD TILLOMED IS Fingolimod Tillomed contains the active substance fingolimod. WHAT FINGOLIMOD TILLOMED IS USED FOR Fingolimod is used in adults and in children and adolescents (10 years of age and above) to treat relapsing-remitting multiple sclerosis (MS), more specifically in: - Patients who have failed to respond despite treatment with an MS treatment. or - Patients who have rapidly evolving severe MS. Fingolimod does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS. WHAT IS MULTIPLE SCLEROSIS MS is a long-term condition that affects the central nervous system (CNS), comprised of the brain and spinal cord. In MS inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and stops the nerves from working properly. This is called demyelination. Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the CNS. Symptoms vary from patient to patient but typically inv Aqra d-dokument sħiħ
Health Products Regulatory Authority 10 October 2023 CRN00DL9P Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fingolimod Tillomed 0.5 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains fingolimod hydrochloride corresponding to 0.5 mg fingolimod. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule, Hard capsule, 15.8 mm in length with bright yellow opaque cap imprinted with HP334 in black ink and white opaque body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fingolimod Tillomed is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: - Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). or - Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be initiated and supervised by a physician experienced in multiple sclerosis. Posology: In adults, the recommended dose of fingolimod is one 0.5 mg capsule taken orally once daily. In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: - Paediatric patients with body weight ≤ 40 kg: one 0.25 mg capsule taken orally once daily. Fingolimod Tillomed 0.5 mg hard capsules are not suitable for paediatric patients with body weight ≤40 kg. Other fingolimod-containing medicinal products are available in a lower strength (as 0.25 mg capsules). - Paediatric patients with body weight > 40 kg: one 0.5 mg capsule taken orally once daily. Paediatric patients who s Aqra d-dokument sħiħ