Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Fingolimod
Pharmathen S.A.
L04AA27
Fingolimod
0.5 milligram(s)
Capsule, hard
fingolimod
Not marketed
2021-04-09
2 PACKAGE LEAFLET: INFORMATION FOR THE USER FINGOLIMOD PHARMATHEN 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 Pharmathen is and what it is used for 2. What you need to know before you take Fingolimod Pharmathen 3. How to take Fingolimod Pharmathen 4. Possible side effects 5. How to store Fingolimod Pharmathen 6. Contents of the pack and other information 1. WHAT FINGOLIMOD PHARMATHEN IS AND WHAT IT IS USED FOR WHAT FINGOLIMOD PHARMATHEN IS Fingolimod Pharmathen contains the active substance fingolimod. WHAT FINGOLIMOD PHARMATHEN IS USED FOR Fingolimod Pharmathen 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 Pharmathen 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 MULTIPLE SCLEROSIS IS 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 va Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 27 January 2023 CRN00CV5Q Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fingolimod Pharmathen 0.5 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 0.5 mg fingolimod (as hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule White to off-white powder in a yellow opaque cap and white opaque body size No 3 hard gelatin capsule with length 15.9 ± 0.3 mm, imprinted with "0.5 mg" on the cap with black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fingolimod Pharmathen is indicated as single disease modifying therapy in highly active relapsing-remitting multiple sclerosis (MS) 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 Pharmathen is one 0.5 mg hard capsule once daily. In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: In paediatric patients with body weight > 40 kg, the recommended dose of Fingolimod Pharmathen is one 0.5 mg hard capsule once daily. Other pharmaceutical strengths are more appropriate for administration to paediatric patients 10 years of age and above with body weight ≤ 40 kg. The same first dose monitoring as for treatment initiation is recommended when treatment is inte Olvassa el a teljes dokumentumot