País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Fingolimod hydrochloride
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
Fingolimod hydrochloride
28capsule Capsules; 7capsule Capsules; 98capsule Capsules
NOVARTIS PHARMA STEIN AG
_CONSUMER MEDICATION INFORMATION LEAFLET (PIL)_ GILENYA ® HARD CAPSULES Fingolimod 0.25 mg & 0.5 mg _ _ 1 WHAT IS IN THIS LEAFLET 1. What Gilenya is used for 2. How Gilenya works 3. Before you use Gilenya 4. How to use Gilenya 5. While you are using it 6. Side effects 7. Storage and Disposal of Gilenya 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT GILENYA IS USED FOR Gilenya is a prescription medicine taken orally, and is used in adults, children and adolescents (10 years of age and above) to treat relapsing forms of multiple sclerosis (MS). Gilenya does not cure MS, but it helps to reduce the number of relapses that occur and to slow the build-up of physical problems due to MS (disability progression). HOW GILENYA WORKS Gilenya can alter the way the body’s immune system works, and help to fight against attacks of the immune system by affecting the ability of some white blood cells to move freely within the body and by stopping the cells that cause inflammation from reaching the brain. This reduces nerve damage caused by MS. Gilenya may also have a direct and beneficial effect on certain brain cells (neural cells) involved in repairing or slowing down the damage caused by MS. In clinical studies Gilenya has been shown to cut down the number of attacks (by slightly more than half in adults and by slightly more than three quarters in children/adolescents) and as a consequence, to reduce the number of severe relapses and relapses that must be treated in hospital, to prolong the time without relapses and to slow the progression of disability (by about a third in adults and by about three quarters in children/adolescents). If you have any questions about how Gilenya works or why this medicine has been prescribed for you or your child, ask your doctor. BEFORE YOU USE GILENYA - _When you must not use it _ Do not take Gilenya if you: have had a heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA) or certain type Llegiu el document complet
Novartis Page 2 Malaysia Package Insert 06-Jun-2019 Gilenya GILENYA ® Immunomodulator DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Gilenya is available as: 0.25 mg hard capsules with an ivory opaque body and cap, with black radial imprint “FTY 0.25mg” on the cap and a black radial band on the capsule body. 0.5 mg hard capsules with a white opaque body and bright yellow cap imprinted with “FTY 0.5 mg” on the cap and 2 radial bands imprinted on the capsule body with yellow ink. ACTIVE SUBSTANCE 0.25 mg hard capsules: Each capsule contains 0.25 mg fingolimod (as hydrochloride). 0.5 mg hard capsules: Each capsule contains 0.5 mg fingolimod (as hydrochloride). Fingolimod hydrochloride is a synthetic analogue of sphingosine. The chemical designation is 2- amino-2[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride. Its molecular formula is C 19 H 33 NO 2 -HCl and it has a molecular weight of 343.93. Fingolimod hydrochloride is a white to almost white powder which is freely soluble in water. ACTIVE MOIETY Fingolimod EXCIPIENTS 0.25 mg hard capsules: mannitol, hydroxypropylcellulose, hydroxypropylbetadex, magnesium stearate, gelatin, titanium dioxide, iron oxide yellow. 0.5 mg hard capsules: mannitol, magnesium stearate, gelatin, titanium dioxide, iron oxide yellow. Pharmaceutical formulations may vary between countries. INDICATIONS Gilenya is indicated for the treatment of adult patients and pediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. DOSAGE AND ADMINISTRATION ASSESSMENT PRIOR TO INITIATING GILENYA Cardiac Evaluation Obtain a cardiac evaluation in patients with certain preexisting conditions (see WARNINGS & PRECAUTIONS). Prior to starting treatment, determine whether patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction [see DOSAGE AND ADMINISTRATIONS & DRUG INTERACTIONS) Complete Blood Count (CBC) Novartis Pag Llegiu el document complet