Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
rilpivirine
JOHNSON & JOHNSON SDN BHD
rilpivirine
30tablet Tablets
JANSSEN-CILAG S.P.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ EDURANT ® FILM-COATED TABLET Rilpivirine (25 mg) 1 WHAT IS IN THIS LEAFLET 1. What EDURANT ® is used for 2. How EDURANT ® works 3. Before you use EDURANT ® 4. How to use EDURANT ® 5. While you are using it 6. Side effects 7. Storage and Disposal of EDURANT ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT EDURANT ® IS USED FOR EDURANT is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. EDURANT is always used in combination with other HIV medicines. Your doctor will discuss with you which combination of medicines is best for you. EDURANT in combination with other HIV medicines is used to treat adults who are infected by HIV and who have never been treated before with HIV medicines. HOW EDURANT ® WORKS EDURANT works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. BEFORE YOU USE EDURANT ® - _When you must not use it _ Do not take EDURANT if you are allergic to rilpivirine or any of the other ingredients of EDURANT. These other ingredients are listed in “Product Description”. Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (medicines to prevent and treat stomach ulcers and heartburn) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose treatment - products that contain St John’s wort (a herbal product used for depression) If you are taking any of the above, ask your doctor about alternatives. _Pregnancy and Lestu allt skjalið
PRODUCT NAME EDURANT ® 25 mg film-coated tablets DOSAGE FORMS AND STRENGTHS COMMERCIAL PRODUCT Dosage Form White to off-white, film-coated, round, biconvex, tablet of 6.4 mm, debossed with “TMC” on one side and “25” on the other side. Strength Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine. Excipient: each tablet contains 56 mg lactose monohydrate. For excipients, see _List of Excipients_ CLINICAL INFORMATION INDICATIONS EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/ml. DOSAGE AND ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology EDURANT must always be given in combination with other antiretroviral medicinal products. _ _ DOSAGE (ADULTS) The recommended dose of EDURANT is one 25 mg tablet once daily TAKEN ORALLY WITH A MEAL (see _Pharmacological properties – _ _Pharmacokinetic Properties_ ). _Dose adjustment with rifabutin coadministration_ For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) once daily, taken with a meal. When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily, taken with a meal (see _Interactions_ ). MISSED DOSE(S)_ _ If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient should take EDURANT with a meal as soon as possible and then take the next dose of EDURANT at the regularly scheduled time. If a patient misses a dose of EDURANT by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule. SPECIAL POPULATIONS Paediatric(17 years of age and younger) The safety and efficacy of EDURANT in adolescents and children are under investigation (see _Pharmacokinetic Properties)_ Lestu allt skjalið