Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MYCOPHENOLIC ACID (AS SODIUM SALT)
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
MYCOPHENOLIC ACID (AS SODIUM SALT)
50Tablet Tablets; 100Tablet Tablets; 120Tablet Tablets
NOVARTIS PHARMA PRODUKTIONS GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ MYFORTIC ® GASTRO-RESISTANT TABLETS Mycophenolic acid (180mg, 360mg) 1 WHAT IS IN THIS LEAFLET 1. What Myfortic is used for 2. How Myfortic works 3. Before you use Myfortic 4. How to use Myfortic 5. While using Myfortic 6. Side effects 7. Storage and Disposal of Myfortic 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT MYFORTIC IS USED FOR Myfortic gastro-resistant tablets belong to the class of drugs known as immunosuppressants. Immunosuppressants reduce your body’s response to anything that it sees as “foreign” – which includes transplant organs. HOW MYFORTIC WORKS Myfortic is used to prevent your body from rejecting a transplanted kidney. Myfortic is used together with other medicines containing ciclosporin and corticosteroids. If you have any questions about how Myfortic works or why this medicine has been prescribed for you, ask your doctor. BEFORE YOU USE MYFORTIC Myfortic will only be prescribed for you by a doctor experienced in transplantation medicine. Follow your doctor’s instructions carefully. They might differ from the general information contained in this leaflet. _- When you must not use it _ _DO NOT TAKE MYFORTIC _ • If you are allergic (hypersensitive) to mycophenolic acid, mycophenolate sodium or mycophenolate mofetil or to any of the other ingredients of Myfortic listed at the end of this leaflet. • if you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage • if you are pregnant or planning to become pregnant or think you may be pregnant • if you are not using effective contraception (see Contraception in women and men). • if you are breast-feeding (see also “Pregnancy and breast-feeding”). If any of the above apply to you, tell your doctor without taking Myfortic. _PREGNANCY AND BREAST-FEEDING _ If you are pregnant or breast-feeding, think you may be pre Baca dokumen lengkap
Novartis Page 2 Malaysia Package Leaflet 31-May-2021 Myfortic MYFORTIC Immunosuppressant DESCRIPTION AND COMPOSITION 180 mg Myfortic tablet comes as a lime green, film-coated, round tablet, with beveled edges and the imprint (debossing) “C” on one side. 360 mg Myfortic _ _ tablet comes as a pale orange-red, film-coated, ovaloid tablet with imprint (debossing) “CT” on one side. PHARMACEUTICAL FORM Gastro-resistant tablets ACTIVE SUBSTANCE Each gastro-resistant tablet contains 180 mg or 360 mg mycophenolic acid (MPA) equivalent to 192.4 mg and 384.8 mg mycophenolate sodium. The two dosage strengths may not be available in all countries. EXCIPIENTS Maize starch; povidone (K-30); crospovidone; lactose; colloidal silicon dioxide; magnesium stearate. The gastro resistant tablet coating of 180 mg Myfortic consists of hypromellose phthalate/ hydroxypropylmethylcellulose phthalate; titanum dioxide; iron oxide yellow; indigotin. The gastro resistant tablet coating of 360 mg Myfortic consists of hypromellose phthalate/ hydroxypropylmethylcellulose phthalate; titanium dioxide; iron oxide yellow; iron oxide red. Pharmaceutical formulations may vary between countries. INDICATIONS Myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN The recommended dose is 720 mg (four 180 mg or two 360 mg Myfortic gastro-resistant tablets) twice daily (1,440 mg daily dose). In patients receiving 2 g mycophenolate mofetil (MMF), treatment can be replaced by 720 mg twice daily (1,440 mg daily dose) of Myfortic. GENERAL TARGET POPULATION Novartis Page 3 Malaysia Package Leaflet 31-May-2021 Myfortic Treatment with Myfortic should be initiated and maintained by appropriately qualified transplant specialists. Myfortic _ _ should be initiated in _de-novo_ patients within 48 hours following transplantation. Myfortic can be taken with or without food. SPECIAL POPULA Baca dokumen lengkap