País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MYCOPHENOLIC ACID (AS SODIUM SALT)
ACCORD HEALTHCARE SDN.BHD.
MYCOPHENOLIC ACID (AS SODIUM SALT)
5 x 10s Tablets; 10 x 10’s Tablets; 12 x 10’s Tablets
INTAS PHARMACEUTICALS LIMITED
Consumer Medication Information Leaflet (RiMUP) ACCOCEPT 180 (Mycophenolic Acid Gastro Resistant Tablets 180 mg) ACCOCEPT 360 (Mycophenolic Acid Gastro Resistant Tablets 360 mg) Mycophenolate Sodium Equivalent to Mycophenolic Acid (180 mg and 360 mg) P a g e 1 | 4 What is in this leaflet 1. What Accocept tablets are used for 2. How Accocept tablets works 3. Before you use Accocept tablets 4. How to use Accocept tablets 5. While you are using Accocept tablets 6. Side effects 7. Storage and disposal of Accocept tablets 8. Product description. 9. Manufacturer and product registration holder 10. Date of revision What Accocept tablets are used for Accocept tablets are used to stop the body’s immune system from rejecting a kidney transplant. It is used together with other medicines containing ciclosporin and corticosteroids. How Accocept tablets works Accocept tablets contains a substance called mycophenolic acid. This belongs to a group of medicines called immuno suppressants. These medicines help to reduce rejecting a kidney transplant along with other medicines containing ciclosporin and corticosteroids Before you use Accocept tablets - When you must not take it Do not take Accocept tablets if you are allergic to Mycophenolic acid, Mycophenolate sodium, Mycophenolate Mofetil or any of the other ingredients of this medicine If you are pregnant. If you are breast-feeding. If you are a woman of child bearing potential and you are not using highly effective contraception methods. If any of the above apply to you, tell your doctor without taking Accocept tablets. - Before you start to take it Talk to your doctor or pharmacist before taking Accocept tablets if: You have or have ever had serious digestive problems, such as stomach ulcer. You have a rare hereditary enzyme deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley- Seegmiller syndrome. - Taking other medicines Tell your doctor or pharmacist if you are taking, have recently taken or might take Llegiu el document complet
Package Insert ACCOCEPT 180 & 360 (Mycophenolic Acid Gastro Resistant Tablets 180 mg and 360 mg) Name and strength of active ingredient Accocept 180 Mycophenolate Sodium Ph. Eur. 192.350 mg equivalent to Mycophenolic Acid 180 mg Accocept 360 Mycophenolate Sodium Ph. Eur. 384.700 mg equivalent to Mycophenolic Acid 360 mg Product Description Accocept 180 Lime Green colored, round shaped, biconvex bevelled edged enteric-coated tablets imprinted with M1 on one side with black ink and plain on the other side. Accocept 360 Peach colored, oblong shaped, biconvex, enteric-coated tablets imprinted with M2 on one side with black ink and plain on the other side. Pharmacological Properties Pharmacodynamic Properties Mechanism of action: Mycophenolic acid (MPA) is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Because T and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells. Pharmacokinetic Properties Absorption Following oral administration, mycophenolate sodium is extensively absorbed. Consistent with its enteric coated design, the time to maximal concentration (T max ) of MPA was approximately 1.5-2 hours. Approximately 10% of all morning pharmacokinetic profiles showed a delayed T max , sometimes up to several hours, without any expected impact on 24 hour/daily MPA exposure. In stable renal transplant patients on ciclosporin based immunosuppression, the gastrointestinal absorption of MPA was 93% and the absolute bioavailability was 72%. Mycophenolic acid gastro-resistant tablets pharmacokinetics are dose proportional and linear over the studied dose range of 180 to 2,160 mg. The effect of food on Mycophenolic acid gastro-resistant tablets may lead to an absorption overlap from one dose interva Llegiu el document complet