Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tacrolimus
Astellas Pharma Co. Limited
L04AD; L04AD02
Tacrolimus
5 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Calcineurin inhibitors; tacrolimus
Marketed
1996-02-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROGRAF 0.5 MG HARD CAPSULES PROGRAF 1 MG HARD CAPSULES PROGRAF 5 MG HARD CAPSULES Tacrolimus 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 Prograf is and what it is used for 2. What you need to know before you take Prograf 3. How to take Prograf 4. Possible side effects 5. How to store Prograf 6. Contents of the pack and other information 1. WHAT PROGRAF IS AND WHAT IT IS USED FOR Prograf belongs to a group of medicines called immunosuppressants. Following your organ transplant (e.g. liver, kidney, heart), your body’s immune system will try to reject the new organ. Prograf is used to control your body’s immune response enabling your body to accept the transplanted organ. Prograf is often used in combination with other medicines that also suppress the immune system. You may also be given Prograf for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROGRAF DO NOT TAKE PROGRAF - If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Prograf (listed in section 6). - If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics (e.g. erythromycin, clarithromycin, josamycin). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist before taking Prograf - You will need to take Prograf every day Soma hati kamili
Health Products Regulatory Authority 15 May 2023 CRN00DKQF Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prograf 5 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg of tacrolimus (as monohydrate). Excipient with known effect: 123.60 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Opaque greyish red hard gelatin capsules imprinted in white with 5 mg and [f] 657, containing white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prograf therapy requires careful monitoring by adequately qualified and equipped personnel. The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe. This can lead to graft rejection or increased incidence of side effects, including under- or over immunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus. Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8). Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained. General considerations The recommended initial dosages presented below are intended to act solely as a guideline. Prograf dosing should primarily be based on clinical assessments of rejecti Soma hati kamili