Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
TACROLIMUS
Accord Healthcare Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
L04AD02
TACROLIMUS 5 mg
HARD CAPSULE
TACROLIMUS 5 mg
POM
IMMUNOSUPPRESSANTS
Withdrawn
2012-05-30
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER TACROLIMUS 0.5 MG HARD CAPSULES TACROLIMUS 1 MG HARD CAPSULES TACROLIMUS 5MG HARD CAPSULES 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. WHAT IS IN THIS LEAFLET 1. What Tacrolimus capsule is and what it is used for 2. What you need to know before you take Tacrolimus capsule 3. How to take Tacrolimus capsule 4. Possible side effects 5. How to store Tacrolimus capsule 6. Contents of the pack and other information 1. WHAT TACROLIMUS CAPSULE IS AND WHAT IT IS USED FOR Tacrolimus belongs to a group of medicines called immunosuppressant. After your organ transplant (e.g. liver, kidney or heart), your body's defence system will try to reject the new organ. Tacrolimus is used to prevent rejection of newly transplanted organs Tacrolimus can also be prescribed to treat rejection of transplanted organ.If you have been taking medicines to prevent rejection and they are not sufficiently effective then your doctor will have changed your treatment by starting you on Tacrolimus. Tacrolimus is often used in combination with ot Belgenin tamamını okuyun
Page 1 of 18 1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tacrolimus 0.5 mg Hard capsules Tacrolimus 1 mg Hard capsules Tacrolimus 5 mg Hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FOR 0.5 MG Each capsule contains 0.5 mg of tacrolimus (as tacrolimus monohydrate) Excipients: 50.14mg of lactose monohydrate FOR 1 MG: Each capsule contains 1 mg of tacrolimus(as tacrolimus monohydrate) Excipients: 48.68 mg of lactose monohydrate FOR 5 MG: Each capsule contains 5 mg of tacrolimus(as tacrolimus monohydrate) Excipients: 98.86 mg of lactose monohydrate For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Capsule hard FOR 0.5 MG: Light yellow / Light yellow hard gelatin capsules, approximately 11.40mm, size "5" imprinted with “TCR” on cap & “0.5” on body containing white to off white granular powder. FOR 1 MG: White / White hard gelatin capsules, approximately 11.40mm, size "5" imprinted with “TCR” on cap & “1” on body containing white to off white granular powder FOR 5 MG: Pink/Pink hard gelatin capsules, approximately 14.30mm, size “4” imprinted with “TCR” on cap & “5” on body containing white to off white granular 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 Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel. This medicinal product Belgenin tamamını okuyun