Tacrolimus 5mg Hard Capsule

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TACROLIMUS

Available from:

Pharm V Solutions Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

ATC code:

L04AD02

INN (International Name):

TACROLIMUS 5 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

TACROLIMUS 5 mg

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Authorization status:

Withdrawn

Authorization date:

2013-03-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
TACROLIMUS 0.5 MG HARD CAPSULES 
TACROLIMUS 1 MG HARD CAPSULES 
TACROLIMUS 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.  

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
immunosuppressants. Following your organ 
transplant (e.g. liver, kidney or heart), your body's immune
system will try to reject the new organ. 
Tacrolimus is used to control your body's immune response enabling
your body to accept the 
transplanted organ.  
Tacrolimus is often used in combination with other medicines that
also suppress the immune 
system. 
You may also be given Tacrolimus 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 TACROLIMUS CAPSULE  
DO NOT TAKE TACROLIMUS CAPSULES: 
  if you are allergic (hypersensitive) to Tacrolimus or any of
the other ingredients of this medicine 
(listed in section 6). 
  if you are allergic (hypersensitive) to macroli

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Tacrolimus 0.5/1/5 mg Hard Capsule 

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: 102.86 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 a full list of excipients see section 6.1 

3. PHARMACEUTICAL 
FORM 

Capsule hard 
FOR 0.5 MG: 
Light yellow / Light yellow hard gelatin capsules, 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, size "4" imprinted with
“TCR” on cap & “1” on body 
containing white to off white granular powder  

FOR 5 MG: 
Pink/Pink hard gelatin capsules 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

should only be prescribed, and changes in immunosuppressive therapy

initiated, by physicians experienced in immunosuppressive therapy
and the management of 
transplanted patients.  
Page 1 of 18 
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 
ef