TACROLIMUS 5 Milligram Capsules Hard

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

TACROLIMUS MONOHYDRATE

Fáanlegur frá:

Accord Healthcare Limited

INN (Alþjóðlegt nafn):

TACROLIMUS MONOHYDRATE

Skammtar:

5 Milligram

Lyfjaform:

Capsules Hard

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Leyfisstaða:

Authorised

Leyfisdagur:

0000-00-00

Upplýsingar fylgiseðill

Artwork No. 
Customer
Description
Market
Language
Size
Min. Font Size
Version No.
Date
-
Accord
Tacrolimus 0,5 / 1 / 5 mg 
IE-MT
English
170 x 550 mm (PIL)
9
7 (Page 1 of 2) ( IB/06/G)
23.11.12 (Tacrolimus (ACC-IE-MT)NEW-PIL)
Colours Used
Pantone Black
• difficulty in sleeping
• trembling
• Headache
• increased blood pressure
• diarrhoea
• Nausea
• kidney problems  
COMMON
• reduction in blood cell counts (platelets, red or 
white blood cells), increase in white blood cell 
counts, changes in red blood cell counts
• reduced magnesium, phosphate, potassium, 
calcium or sodium in the blood, fluid overload, 
increased uric acid or lipids in the blood, 
decreased appetite, increased acidity of the 
blood, other changes in the blood salts
• anxiety symptoms, confusion and disorientation, 
depression, mood changes, nightmare, 
hallucinations,  mental disorders
• fits, disturbances in consciousness, tingling and 
numbness (sometimes painful) in the hands and 
feet, dizziness, impaired writing ability, nervous 
system disorders
• blurred vision, increased sensitivity to light, eye 
disorders
• ringing sound in your ears
• reduced blood flow in the heart vessels, faster 
heartbeat
• bleeding, partial or complete blocking of blood 
vessels, reduced blood pressure
• shortness in breath, changes in the lung tissue, 
collection of liquid around the lung, inflammation 
of the pharynx, cough, flu-like symptoms
• inflammations or ulcers causing abdominal pain 
or diarrhoea, bleedings in the stomach, 
inflammations or ulcers in the mouth, collection 
of fluid in the belly, vomiting, abdominal pains, 
indigestion, constipation, flatulence, bloating, 
loose stools, stomach problems
• changes in liver enzymes and function, yellowing 
of the skin due to liver problems, liver tissue 
damage and inflammation of the liver
• itching, rash, hair loss, acne, increased sweating
• pain in joints, limbs or back, muscle cramp

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tacrolimus 5mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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 should only be prescribed and changes in immunosuppressive therapy, initiated by physicians experienced in
immunosuppressive therapy and the management of transplanted 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 mai