NEORAL 50 Milligram Capsules, Soft

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CICLOSPORIN

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

L04AD01

INN (International Name):

CICLOSPORIN

Dosage:

50 Milligram

Pharmaceutical form:

Capsules, Soft

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Calcineurin inhibitors

Authorization status:

Authorised

Authorization date:

1995-10-16

Patient Information leaflet

1

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

NEORAL 25 MG SOFT CAPSULES 
NEORAL 50 MG SOFT CAPSULES 
NEORAL 100 MG SOFT CAPSULES 

ciclosporin 

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 Neoral is and what it is used for 
2. 
What you need to know before you take Neoral 
3. 
How to take Neoral 
4. 
Possible side effects 
5. 
How to store Neoral 
6. 
Contents of the pack and other information 

1. 
WHAT NEORAL IS AND WHAT IT IS USED FOR 

WHAT NEORAL IS 
The name of your medicine is Neoral. It contains the active
substance ciclosporin. This belongs to a 
group of medicines known as immunosuppressive agents. These
medicines are used to lower the 
body’s immune reactions.  

WHAT NEORAL IS USED FOR AND HOW NEORAL WORKS  


IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE
MARROW AND STEM CELL TRANSPLANTATION, the 
function of Neoral is to control your body’s immune system.
Neoral prevents rejection of 
transplanted organs by blocking the development of certain cells
which would normally attack 
the transplanted tissue. 


IF YOU HAVE AN AUTOIMMUNE DISEASE, in which your body’s immune
response attacks your 
body’s own cells, Neoral stops this immune reaction. Such
diseases include eye problems 
which threaten your vision (endogenous uveitis, including Behçet's
uveitis), severe cases of 
certain skin diseases (a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neoral 50mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg ciclosporin.
Excipients with known effect:
Ethanol: 50 mg/capsule. Neoral soft capsules contain 11.8% v/v ethanol
(9.4% m/v).
Propylene glycol: 50 mg/capsule.
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
202.5 mg/capsule.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
Yellow-white, oblong soft gelatin capsules, imprinted with “NVR
50mg” in red.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Transplantation indications
_Solid organ transplantation_
Prevention of graft rejection following solid organ transplantation.
Treatment of transplant cellular rejection in patients previously
receiving other immunosuppressive agents.
_Bone marrow transplantation_
Prevention of graft rejection following allogeneic bone marrow and
stem cell transplantation.
Prevention or treatment of graft-versus-host disease (GVHD).
Non-transplantation indications
_Endogenous uveitis_
Treatment of sight-threatening intermediate or posterior uveitis of
non-infectious aetiology in patients in whom
conventional therapy has failed or caused unacceptable side effects.
Treatment of Behçet uveitis with repeated inflammatory attacks
involving the retina in patients without neurological
manifestations.
_Nephrotic syndrome_
Steroid-dependent and steroid-resistant nephrotic syndrome, due to
primary glomerular diseases such as minimal
change nephropathy, focal and segmental glomerulosclerosis, or
membranous glomerulonephritis.
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