Neoral 50mg Soft Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ciclosporin

Available from:

Novartis Ireland Limited

ATC code:

L04AD; L04AD01

INN (International Name):

Ciclosporin

Dosage:

50 milligram(s)

Pharmaceutical form:

Capsule, soft

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Calcineurin inhibitors; ciclosporin

Authorization status:

Marketed

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. See Section 4.
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 (atopic dermatitis, or eczema and psoriasis), severe
rheumatoid arthritis and a
kidney disease called nephrotic syndrome.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEORAL
If you are taking Neoral following a

Summary of Product characteristics

Health Products Regulatory Authority
28 June 2023
CRN00DP1V
Page 1 of 18
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: 90.36 mg/capsule.
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
202.5 mg/capsule.
For the full list of excipients see section 6
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.
Neoral can be used to induce and maintain remissions. It can also be
used to maintain steroid-induced remission, allowing
withdrawal of steroids.
_Rheumatoid arthritis_
Treatment of severe, active rheumatoid arthritis.
_Psoriasis_
Treatment of severe psoriasis in patients in whom conventional therapy
is inappropriate or ineffect