Sandimmun Neoral

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

CICLOSPORIN

Fáanlegur frá:

Novartis Pharmaceuticals UK Limited

ATC númer:

L04AD01

INN (Alþjóðlegt nafn):

CICLOSPORIN

Lyfjaform:

CAPSULE

Samsetning:

CICLOSPORIN 100 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

IMMUNOSUPPRESSANTS

Leyfisstaða:

Authorised

Leyfisdagur:

2005-10-27

Upplýsingar fylgiseðill

Page 1 of 22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SANDIMMUN NEORAL 25 MG SOFT CAPSULES
SANDIMMUN 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 Sandimmun Neoral is and what it is used for
2.
What you need to know before you take Sandimmun Neoral
3.
How to take Sandimmun Neoral
4.
Possible side effects
5.
How to store Sandimmun Neoral
6.
Contents of the pack and other information
1.
WHAT SANDIMMUN NEORAL IS AND WHAT IT IS USED FOR
WHAT SANDIMMUN NEORAL IS
The name of your medicine is Sandimmun 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 SANDIMMUN NEORAL IS USED FOR AND HOW SANDIMMUN NEORAL WORKS
IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE MARROW AND STEM CELL
TRANSPLANTATION, the
function of Sandimmun Neoral is to control your body’s immune
system. Sandimmun
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, Sandimmun 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
synd

Vara einkenni

Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 23
1.
NAME OF THE MEDICINAL PRODUCT
Sandimmun Neoral 25 mg soft capsules
Sandimmun Neoral 100 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg ciclosporin.
Excipients with known effect:
Ethanol: 25 mg/capsule. Sandimmun Neoral soft capsules contain 11.8%
v/v ethanol (9.4% m/v).
Propylene glycol: 25 mg/capsule.
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
101.25 mg/capsule.
Each capsule contains 100 mg ciclosporin.
Excipients with known effect:
Ethanol: 100 mg/capsule. Sandimmun Neoral soft capsules contain 11.8%
v/v ethanol (9.4% m/v).
Propylene glycol: 100 mg/capsule.
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
405.0 mg/capsule.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft
Blue-grey, oval soft gelatin capsules, imprinted with “NVR 25mg”
in red.
Blue-grey, oblong soft gelatin capsules, imprinted with “NVR
100mg” 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.
Page 3 of 23
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 an