Sandimmun Neoral 100 mg/ml oral solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CICLOSPORIN

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

L04AD01

INN (International Name):

CICLOSPORIN 100 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

CICLOSPORIN 100 mg/ml

Prescription type:

POM

Therapeutic area:

IMMUNOSUPPRESSANTS

Authorization status:

Authorised

Authorization date:

2005-10-27

Patient Information leaflet

Page 1 of 12
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SANDIMMUN NEORAL
® 100 MG/ML ORAL SOLUTION
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 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 syndrome.

Summary of Product characteristics

Page 1 of 25
1.
NAME OF THE MEDICINAL PRODUCT
Sandimmun Neoral 100 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains 100 mg ciclosporin.
Excipients with known effect:
Ethanol: 94.70 mg/ml. Sandimmun Neoral oral solution contains 12% v/v
ethanol (9.5% m/v).
Propylene glycol: 94.70 mg/ml.
Macrogolglycerol hydroxystearate/ Polyoxyl 40 hydrogenated castor oil:
383.70 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear, faintly yellow to brownish yellow solution.
The formulation of Sandimmun Neoral is a microemulsion preconcentrate.
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.
Page 2 of 25
_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.
Sandimmun 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
ineffe