SANDIMMUN 25 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:

25 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:

1988-03-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sandimmun 25mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg ciclosporin.
Excipients with known effect:
Ethanol: 25 mg/capsule. Sandimmun soft capsules contain 12.8% v/v ethanol (10.2% m/v).
Sorbiol partially dehydrated: 30mg/capsule
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
Pink, oval soft gelatin capsules
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 06/09/2016_
_CRN 2180031_
_page number: 1_
Sandimmun can be used to induce and maintain remissions. It can also be used to maintain steroid-induced remission,
allowing withdrawal