Sandimmun 100mg Soft Capsules

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Ciclosporin

Sẵn có từ:

Novartis Ireland Limited

Mã ATC:

L04AD; L04AD01

INN (Tên quốc tế):

Ciclosporin

Liều dùng:

100 milligram(s)

Dạng dược phẩm:

Capsule, soft

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Calcineurin inhibitors; ciclosporin

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1988-03-21

Tờ rơi thông tin

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

Đặc tính sản phẩm

Health Products Regulatory Authority
28 June 2023
CRN00DP1V
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sandimmun 100mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg ciclosporin.
Excipients with known effect:
Ethanol: 100 mg/capsule. Sandimmun soft capsules contain 12.8% v/v
ethanol (10.2% m/v).
Sorbitol partially dehydrated: 103.8mg/capsule.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
Dusty rose, oblong 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.
Sandimmun 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.
Health Products Regulatory Authority
28 June 2023
CRN00DP1V
Page 2 of 18
_Psoriasis_
Treatment of severe psoriasis in patients in whom conventional therapy
is inappropriate or ineffective.
_Atopic dermatitis_
Sand