Deximune 25 mg Soft Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ciclosporin

Available from:

Dexcel Pharma GmbH

ATC code:

L04AD; L04AD01

INN (International Name):

Ciclosporin

Dosage:

25 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:

2007-03-02

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
05 March 2024
CRN00F1K1
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Deximune 25 mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 25 mg Ciclosporin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
Deximune 25 mg soft capsules are gray soft gelatin capsules with
imprinting 'DX 25 mg'.
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.
_ _
_PSORIASIS_
Treatment of severe psoriasis in patients in whom conventional therapy
is inappropriate or ineffective.
_ _
_ATOPIC DERMATITIS_
Deximune Capsules are indicated in patients with severe atopic
dermatitis when systemic therapy is required.
_RHEUMATOID ARTHRITIS_
Treatment of severe, active rheumatoid arthritis.
_ _
_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.
Deximune Capsules can be used to induce and maintain remissions. It
can also be used to maintain steroid-induced remission,
allowing withdrawal of steroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose r