Capimune 50mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ciclosporin

Available from:

Viatris UK Healthcare Ltd

ATC code:

L04AD01

INN (International Name):

Ciclosporin

Dosage:

50mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 08020200; GTIN: 5016695002781

Patient Information leaflet

December 2015
Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAPIMUNE 25 MG SOFT CAPSULES CAPIMUNE 50 MG SOFT CAPSULES
CAPIMUNE
100 MG, SOFT CAPSULES
CICLOSPORIN
READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START TAKING THE
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
1.
Keep this leaflet. You may need to read it again.
2.
If you have any further questions, ask your doctor or pharmacist.
3.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their sign of illness are the same as yours.
4.
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 Capimune soft gel capsules are and what they are used for
2.
What you need to know before you take Capimune soft gel capsules
3.
How to take Capimune soft gel capsules
4.
Possible side effects
5.
How to store Capimune soft gel capsules
6.
Contents of the pack and other information
1.
WHAT CAPIMUNE SOFT GEL CAPSULES ARE AND WHAT THEY ARE USED FOR
WHAT
CAPIMUNE SOFT GEL CAPSULES ARE
The name of your medicine is Capimune soft gel capsules. 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 Capimune soft gel capsules are used for and how Capimune soft gel
capsules work
• If you have had an organ transplant, bone marrow and stem cell
transplantation, the function of
Capimune soft gel capsules is to control your body’s immune system.
Capimune soft capsules
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, Capimune soft gel capsules stops this immune reaction. Such
diseases include eye
problems which threaten your vision (endogenous uveitis, inclu

Summary of Product characteristics

OBJECT 1
CAPIMUNE 50 MG SOFT CAPSULES
Summary of Product Characteristics Updated 14-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Capimune 50 mg, Soft capsules
2. Qualitative and quantitative composition
Each soft capsule contains 50 mg of Ciclosporin
Excipient with known effect
Each soft capsule 50mg contains 50.00mg ethanol and 190.00 mg
macrogolglycerol hydroxystearate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Soft Capsules.
50 mg: White 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.
Capimune 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 ineffective.
_Atopic dermatitis _
Capimune is indicated in patients with severe atopic dermatitis when
systemic therapy is required.
4.2 P