Neoral 100mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Ciclosporin

Tilgjengelig fra:

Novartis Pharmaceuticals UK Ltd

ATC-kode:

L04AD01

INN (International Name):

Ciclosporin

Dosering :

100mg

Legemiddelform:

Oral capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Caution - AMP level prescribing advised

Produkt oppsummering:

BNF: 08020200; GTIN: 5013054140085

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
NEORAL
® 25MG SOFT GELATIN CAPSULES
NEORAL
® 50MG SOFT GELATIN CAPSULES
NEORAL
® 100MG SOFT GELATIN 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.

The name of this product is Neoral 25mg Soft Gelatin Capsules, Neoral
50mg Soft Gelatin Capsules or Neoral 100mg Soft Gelatin Capsules, but
will be referred to as Neoral Capsules or Neoral throughout the
remainder
of this leaflet.

Also available in 10mg strength.
WHAT IS IN THIS LEAFLET
1. What Neoral is and what it is used for
2. What you need to know before you take Neoral
3. How to take Neoral
4. Possible side effects
5. How to store Neoral
6. Contents of the pack and other information
1. WHAT NEORAL IS AND WHAT IT IS USED FOR
WHAT NEORAL IS
The name of your medicine is 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 NEORAL IS USED FOR AND HOW NEORAL WORKS
 IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE MARROW AND STEM CELL
TRANSPLANTATION, the function of Neoral is to control your body’s
immune
system. 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, Neoral stops this immune
reaction. Such diseases include eye problems which threaten your
vision
(endogenous uv

Preparatomtale

OBJECT 1
NEORAL SOFT GELATIN CAPSULES
Summary of Product Characteristics Updated 10-Mar-2016 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
NEORAL
®
Soft Gelatin Capsules
Neciclopin
®
Soft Gelatin Capsules
2. Qualitative and quantitative composition
Each capsule contains 10 mg, 25 mg, 50 mg or 100 mg ciclosporin.
Excipients with known effect:
NEORAL Soft Gelatin Capsules contain:
Ethanol: 11.8% v/v ethanol (9.4% m/v) (10mg, 25mg, 50 mg and 100 mg
capsules).
Propylene glycol: 10 mg/capsule (10 mg capsules); 25 mg/capsule (25 mg
capsules); 50 mg/capsule (50
mg capsules); 100 mg/capsule (100 mg capsules).
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
40.5 mg/capsule (10 mg
capsules), 101.25 mg/capsule (25 mg capsules), 202.5 mg/capsule (50 mg
capsules), 405.0 mg/capsule
(100 mg capsules).
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Capsule, soft
Neoral Soft Gelatin Capsules 10mg: Yellow-white, oval soft gelatin
capsules, imprinted “NVR 10“ in
red.
Neoral Soft Gelatin Capsules 25mg: Blue-grey, oval soft gelatin
capsules, imprinted with “NVR 25mg“
in red.
Neoral Soft Gelatin Capsules 50mg: Yellow-white, oblong soft gelatin
capsules, imprinted with “NVR
50mg“ in red.
Neoral Soft Gelatin Capsules 100mg: Blue-grey, oblong soft gelatin
capsules, imprinted with “NVR
100mg“ in red.
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 c