Neoral 100 mg Soft Capsules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Ciclosporin

Disponibil de la:

PCO Manufacturing Ltd.

Codul ATC:

L04AD; L04AD01

INN (nume internaţional):

Ciclosporin

Dozare:

100 milligram(s)

Forma farmaceutică:

Capsule, soft

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Calcineurin inhibitors; ciclosporin

Statutul autorizaţiei:

Authorised

Data de autorizare:

2005-03-11

Prospect

_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEORAL
® 25MG SOFT CAPSULES
NEORAL
® 50MG SOFT CAPSULES
NEORAL
® 100MG 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 onto
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.
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 uveitis, including Behcet'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 TAKE NEORAL
If you are taking Neoral following a transplant it will

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neoral 100 mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg ciclosporin.
Excipients:
Ethenol
Polyoxyl 40 hydrogenated castor oil
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Soft Capsules.
_Product imported from Greece & Poland_
Oval, blue-grey capsules, imprinted with the ‘NVR’ and ‘100mg’
in red printing ink
_Product imported from the UK:_
Oval, blue-grey capsules, imprinted with the Sandoz triangle and
‘100mg’ in red printing ink
4 CLINICAL PARTICULARS
As per PA0013/054/003.
5 PHARMACOLOGICAL PROPERTIES
As per PA0013/054/003.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
DL-
-tocopherol
Absolute ethanol
Propylene glycol
Corn-oil-mono-di-triglycerides
Polyoxyl 40 hydrogenated castor oil
Black iron oxide (E172)
Titanium dioxide (E171)
Glycerol 85%
Gelatin
_Product imported from Greece also contains (in red printing ink):_
Carminic acid
Aluminium chloride
Sodium hydroxide
Hypromellose
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store