Neoral 25 mg Soft Capsules

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Ciclosporin

Saadav alates:

PCO Manufacturing Ltd.

ATC kood:

L04AD; L04AD01

INN (Rahvusvaheline Nimetus):

Ciclosporin

Annus:

25 milligram(s)

Ravimvorm:

Capsule, soft

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

Calcineurin inhibitors; ciclosporin

Volitamisolek:

Authorised

Loa andmise kuupäev:

1995-10-16

Infovoldik

_ _
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

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neoral 25 mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 25 mg of ciclosporin.
Excipients: ethanol polyoxyl 40 hydrogenated castor oil
(polyoxyethylated hydrogenated castor oil 40)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft Capsules
_Product imported from the UK, Greece and Romania:_
Oval, blue-grey capsules, imprinted with “NVR” and “25mg” in
red printing ink.
4 CLINICAL PARTICULARS
As per PA0013/054/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA0013/054/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
DL-
-tocopherol
Absolute ethanol
Propylene glycol
Corn-oil-mono-di-triglycerides
Polyoxyl 40 hydrogenated castor oil (polyoxyethylated hydrogenated
castor oil 40)
Black iron oxide (E172)
Titanium dioxide (E171)
Glycerol 85%
Gelatin
Carminis acid
_Product imported from Greece and Romania also contain (in red
printing ink):_
Aluminium chloride
Sodium hydroxide
Hypromellose
6.2 INCOMPATIBILITIES
Not applicable.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_9_
_/_
_0_
_2_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_2_
_1_
_7_
_3_
_2_
_6_
_8_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
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 in the original