Asacolon 800mg Gastro-resistant Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Mesalazine

Tilgjengelig fra:

Imbat Limited

ATC-kode:

A07EC; A07EC02

INN (International Name):

Mesalazine

Dosering :

800 milligram(s)

Legemiddelform:

Gastro-resistant tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Aminosalicylic acid and similar agents; mesalazine

Autorisasjon status:

Authorised

Autorisasjon dato:

2016-07-01

Informasjon til brukeren

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOLON
® 800MG GASTRO-RESISTANT TABLETS
(mesalazine)
Your medicine is imported from the UK under the name of
‘Octasa’ but is marketed as ‘Asacolon’ in Ireland.
Your medicine is available using the above name but will be
referred to as Asacolon throughout this leaflet.
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, please 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 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 Asacolon is and what it is used for
2.
What you need to know before you take Asacolon
3.
How to take Asacolon
4.
Possible side effects
5.
How to store Asacolon
6.
Contents of the pack and other information
1.
WHAT ASACOLON IS AND WHAT IT IS USED FOR
The name of your medicine is Asacolon 400mg
Gastro-resistant Tablets. The tablets are called gastro-
resistant tablets because they are covered with a coating
which allows the tablets to pass through the stomach without
dissolving. The tablet coating will break down in the bowel
where the active mesalazine is released.
Asacolon Gastro-resistant Tablets contain the active
substance mesalazine. This is an anti-inflammatory
medicine used to treat ulcerative colitis and to prevent further
episodes of Crohn’s disease.

Ulcerative colitis is a disease in which the lining of the
large bowel (colon) or back passage (rectum) becomes
inflamed (red and swollen). Asacolon acts locally at the
inflamed sites to reduce the inflammation. It can also be
used to prevent further attacks of ulcerative colitis.

Crohn’s disease is a disease in which the lining of the
small a

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Asacolon 800mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains: 800mg mesalazine
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
_Product imported from the UK_
The tablets are reddish to brownish and oblong-shaped.
4 CLINICAL PARTICULARS
As per PA2018/001/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2018/001/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Sodium starch glycolate (Type A)
Magnesium stearate (vegetable origin) (E572)
Talc (E553b)
Povidone (E1201)
Methacrylic acid-methyl methacrylate copolymer (1:2)
Triethyl citrate
Iron oxides (E172)
Macrogol 6000
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
blister strips and outer carton of the product as
marketed in the country of origin.
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_
_ _
_2_
_0_
_/_
_0_
_2_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_1_
_9_
_6_
_9_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips.
Pack size: 90 gastro-resistant tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED M