Asacolon 800mg Gastro-resistant Tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Mesalazine

Fáanlegur frá:

IMED Healthcare Ltd.

ATC númer:

A07EC; A07EC02

INN (Alþjóðlegt nafn):

Mesalazine

Skammtar:

800 milligram(s)

Lyfjaform:

Gastro-resistant tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Aminosalicylic acid and similar agents; mesalazine

Leyfisstaða:

Authorised

Leyfisdagur:

2018-04-06

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
ASACOLON 800 MG GASTRO-RESISTANT TABLETS
mesalazine
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 800 mg 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 and
large
bowel is affected and becomes inflamed. If you have been treated by
surgery for Crohn’s disease and it is under control, Asacolon act to
prevent
further episodes of Crohn’s disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASACOLON
DO NOT

Vara einkenni

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(s) with known effect:
Lactose, see section 4.4.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
_Product imported from the United Kingdom_
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)
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 for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips within an outer cardboard carton containing 90 tablets
per pack.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL