MESALAZINE ESPL 1600 Milligram Modified-release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MESALAZINE

Available from:

ESPL Regulatory Consulting Limited

ATC code:

A07EC02

INN (International Name):

MESALAZINE

Dosage:

1600 Milligram

Pharmaceutical form:

Modified-release Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Aminosalicylic acid and similar agents

Authorization status:

Authorised

Authorization date:

2018-02-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MESALAZINE 1600 MG MODIFIED-RELEASE TABLETS
mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mesalazine is and what it is used for
2.
What you need to know before you use Mesalazine
3.
How to use Mesalazine
4.
Possible side effects
5.
How to store Mesalazine
6.
Contents of the pack and other information
1.
WHAT MESALAZINE IS AND WHAT IT IS USED FOR
Mesalazine contains the active substance mesalazine. It is an
anti-inflammatory medicine used for the
treatment of ulcerative colitis. Ulcerative colitis is a disease in
which the lining of the large intestine (colon)
or the back passage (rectum) becomes inflamed (red and swollen). This
may lead to frequent and bloody
stools, often with abdominal cramps.
Mesalazine treats and prevents inflammation throughout the entire
colon and rectum (mild to moderate acute
ulcerative colitis and for the prevention of relapse).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MESALAZINE
DO NOT USE MESALAZINE :
-
if you are allergic to mesalazine or any of the other ingredients of
this medicine (listed in section 6).
-
if you are allergic to salicylates (e.g. acetylsalicylic acid)
-
if you have severe liver problems
-
if you have severe kidney problems
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Mesalazine if you have
any medical conditions or illnesses,
particularly if you have:
-
any lung disease problems, e.g. asthma.
-
impaired function of kidneys or lungs, especially if you are elderly.
-
su

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mesalazine 1600 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains: 1600 mg mesalazine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
Film-coated, red/brown oblong tablets dimension of 23 x 11 x 9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Ulcerative colitis._
For the treatment of mild to moderate acute disease. For the
maintenance of remission.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, including the elderly (>65 years)
The dose should be adjusted according to the severity of the disease
and tolerance.
_Acute disease_: In the event of exacerbation, the dose can be
increased to 4800 mg daily, once daily or in 2-3 divided
doses.
Once clinical remission is achieved, the dose should gradually be
decreased to maintenance dose.
Continued therapy should be carefully considered in subjects not
responding by week 8.
_Maintenance treatment_: 1600 mg once daily.
Elderly population
No studies have been carried out in older people.
Paediatric population
The safety and efficacy of Mesalazine ESPL in children and adolescents
aged younger than 18 years of age has not
been established.
Method of administration: oral.
The tablets must be swallowed whole with a glass of water. They must
not be chewed, crushed or broken before
swallowing. The tablets can be taken with or without food.If one or
more doses have been missed, the next dose is to be
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