Mesalazine ESPL 1600mg modified-release tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MESALAZINE

Available from:

ESPL Regulatory Consulting Ltd

ATC code:

A07EC02

INN (International Name):

MESALAZINE

Pharmaceutical form:

MODIFIED-RELEASE TABLET

Composition:

MESALAZINE 1600 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Authorization status:

Authorised

Authorization date:

2018-11-22

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MESALAZINE ESPL 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 ESPL is and what it is used for
2.
What you need to know before you use Mesalazine ESPL
3.
How to use Mesalazine ESPL
4.
Possible side effects
5.
How to store Mesalazine ESPL
6.
Contents of the pack and other information
1.
WHAT MESALAZINE ESPL IS AND WHAT IT IS USED FOR
Mesalazine ESPL 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 ESPL 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 ESPL
DO NOT USE MESALAZINE ESPL:
-
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 ESPL if you
have any medical
conditions or illnesses, particularly if you have:
-
any lung disease problems, e.g. asthma.
-
impaired f

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
Mesalazine ESPL 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.
_ _
Other oral mesalazine formulations are available if an alternative
dose for maintenance treatment is
considered more appropriate.
_ _
_ _
Elderly population
_ _
No studies have been carried out in older people.
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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 taken as usual.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to salicylates (including mesalazine) or any of the
excipients listed in section
6.1.
•
Severe liver impairment.
•
Severe renal impairment (GFR < 30 mL/min/1.73 m
2
).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Blood tests (differential blood count; liver function parameters such