Mezavant XL 1200mg gastro-resistant, prolonged release tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Mesalazine

Disponible des:

Imbat Limited

Codi ATC:

A07EC; A07EC02

Designació comuna internacional (DCI):

Mesalazine

Dosis:

1200 milligram(s)

formulario farmacéutico:

Prolonged-release tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Aminosalicylic acid and similar agents; mesalazine

Estat d'Autorització:

Authorised

Data d'autorització:

2011-06-03

Informació per a l'usuari

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MEZAVANT
® XL 1200MG GASTRO-RESISTANT,
PROLONGED RELEASE TABLETS
(mesalazine)
Your medicine is available using the above name but will be
referred to as Mezavant XL 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, 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 Mezavant XL is and what it is used for
2.
What you need to know before you take Mezavant XL
3.
How to take Mezavant XL
4.
Possible side effects
5.
How to store Mezavant XL
6.
Contents of the pack and other information
1.
WHAT MEZAVANT XL IS AND WHAT IT IS USED
FOR
Pharmacotherapeutic group: Aminosalicylic acid and similar
agents.
Mezavant XL contains the active substance mesalazine, which
is an anti-inflammatory drug for the treatment of ulcerative
colitis.
Ulcerative colitis is a disease of the colon (large bowel) and
rectum (back passage), where the lining of the gut becomes
red and swollen (inflamed) resulting in symptoms of frequent
and bloody stools together with stomach cramps.
When given for an acute episode of ulcerative colitis,
Mezavant XL acts through the entire colon and rectum to
treat the inflammation and reduce symptoms. The tablets can
also be taken to help prevent recurrence of ulcerative colitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MEZAVANT XL
DO NOT TAKE MEZAVANT XL

If you are allergic (hypersensitive) to a family of drugs
known as salicylates (which include aspirin)

If you are allergic (hypersensitive) to mesalazine or any
of the other ingredients of this medicine (l

Fitxa tècnica

Health Products Regulatory Authority
27 September 2019
CRN0094PY
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mezavant XL 1200mg gastro-resistant, prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1200mg mesalazine.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant, prolonged release tablets.
_Product imported from Italy:_
Red-brown, ellipsoidal, film-coated tablet, debossed on one side with
S476.
4 CLINICAL PARTICULARS
As per PA1575/004/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1575/004/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Carmellose sodium
Carnauba Wax
Stearic Acid
Silica, Colloidal Hydrated
Sodium Starch Glycolate
Talc
Magnesium Stearate
Methacrylic Acid Copolymer Type A, Type B
Triethylcitrate
Titanium Dioxide (E171)
Red Ferric Oxide (E172)
Macrogol 6000
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25°C.
Health Products Regulatory Authority
27 September 2019
CRN0094PY
Page 2 of 2
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled outer carton containing blister strips
Pack size: 60
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/153/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 3rd June 2011
10 DATE OF REVISION OF THE TEXT
September 2019