Mezavant XL 1200 mg gastro-resistant, prolonged release tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Mesalazine

Disponible des:

PCO Manufacturing Ltd.

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:

2012-06-28

Informació per a l'usuari

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MEZAVANT
® XL 1200 MG GASTRO-RESISTANT,
PROLONGED RELEASE 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, 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 gastro-resistant, prolonged release tablets contain
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 (listed in section 6 of
this leaflet)
−
If you have severe kidney

Fitxa tècnica

Health Products Regulatory Authority
21 May 2019
CRN00902D
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mezavant XL 1200 mg 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 and The Netherlands:_
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
Tablet Core:
Carmellose sodium
Carnauba Wax
Stearic Acid
Silica, Colloidal Hydrated
Sodium Starch Glycolate (Type A)
Talc
Magnesium Stearate
Film-Coating:
Methacrylic Acid-Methyl Methacrylate Copolymer (1:1)
Methacrylic Acid-Methyl Methac1ylate Copolymer (l:2)
Triethylcitrate
Titanium Dioxide (E1 71)
Red Ferric Oxide (E 172)
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.
Health Products Regulatory Authority
21 May 2019
CRN00902D
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25 °C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Outer cardboard carton containing blister strips Pack size: 60
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/289/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28
th
June 2012
10 DATE OF REVISION OF THE TEXT
May 2019