Mezavant XL 1200 mg gastro-resistant, prolonged release tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Mesalazine

Saatavilla:

IMED Healthcare Ltd.

ATC-koodi:

A07EC; A07EC02

INN (Kansainvälinen yleisnimi):

Mesalazine

Annos:

1200 milligram(s)

Lääkemuoto:

Prolonged-release tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Aminosalicylic acid and similar agents; mesalazine

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-02-14

Pakkausseloste

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 or severe liver problems
WARNINGS

Valmisteyhteenveto

Health Products Regulatory Authority
13 February 2023
CRN00DDDM
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 1200 mg mesalazine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant, prolonged release tablets
_Product imported from Italy, the Netherlands, Norway and Spain_
Red-brown, ellipsoidal, film-coated tablet, debossed on one side with
S476.
4 CLINICAL PARTICULARS
As per PA23211/004/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23211/004/001
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:
Talc
Methacrylic Acid - Methyl methacrylate copolymer (1:1)
Methacrylic Acid – Methyl methacrylate copolymer (1:2)
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 is the date shown on the
container and outer carton of the product on the market in
the country of origin.
Health Products Regulatory Authority
13 February 2023
CRN00DDDM
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
Tablets are packed in a coated aluminium blister in an overlabelled
carton.
Packs contain 60 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/093/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: