MEZAVANT XL

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

MESALAZINE

Доступна з:

Shire Pharmaceutical Contracts Limited

Код атс:

A07EC02

ІПН (Міжнародна Ім'я):

MESALAZINE

Дозування:

1200 Milligram

Фармацевтична форма:

Tablet Prolonged Release

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

mesalazine

Статус Авторизація:

Marketed

Дата Авторизація:

2007-02-23

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEZAVANT XL 1200MG 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
reccurrence 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 p

Характеристики продукта

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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant, prolonged release tablets.
Red-brown, ellipsoidal, film-coated tablet, debossed on one side with
S476.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the induction of clinical and endoscopic remission in patients
with mild to moderate, active ulcerative colitis. For
maintenance of remission.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Mezavant XL is intended for once daily, oral administration. The
tablets must not be crushed or chewed and should be
taken with food.
Adults, including the elderly (>65 years)
For induction of remission: 2.4 to 4.8g (two to four tablets) should
be taken once daily. The highest dose of 4.8g/day is
recommended for patients not responding to lower doses of mesalazine.
When using the highest dose (4.8g/day), the
effect of the treatment should be evaluated at 8 weeks.
For maintenance of remission: 2.4g (two tablets) should be taken once
daily.
Children and adolescents:
Mezavant XL is not recommended for use in children below the age of 18
years due to a lack of data on safety and
efficacy.
Specific studies have not been performed to investigate Mezavant XL in
patients with hepatic or renal impairment (see
sections 4.3 and 4.4).
4.3 CONTRAINDICATIONS
History of hypersensitivity to salicylates (including mesalazine) or
any of the excipients of Mezavant XL.
Severe renal impairment (GFR <30ml/min/1.73m
2
) and/or severe hepatic impairment.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Reports of renal impairment, including minimal change nephropathy,
acute / chronic interstitial nephritis and renal
failure have been associated with preparations containing mesalazine
and pro-drugs of mesalazine. Mezavant should be
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
_