Mezavant XL 1200mg gastro-resistant prolonged release tablets.

国: マレーシア

言語: 英語

ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有効成分:

MESALAZINE

から入手可能:

Takeda Malaysia Sdn Bhd

INN（国際名）:

MESALAZINE

パッケージ内のユニット:

60tablet Tablets

製:

COSMO S.P.A.,

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MEZAVANT XL GASTRO-RESISTANT, PROLONGED RELEASE TABLETS
Mezalazine 1200mg
1
WHAT IS IN THIS LEAFLET
1.
What
_Mezavant XL _
is used for
2.
How
_Mezavant XL _
works
_3._
_ _
Before you use
_Mezavant XL _
_4._
_ _
How to use
_Mezavant XL _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Mezavant XL _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _MEZAVANT XL _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.
HOW _MEZAVANT XL _WORKS
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
BEFORE YOU USE _MEZAVANT XL _
_When you must not use it _
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 Ingredients)
•
If you have severe kidney or
severe liver problems
_Before you start use it _
Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you
_Talk to your doctor before using _
_Mezavant XL _
•
If you have any kidney or liver
problems
•
If you have previously had
inflammation of the heart (which
may be the result of an infection in
the heart)
•
If you have ever developed a
severe skin rash or skin peeling,
blistering

製品の特徴

Takeda
PACKAGE INSERT
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 List of Excipients.
3
PHARMACEUTICAL FORM
Gastro-resistant, prolonged release tablets.
Red-brown, ellipsoidal, film-coated tablet (dimensions 20.5 × 9.5 ×
7.5 mm), 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.
Hepatic or Renal Impairment
Specific studies have not been performed to investigate Mezavant XL in
patients with hepatic or renal
impairment (see Contraindications and Special warnings and precautions
for use)
4.3
CONTRAINDICATIONS
History of hypersensitivity to salicylates (including mesalazine) or
any of the excipients of Mezavant XL.
Severe renal impairment (GFR <30mL/min/1.73m2) 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. M