Mezavant XL 1200 mg gastro-resistant, prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mesalazine

Available from:

Takeda Pharmaceuticals International AG Ireland Branch

ATC code:

A07EC; A07EC02

INN (International Name):

Mesalazine

Dosage:

1200 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Aminosalicylic acid and similar agents; mesalazine

Authorization status:

Marketed

Authorization date:

2007-02-23

Patient Information leaflet

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
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

Summary of Product characteristics

Health Products Regulatory Authority
22 May 2023
CRN00DHCF
Page 1 of 10
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.
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
Adults, including the elderly (>65 years)
For the induction and maintenance of clinical and endoscopic remission
in patients with mild to moderate, active ulcerative
colitis.
Children and adolescents (weighing more than 50 kg and age 10 years or
older)
For the induction and maintenance of clinical and endoscopic remission
in patients with mild to moderate, active ulcerative
colitis.
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 g to 4.8 g (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 (4.8 g/day), the effect of
the treatment should be evaluated at 8 weeks.
For maintenance of remission: 2.4 g (two tablets) should be taken once
daily.
_Children and adolescents (weighing more than 50 kg and age 10 years
or older)_
For induction of remission (initial 8 weeks): 2.4 g to 4.8 g (two to
four tablets) should be taken once daily.
For maintenance of remission: 2.4 g (two tablets) should be taken once
daily.
Mesalazine 1200‑mg tablets should not be used by paediatric patients
weighing 50 kg or less and should not be used in
paediatric patients below the age of 10 years due to a lack of data on
safety and efficacy in these patients.
_ _