Mezavant XL 1200mg, gastro-resistant, prolonged release Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Disponible desde:

Takeda Pharmaceuticals International AG Ireland Branch Block 2 Miesian Plaza 50 – 58 Baggot Street Lower Dublin 2 D02 HW68, Ireland

Código ATC:

A07EC02

Designación común internacional (DCI):

MESALAZINE 1200 mg

formulario farmacéutico:

GASTRO-RESISTANT TABLET PROLONGED-RELEASE TABLET

Composición:

MESALAZINE 1200 mg

tipo de receta:

POM

Área terapéutica:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Estado de Autorización:

Authorised

Fecha de autorización:

2011-08-19

Información para el usuario

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
acetylsalicylic acid [Αspirin])
−
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

Ficha técnica

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.
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 4.8 g/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.
Hepatic and renal impairment
Specific studies have not been performed to i