Mezavant XL 1200mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Mesalazine

Διαθέσιμο από:

CST Pharma Ltd

Φαρμακολογική κατηγορία (ATC):

A07EC02

INN (Διεθνής Όνομα):

Mesalazine

Δοσολογία:

1.2gram

Φαρμακοτεχνική μορφή:

Modified-release tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 01050100; GTIN: 5055946807195

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEZAVANT® XL 1200MG, GASTRO-RESISTANT, PROLONGED RELEASE TABLETS
(MESALAZINE)
This medicine is available as above name but will be referred to as
Mezavant XL throughout the
following leaflet.
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 oth

Αρχείο Π.Χ.Π.

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 the 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 4.8 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 _
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 <30 ml/min/1.73 m
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
used with
caution in patients with confirmed mild to moderate renal