Cortiment MMX 9 mg, Prolonged release tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

BUDESONIDE

זמין מ:

Ferring Pharmaceuticals Limited

קוד ATC:

A07EA06

INN (שם בינלאומי):

BUDESONIDE

טופס פרצבטיות:

PROLONGED-RELEASE TABLET

הרכב:

BUDESONIDE 9 milligram(s)

סוג מרשם:

POM

איזור תרפויטי:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

מצב אישור:

Authorised

תאריך אישור:

2015-01-22

עלון מידע

Page 1 of 5
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CORTIMENT
MMX 9MG
PROLONGED RELEASE TABLETS
Budesonide
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.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT
IS
IN THIS
LEAFLET:
1.
What Cortiment
MMX
is and it is used for?
2.
What you need to know before you take Cortiment
MMX
3.
How to take Cortiment
MMX
4.
Possible side effects
5.
How to store Cortiment
MMX
6.
Contents of the pack and other information
1.
WHAT CORTIMENT
MMX IS AND WHAT IT IS USED FOR
Cortiment
MMX
tablets contain a medicinal product called budesonide. This belongs to
a category of
medicinal products called 'corticosteroids'. These are used to reduce
inflammation.
Cortiment
MMX
tablets are used for adults for the treatment of inflammation of the
large intestine
(colon) and the rectum. This is called ulcerative colitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CORTIMENT
MMX
DO NOT TAKE CORTIMENT
MMX
If you are allergic to budesonide or one of the other ingredients of
this medicine (listed in section
6).
Cortiment
MMX
9 mg tablets contain lecithin which is a derivate from soya oil. If
you are allergic to
peanut or soya, do not use this medicinal product.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Cortiment
MMX
:
-
if you have an infection, such as a virus infection, a bacterial
infection or a fungal infection;
-
if you have ever had tuberculosis (TBC);
-
if you have ever had high blood pressure;
-
if you have diabetes;
-
if you ever had brittle bones;
Page 2 of 5
-
if you ever had a stomach ulcer;
-
if you ever had elevated eyeball pressure (glaucoma

מאפייני מוצר

Page
1
of
10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cortiment
MMX
9 mg, prolonged release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 9 mg of budesonide.
Excipients with known effect:
Lactose monohydrate 50 mg
Contains lecithin, derived from soya oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged release tablet.
_ _
White to off-white, round, biconvex, film-coated, gastro-resistant
tablet, approximately 9.5 mm
diameter, approximately 4.7 mm thickness, debossed on one side with
“MX9”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cortiment is indicated in adults for induction of remission in
patients with mild to moderate active
ulcerative colitis (UC) where 5-ASA treatment is not sufficient.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The recommended daily dose for induction of remission is one 9 mg
tablet in the morning, for up to
8 weeks.
When treatment is discontinued, it may be useful to gradually reduce
the dose (for more details on
treatment discontinuation, see section 4.4).
_Paediatric population _
The safety and efficacy of Cortiment tablets in children aged 0-18
years have not yet been
established. No data are available, therefore the use in paediatric
population is not recommended
until further data become available.
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2
of
10
_Elderly _
No special dose adjustment is recommended. However, experience of the
use of Cortiment in the
elderly is limited.
_Hepatic and renal impairment population _
_ _
Cortiment 9 mg was not studied in patients with hepatic and renal
impairment, therefore caution
should be exercised in the administration and monitoring of the
product in these patients.
_ _
Method of administration
One tablet of Cortiment 9 mg is taken orally in the morning, with or
without food. The tablet should
be swallowed with a glass of water and must not be broken, crushed or
chewed as the film coating
is intended to ensure a prolonged release.
4.3
CONTRAINDICATIONS
Hypersensit