Cortiment 9 mg, Prolonged release tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

BUDESONIDE

Commercializzato da:

Ferring Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24 , Ireland

Codice ATC:

A07EA06

INN (Nome Internazionale):

BUDESONIDE 9 mg

Forma farmaceutica:

PROLONGED-RELEASE TABLET

Composizione:

BUDESONIDE 9 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2015-01-22

Foglio illustrativo

Package leaflet: Information for the patient
Cortiment
®
9 mg
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 is and what it is used for
2.
What you need to know before you take Cortiment
3.
How to take Cortiment
4.
Possible side effects
5.
How to store Cortiment
6.
Contents of the pack and other information
1. What Cortiment is and what it is used for
Cortiment tablets contain a medicinal substance called budesonide.
Budesonide
belongs to a category of medicinal products called 'corticosteroids',
which are used to
reduce inflammation.
Cortiment tablets are used in adults to treat:
• ulcerative colitis which is an inflammation of the large intestine
(colon) and the rectum.
• acute episodes of microscopic colitis which is a disease with
chronic inflammation of
the large intestine (colon) typically with chronic watery diarrhea.
2. What you need to know before you take Cortiment
Do not take Cortiment
If you are allergic to budesonide or one of the other ingredients of
this medicine (listed in
section 6).
If you are allergic to peanut or soya since Cortiment contains
lecithin, which is a
derivative from soya oil.
Warnings and precautions
Contact your doctor if you experience blurred vision or other visual
disturbances.
Talk to your doctor before taking Cortiment:
•
if you have an infection, such as a virus infection, a bacterial
infection or a fungal
infection;
•
if you have ever had high blood pressure;
•
if you have diabetes;
•
if you ever had brittle bones;

Scheda tecnica

1 (11)
1.
NAME OF THE MEDICINAL PRODUCT
Cortiment 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
•
induction of remission in patients with active microscopic colitis
(MC).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
Ulcerative colitis and microscopic colitis:
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.
2 of 11
_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
int