CORTIMENT PROLONGED RELEASE TABLETS 9MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

BUDESONIDE

Boleh didapati daripada:

Ferring Sdn. Bhd.

INN (Nama Antarabangsa):

BUDESONIDE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

COSMO S.P.A.,

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
CORTIMENT
® 9MG PROLONGED RELEASE TABLETS
Budesonide 9mg
WHAT IS IN THIS LEAFLET
1. What Cortiment is used for
2. How Cortiment works
3. Before you take Cortiment
4. How to take Cortiment
5. While you are taking Cortiment
6. Side effects
7. Storage and disposal of Cortiment
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
1. WHAT CORTIMENT IS USED FOR
Cortiment tablets are used
FOR ADULTS FOR
THE INDUCTION OF REMISSION
in patients
with mild to moderate active ulcerative
colitis (UC) where 5-aminosalicylic acid
(5-ASA) treatment is not sufficient or
not tolerated.
2. HOW CORTIMENT WORKS
Cortiment contains the active substance
_budesonide_
.
This is an intestinal
_antiinflammatory _
_agent,_
corticosteroids acting locally. In
general,
_budesonide_
inhibits many
inflammatory processes. The mode of
action of Cortiment is based on a local
action in the gut.
3
. BEFORE YOU TAKE CORTIMENT
_When you must not use it: _
Do not take Cortiment
•
IF YOU ARE ALLERGIC
to budesonide,
soya oil, peanut oil or to any of the
other ingredients of Cortiment (listed
in ingredients section)
•
if you have rare hereditary
problems such as galactose
intolerance, the Lapp lactase
deficiency or glucose - galactose
malabsorption.
→ If this applies to you,
DO NOT TAKE CORTIMENT AND TELL YOUR DOCTOR IMMEDIATELY.
_ Before you start to use it: _
WARNING AND PRECAUTIONS
•
TELL YOUR DOCTOR OR PHARMACIST IF
YOU HAVE OR HAVE HAD ANY OF THE
FOLLOWING CONDITIONS:
- infections
- hypertension
- diabetes mellitus
- osteoporosis
- peptic ulcer
- glaucoma or cataracts
- family history of diabetes or
glaucoma
- with any other condition where the
use of glucocorticoids may have
unwanted effects.
- reduced liver function
Visual disturbance may be reported with
systemic and topical corticosteroid use.
If you presents with symptoms such as
blurred vision or other visual
disturbances, you should consult your
doctor or pharmacist for referral to an
ophthalmolog

Ciri produk

PROPOSED PACKAGING MATERIAL
Code
CORT-I-HK,SG,MY,PH-01.01
Size
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.: common pack_ _
Code of previous
version
CORT-I-MY-01.01
Changes
Common pack – SG PH HK MY
☐
CCDS version:
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
Sok Bee, 08-May-2023
For Internal Use - Internal
CORTIMENT
®
PROLONGED RELEASE TABLETS 9 MG
CORTICOSTEROID
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.
List of excipients:
Tablet Core:
Stearic Acid (E570), Lecithin (soya) (E322), Microcrystalline
cellulose (E460), Hydroxypropylcellulose (E463), Lactose
Monohydrate, Silica, Colloidal Hydrated (E551), Magnesium Stearate
(E470b).
Tablet Film-coating:
Methacrylic acid – methyl methacrylate copolymer (1:1), Methacrylic
acid – methyl methacrylate copolymer (1:2), Talc
(E553b), Titanium Dioxide (E171), Triethyl citrate.
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”.
THERAPEUTIC INDICATIONS
Budesonide (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.
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 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE).
Paediatric population
The safety and efficacy of Budesonide (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 availabl