CORTIMENT PROLONGED RELEASE TABLETS 9 MG

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

(Tablet Core) Budesonide micronized

Dostopno od:

FERRING PHARMACEUTICALS PRIVATE LIMITED

Koda artikla:

A07EA06

Farmacevtska oblika:

TABLET, FILM COATED, EXTENDED RELEASE

Sestava:

(Tablet Core) Budesonide micronized 9.0 mg

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

Cosmo SpA

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2017-08-04

Lastnosti izdelka

Cortiment Shared Pack Master PI
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 available.
Elderly
No special dose adjustment is recommended. However, experience of the
use of Budesonide
(CORTIMENT) in the elderly is limited.
Hepatic and renal impairment population
Budesonide (CORTIMENT) 9 mg was not studied in patients with hepatic
and renal impairment,
therefore caution should be exercised in the administration an