CORTIMENT

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

BUDESONIDE

Dostupné z:

FERRING PHARMACEUTICALS LTD

ATC kód:

A07EA06

Forma lieku:

TABLETS PROLONGED RELEASE

Zloženie:

BUDESONIDE 9 MG

Spôsob podávania:

PER OS

Typ predpisu:

Required

Výrobca:

COSMO SPA, ITALY

Terapeutické oblasti:

BUDESONIDE

Terapeutické indikácie:

For induction of remission in patients with mild to moderate active ulcerative colitis (UC).

Dátum Autorizácia:

2020-12-31

Príbalový leták

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)-1986
The medicine is dispensed with a doctor’s prescription only
_ _
CORTIMENT
®
MMX
Prolonged release tablets
ACTIVE INGREDIENT:
Each prolonged release tablet of Cortiment
®MMX
contains 9 mg budesonide.
INACTIVE INGREDIENTS AND ALLERGENS: see section 2 under “Important
information about some of
this medicine’s ingredients” and section 6 “Additional
information”.
Read the entire leaflet carefully before you start using this
medicine.
This leaflet contains concise information about the medicine. If you
have further questions,
consult your doctor or pharmacist. This medicine has been prescribed
to treat your illness. Do not
pass it on to others. It may harm them even if it seems to you that
their illness is similar to yours.
This medicine is intended for adults above 18 years of age.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
The medicine is used to induce remission in patients with mild to
moderate active ulcerative colitis
(UC).
THERAPEUTIC GROUP: glucocorticoids.
2.
BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient or to any of the
other ingredients in this
medicine (see section 6)
•
you are allergic to peanuts or soya, since Cortiment
®MMX
tablets contain lecithin which is
produced from soya oil.
SPECIAL WARNING ABOUT USING THIS MEDICINE
Contact your doctor if you experience blurred vision or other visual
disturbances.
Before starting treatment with the medicine, tell your doctor if:
•
you have an infection, such as a viral, bacterial, or fungal infection
•
you have ever had high blood pressure
•
you have diabetes
•
you have ever had brittle bones
•
you have ever had a stomach ulcer
•
you have ever had elevated eye pressure (glaucoma) or cataract
•
a family member has ever had diabetes or elevated eye pressure
(glaucoma)
•
you have ever had liver problems
•
you took other steroid therapy before starting treatment with
Cortiment
®MMX
as th

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cortiment
MMX
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 a 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 for induction of remission in patients with
mild to
moderate active ulcerative colitis (UC).
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 has 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
Cortiment in the elderly is limited.
_Hepatic and renal impairment population _
Cortiment 9mg 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 9mg 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
Hypersensitivity to the active substance or to soya oil, peanut oil or
to any of the
excipients list