Cortiment 9mg modified-release tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Budesonide

Disponible des:

Ferring Pharmaceuticals Ltd

Codi ATC:

A07EA06

Designació comuna internacional (DCI):

Budesonide

Dosis:

9mg

formulario farmacéutico:

Modified-release tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 01050200; GTIN: 05015919640211

Informació per a l'usuari

Package leaflet: Information
for the user
Cortiment
®
9 mg
Prolonged release tablets
Budesonide
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 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
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;
• if you ever had a stomach ulcer;
• if you ever had elevated eyeball pressure (glaucoma)
or grey cataract;
• if a family member has ever had diabetes or
elevated eyeball pressure (glaucoma);
• if you ever had liver problems;
• if you transfer from other cortisone therapy to
Cortiment as this may result in e.g. pain in the
muscles and joints, tiredness, headache, nausea,
and vomiting;
• if you know that you need to be vaccinated;
• if you have been treated with a stronger cortisone
preparation before starting treatment with
Cortiment, your symptoms may reappear;
• if you get an infection during the treatment,
Cortiment can hide the signs of in

Fitxa tècnica

OBJECT 1
CORTIMENT 9 MG, PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 14-Jul-2017 | Ferring
Pharmaceuticals Ltd
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 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 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.
_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 pro