Efmody

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

hydrocortisone

Tillgänglig från:

Diurnal Europe B.V.

ATC-kod:

H02AB09

INN (International namn):

hydrocortisone

Terapeutisk grupp:

Corticosteroids for systemic use

Terapiområde:

Adrenal Hyperplasia, Congenital

Terapeutiska indikationer:

Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.

Produktsammanfattning:

Revision: 3

Bemyndigande status:

Authorised

Tillstånd datum:

2021-05-27

Bipacksedel

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
EFMODY 5
MG MODIFIED-RELEASE HARD CAPSULES
EFMODY 10
MG MODIFIED-RELEASE HARD CAPSULES
EFMODY 20
MG MODIFIED-RELEASE HARD CAPSULES
hydrocortisone
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Efmody is and what it is used for
2.
What you need to know before you take Efmody
3.
How to take Efmody
4.
Possible side effects
5.
How to store Efmody
6.
Contents of the pack and other information
1.
WHAT EFMODY IS AND WHAT IT IS USED FOR
Medicine contains the active substance hydrocortisone. Hydrocortisone
belongs to a group of
medicines known as corticosteroids.
Hydrocortisone is a copy of the hormone cortisol. Cortisol is made by
the adrenal glands in the body.
Efmody is used when the adrenal gland are not making enough cortisol
due to an inherited condition
called congenital adrenal hyperplasia. It is for use in adults and
adolescents from 12 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFMODY
DO NOT TAKE EFMODY
-
If you are allergic to hydrocortisone or any of the other ingredients
of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Efmody if the
following apply:
_Adrenal crisis _
-
You have an adrenal crisis. If you are vomiting or seriously unwell,
you may need an injection
of hydrocortisone. Your doctor will train you how to do this in an
emergency.
_Infections _
-
You have an infection or you do not feel well. Your doctor may need to
prescribe extra
hydrocortis

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Efmody 5 mg modified-release hard capsules
Efmody 10 mg modified-release hard capsules
Efmody 20 mg modified-release hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Efmody 5 mg modified-release hard capsules.
Each modified-release hard capsule contains 5 mg hydrocortisone.
Efmody 10 mg modified-release hard capsules.
Each modified-release hard capsule contains 10 mg hydrocortisone.
Efmody 20 mg modified-release hard capsules.
Each modified-release hard capsule contains 20 mg hydrocortisone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release hard capsules.
Efmody 5 mg modified-release hard capsules.
A capsule (approx.19 mm long) with an opaque blue cap and opaque white
body printed with
“CHC 5 mg” containing white to off white granules.
Efmody 10 mg modified-release hard capsules.
A capsule (approx.19 mm long) with an opaque green cap and opaque
white body printed with
“CHC 10 mg” containing white to off white granules.
Efmody 20 mg modified-release hard capsules.
A capsule (approx. 22 mm long) with an opaque orange cap and opaque
white body printed with
“CHC 20 mg” containing white to off white granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged
12 years and over and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should be initiated by physicians experienced in the
management of CAH.
3
As maintenance therapy the dose must be individualised according to
the response of the individual
patient. The lowest possible dose should be used.
Monitoring of the clinical response is necessary and patients should
be observed closely for signs that
might require dose adjustment, including changes in clinical status
resulting from remissions or
exacerbations of the disease, changes in electrolytes particularly
hypokalaemia, individual
responsiveness to the medicinal product, and the effect