Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Chenodeoxycholic acid

Saatavilla:

Leadiant GmbH

ATC-koodi:

A05AA01

INN (Kansainvälinen yleisnimi):

chenodeoxycholic acid

Terapeuttinen ryhmä:

Bile and liver therapy

Terapeuttinen alue:

Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors

Käyttöaiheet:

Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.

Tuoteyhteenveto:

Revision: 6

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-04-10

Pakkausseloste

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHENODEOXYCHOLIC ACID LEADIANT 250 MG HARD CAPSULES
chenodeoxycholic acid
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Chenodeoxycholic acid Leadiant is and what it is used for
2.
What you need to know before you take Chenodeoxycholic acid Leadiant
3.
How to take Chenodeoxycholic acid Leadiant
4.
Possible side effects
5.
How to store Chenodeoxycholic acid Leadiant
6.
Contents of the pack and other information
1.
WHAT CHENODEOXYCHOLIC ACID LEADIANT IS AND WHAT IT IS USED FOR
Chenodeoxycholic acid Leadiant capsules contain a substance called
chenodeoxycholic acid. This
substance is normally produced by the liver from cholesterol. It is a
part of the bile, a fluid which helps
in the digestion of fat and vitamins from food. Patients with a rare
condition known as
cerebrotendinous xanthomatosis (CTX) cannot produce chenodeoxycholic
acid and this causes a
build-up of fatty deposits in various areas of the body. This can
cause damage to the affected areas.
Chenodeoxycholic acid Leadiant capsules treats CTX by replacing the
chenodeoxycholic acid, which
prevents the build-up of the fatty deposits.
Chenodeoxycholic acid Leadiant capsules can be used from the age of
one month and patients with
CTX will require tre

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Chenodeoxycholic acid Leadiant 250 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 250 mg of chenodeoxycholic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Size 0 capsule, 21.7 mm in length with a yellow body and orange cap,
containing a white, compressed
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chenodeoxycholic acid is indicated for the treatment of inborn errors
of primary bile acid synthesis
due to sterol 27-hydroxylase deficiency (presenting as
cerebrotendinous xanthomatosis (CTX)) in
infants, children and adolescents aged 1 month to 18 years and adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and monitored by physicians experienced in
the management of CTX or
inborn errors of primary bile acid synthesis.
During the initiation of therapy and dose adjustment, serum
cholestanol levels and/or urine bile
alcohols should be monitored every 3 months till metabolic control and
then annually. The lowest dose
of chenodeoxycholic acid that effectively reduces the serum
cholestanol and/or urine bile alcohols
levels to within the normal range should be chosen. Liver function
should also be monitored.
Concurrent elevation of liver enzymes above normal levels may indicate
overdose. After the initiation
period, cholestanol, urine bile alcohols and liver function should be
determined annually, at a
minimum, and the dose adjusted accordingly (see section 4.4).
Additional or more frequent
investigations may need to be undertaken to monitor therapy during
periods of fast growth,
concomitant disease and pregnancy (see section 4.6).
In case of persistent lack of therap