Artesonin 30 mg zachte capsules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ALITRETINOÏNE

Beschikbaar vanaf:

Regiomedica GmbH

ATC-code:

D11AH04

INN (Algemene Internationale Benaming):

ALITRETINOÏNE

farmaceutische vorm:

Capsule, zacht

Samenstelling:

GELATINE (E 441) ; GLYCEROL (E 422) ; GLYCEROLMONOSTEARAAT (E 471) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; PLANTAARDIGE OLIE, GEHYDREERD ; SOJABOONOLIE, GEDEELTELIJK GEHYDREERD ; SOJAOLIE, GEZUIVERD ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Alitretinoin

Autorisatie datum:

2019-01-18

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARTESONIN 10 MG ZACHTE CAPSULES
ARTESONIN 30 MG ZACHTE CAPSULES
Alitretinoïne
WARNING
CAN SERIOUSLY HARM AN UNBORN BABY
Women must use effective contraception
Do not use if you are pregnant or you think you may be pregnant
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 Artesonin is and what it is used for
2.
What you need to know before you take Artesonin
3.
How to take Artesonin
4.
Possible side effects
5.
How to store Artesonin
6.
Contents of the pack and other information
1. WHAT ARTESONIN IS AND WHAT IT IS USED FOR
The active substance in Artesonin is alitretinoin. It belongs to a
group of medicines known as
_retinoids, _which are related to Vitamin A. Artesonin capsules come
in two strengths, containing 10 mg
or 30 mg of alitretinoin.
Artesonin is used to treat adults with severe chronic hand eczema that
has not got better after any other
topical treatments, including steroids. Treatment with Artesonin must
be supervised by a specialist
skin doctor (a dermatologist).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARTESONIN
DO NOT TAKE ARTESONIN:

If you are PREGNANT or BREAST-FEEDING.

If there is any chance you could become pregnant, you must follow the
precautions under
“Pregnancy and prevention programme, see section on

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAAM VAN HET GENEESMIDDEL
Artesonin 10 mg zachte capsules
Artesonin 30 mg zachte capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, soft contains 10 mg of alitretinoin
Each capsule, soft contains 30 mg of alitretinoin
Excipients with known effect
Soya-bean oil.
Each 10 mg capsule contains 92.94 mg soya-bean oil.
Each 30 mg capsule contains 278.83 mg soya-bean oil.
Sorbitol.
Each 10 mg capsule contains 13.28 mg sorbitol.
Each 30 mg capsule contains 25.55 mg sorbitol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FROM
Capsule, soft
Artesonin 10 mg capsules are light brown, oval, soft-gelatin capsules,
10 mm x 6 mm, containing a
yellow to orange, opaque, viscous suspension.
Artesonin 30 mg capsules are yellow, oval, soft-gelatin capsules, 13
mm x 8 mm, containing a yellow
to orange, opaque, viscous suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Artesonin is indicated for use in adults who have severe chronic hand
eczema that is unresponsive to
treatment with potent topical corticosteroids.
Patients in whom the eczema has predominantly hyperkeratotic features
are more likely to respond to
treatment than in those in whom the eczema predominantly presents as
pompholyx (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Artesonin should only be prescribed by dermatologists, or physicians
with experience in the use of
systemic
retinoids
who
have
full
understanding
of
the
risks
of
systemic
retinoid
therapy
and
monitoring requirements. Prescriptions of Artesonin for women of
childbearing potential should be
limited to 30 days of treatment and continuation of treatment requires
a new prescription. Ideally,
pregnancy testing, issuing a prescription and dispensing of Artesonin
should occur on the same day.
Dispensing of Artesonin should occur within a maximum of 7 days of the
prescription.
Posology
The recommended dose for alitretinoin is 10 mg or 30 mg once daily.
The recommended starting dose for alitretinoin is 30 mg once