Yselty

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

linzagolix choline

Tilgængelig fra:

Theramex Ireland Limited

ATC-kode:

H01CC04

INN (International Name):

linzagolix choline

Terapeutisk gruppe:

Pituitary and hypothalamic hormones and analogues

Terapeutisk område:

Leiomyoma

Terapeutiske indikationer:

Yselty is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Produkt oversigt:

Revision: 3

Autorisation status:

Authorised

Autorisation dato:

2022-06-14

Indlægsseddel

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
YSELTY 100 M
G FILM-COATED TABLETS
linzagolix
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 Yselty is and what it is used for
2.
What you need to know before you take Yselty
3.
How to take Yselty
4.
Possible side effects
5.
How to store Yselty
6.
Contents of the pack and other information
1.
WHAT YSELTY IS AND WHAT IT IS USED FOR
Yselty contains the active substance linzagolix. It is used to treat
moderate to severe symptoms of
uterine fibroids (commonly known as myomas), which are noncancerous
tumours of the uterus
(womb). Yselty is used in adult women (over 18 years of age) of
childbearing age. In some women,
uterine fibroids may cause heavy menstrual bleeding (your
‘period’) and pelvic pain (pain below the
belly button).
Linzagolix blocks the action of a hormone, gonadotropin releasing
hormone, that helps to regulate the
release of female sex hormones estradiol and progesterone. These
hormones trigger women’s periods
(menstruation). When blocked, the levels of the hormones estrogen and
progesterone circulating in the
body are reduced. By decreasing their levels, linzagolix stops or
reduces menstrual bleeding and
decreases pain and pelvic discomfort and other symptoms associated
with uterine f

Produktets egenskaber

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
Yselty 100 mg film-coated tablets
Yselty 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Yselty 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of linzagolix (as choline
salt).
_Excipient(s) with known effect_
Each film-coated tablet contains 119.4 mg lactose.
Yselty 200 mg film-coated tablets
Each film-coated tablet contains 200 mg of linzagolix (as choline
salt).
_Excipient(s) with known effect _
Each film-coated tablet contains 238.8 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yselty 100 mg film-coated tablets
Round, pale yellow, film-coated tablets of 10 mm diameter, debossed
“100” on one side and plain-
faced on the other side.
Yselty 200 mg film-coated tablets
Oblong, pale yellow, film-coated tablets of 19 mm by 9 mm, debossed
“200” on one side and plain-
faced on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Yselty is indicated for the treatment of moderate to severe symptoms
of uterine fibroids in adult women
of reproductive age.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Yselty treatment should be initiated and supervised by a physician
experienced in the diagnosis and
treatment of uterine fibroids.
_ _
Pregnancy must be ruled out prior to initiating treatment with Yselty.
Yselty should preferably be started in the first week of the menstrual
cycle and should be taken
continuously once daily.
The recommended dose of Yselty is:
•
100 mg or, if needed, 200 mg once daily with concomitant hormonal
add-back therapy (ABT,
estradiol 1 mg and norethisterone acetate 0.5 mg tablet once daily),
see section 5.1.
•
100 mg once daily fo