Ryeqo

Negara: Uni Eropa

Bahasa: Inggris

Sumber: EMA (European Medicines Agency)

Bahan aktif:

Relugolix, norethisterone acetate, estradiol hemihydrate

Tersedia dari:

Gedeon Richter Plc.

Kode ATC:

H01CC54

INN (Nama Internasional):

relugolix, estradiol, norethisterone acetate

Kelompok Terapi:

Pituitary and hypothalamic hormones and analogues

Area terapi:

Leiomyoma

Indikasi Terapi:

Ryeqo is indicated in adult women of reproductive age for:- treatment of moderate to severe symptoms of uterine fibroids,- symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

Ringkasan produk:

Revision: 6

Status otorisasi:

Authorised

Tanggal Otorisasi:

2021-07-16

Selebaran informasi

33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
RYEQO 40 MG/1 MG/0.5 MG FILM-COATED TABLETS
relugolix/estradiol/norethisterone acetate
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 Ryeqo is and what it is used for
2.
What you need to know before you take Ryeqo
3.
How to take Ryeqo
4.
Possible side effects
5.
How to store Ryeqo
6.
Contents of the pack and other information
1.
WHAT RYEQO IS AND WHAT IT IS USED FOR
Ryeqo contains the active substances relugolix, estradiol and
norethisterone acetate.
It is used to treat
-
moderate to severe symptoms of uterine fibroids (commonly known as
myomas), which are
non-cancerous tumours of the uterus (womb).
-
symptoms associated with endometriosis in women with a history of
previous medical or
surgical treatment for their endometriosis (endometriosis is an often
painful disorder in which
tissue similar to the tissue that normally lines the inside of your
uterus - the endometrium -
grows outside your uterus).
Ryeqo is used in adult women (over 18 years of age) before they reach
menopause.
In some women, uterine fibroids may cause heavy menstrual bleeding
(your ‘period’) and pelvic pain
(pain below the belly button). Ryeqo is used for the treatment of your
fibroids to stop or reduce
bleeding and to decr

Karakteristik produk

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
Ryeqo 40 mg/1 mg/0.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg relugolix, 1 mg estradiol (as
hemihydrate), and 0.5 mg
norethisterone acetate.
Excipient with known effect
Each film-coated tablet contains approximately 80 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow to yellow, round film-coated tablet of 8 mm with
“415” on one side and plain-faced on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ryeqo is indicated in adult women of reproductive age for:
-
treatment of moderate to severe symptoms of uterine fibroids,
-
symptomatic treatment of endometriosis in women with a history of
previous medical or
surgical treatment for their endometriosis (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ryeqo treatment should be initiated and supervised by a physician
experienced in the diagnosis and
treatment of uterine fibroids and/or endometriosis.
Posology
One tablet of Ryeqo must be taken once daily, at about the same time
with or without food. Tablets
should be taken with some liquid as needed (see section 5.2).
BMD loss and osteoporosis
A dual X ray absorptiometry (DXA) scan is recommended after 1 year of
treatment. In patients with
risk factors for osteoporosis or bone loss, a DXA scan is recommended
prior to starting Ryeqo
treatment (see section 4.4).
Initiation of treatment
Pregnancy must be ruled out prior to initiating treatment with Ryeqo.
3
When starting treatment, the first tablet must be taken within 5 days
of the onset of menstrual
bleeding. If treatment is initiated on another day of the menstru