Country: European Union
Language: English
Source: EMA (European Medicines Agency)
linzagolix choline
Theramex Ireland Limited
H01CC04
linzagolix choline
Pituitary and hypothalamic hormones and analogues
Leiomyoma
Yselty is indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Revision: 3
Authorised
2022-06-14
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 Read the complete document
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 Read the complete document