YSELTY 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Yselty 200 mg film-coated tablets

linzagolix

This medicine is subject to additional monitoring, which will allow for 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.

Contents of the pack

1. What is Yselty and what is it used for
2. What you need to know before you take Yselty
3. How to take Yselty
4. Possible side effects
5. Storage of Yselty
6. Contents of the pack and other information

1. What is Yselty and what is it used for

Yselty contains the active substance linzagolix. It is used to treat

• moderate to severe symptoms of uterine fibroids, which are non-cancerous tumors of the uterus (womb).
• symptoms associated with endometriosis in women with a history of previous medical or surgical treatment for endometriosis (endometriosis is a often painful disorder in which tissue similar to the tissue that normally lines the inside of the uterus - the endometrium - grows outside the uterus).

Yselty is used in adult women (aged 18 years and older) of childbearing age.

In some women, uterine fibroids can cause heavy menstrual bleeding (heavy periods) and pelvic pain (pain below the belly button). Yselty is used to treat fibroids in order to stop or reduce bleeding and decrease pain and pelvic discomfort associated with uterine fibroids.

Women with endometriosis may experience pelvic pain or lower abdominal pain, painful menstruation, and painful intercourse. Yselty is used to treat endometriosis to reduce symptoms due to displacement of uterine lining tissue.

Linzagolix blocks the action of a hormone, gonadotropin-releasing hormone, which helps regulate the release of female sex hormones estradiol and progesterone. These hormones trigger menstruation (periods) in women. When blocked, the levels of circulating estrogen and progesterone hormones are reduced. By reducing their levels, linzagolix stops or reduces menstrual bleeding and decreases pain and pelvic discomfort and other symptoms associated with uterine fibroids and endometriosis.

2. What you need to know before you take Yselty

Do not take Yselty

If you have any of the following conditions:

• are allergic to linzagolix or any of the other ingredients of this medicine (listed in section 6);
• are pregnant or think you may be pregnant or are breast-feeding
• have osteoporosis (a disease that makes bones fragile)
• have any genital bleeding of unknown origin.

If you are taking Yselty with additional hormonal treatment of estradiol and norethisterone acetate (also known as add-back therapy), follow the instructions in the section "Do not take..." of the package leaflets of estradiol and norethisterone acetate.

Warnings and precautions

Consult your doctor or pharmacist before starting Yselty.

Before starting treatment with Yselty, your doctor will review your medical and family history and explain the relevant risk factors. Your doctor will also need to check your blood pressure and make sure you are not pregnant. You may also need to undergo a physical examination and additional tests before starting treatment, such as a bone density test, which will be specific to your needs or medical problems.

Stop taking Yselty and seek urgent medical attention if:

• you notice signs of liver disease:

• yellowing of the skin or the whites of the eyes (jaundice).
• nausea or vomiting, fever, extreme tiredness.
• dark-colored urine, itching, or abdominal pain in the upper right side.

• you become pregnant.

Consult your doctor or pharmacist before starting Yselty if:

• you have impaired liver or kidney function.

Yselty is not recommended for use in women with severe liver impairment or moderate to severe kidney impairment, as the blood level of linzagolix may become too high.

• you have increased liver enzyme levels in the blood.

A temporary increase in liver enzyme levels in the blood without symptoms may occur during treatment with Yselty.

• you have heart problems or blood circulation problems, a family history of changes in heart electrical activity known as "QT interval prolongation", or if you are taking a medicine that affects heart activity.
• you have high levels of fat in the blood (cholesterol). These levels should be monitored during treatment, as Yselty may cause further increases.
• you have had a fracture that was not caused by a major injury or have other risks of bone mineral loss or reduced bone density. Yselty may reduce bone mineral density, so your doctor may want to check it beforehand in this case.
• you have previously suffered from depression, mood changes, suicidal thoughts, or any depressive symptoms, as these have been reported with medicines that work in the same way as Yselty.
• you think you may be pregnant. Normally, Yselty significantly reduces or even stops menstrual bleeding (periods) during treatment and for some weeks after, making it difficult to recognize pregnancy. See the section "Pregnancy and breast-feeding".

Yselty has not been shown to have contraceptive effects. See the section "Pregnancy and breast-feeding".

Yselty can be used with another tablet that contains the hormones estradiol and norethisterone acetate (also known as add-back therapy). If you are prescribed this, read the package leaflet of the tablet that contains these hormones, as well as this leaflet.

Children and adolescents

Yselty is not recommended for girls and adolescents under 18 years of age, as it has not been studied in this age group.

Other medicines and Yselty

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including hormonal contraception.

In particular, tell your doctor or pharmacist if you are taking:

• repaglinide (a medicine used to treat diabetes)
• paclitaxel, sorafenib (medicines used to treat cancer)

Yselty is not recommended if you are using one of these medicines.

Pregnancy and breast-feeding

Do not use Yselty if you are pregnant or breast-feeding, as it may harm your baby. If you think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine.

If you become pregnant, stop taking Yselty and contact your doctor. Since Yselty reduces or stops menstrual bleeding, it may be difficult to recognize pregnancy. Perform a pregnancy test if there is any possibility that you may be pregnant.

Women who may become pregnant must use a non-hormonal effective contraceptive method when taking Yselty.

Driving and using machines

Yselty has no influence on the ability to drive and use machines.

Yselty contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Yselty

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Uterine fibroids:

Your doctor will calculate the correct dose of Yselty for you. The following dose options for Yselty 200 mg tablets are possible:

• One 200 mg Yselty tablet taken once daily, along with another tablet, also taken once daily, that contains the hormones estradiol and norethisterone acetate (also known as add-back therapy). If your doctor prescribes add-back therapy, it is important that you take it always with the Yselty tablets, as this will help reduce side effects, such as the risk and extent of bone mineral density loss.

• For short-term use (up to 6 months), a 200 mg Yselty tablet may be given once daily without estradiol or norethisterone acetate to treat symptoms associated with large fibroid or uterine size.

Note that if a lower dose is needed, Yselty can be used at a dose of 100 mg.

Endometriosis:

• One 200 mg Yselty tablet taken once daily, along with a medicine that contains the hormones estrogen and progestogen (also known as add-back therapy). It is important to take the add-back therapy with the Yselty tablets, as this will help reduce side effects, such as the risk and extent of bone mineral density loss.

Take the recommended dose once daily.

Start taking Yselty, preferably during the first week of your menstrual cycle, which is the week you have bleeding.

Swallow the tablet with a glass of water, with or without food.

Duration of treatment

Your doctor will decide how long you should continue treatment, based on the risk of bone mineral density loss. In the case of fibroids, the 200 mg dose without add-back therapy should not be prescribed for more than 6 months.

Your doctor will check your bone mineral density by requesting a test after the first 12 months of treatment with Yselty, to check if treatment with estradiol and norethisterone acetate can continue. If you continue treatment with Yselty for more than one year, your doctor will continue to check your bone mineral density at regular intervals.

If you take more Yselty than you should

Tell your doctor if you think you have taken too much Yselty.

No serious harmful effects have been reported when taking several doses of this medicine at the same time. If Yselty is used with add-back therapy, an overdose of the hormones may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness, tiredness, and withdrawal bleeding.

If you forget to take Yselty

If you forget to take a dose, take it as soon as you remember and then take the next tablet at the usual time the next day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Yselty

If you want to stop taking Yselty, consult your doctor first. Your doctor will explain the effects of stopping treatment and discuss other options with you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may occur with the following frequencies:

Very common(may affect more than 1 in 10 people)

• hot flushes

Common(may affect up to 1 in 10 people)

• mood changes, such as mood swings and emotional instability (i.e., rapid changes in emotions), anxiety, depression, irritability, and emotional disorder
• excessive, irregular, or prolonged uterine bleeding
• vaginal dryness
• pelvic pain
• joint pain
• headache
• reduced bone mineral density or bone strength
• increased liver enzyme levels in the blood
• nausea, vomiting, abdominal pain
• constipation
• decreased sex drive (libido)
• weakness
• increased sweating
• night sweats

Uncommon(may affect up to 1 in 100 people)

• high blood pressure

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Yselty

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Yselty

• The active substance is linzagolix.

One 200 mg Yselty tablet contains 200 mg of linzagolix.

• The other ingredients are:

Tablet core: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, sodium croscarmellose, and magnesium stearate. See section 2 "Yselty contains lactose and sodium".

Coating: macrogol and polyvinyl alcohol graft copolymer (E 1209), talc (E 553b), titanium dioxide (E 171), yellow iron oxide (E 172)

Appearance and packaging

Yselty 200 mg are film-coated tablets, oblong (19 × 9 mm), light yellow in color, with the inscription "200" on one side and smooth on the other side.

Yselty is available in a carton box with 2 or 6 blisters, each containing 14 film-coated tablets.

Package sizes: 28 or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Manufacturer

Theramex Poland Sp. z o. o.

Amsterdam Building,

ul. Poleczki 35,

02-822 Warszawa

Poland

Date of last revision of this leaflet: 11/2024

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu