Prospect: information for the patient

Yselty 100 mg film-coated tablets

linzagolix

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

6. Contents of the pack and additional information

Yselty contains the active ingredient 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 painful condition in which tissue similar to the lining of the uterus -endometrium- grows outside the uterus).

Yselty is used in adult women (over 18 years old) of childbearing age.

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

Women with endometriosis may experience pelvic pain or lower abdominal pain, menstrual pain, and pain during sex. Yselty is used to treat endometriosis to reduce symptoms caused by the displacement of the lining of the uterus.

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

Do not take Yselty

If you have any of the conditions listed below:

• are allergic to linzagolix or any of the other components of this medication (listed in section 6);
• are pregnant or think you may be pregnant or if you are breastfeeding
• have osteoporosis (a disease that makes bones fragile)
• are experiencing unexplained genital bleeding

If you are taking Yselty with an additional estradiol and noretisterone acetate hormone treatment (also known as complementary hormone treatment), follow the instructions listed in the "Do not take..." section of the estradiol and noretisterone acetate prospectus.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Yselty.

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

Stop taking Yselty and seek immediate medical attention if:

• you notice signs of liver disease:

• yellowing of the skin or white of the eyes (jaundice).
• nausea or vomiting, fever, intense fatigue.
• dark urine, itching, or localized abdominal pain in the upper part.

• you become pregnant.

Consult your doctor or pharmacist before starting to take Yselty if:

• you have impaired liver or kidney function.

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

• you have an increase in liver enzyme levels in the blood.

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

• you have heart or blood circulation problems, a family history of changes in heart electrical activity known as "prolongation of the QT interval," or if you are taking a medication that modifies heart electrical activity.
• you have high levels of fat in the blood (cholesterol). These levels should be monitored during treatment, as Yselty may cause higher increases.

• you have had a fracture that was not caused by significant trauma or have other risks of bone mineral loss or bone density reduction. Yselty may reduce bone mineral density, so your doctor may want to check it in this case.
• you have previously experienced depression, mood changes, thoughts of suicide, or any depressive symptoms, as these have been reported with medications that act in the same way as Yselty.
• you think you may be pregnant. Yselty usually significantly reduces or even stops menstrual bleeding (periods) during treatment and for several weeks after, making it difficult to recognize pregnancy. See the "Pregnancy and breastfeeding" section.

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

Yselty can be used with another tablet containing the hormones estradiol and noretisterone acetate (also known as complementary hormone treatment). If you are prescribed it, read the prospectus of the tablet containing these hormones carefully, as well as this prospectus.

Children and adolescents

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

Other medications and Yselty

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including hormonal contraception.

Particularly, inform your doctor or pharmacist if you are taking:

• repaglinide (a medication used to treat diabetes)
• paclitaxel, sorafenib (medications used to treat cancer)

Yselty is not recommended for use if you are using one of these medications.

Pregnancy and breastfeeding

Do not use Yselty if you are pregnant or breastfeeding, as it may harm your baby. If you think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

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 should use an effective non-hormonal contraceptive method while taking Yselty.

Driving and operating machines

The influence of Yselty on the ability to drive and operate machines is negligible.

Yselty contains lactose and sodium

If you have been informed that you have an intolerance to certain sugars, consult your doctor before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Uterine fibroids:

Your doctor will calculate the appropriate dose of Yselty for you.The following dose options are possible:

• 100 mg of Yselty (one tablet) or 200 mg of Yselty (two 100 mg tablets), taken once a day along with another tablet, also taken once a day, that contains estradiol and norethisterone acetate (also known as hormone replacement therapy). If your doctor prescribes hormone replacement therapy, it is essential to take it always along with Yselty tablets, as this will help reduce adverse effects, such as the risk and extent of bone mineral density loss.

• In women for whom estradiol and norethisterone acetate are not suitable, Yselty can be taken at a dose of one 100 mg tablet per day without estradiol and norethisterone acetate.

• For short-term use (only up to 6 months), Yselty 200 mg per day (two 100 mg tablets) without estradiol or norethisterone acetate can be administered to treat symptoms associated with a large uterine or fibroid size.

Endometriosis:

• Two 100 mg Yselty tablets taken once a day along with a medication that contains estrogen and progestogen (also known as hormone replacement therapy). It is essential to take hormone replacement therapy with Yselty tablets, as this will help reduce adverse effects, such as the risk and extent of bone mineral density loss.

Take the recommended doseonce a day.

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

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

Treatment duration

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 (two 100 mg tablets) dose without hormone replacement therapy should not be prescribed for a period exceeding 6 months.

Your doctor will check bone mineral density by requesting an examination after the first 12 months of treatment with Yselty, to check if treatment can continue. If treatment with Yselty continues for more than a year, your doctor will continue to check your bone mineral density at regular intervals.

If you take more Yselty than you should

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

No serious adverse effects have been reported when taking several doses of this medication at once. If Yselty is used along with additional hormone replacement therapy of estradiol and norethisterone acetate, overdose of the hormones may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness, fatigue, and amenorrhea.

If you forget to take Yselty

If you forget to take a dose, take it as soon as you remember and then take the tablet the next day as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Yselty

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects may appear with the following frequencies:

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

• Headaches

Frequent (may affect up to 1 in 10 people)

• Mood disorders, such as mood changes 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
• Headaches
• Reduction in bone mineral density or bone resistance
• Increased levels of liver enzymes in the blood
• Nausea, vomiting, abdominal pain
• Constipation
• Decreased interest in sex (libido)
• Weakness
• Increased sweating
• Nocturnal sweating

Rare (may affect up to 1 in 100 people)

• High blood pressure

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister pack and on the carton box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Yselty

• The active ingredient is linzagolix.

One Yselty 100 mg tablet contains 100 mg of linzagolix.

• The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, sodium croscarmellose, and magnesium stearate. See section 2 "Yselty contains lactose and sodium".

Coating: copolymer of grafting of macrogol and poly (vinyl alcohol) (E 1209), talc (E 553b), titanium dioxide (E 171), and yellow iron oxide (E 172)

Appearance of the product and content of the container

Yselty 100 mg are film-coated tablets, round, 10 mm in diameter, light yellow in color, with the inscription "100" on one face and smooth on the other face.

Yselty is presented in a cardboard box with 2 or 6 blisters containing 14 film-coated tablets each.

Container sizes: 28 or 84 film-coated tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder

Theramex Ireland Limited

3rd Floor, Kilmore House,

Park Lane, Spencer Dock,

Dublin 1

D01 YE64

Ireland

Responsible for manufacturing

Theramex Poland Sp. z o. o.

Amsterdam Building,

ul. Poleczki 35,

02-822Warsaw

Poland

Last review date of this leaflet: 11/2024

Other sources of information

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