Yselty

Patient Information Leaflet

Yselty 100 mg film-coated tablets

linzagolix
This medicinal product is subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Yselty is and what it is used for
2. What you need to know before taking 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 Yselti is and what it is used for

Yselti contains the active substance linzagolix. It is used to treat:

• moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus,
• symptoms associated with endometriosis in women with a history of prior medical or surgical treatment for endometriosis (endometriosis is a disorder, often linked with pain, in which tissue similar to the normal lining of the inside of the uterus – the endometrium – grows outside the uterus).

Yselti is used in adult women (over 18 years of age) of reproductive age.
In some women, uterine fibroids can cause heavy menstrual bleeding (the "period") and pelvic pain (pain below the navel). Yselti is used to treat fibroids in order to stop or reduce bleeding and relieve pelvic pain and discomfort associated with uterine fibroids.
Women with endometriosis may experience pelvic or lower abdominal pain, pain during menstruation, and pain during sexual intercourse. Yselti is used to treat endometriosis to alleviate symptoms caused by misplaced uterine lining tissue.
Linzagolix blocks the action of a hormone (gonadotropin-releasing hormone) that helps regulate the release of the female sex hormones estradiol and progesterone. These hormones trigger the menstrual cycle (periods) in women. When this action is blocked, circulating levels of estrogen and progesterone in the body are reduced. By lowering these hormone levels, linzagolix stops or reduces menstrual bleeding and decreases pelvic pain, discomfort, and other symptoms associated with uterine fibroids and endometriosis.

2. What you should know before taking Yselty

Do not take Yselty
If you have any of the following conditions:

• if you are allergic to linzagolix or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, suspect you may be pregnant, or are breastfeeding;
• if you have osteoporosis (a condition that weakens the bones);
• if you have genital bleeding of unknown origin.

If you are taking Yselty in combination with additional hormonal therapy containing estradiol and
norethisterone acetate (also known as add-back therapy), follow the instructions in the “Do not take...”
section of the package leaflets for estradiol and norethisterone acetate.
Warnings and precautions
Talk to your doctor or pharmacist before taking Yselty.
Before starting treatment with Yselty, your doctor will discuss your personal and family medical
history and relevant risk factors. Your doctor must also check your blood pressure and ensure that you
are not pregnant. You may also need a physical examination and further tests before starting treatment,
such as a scan to measure bone strength, tailored to your specific medical needs and/or concerns.
Stop taking Yselty and contact your doctor urgently if you notice:

• signs of liver disease:
  • yellowing of the skin or whites of the eyes (jaundice);
  • nausea or vomiting, fever, severe fatigue;
  • dark urine, itching, or pain in the upper abdomen;
• if you become pregnant.

Talk to your doctor or pharmacist before taking Yselty if:

• you have impaired liver or kidney function. Yselty is not recommended in women with severely reduced liver function or with moderately to severely reduced kidney function, as the level of linzagolix in the blood may become too high;
• you have elevated liver enzyme levels in the blood. During treatment with Yselty, temporary, asymptomatic increases in liver enzyme levels in the blood may occur;
• you have heart or blood circulation problems, a family history of disturbances in the heart's electrical activity known as “QT interval prolongation,” or are taking a medicine that affects the heart's electrical activity;
• you have elevated levels of fats in the blood (cholesterol). These levels should be monitored during treatment, as Yselty may cause further increases;
• you have had a fracture not caused by major trauma or have other risks for bone mineral loss or reduced bone density. Yselty may reduce bone mineral density, so your doctor may wish to monitor you preventively in such cases;
• you have previously suffered from depression, mood changes, suicidal thoughts, or any depressive symptoms, as such symptoms have been reported with medicines that work similarly to Yselty;
• if you think you may be pregnant. Yselty usually causes a significant reduction or may even stop menstrual bleeding (the “period”) during treatment and for several weeks afterward, making it difficult to recognize pregnancy. See section “Pregnancy and breastfeeding”.

Yselty has not been shown to have a contraceptive effect. See section “Pregnancy and
breastfeeding”.
Yselty may be used in combination with another tablet containing the hormones estradiol and
norethisterone acetate (also known as add-back hormonal therapy). If this has been prescribed for you,
please read carefully both the package leaflet for the tablet containing these hormones and this leaflet.
Children and adolescents
Yselty is not recommended for children and adolescents under 18 years of age, as it has not been
studied in this age group.
Other medicines and Yselty
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including hormonal contraceptives.
In particular, inform 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 taking any of these medicines.

Pregnancy and breastfeeding
Do not use Yselty during pregnancy or breastfeeding, as it may harm the baby. If you suspect you are
pregnant or are planning a pregnancy, consult your doctor before taking 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
chance you could be pregnant.
Women of childbearing potential must use an effective non-hormonal contraceptive method during
treatment with Yselty.
Driving and using machines
Yselty does not affect the ability to drive or use machinery.
Yselty contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking
this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Yselty

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Uterine fibroids:

Your doctor will determine the appropriate dose of Yselty for you. Possible dosing options are:

• Yselty 100 mg (one tablet) or Yselty 200 mg (two 100 mg tablets), taken once daily in combination with another tablet taken once daily containing the hormones estradiol and norethisterone acetate (also known as add-back therapy). If your doctor prescribes this add-back therapy, it is important to always take it together with Yselty tablets, as it helps reduce side effects, including the risk and extent of bone mineral density loss;

• in women for whom estradiol and norethisterone acetate are not suitable, Yselty may be taken at a dose of one 100 mg tablet daily alone, that is, without estradiol and norethisterone acetate;

for short-term use (not exceeding 6 months), Yselty 200 mg daily (two 100 mg tablets) without estradiol and norethisterone acetate may be administered for the treatment of symptoms associated with fibroids or a large uterus.

Endometriosis:

• Two tablets of Yselty 100 mg taken once daily in combination with a medicinal product containing estrogen and progestin hormones (also known as add-back therapy). It is important to take the add-back therapy together with Yselty tablets, as it helps reduce side effects, including the risk and extent of bone mineral density loss.

Take the recommended dose once daily.
Start taking Yselty preferably during the first week of the menstrual cycle, which is the week when you have bleeding.
Swallow the tablet or tablets with a glass of water, with or without food.

Duration of treatment

Your doctor will decide how long to continue treatment, based on the risk of bone mineral density loss. For uterine fibroids, the 200 mg dose (two 100 mg tablets) without add-back therapy should be prescribed for no longer than 6 months.

Your doctor will monitor bone mineral density by arranging a scan after the first 12 months of Yselty treatment to determine whether continued treatment is appropriate. If you continue Yselty treatment for more than one year, your doctor will continue to monitor 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 harmful effects have been reported following the simultaneous intake of multiple doses of this medicine. If Yselty is used in combination with add-back hormonal therapy consisting of estradiol and norethisterone acetate, hormone overdose may cause nausea and vomiting, breast tenderness, stomach pain, drowsiness, fatigue, and withdrawal bleeding.

If you forget to take Yselty

If you miss a dose, take it as soon as you remember, then continue taking the tablet the next day as usual. Do not take a double dose to make up for the missed tablet.

If you stop taking Yselty

If you wish 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following frequencies may be observed for adverse reactions:
Very common (may affect more than 1 in 10 people):

• hot flush

Common (may affect up to 1 in 10 people):

• mood disorders, such as mood swings, emotional lability (i.e. rapid changes in emotions), anxiety, depression, irritability, emotional disturbances;
• excessive, irregular or prolonged bleeding from the uterus (uterine bleeding);
• vaginal dryness;
• pelvic pain;
• joint pain;
• headache;
• reduction in bone mineral density or bone strength;
• increased levels of liver enzymes in the blood;
• nausea, vomiting, stomach area pain;
• constipation;
• decreased interest in sex (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, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Yselty

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard box,
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Yselty contains

• The active substance is linzagolix. One Yselty 100 mg tablet contains 100 mg of linzagolix.
• The other components are: tablet core: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium croscarmellose, and magnesium stearate. See section 2 “Yselty contains lactose and sodium”; film coating: poly(vinyl alcohol) graft copolymer with macrogol (E1209), talc (E553b), titanium dioxide (E171), and iron oxide yellow (E172).

Description of the appearance of Yselty and package contents
Yselty 100 mg film-coated tablets are round in shape, 10 mm in diameter, light yellow in colour, with “100” engraved on one side and smooth on the other side.
Yselty is supplied in a cardboard box containing 2 or 6 blisters of 14 film-coated tablets (tablets) each.
Pack 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu

Patient Information Leaflet

Yselty 200 mg film-coated tablets

linzagolix
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Yselty is and what it is used for
2. What you need to know before taking 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 Yselti is and what it is used for

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

• moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus,
• symptoms associated with endometriosis in women with a history of prior medical or surgical treatment for endometriosis (endometriosis is a disorder, often associated with pain, in which tissue similar to the normal lining of the inside of the uterus – the endometrium – grows outside the uterus).

Yselti is used in adult women (over 18 years of age) of reproductive age.
In some women, uterine fibroids can cause heavy menstrual bleeding (the “period”) and pelvic pain (pain below the navel). Yselti is used to treat fibroids in order to stop or reduce bleeding and relieve pelvic pain and discomfort associated with uterine fibroids.
Women with endometriosis may experience pelvic or lower abdominal pain, pain during menstruation, and pain during sexual intercourse. Yselti is used to treat endometriosis to alleviate symptoms caused by misplaced uterine lining tissue.
Linzagolix blocks the action of a hormone (gonadotropin-releasing hormone) that helps regulate the release of the female sex hormones estradiol and progesterone. These hormones trigger the menstrual cycle (periods) in women. When this action is blocked, circulating levels of the hormones estrogen and progesterone in the body are reduced. By lowering their levels, linzagolix stops or reduces menstrual bleeding and reduces pain, pelvic discomfort, and other symptoms associated with uterine fibroids and endometriosis.

2. What you should know before taking Yselty

Do not take Yselty
If you have any of the following conditions:

• if you are allergic to elagolix or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, suspect you may be pregnant, or are breastfeeding;
• if you have osteoporosis (a condition that weakens the bones);
• if you have genital bleeding of unknown origin.

If you are taking Yselty in combination with additional hormonal therapy containing estradiol and
norethisterone acetate (also known as add-back therapy), follow the instructions under "Do not take..." in the package leaflets of estradiol and norethisterone acetate.
Warnings and precautions
Talk to your doctor or pharmacist before taking Yselty.
Before starting treatment with Yselty, your doctor will discuss your personal and family medical history and relevant risk factors. Your doctor must also check your blood pressure and confirm that you are not pregnant. You may also require a physical examination and additional tests before starting treatment, such as a scan to measure your bone strength, tailored to your specific medical needs and/or concerns.
Stop taking Yselty and contact your doctor immediately if you notice:

• signs of liver disease:
  • yellowing of the skin or whites of the eyes (jaundice);
  • nausea or vomiting, fever, severe fatigue;
  • dark urine, itching, or pain in the upper abdomen;
• if you become pregnant.

Talk to your doctor or pharmacist before taking Yselty if:

• you have reduced liver or kidney function. Yselty is not recommended in women with severely reduced liver function or with moderately to severely reduced kidney function, as the level of elagolix in the blood may become too high;
• you have elevated liver enzymes in the blood. During treatment with Yselty, a temporary, asymptomatic increase in liver enzyme levels in the blood may occur;
• you have heart or blood circulation problems, a family history of disturbances in the heart's electrical activity known as "QT interval prolongation," or you are taking a medicine that affects the heart's electrical activity;
• you have elevated levels of fats in the blood (cholesterol). These levels should be monitored during treatment, as Yselty may cause further increases;
• you have previously experienced a fracture not caused by major trauma or have other risks for bone mineral loss or reduced bone density. Yselty may reduce bone mineral density, so your doctor may want to monitor you preventively in such cases;
• you have previously suffered from depression, mood changes, suicidal thoughts, or any depressive symptoms, as such symptoms have been reported with medicines that work similarly to Yselty;
• if you think you may be pregnant. Yselty usually causes a significant reduction or may even stop menstrual bleeding ("period") during treatment and for several weeks afterward, making it difficult to recognize pregnancy. See section "Pregnancy and breastfeeding".

Yselty has not been shown to have a contraceptive effect. See section "Pregnancy and breastfeeding".
Yselty may be used in combination with another tablet containing the hormones estradiol and
norethisterone acetate (also known as add-back hormonal therapy). If this has been prescribed for you, carefully read both the package leaflet for the tablet containing these hormones and this leaflet.
Children and adolescents
Yselty is not recommended for children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Yselty
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including hormonal contraceptives.
In particular, inform 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 taking any of these medicines.

Pregnancy and breastfeeding
Do not use Yselty during pregnancy or breastfeeding, as it may harm the unborn or nursing baby. If you suspect or are planning a pregnancy, consult your doctor before taking this medicine.
If you become pregnant, stop taking Yselty and contact your doctor. Because Yselty reduces or stops menstrual bleeding, it may be difficult to recognize a pregnancy. Perform a pregnancy test if there is any possibility you may be pregnant.
Women of reproductive age must use an effective non-hormonal contraceptive method while taking Yselty.
Driving and using machines
Yselty does not affect the ability to drive or operate machinery.
Yselty contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Yselty

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Uterine fibroids:
Your doctor will determine the appropriate dose of Yselty for you. The following dosage options are possible for
Yselty 200 mg tablets:

• one 200 mg Yselty tablet to be taken once daily, together with another tablet taken once daily containing the hormones estradiol and norethisterone acetate (also known as add-back therapy). If your doctor prescribes this add-back therapy, it is

important to always combine it with Yselty tablets, as it helps reduce undesirable effects, including the risk and extent of bone mineral density loss;

• for short-term use (only up to 6 months), one Yselty 200 mg tablet may be administered once daily without estradiol and norethisterone acetate for the treatment of symptoms associated with fibroids or a large uterus.

Note that if a lower dose of Yselty is required, a 100 mg dose may be used.
Endometriosis:

• One Yselty 200 mg tablet taken once daily together with a medicine containing estrogen and progestin hormones (also known as add-back therapy). It is important to take the add-back therapy together with the Yselty tablet, as it helps reduce undesirable effects, including 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 when 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. For uterine fibroids, the 200 mg dose without add-back therapy should be prescribed for no longer than 6 months.
Your doctor will monitor your bone mineral density by arranging a scan after the first 12 months of treatment with Yselty to determine whether continued treatment with estradiol and norethisterone acetate is possible. If you continue treatment with Yselty for more than one year, your doctor will continue to monitor your bone mineral density at regular intervals.
If you take more Yselty than you should
Inform your doctor if you think you have taken an excessive amount of Yselty.
No serious harmful effects have been reported following the simultaneous intake of multiple doses of this medicine. If Yselty is used in combination with add-back hormonal therapy consisting of estradiol and norethisterone acetate, hormone overdose may cause nausea and vomiting, breast tenderness, stomach pain, drowsiness, fatigue, and withdrawal bleeding.
If you forget to take Yselty
If you miss a dose, take it as soon as you remember, and then take the next tablet the following day as usual. Do not take a double dose to make up for the missed tablet.
If you stop taking Yselty
If you wish to stop taking Yselty, consult your doctor first. Your doctor will explain the consequences of stopping treatment and discuss other options with you.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with the frequencies listed below:
Very common (may affect more than 1 in 10 people):

• hot flush

Common (may affect up to 1 in 10 people):

• mood disorders, such as mood swings, emotional lability (i.e. rapid changes in emotions), anxiety, depression, irritability, emotional disturbances;
• excessive, irregular or prolonged bleeding from the uterus (uterine bleeding)
• vaginal dryness
• pelvic pain
• joint pain
• headache
• reduction in bone mineral density or bone strength
• increased levels of liver enzymes in the blood
• nausea, vomiting, stomach area pain
• constipation
• decreased interest in sex (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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the cardboard box
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Yselty contains

• The active substance is linzagolix. One tablet of Yselty 200 mg contains 200 mg of linzagolix.
• The other components are: tablet core: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, sodium croscarmellose and magnesium stearate. See section 2 “Yselty contains lactose and sodium”; film coating: poly(vinyl alcohol) graft copolymer (E1209), talc (E553b), titanium dioxide (E171) and yellow iron oxide (E172).

Description of the appearance of Yselty and package contents
The 200 mg film-coated tablets of Yselty are oblong (19 × 9 mm), pale yellow in colour, with “200” engraved on one side and smooth on the other side.
Yselty is supplied in a cardboard box containing 2 or 6 blisters of 14 film-coated tablets (tablets) each.
Pack 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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.