Yselty 200 mg film-coated tablet

• 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.

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

If you have any of the conditions listed below:

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

If you are taking Yselty together with additional hormonal therapy of 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.

Talk to your doctor or pharmacist before taking Yselty.

Before you start treatment with Yselty, your doctor will discuss your medical and family history and relevant risk factors with you. Your doctor will also need to check your blood pressure and make sure you are not pregnant. You may also need a physical examination and additional checks before you start treatment, such as a scan to measure how strong your bones are, that will be specific to your medical needs and/or concerns.

Stop taking Yselty and get urgent medical attention if you notice:

• signs of liver disease:
  • yellowing of your skin or the whites of your eyes (jaundice).
  • nausea or vomiting, fever, severe tiredness.
  • dark urine, itching or upper abdominal pain.
• 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 or moderately or severely reduced kidney function as the linzagolix blood level may become too high.
• increased levels of liver enzymes in the blood.
  Temporary increased levels of liver enzymes in the blood without symptoms may occur during treatment with Yselty.
• heart or blood circulation problems, a family history of changes in the electrical activity of the heart known as “QT prolongation” or you are taking a medicine that changes the electrical activity in the heart.
• increased blood fat levels (cholesterol). These levels should be monitored during treatment as Yselty may lead to further increases.
• had a fracture that was not caused by a major trauma, or other risks of bone mineral loss or reduced bone density. Yselty can lower bone mineral density, so your doctor may want to check it beforehand in this case.
• previously suffered from depression, mood changes, thoughts about suicide or any depressive symptoms as these have been reported with medications that work in the same way as Yselty does.
• if you think you might be pregnant. Yselty usually leads to a significant reduction or may even stop your menstrual bleeding (your ‘period’) during treatment and for a few weeks afterwards, making it difficult to recognise pregnancy. See under “Pregnancy and breast-feeding.

Yselty has not been shown to provide contraception. See under “Pregnancy and breast-feeding”.

Yselty can be used together with another tablet containing the hormones estradiol and norethisterone acetate (also known as hormonal add-back therapy). If prescribed to you, read the leaflet of the tablet containing these hormones carefully as well as this leaflet.

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

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

Particularly 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 using one of these medicines.

Do not use Yselty if you are pregnant or breast-feeding as it might harm your baby. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you become pregnant, stop taking Yselty and contact your doctor. Because Yselty reduces or stops your periods it might be difficult to recognise pregnancy. Carry out a pregnancy test if there is any chance you may be pregnant.

Women who could become pregnant should use effective non-hormonal contraception when taking Yselty.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Your doctor will work out how long to continue treatment, based on the risk of bone mineral density loss. The 200 mg dose without add-back therapy should be prescribed for no longer than 6 months.

Your doctor will check your bone mineral density by arranging a scan after the first 12 months of Yselty treatment to see if treatment with estradiol and norethisterone acetate can continue. If you continue Yselty treatment beyond one year, your doctor will keep checking your bone mineral density at regular intervals.

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

There have been no reports of serious harmful effects from taking several doses of this medicine at once. If Yselty is used together with the additional hormonal therapy of estradiol and norethisterone acetate, overdose of the hormones may cause nausea and vomiting, breast tenderness, stomach pain, drowsiness, fatigue and withdrawal bleeding.

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

If you would like to stop taking Yselty, talk to your doctor first. Your doctor will explain the effects of stopping treatment and discuss other possibilities with you.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly:

for United Kingdom (Great Britain and Northern Ireland)

or search for MHRA Yellow Card in the Google Play or Apple App Store

for Ireland

By reporting side effects you can help provide more information on the safety of this medicine.

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

Yselty 200 mg film-coated tablets are oblong (19 × 9 mm), pale yellow, engraved with “200” on one side and plain on the other side.

Yselty is provided in a cardboard box with 2 or 6 blisters containing 14 film-coated tablets (tablet) per blister.

Pack sizes: 28 or 84 film-coated tablets.

Not all pack sizes may be marketed.