Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - yselty

Document Subject

Generated Narrative: MedicinalProductDefinition mp29aa13d063497263a16ff19921f8de13

identifier: http://ema.europa.eu/identifier/EU/1/21/1606/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Yselty 100 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-29aa13d063497263a16ff19921f8de13

identifier: http://ema.europa.eu/identifier/EU/1/21/1606/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - yselty

Attesters

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

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 fibroids.

Do not take Yselty
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. Warnings and precautions
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.

Children and adolescents Yselty is not recommended for children and adolescents under 18 years 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.

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.

Pregnancy and breast-feeding 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.

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, 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 .

Treatment with Yselty will be prescribed by a doctor who is experienced in the care of patients with uterine fibroids. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will work out the right dose of Yselty for you. The following dose options are possible:

• Either 100 mg Yselty (one tablet) or 200 mg Yselty (two tablets of 100 mg), taken once daily together with another tablet 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 with your Yselty tablets as this will help to reduce side effects including the risk and extent of bone mineral density loss.

• For women for whom estradiol and norethisterone acetate are not suitable, Yselty can be taken in a dose of one tablet of 100 mg daily alone, i.e. without estradiol and norethisterone acetate.

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

Take the recommended dose once daily. Start taking Yselty preferably in the first week of your menstrual cycle, which is the week you have bleeding. Swallow the tablet(s) with one glass of water, with or without food.

Duration of use Your doctor will work out how long to continue treatment, based on the risk of bone mineral density loss. The 200 mg dose (two tablets of 100 mg) 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 can continue. If you continue Yselty treatment beyond one year, your doctor will keep checking 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.

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 forget to take Yselty 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 stop taking Yselty 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Side effects can occur with the following frequencies: 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, affect lability (i.e. rapid changes in emotions), anxiety, depression, irritability, emotional disorder
• excessive, irregular, or prolonged bleeding from the womb (uterine bleeding)
• vaginal dryness
• pelvic pain
• joint pain
• headache
• reduction in bone mineral density or bone strength
• increased liver enzyme blood levels
• nausea (feeling sick), vomiting, pain in stomach region
• constipation
• decreased interest in sex (libido)
• weakness
• increased sweating
• night sweats
• high blood pressure

Reporting of side effects 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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Yselty contains

• The active substance is linzagolix. One tablet of Yselty 100 mg contains 100 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).

What Yselty looks like and contents of the pack Yselty 100 mg film-coated tablets are round shaped of 10 mm diameter, pale yellow, engraved with 100 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.

Marketing Authorisation Holder
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YEIreland

Manufacturer Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu France

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: