Yselty 200 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Yselty 200 mg film-coated tablets
linzagolix
This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any side effects you may experience. Section 4 includes information on how to report side effects.
Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Yselty is and what it is used for
- What you need to know before taking Yselty
- How to take Yselty
- Possible side effects
- How to store Yselty
- Contents of the pack and other information
1. What Yselty is and what it is used for
Yselty contains the active substance linzagolix. It is used to treat
- moderate to severe symptoms of uterine fibroids, which are non-cancerous tumours of the uterus (womb).
- symptoms associated with endometriosis in women with a history of prior medical or surgical treatment for endometriosis (endometriosis is a disorder often causing pain, in which tissue similar to the one that normally lines the inside of the uterus—the endometrium—grows outside the uterus).
Yselty is used in adult women (over 18 years of age) of reproductive age.
In some women, uterine fibroids can cause heavy menstrual bleeding (periods with excessive blood loss) and pelvic pain (pain below the navel). Yselty is used to treat fibroids in order to stop or reduce bleeding and decrease pelvic pain and discomfort associated with uterine fibroids.
Women with endometriosis may experience pelvic or lower abdominal pain, menstrual pain, and pain during sexual intercourse. Yselty is used in the treatment of endometriosis to reduce symptoms caused by misplaced uterine lining tissue.
Linzagolix blocks the action of a hormone called gonadotropin-releasing hormone (GnRH), which helps regulate the release of the female sex hormones estradiol and progesterone. These hormones trigger menstruation (periods) in women. When this hormone is blocked, circulating levels of estrogen and progesterone hormones in the body are reduced. By lowering their levels, linzagolix stops or reduces menstrual bleeding and decreases pelvic pain, discomfort, and other symptoms associated with uterine fibroids and endometriosis.
2. What you need to know before taking Yselty
Do not take Yselty
If you have any of the following conditions:
- you are allergic to linzagolix or to any of the other ingredients of this medicine (listed in section 6);
- you are pregnant or think you might be pregnant, or if you are breastfeeding;
- you have osteoporosis (a condition that causes bones to become fragile);
- you have genital bleeding of unknown origin.
If you are taking Yselty together with additional hormonal treatment containing estradiol and norethisterone acetate (also known as add-back hormonal treatment), follow the instructions under the "Do not take..." section in the package leaflets for estradiol and norethisterone acetate.
Warnings and precautions
Talk to your doctor or pharmacist before starting Yselty.
Before starting treatment with Yselty, your doctor will review your personal and family medical history and explain relevant risk factors to you. Your doctor will also need to check your blood pressure and confirm that you are not pregnant. You may also need to undergo a physical examination and additional tests before starting treatment, such as a bone density assessment, tailored to your individual needs or medical conditions.
Stop taking Yselty and seek urgent medical attention if:
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you notice signs of liver disease:
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yellowing of the skin or whites of the eyes (jaundice);
-
nausea or vomiting, fever, extreme fatigue;
-
dark urine, itching, or upper abdominal pain.
-
you become pregnant.
Talk to your doctor or pharmacist before starting Yselty if:
- you have impaired liver or kidney function.
The use of Yselty is not recommended in women with severe hepatic impairment or moderate to severe renal impairment, as blood levels of linzagolix may become too high.
- you have elevated liver enzyme levels in the blood.
During treatment with Yselty, temporary increases in liver enzyme levels in the blood may occur without symptoms.
- you have heart or circulatory problems, a family history of changes in the heart's electrical activity known as "QT interval prolongation," or if you are taking a medicine that affects the heart's electrical activity.
- you have elevated blood lipid levels (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 risk factors for bone mineral loss or reduced bone density. Yselty may reduce bone mineral density, so your doctor may wish to assess this beforehand.
- you have previously had depression, mood changes, suicidal thoughts, or any depressive symptoms, as these have been reported with medicines that work similarly to Yselty.
- you think you might be pregnant. Generally, Yselty significantly reduces or may even stop menstrual bleeding (period) during treatment and for several weeks afterwards, making it difficult to recognize pregnancy. See section "Pregnancy and breastfeeding."
Yselty has not been shown to have contraceptive effects. See section "Pregnancy and breastfeeding."
Yselty may be used together with another tablet containing the hormones estradiol and norethisterone acetate (also known as add-back hormonal treatment). If prescribed, please read the package leaflet for the tablet containing 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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).
The use of Yselty is not recommended if you are taking any of these medicines.
Pregnancy and breastfeeding
Do not use Yselty if you are pregnant or breastfeeding, as it may harm your baby. If you think you might 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 immediately. Because Yselty reduces or stops menstruation, it may be difficult to recognize pregnancy. Perform a pregnancy test if there is any possibility you might be pregnant.
Women who can become pregnant must use an effective non-hormonal method of contraception while taking Yselty.
Driving and use of machines
Yselty has no or negligible 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 certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".
3. How to take Yselty
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Uterine fibroids:
Your doctor will calculate the appropriate dose of Yselty for you. The following dosage options are possible for Yselty 200 mg tablets:
-
One 200 mg Yselty tablet taken once daily, together with another tablet taken once daily, containing the hormones estradiol and norethisterone acetate (also known as add-back hormonal treatment). If your doctor prescribes the add-back treatment, it is important that you always take it together with the Yselty tablets, as this will help reduce adverse effects, such as the risk and extent of loss of bone mineral density.
-
For short-term use (only up to 6 months), one Yselty 200 mg tablet per day may be administered without estradiol or norethisterone acetate to treat symptoms associated with large fibroid or uterine size.
Note that if a lower dose is required, Yselty 100 mg tablets may be used.
Endometriosis:
- One 200 mg Yselty tablet taken once daily together with a medication containing estrogen and progestogen hormones (also known as add-back hormonal treatment). It is important to take the add-back treatment together with the Yselty tablets, as this will help reduce adverse effects, such as the risk and extent of loss of bone mineral density.
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 loss of bone mineral density. In the case of fibroids, the 200 mg dose without add-back hormonal treatment should not be prescribed for longer than 6 months.
Your doctor will monitor your bone mineral density by requesting a scan after the first 12 months of treatment with Yselty, to assess whether treatment with estradiol and norethisterone acetate can continue. If Yselty treatment continues beyond 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 intake of several doses of this medicine at once. If Yselty is used together with the additional hormonal treatment of estradiol and norethisterone acetate, overdose of the hormones may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness, fatigue, 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 the following day as usual. Do not take a double dose to make up for forgotten doses.
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 further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse 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 disorders, such as mood changes and emotional instability (i.e., rapid changes in emotions), anxiety, depression, irritability, and emotional disturbance
- 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 levels of liver enzymes in blood
- nausea, vomiting, abdominal 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 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Yselty Storage
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and cardboard box after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 components are:
Tablet core: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, sodium croscarmellose, and magnesium stearate. See section 2, "Yselty contains lactose and sodium".
Film coating: macrogol grafted copolymer and poly (vinyl alcohol) (E 1209), talc (E 553b), titanium dioxide (E 171), iron oxide yellow (E 172).
Appearance of the product and contents of the pack
Yselty 200 mg are film-coated tablets, oblong (19 × 9 mm), light yellow in colour, marked with "200" on one side and smooth on the other.
Yselty is supplied in a cardboard box containing 2 or 6 blisters, each blister containing 14 film-coated tablets.
Pack sizes: 28 or 84 film-coated tablets.
Only certain 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 the most recent 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