Jaydess 13.5 mg intrauterine system

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Jaydess 13.5 mg intrauterine system

levonorgestrel

? This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Jaydess is and what it is used for
2. What you need to know before using Jaydess
3. How to use Jaydess
4. Possible side effects
5. How to store Jaydess
6. Contents of the pack and other information

1. What Jaydess is and what it is used for

Jaydess is used for the prevention of pregnancy (contraception) for up to three years.

Jaydess is a T-shaped intrauterine delivery system (IUS) that, after insertion into the uterus, slowly releases a small amount of the hormone levonorgestrel.

Jaydess works by reducing the monthly growth of the uterine lining and thickening cervical mucus. These actions prevent sperm and egg from meeting, thereby preventing fertilization of an egg by sperm.

2. What you need to know before starting to use Jaydess

General considerations Before starting to use Jaydess, your doctor will ask you some questions about your personal medical history. This leaflet describes several situations in which Jaydess should be removed, or in which the reliability of Jaydess may decrease. In such situations, you should not have intercourse or should use a condom or another barrier method. Like other hormonal contraceptives, Jaydess does not protect against HIV infection (AIDS) or any other sexually transmitted diseases. Jaydess is not suitable for use as an emergency contraceptive (post-coital contraception).

DO NOT use Jaydess

• if you are pregnant (see section "Pregnancy, breastfeeding and fertility")
• if you currently have pelvic inflammatory disease (PID; infection of the female reproductive organs) or have had this condition several times in the past
• if you have conditions associated with an increased risk of pelvic infections
• if you have a lower genital tract infection (an infection of the vagina or cervix)
• if you have had a uterine infection after childbirth or after a spontaneous or induced abortion within the last 3 months
• if you currently have abnormal cells in the cervix
• if you have or suspect you have cervical or uterine cancer
• if you have tumours sensitive to progestogenic hormones for growth, e.g. breast cancer
• if you have unexplained uterine bleeding
• if you have abnormalities of the cervix or uterus, including fibroids that distort the uterine cavity
• if you have active liver disease or a liver tumour
• if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before using Jaydess, tell your doctor if:

• you have diabetes. Generally, there is no need to change your antidiabetic medication while using Jaydess, but your doctor may need to check this
• you have epilepsy. A seizure may occur during insertion or removal
• you have previously had an ectopic pregnancy (pregnancy outside the uterus).

Also, speak with your doctor if you experience any of the following conditions before using Jaydess or if any of them occur for the first time while using this medicine:

• migraine with visual disturbances or other symptoms that may indicate transient cerebral ischaemia (temporary blockage of blood supply to the brain)
• exceptionally severe headache
• jaundice (yellowing of the skin, whites of the eyes and/or nails)
• marked increase in blood pressure
• serious arterial diseases such as stroke or heart attack.

The following signs and symptoms may indicate that you could have an ectopic pregnancy and you should consult your doctor immediately (see also section "Pregnancy, breastfeeding and fertility"):

• your menstrual periods have stopped and you then develop persistent bleeding or pain
• you have severe or persistent pain in the lower abdomen
• you have normal signs of pregnancy but also have bleeding and feel dizzy
• you have a positive pregnancy test.

Contact your doctor immediately if any of the following occur (see also section 4), and remember to inform them that you have Jaydess inserted, especially if you were not the person who inserted it:

• severe pain (like menstrual cramps) or heavy bleeding after insertion, or if you experience pain/bleeding lasting more than a few weeks. This could, for example, be a sign of infection, perforation, or that Jaydess is not in the correct position.
• you can no longer feel the threads in your vagina. This could be a sign of expulsion or perforation. You can check this by carefully inserting a finger into your vagina and feeling for the threads at the end of your vagina, near the opening of the uterus (cervix). Do not pull on the threads, as you might accidentally remove Jaydess. Use a barrier method (such as condoms) until your doctor has confirmed that the IUD is still in place.
• you or your partner can feel the lower part of Jaydess. Avoid sexual intercourse until your doctor has confirmed that the IUD is still in place.
• your partner feels the removal threads during sexual intercourse.
• you think you may be pregnant.
• you have persistent abdominal pain, fever, or abnormal vaginal discharge, which may be signs of infection. Infections must be treated immediately.
• you experience pain or discomfort during sexual intercourse, which could, for example, be a sign of infection, ovarian cyst, or incorrect positioning of Jaydess.
• you experience sudden changes in your menstrual periods (e.g. if you previously had light or no bleeding and then develop persistent bleeding or pain, or start bleeding heavily), which could indicate that Jaydess is not in the correct position or has been expelled.

The use of sanitary pads is recommended. If you use tampons or menstrual cups, change them carefully to avoid pulling on the Jaydess threads. If you suspect that Jaydess may have moved from its position (see the list above for possible signs), avoid sexual intercourse or use a barrier method (such as condoms), and contact your doctor.

Breast cancer

Women who take oral contraceptives have a slightly increased risk of breast cancer. This risk returns to the baseline level appropriate for age 10 years after stopping the pill.

Some scientific studies have suggested a slightly increased risk of breast cancer with the use of levonorgestrel-releasing IUDs such as Jaydess, while other studies have not shown an increased risk. Talk to your doctor if you have any concerns.

Psychiatric disorders

Some women using hormonal contraceptives such as Jaydess have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts.

If you experience mood changes or depressive symptoms, contact your doctor for further medical advice as soon as possible.

Children and adolescents

Jaydess is not indicated for use before the first menstrual period (menarche).

Other medicines and Jaydess

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding and fertility

Pregnancy

Jaydess must not be used during pregnancy.

In some women, periods may stop while using Jaydess. The absence of periods is not necessarily a sign of pregnancy. If you miss your period and have other symptoms of pregnancy, you should see your doctor for an examination and a pregnancy test.

If you have not had a period for six weeks and are concerned, consider taking a pregnancy test. If the result is negative, no further testing is needed unless you develop other signs of pregnancy.

If you become pregnant with Jaydess in place, you must see your healthcare provider immediately to have Jaydess removed. Removal may cause miscarriage. However, if Jaydess is left in place during pregnancy, not only is the risk of miscarriage increased, but also the risk of premature delivery. If Jaydess cannot be removed, discuss with your healthcare provider the benefits and risks of continuing the pregnancy. If the pregnancy continues, you will be closely monitored and must contact your healthcare provider immediately if you experience stomach cramps, stomach pain, or fever.

Jaydess contains a hormone called levonorgestrel, and isolated cases of effects on the genitals of female babies have been reported when exposed to levonorgestrel-releasing intrauterine devices in utero.

If you wish to become pregnant, contact your doctor to have Jaydess removed.

Ectopic pregnancy (pregnancy outside the uterus)

It is rare to become pregnant while using Jaydess. However, if you do become pregnant while using Jaydess, the risk of the pregnancy being outside the uterus (ectopic or tubal pregnancy) is increased. Women who have previously had an ectopic pregnancy, tubal surgery, or pelvic infection are at higher risk of this type of pregnancy. Ectopic pregnancy is a serious condition requiring immediate medical attention (see section 2, "Warnings and precautions" for signs and symptoms) and may affect future fertility.

Breastfeeding

You may use Jaydess during breastfeeding. Levonorgestrel (the active ingredient in Jaydess) has been identified in small amounts in breast milk of lactating women. However, no negative effects on the growth and development of the infant or on the quantity or quality of breast milk have been observed.

Fertility

Your normal fertility will return after removal of Jaydess.

Driving and use of machines

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

3. How to use Jaydess

Starting to use Jaydess

• Before inserting Jaydess, you must ensure that you are not pregnant.
• Jaydess should be inserted within 7 days of the start of menstruation. When inserted during this time, Jaydess is effective immediately and will prevent pregnancy from the moment of insertion.
• If Jaydess cannot be inserted within 7 days of the start of menstruation, or if your menstrual cycle is irregular, Jaydess may be inserted on another day. In this case, you must not have had unprotected sexual intercourse since your last menstrual period, and a negative pregnancy test must be confirmed before insertion. Additionally, Jaydess may not reliably prevent pregnancy immediately after insertion. Therefore, you must use a barrier contraceptive method (such as a condom) or abstain from vaginal intercourse for the first 7 days following insertion of Jaydess.
• Jaydess is not indicated for use as emergency contraception (post-coital contraception).

Starting to use Jaydess after childbirth

• Jaydess may be inserted after childbirth once the uterus has returned to its normal size, and no earlier than 6 weeks postpartum (see section 4 “Possible side effects – Perforation”).
• See also “Starting to use Jaydess” above for additional information regarding timing of insertion.

Starting to use Jaydess after an abortion

Jaydess may be inserted immediately after an abortion if the pregnancy lasted less than 3 months, provided there are no genital infections. Jaydess will be effective from the moment of insertion.

Replacing Jaydess

Jaydess may be replaced at any time during your menstrual cycle with a new Jaydess device. The new Jaydess will be effective immediately upon insertion.

Switching from another contraceptive method (such as combined hormonal contraceptives, implants)

• Jaydess may be inserted immediately if it can be confirmed that you are not pregnant.
• If more than 7 days have passed since the start of menstrual bleeding, you should either abstain from vaginal intercourse or use additional contraceptive protection for the following 7 days.

Insertion of Jaydess

Examinations by your doctor prior to insertion may include:

• a cervical smear test (Papanicolaou test)
• breast examination
• other tests, e.g. to rule out infections, including sexually transmitted infections, and a pregnancy test, if necessary. Your doctor will also perform a gynecological examination to determine the position and size of the uterus.

After a gynecological examination:

• a device called a speculum is inserted into the vagina, and the cervix may be cleaned with an antiseptic solution. Jaydess is then placed into the uterus using a narrow, flexible plastic tube (the insertion tube). Local anaesthesia may be applied to the cervix prior to insertion.
• some women may experience dizziness or fainting during or after insertion or removal of Jaydess.
• you may experience some pain and bleeding during or shortly after insertion.

After Jaydess insertion, your doctor should provide you with a patient reminder card for follow-up visits. Please carry this card to every appointment.

Follow-up visit and when to contact your doctor:

You should have Jaydess checked 4–6 weeks after insertion, and then periodically thereafter, at least once a year. Your doctor will determine the frequency and type of check-ups appropriate for your individual case. Bring the patient reminder card provided by your doctor to each visit. Additionally, you should contact your doctor if any of the symptoms described in section 2 “Warnings and precautions” occur.

Removal of Jaydess

Jaydess must be removed no later than at the end of the third year of use.

Your doctor can easily remove Jaydess at any time, after which fertility is restored. Some women may feel dizzy or faint during or after removal of Jaydess. You may experience some pain and bleeding during removal.

Continuation of contraception after removal

If you do not wish to become pregnant, Jaydess should not be removed after the seventh day of the menstrual cycle (monthly period), unless you use another contraceptive method (e.g. condoms) for at least 7 days prior to IUD removal.

If you have irregular periods (menstruation) or no periods at all, you should use a barrier contraceptive method for 7 days before removal.

Alternatively, a new Jaydess may be inserted immediately after removal, in which case no additional contraception is needed. If you do not wish to continue with the same contraceptive method, please consult your doctor about other reliable contraceptive options.

4. Possible adverse effects

Like all medicines, Jaydess can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you notice any of the following symptoms:

• allergic reactions, including rash, hives (urticaria), and angioedema (characterized by sudden swelling of the eyes, mouth, and throat, for example).

Also refer to section 2 to find out when you should contact your doctor immediately.

The following is a list of possible adverse effects according to their frequency:

Very common adverse effects: may affect more than 1 in 10 people

• headache
• abdominal/pelvic pain
• acne/oily skin
• menstrual changes, including increased or decreased menstrual bleeding, spotting, infrequent periods, and absence of bleeding (see also the next section on irregular and infrequent bleeding)
• ovarian cyst (see also the next section on ovarian cysts)
• inflammation of the external genital organs and vagina (vulvovaginitis)

Common adverse effects: may affect up to 1 in 10 people

• depressed mood/depression
• decreased libido
• migraine
• nausea
• hair loss
• upper genital tract infection
• painful menstruation
• breast pain/discomfort
• expulsion of the device (complete or partial); (see the following section on expulsion)
• genital discharge
• weight gain

Uncommon adverse effects: may affect up to 1 in 100 people

• dizziness
• excessive body hair
• uterine perforation (see also the following section on perforation)

Description of selected possible adverse effects:

Irregular or infrequent bleeding

Jaydess is likely to affect your menstrual cycle. It may alter your periods so that you experience spotting (light bleeding), longer or shorter periods, heavier or lighter bleeding, or complete absence of bleeding.

You may experience bleeding and spotting between periods, especially during the first 3 to 6 months. Sometimes bleeding is heavier than usual at first.

Generally, you are likely to experience a gradual reduction in both the amount and number of bleeding days each month. Some women eventually find that their periods stop completely.

Monthly thickening of the uterine lining may not occur due to the hormone's effect, and therefore there may be nothing to shed as a menstrual period. This does not necessarily mean you have reached menopause or that you are pregnant. Your own hormone levels usually remain normal.

When the system is removed, your period should return to normal soon afterward.

Pelvic infection

The Jaydess inserter and Jaydess itself are sterile. Nevertheless, there is an increased risk of pelvic infection (infections of the lining of the uterus or fallopian tubes) at the time of insertion and during the first 3 weeks following insertion.

Pelvic infections in users of IUSs are usually associated with the presence of sexually transmitted infections. The risk of infection increases if you or your partner have multiple sexual partners or if you have previously had pelvic inflammatory disease (PID).

Pelvic infections must be treated immediately.

Pelvic infections such as PID can have serious consequences and may impair fertility and increase the risk of future ectopic pregnancy (pregnancy outside the uterus). In extremely rare cases, a serious infection or sepsis (a very severe infection that may be life-threatening) may occur shortly after insertion.

Jaydess must be removed if you experience recurrent PID or if an infection is severe or does not respond to treatment.

Expulsion

Uterine muscle contractions during menstruation may sometimes push the IUS out of place or expel it. This is more likely to occur if you are overweight at the time of IUS insertion or if you have a history of heavy periods. If the IUS moves out of place, it may not work properly, and therefore the risk of pregnancy increases. If the IUS is expelled, you are no longer protected against pregnancy.

Possible symptoms of expulsion include pain and abnormal bleeding, but Jaydess may also be expelled without you noticing. Because Jaydess reduces menstrual flow, an increase in flow may indicate expulsion.

You are advised to check the threads with your finger, for example while showering. See also section 2, "Warnings and precautions," for instructions on how to check whether Jaydess is in place. If you notice signs suggesting expulsion or are unable to feel the threads, you should use an additional contraceptive method (such as a condom) and consult your healthcare professional.

Perforation

During insertion of Jaydess, the uterine wall may be penetrated or perforated, although perforation may not be detected until later. If Jaydess ends up outside the uterine cavity, it will not be effective in preventing pregnancy and should be removed as soon as possible. Surgical intervention may be required to remove Jaydess. The risk of perforation is increased in women who are breastfeeding, in women who have given birth within 36 weeks prior to insertion, and may be increased in women with a fixed retroverted uterus (fixed retroversion). If you suspect you may have experienced perforation, seek medical assistance promptly and remind the healthcare provider that you have Jaydess inserted, especially if it was not the person who inserted it.

Ovarian cyst

Since the contraceptive effect of Jaydess is primarily due to its local effect on the uterus, ovulation (release of the egg) usually continues while using this medicine. Sometimes an ovarian cyst may develop. In most cases, there are no symptoms.

An ovarian cyst may require medical attention, or more rarely surgical intervention, but usually resolves spontaneously.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Jaydess

No special storage conditions are required.

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

Do not open the blister pack. Only your doctor or nurse should do this.

Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Jaydess

The active substance is levonorgestrel. The intrauterine delivery system contains 13.5 mg of levonorgestrel.

The other components are:

• polydimethylsiloxane elastomer
• anhydrous colloidal silica
• polyethylene
• barium sulfate
• black iron oxide (E172)
• silver

Appearance of the product and contents of the pack

Jaydess is an intrauterine delivery system (IUS) in the shape of a T. The vertical arm of the T-shaped body carries a drug reservoir containing levonorgestrel. Two removal threads are tied to a loop at the lower end of the vertical arm. In addition, the vertical shaft has a silver ring located near the horizontal arms, which is visible on ultrasound examination.

Pack sizes:

• 1 × 1 intrauterine delivery system
• 5 × 1 intrauterine delivery system

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Bayer Hispania, S.L.
Av. Baix Llobregat 3-5
08970 Sant Joan Despí (Barcelona)
Spain

Manufacturer

Bayer Oy
Pansiontie 47
20210 Turku
Finland

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

• Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Portugal, Romania, Spain, Sweden: Jaydess

• Estonia, Latvia, Lithuania: Fleree

Date of the most recent review of this leaflet: November 2025

Other sources of information

Detailed and up-to-date information on this medicinal product is available by scanning with your mobile phone (smartphone) the QR code included in the package leaflet, packaging, and patient reminder card. You may also access the same information at the following internet address: https://cima.aemps.es/info/77169

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The following information is intended for healthcare professionals only:

INSERTION INSTRUCTIONS

Jaydess 13.5 mg intrauterine delivery system

For insertion by a healthcare professional using an aseptic technique.

Jaydess is supplied within an inserter in a sterile pack, which should not be opened until required for insertion. Do not re-sterilize. This product is for single use only. Do not use if the blister is damaged or open. Do not insert after the expiry date stated on the carton and blister after "EXP".

Disposal of unused medicine or waste material must be carried out in accordance with local regulations.

Jaydess is supplied with a patient reminder card inside the pack. Complete the card and give it to the patient after insertion.

Preparation for insertion

• Examine the patient to rule out contraindications for insertion of Jaydess (see Summary of Product Characteristics, section 4.3 and section 4.4 under Examination/medical consultation).
• Insert a speculum, visualize the cervix, and then thoroughly clean the cervix and vagina with an appropriate antiseptic solution.
• Use an assistant if necessary.
• Grasp the anterior lip of the cervix with a tenaculum or other forceps to stabilize the uterus. If the uterus is retroverted, grasping the posterior lip of the cervix may be more appropriate. Gentle traction with the forceps may be applied to straighten the cervical canal. The forceps should remain in place, and gentle counter-traction should be applied to the cervix throughout the insertion procedure.
• Insert a uterine sound through the cervical canal to the uterine fundus to measure the depth and confirm the direction of the uterine cavity, and to rule out any intrauterine abnormalities (e.g., septum, submucosal fibroids) or the presence of a previously inserted intrauterine device not yet removed. If difficulties are encountered, consider cervical dilation. If cervical dilation is required, consider the use of analgesics and/or paracervical block.

Insertion

1. First, fully open the sterile pack. Then use an aseptic technique and sterile gloves.

Push the slider forward in the direction of the arrow until fully loaded to insert Jaydess into the insertion tube.

IMPORTANT! Do not pull the removal thread downwards, as this may cause Jaydess to be released prematurely. Once released, Jaydess cannot be reloaded.

Holding the slider at the end of its travel, position the upper edge of the flange at the length of the uterine cavity measured with the sound. Holding the slider at the end of its travel, insert the inserter through the cervical canal until the flange is approximately 1.5–2.0 cm from the cervix.
IMPORTANT! Do not force the inserter. Dilate the cervical canal if necessary.

Holding the inserter firmly, pull the slider to the mark to open the horizontal arms of Jaydess. Wait 5–10 seconds for the horizontal arms to fully open. Gently advance the inserter forward toward the uterine fundus until the flange reaches the cervix. Jaydess is now positioned at the uterine fundus.

While keeping the inserter in place, release Jaydess by pulling the slider all the way down. While keeping the slider fully down, carefully remove the inserter by pulling it out. Cut the threads so that approximately 2–3 cm remain visible outside the cervix.

IMPORTANT! If it is suspected that the system is not in the correct position, check its location (e.g., by ultrasound). Remove the system if it is not correctly positioned within the uterine cavity. A removed system must not be reinserted.

Removal/replacement

For information on removal/replacement, refer to the Jaydess product information.

Jaydess is removed by gently pulling the threads with forceps. A new Jaydess may be inserted immediately after removal. After removal of Jaydess, the system should be examined to ensure it is intact and has been completely removed.

Inclusion at national level of the QR code linking to the Technical Data Sheet

The Technical Data Sheet for Jaydess is available at the internet address https://cima.aemps.es/info/77169