Label: information for the user

Jaydess 13.5mg intrauterine system

levonorgestrel

?This medicinal product is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to use this medicinal product, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any doubts, consult your doctor or nurse.
• This medicinal product has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

1.What is Jaydess and how is it used

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

3.How to use Jaydess

4.Possible adverse effects

5.Storage of Jaydess

6.Contents of the package and additional information

Jaydess is used for pregnancy prevention (contraception) with a duration of up to three years.

Jaydess is an intrauterine system (IUS) in the shape of a T that, after being placed inside the uterus, slowly releases a small amount of the hormone levonorgestrel.

Jaydess works by reducing the monthly growth of the uterine lining and thickening the cervical mucus. These actions prevent sperm and the egg from coming into contact and thus prevent the fertilization of an egg by sperm.

DO NOT use Jaydess

-if you are pregnant (see section "Pregnancy, lactation and fertility")

-if you currently have pelvic inflammatory disease (PID; female reproductive organ infection) or have had this condition several times in the past

-if you have conditions associated with a higher risk of pelvic infections

-if you have a lower genital tract infection (a vaginal or cervical infection)

-if you have had a uterine infection after giving birth or after a provoked or spontaneous abortion in the last 3 months

- if you currently have abnormal cervical cell changes

-if you have or suspect you have cervical or uterine cancer

-if you have tumors that are sensitive to progestogenic hormones to grow, e.g. breast cancer

-if you have unexplained uterine bleeding

-if you have a uterine or cervical anomaly, including fibroids that deform the uterine cavity

-if you have liver disease or active liver cancer

-if you are allergic to levonorgestrel or any of the other components of this medication (including in section 6).

Warnings and Precautions

Before using Jaydess, inform your doctor if:

-you have diabetes. There is usually no need to modify your antidiabetic medication while using Jaydess, but your doctor may need to check it

-you have epilepsy. Seizures can occur during placement or removal

-you have had a past ectopic pregnancy or extrauterine pregnancy (pregnancy outside the uterus).

Also, talk to your doctor if you experience any of the following situations before using Jaydess or if any of them appear for the first time while using this medication:

-migraine, with visual disturbances or other symptoms that may be signs of transient cerebral ischemia (temporary obstruction of blood supply to the brain)

-exceptionally intense headache

-jaundice (yellowing of the skin, white of the eyes, and/or nails)

-marked increase in blood pressure

-severe arterial diseases such as stroke or heart attack.

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

-your menstrual periods have stopped and then start having persistent bleeding or pain

-you have intense or persistent pain in the lower abdomen

-you have normal pregnancy signs, but also have bleeding and feel dizzy

-you have a positive pregnancy test.

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

-severe pain (such as menstrual cramps) or heavy bleeding after placement or if you experience pain/bleeding that lasts for more than a few weeks. This can be, for example, a sign of infection, perforation, or that Jaydess is not in its correct position.

-you no longer feel the threads in your vagina. This can be a sign of expulsion or perforation. You can check it by carefully introducing a finger into your vagina and feeling the threads at the end of your vagina, near the cervix. Do not pull the threads, as you may accidentally remove Jaydess. Use a barrier method (such as condoms) until your doctor has checked that the IUD is still in its correct position.

-you or your partner can feel the lower part of Jaydess. Avoid sex until your doctor has checked that the IUD is still in its correct position.

-your partner notices the extraction threads during sex.

-you think you may be pregnant.

-you have persistent abdominal pain, fever, or abnormal vaginal discharge, which can be a sign of infection. Infections must be treated immediately.

-you feel pain or discomfort during sex, which can be, for example, a sign of infection, ovarian cyst, or that Jaydess is not in its correct position.

-there are sudden changes in your menstrual periods (for example, if you have a light or absent menstrual period and then start experiencing persistent bleeding or pain, or if you start bleeding heavily), which can be a sign that Jaydess is not in its correct position or has been expelled.

It is recommended to use sanitary pads. If you use tampons or menstrual cups, change them carefully to avoid pulling the Jaydess threads. If you think you may have moved Jaydess out of its position (see the previous list for possible signs), avoid sex or use a barrier method (such as condoms), and contact your doctor.

Mental Health Disorders

Some women who use hormonal contraceptives like Jaydess have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts.

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

Children and Adolescents

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

Other Medications and Jaydess

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

Pregnancy, Lactation and Fertility

Pregnancy

Jaydess should not be used during pregnancy.

In some women, Jaydess may cause the menstrual period to disappear. Not having a period is not necessarily a sign of pregnancy. If you do not have a period and have other pregnancy symptoms, you should see your doctor for an examination and pregnancy test.

If you have not had a period for six weeks and are concerned, consider taking a pregnancy test. If it is negative, there is no need to take another test unless you have other pregnancy symptoms.

If you become pregnant with Jaydess inserted, you should see your healthcare provider immediately to remove Jaydess. Removal may cause a miscarriage. However, if Jaydess is left in place during pregnancy, there is a higher risk of miscarriage and premature birth. If Jaydess cannot be removed, consult your healthcare provider about the benefits and risks of continuing the pregnancy. If the pregnancy continues, you will be closely monitored during it and should contact your healthcare provider immediately if you experience abdominal cramps, stomach pain, or fever.

Jaydess contains a hormone called levonorgestrel, and there have been isolated cases of effects on the genitals of female babies if they are exposed to levonorgestrel-containing IUDs while in the uterus.

If you want to become pregnant, you should 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 become pregnant while using Jaydess, there is an increased risk of ectopic pregnancy. Women who have had a previous ectopic pregnancy, tubal surgery, or pelvic infection are at higher risk of ectopic pregnancy. Ectopic pregnancy is a serious condition that requires immediate medical attention (see section 2, "Warnings and Precautions" for signs and symptoms) and can affect future fertility.

Lactation

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

Fertility

Your usual fertility level will return after Jaydess is removed.

Driving and Using Machines

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

Starting to use Jaydess

• You must ensure you are not pregnant before inserting Jaydess.
• Jaydess must be inserted within 7 days of the start of your period. When inserted during those days, Jaydess will work from the moment of insertion and prevent pregnancy.
• If you cannot insert Jaydess within 7 days of the start of your period or if your period is irregular, then Jaydess can be inserted on any other day. In this case, you must not have had sexual intercourse without contraception since your last menstrual period, and you must have a negative pregnancy test before insertion. Additionally, Jaydess may not prevent pregnancy reliably from the moment of insertion. Therefore, you must use a barrier contraceptive method (such as a condom) or abstain from vaginal sexual intercourse in the following 7 days after Jaydess insertion.
• Jaydess is not indicated for use as emergency contraception (postcoital contraception).

Starting to use Jaydess after giving birth

• Jaydess can be inserted after giving birth after the uterus has recovered to its normal size, and not before 6 weeks after delivery (see section 4 “Possible adverse effects – Perforation”).
• See also “Starting to use Jaydess” above to know what else you need to know for the time of insertion.

Starting to use Jaydess after an abortion

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

Replacing Jaydess

Jaydess can be replaced at any time during your menstrual cycle with a new Jaydess. Jaydess will work from the moment of insertion.

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

• Jaydess can be inserted immediately if you can ensure you are not pregnant.
• If more than 7 days have passed since the start of your menstrual period, you must abstain from vaginal sexual intercourse or use additional contraceptive protection for the following 7 days.

Insertion of Jaydess

Pre-insertion checks by your doctor may include:

• a cervical cytology test (Papanicolaou test)
• breast examination
• other tests, p.eg. to exclude infections, including sexually transmitted diseases, 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 can be cleaned with an antiseptic solution. Jaydess is then placed in the uterus using a thin and flexible plastic tube (the insertion tube). Local anesthesia may be applied to the cervix before insertion.
• some women may experience dizziness or fainting during insertion or after inserting or removing Jaydess.
• you may experience some pain and bleeding during insertion or shortly after.

After Jaydess insertion, your doctor should provide you with a reminder card for the patient for follow-up visits. Bring this card to each visit.

Follow-up visit and when to consult your doctor:

You should have Jaydess checked 4–6weeks after its insertion, and subsequently at regular intervals, at least once a year. Your doctor will determine the frequency and type of reviews that suit your individual case. Bring the reminder card for the patient that your doctor has provided to each visit. Additionally, you must contact your doctor if any of the symptoms described in section 2 “Warnings and precautions” appear.

Removal of Jaydess

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

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

Continuing contraception after removal

If you do not want to become pregnant, Jaydess should not be removed after the seventh day of the menstrual cycle (period), unless you use other contraceptive methods (p.eg. condoms) for at least 7 days before SLI removal.

If you have irregular periods (menstruation) or do not have a period, you must use a barrier contraceptive method for 7 days before removal.

You can also insert a new Jaydess immediately after removal, in which case no additional protection is needed. If you do not want to continue with the same contraceptive method, ask your doctor for advice on other reliable contraceptive methods.

Like all medications, Jaydess may cause side effects, although not everyone will experience them.

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

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

Also see section 2 to know when to contact your doctor immediately.

The following is a list of possible side effects based on their frequency:

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

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

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

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

Rare side effects:may affect up to 1 in 100 people

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

Description of possible side effects selected:

Irregular or infrequent bleeding:

Jaydess may affect your menstrual cycle. You may experience changes in your periods, including spotting, longer or shorter periods, heavier or lighter bleeding, or absence ofbleeding.

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

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

You may not experience the monthly thickening of the uterine lining due to the hormone effect, and therefore there may be nothing to come out or shed in the form of a menstrual period. This does not necessarily mean that you have reached menopause or are pregnant. Your own hormone levels usually remain normal.

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

Pelvic infection:

The Jaydess inserter and Jaydess itself are sterile. Despite this, there is a higher risk of pelvic infection (infections of the uterine lining or fallopian tubes) at the time of placement and during the first 3weeks after placement.

Pelvic infections in SLI users are usually related to the presence of sexually transmitted diseases. The risk of infection increases if you or your partner have multiple sexual partners or if you have had a previous pelvic inflammatory disease (PID).

Pelvic infections should be treated immediately.

Pelvic infections like PID can have serious consequences and may affect fertility and increase the risk of a future ectopic pregnancy (pregnancy outside the uterus). In extremely rare cases, a severe infection or septicemia (very severe infection that can be fatal) may occur shortly after insertion.

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

Expulsion:

The uterine contractions during menstruation may sometimes push the SLI out of its place or expel it. This is more likely to happen if you were overweight at the time of SLI insertion or if you have a history of heavy menstrual bleeding. If the SLI comes out of its place, it may not work properly, and the risk of pregnancy increases. If the SLI is expelled, you are no longer protected against pregnancy.

The possible symptoms of expulsion are pain and abnormal bleeding, but Jaydess can also be expelled without noticing.Because Jaydess reduces menstrual flow, an increase in it may be indicative of expulsion.

It is recommended that you check the strings with your finger, for example, while showering. See also section 2, "Warnings and precautions" to know how to check if Jaydess is in place. If you experience signs indicating expulsion or cannot feel the strings, you should use an additional contraceptive method (such as a condom), and consult your healthcare provider.

Perforation:

During Jaydess placement, a penetration or perforation of the uterine wall may occur, although perforation may not be detected until later. If Jaydess is lodged outside the uterine cavity, it is not effective in preventing pregnancy and should be removed as soon as possible. You may need surgical intervention to remove Jaydess. The risk of perforation increases in women who are breastfeedingas well as in women who have given birth up to 36 weeks before insertionand may increase inwomenwith a fixed uterus tilted backward (retroverted and fixed uterus). If you suspect that you may have suffered a perforation, seek medical assistance quickly and remind them that you have Jaydess inserted, especially if it was not the person who inserted it.

Ovarian cyst:

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

An ovarian cyst may require medical assistance, or more rarely, surgical intervention, but it usually resolves on its own.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance ofMedications for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keep this medication 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 medication after the expiration date that appears on the case and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Jaydess

Theactive principleis levonorgestrel. The intrauterine delivery system contains 13.5mg of levonorgestrel.

Theother componentsare:

-dimethylsiloxane elastomer

-anhydrous colloidal silica

-polyethylene

-barium sulfate

-iron oxide black (E172)

-silver

Appearance of the product and contents of the package

Jaydess is an intrauterine delivery system (IUD) in the shape of a T. The vertical arm of the T-shaped body carries a drug reservoir containing levonorgestrel. There are two extraction threads attached to a handle at the lower end of the vertical arm. In addition, the vertical axis has a silver ring located near the horizontal arms, which is visible by ultrasound examination.

Package size:

-1x1 intrauterine delivery system.

-5x1 intrauterine delivery system.

Only some package sizes may be commercially available.

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer responsible

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 last revision of this leaflet: May 2024

Other sources of information

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet, packaging, and patient reminder card with your smartphone. You can also access the same information on the following internet address:https://cima.aemps.es/info/77169

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The following information is intended only for healthcare professionals:

INSERTION INSTRUCTIONS

Jaydess 13.5mg intrauterine delivery system

For insertion by a healthcare professional using an aseptic technique.

Jaydess is supplied in a sterile inserter within a sterile package that should not be opened until it is necessary for insertion. Do not re-sterilize. In this presentation, Jaydess is for single use only. Do not use if the blister is damaged or open. Do not insert after the expiration date appearing on the case and on the blister after "CAD".

The disposal of unused medicinal product or waste material will be carried out in accordance with local regulations.

Jaydess is provided with a patient reminder card within the package. Complete the card and give it to the patient after insertion.

Preparation for insertion

-Examine the patient to rule out contraindications for Jaydess insertion (see Technical Dossier, section 4.3 and section 4.4 under Exploration/medical consultation).

-Insert a speculum, visualize the cervix, and then thoroughly clean the cervix and vagina with an appropriate antisepsis solution.

-Assist with a helper if necessary.

-Hold the anterior lip of the cervix with a tenaculum or other forceps to stabilize the uterus. If the uterus is retroverted, it may be more appropriate to hold the posterior lip of the cervix. A gentle traction can be applied with the forceps to straighten the cervical canal. The forceps should remain in place and a gentle 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 possibility of intrauterine anomaly (e.g., septum, submucosal fibroids) or the presence of a previously inserted intrauterine device that has not been removed. If difficulties are encountered, consider cervical dilation. If cervical dilation is necessary, evaluate the use of analgesics and/or a paracervical block.

Insertion

1. First, open the sterile package completely. Then use an aseptic technique and sterile gloves.

IMPORTANT!Do not pull the slider down because this may prematurely release Jaydess. Once released, Jaydess cannot be reloaded.

IMPORTANT!If the system is suspected to be in the wrong position, check its location (e.g., by ultrasound). Remove the system if it is not properly placed within the uterine cavity. Do not reinsert a removed system.

Removal/exchange

For information on removal/exchange, see the Jaydess Technical Dossier.

Inclusion of the QR code at national level that directs to the Technical Dossier

The Technical Dossier of Jaydess is available on the internet addresshttps://cima.aemps.es/info/77169