Jaydess

Package leaflet: Information for the user

Jaydess 13.5 mg intrauterine system

Levonorgestrel
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while using this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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 other people.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. See section 4.

Contents of this leaflet:

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 indicated for the prevention of pregnancy (contraception) for up to three years.
Jaydess is a T-shaped intrauterine system (IUS) that, once inserted into the uterus, slowly releases a small amount of the hormone levonorgestrel.
Jaydess reduces the monthly growth of the inner lining of the uterus and thickens cervical mucus. This prevents contact between sperm and the oocyte, thereby preventing fertilization of the oocyte by sperm.

2. What you need to know before using Jaydess

General considerations
Before you start using Jaydess, your healthcare provider will ask you some questions about your medical history.
This patient information leaflet describes several situations in which Jaydess must be removed or in which the effectiveness of Jaydess may be reduced. In such circumstances, you must not have sexual intercourse or must use a condom or another barrier contraceptive method.
Jaydess, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.
Jaydess is not indicated 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 or have had recurrent pelvic inflammatory disease (PID; infection of the female reproductive organs)
• if you have conditions associated with increased susceptibility to pelvic infections
• if you have an infection of the lower genital tract (an infection of the vagina or cervix [neck of the uterus])
• if you have had a uterine infection after childbirth, after termination of pregnancy or after an abortion within the last 3 months
• if you currently have abnormalities of the cells of the cervix
• if you have a confirmed or suspected malignant tumour of the cervix or uterus
• if you have tumours whose growth is sensitive to progestogenic hormones (e.g. breast cancer)
• if you have unexplained vaginal 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your healthcare provider before using Jaydess if:

• you have diabetes. Generally, no changes to your antidiabetic therapy are needed during use of Jaydess, but your healthcare provider may need to monitor your treatment.
• you have epilepsy. A seizure may occur during insertion or removal of the device.
• you have previously had an ectopic or extrauterine pregnancy (a pregnancy outside the uterus).

Also, talk to your healthcare provider if any of the following conditions apply to you, either before starting Jaydess or if they occur for the first time while using Jaydess:

• migraine with visual disturbances or other symptoms that could be signs of transient ischaemic attack (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
• severe arterial disease such as stroke or heart attack.

The following signs and symptoms may indicate an ectopic pregnancy, so you should contact your healthcare provider immediately (see also section “Pregnancy, breastfeeding and fertility”):

• Your periods have stopped and you then develop persistent bleeding or pain
• You experience strong or persistent pain in the lower abdomen
• You have typical signs of pregnancy but also have bleeding and dizziness
• Your pregnancy test is positive

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

• severe pain (similar to menstrual cramps) or heavy bleeding after insertion, or if pain/bleeding persists for more than a few weeks. This could be a sign of infection, perforation, or may indicate that Jaydess is not correctly positioned.
• you can no longer feel the threads in the vagina. This may be a sign of expulsion or perforation. You may gently check by inserting a finger into the vagina to feel the threads at the end of the vagina near the opening of the uterus (cervix). Do not pull on the threads, as you may accidentally remove Jaydess. Use barrier contraception (such as a condom) until your healthcare provider confirms that the intrauterine device is still in place.
• you or your partner can feel the lower end of Jaydess. Avoid sexual intercourse until your healthcare provider has confirmed that the intrauterine system is still correctly positioned.
• your partner feels the removal threads during sexual intercourse
• you think you might be pregnant
• you have persistent abdominal pain, fever or unusual vaginal discharge, which may be signs of infection. Infections must be treated immediately.
• you experience pain or discomfort during sexual intercourse, which could be a sign of infection, ovarian cyst, or may indicate that Jaydess is not correctly positioned.
• your menstrual pattern changes suddenly (e.g. periods become light or absent and are followed by persistent bleeding or pain, or very heavy bleeding), which may 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, you must change them carefully to avoid pulling out the Jaydess threads. If you think Jaydess may have moved from its position (see the list above for possible signs), avoid sexual intercourse or use a barrier contraceptive method (such as a condom) and contact your doctor.

Breast cancer
Women who take the oral contraceptive pill have a slightly increased risk of breast cancer. This risk returns to the baseline age-appropriate level within 10 years after stopping the pill.
Some scientific studies have suggested a slight increase in the risk of breast cancer with the use of levonorgestrel-releasing intrauterine systems such as Jaydess, while other studies have not shown an increased risk. For any concerns, please consult your doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Jaydess, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, consult your doctor as soon as possible for further medical advice.

Children and adolescents
The use of Jaydess is not indicated before the onset of first menstruation (menarche).

Other medicines and Jaydess
Inform your healthcare provider if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility
Pregnancy
Jaydess must not be used during pregnancy.
During use of Jaydess, menstruation may stop completely in some women. Absence of menstruation is not necessarily a sign of pregnancy. If you miss your period and have other symptoms of pregnancy, consult a doctor and take a pregnancy test.
If you have missed your period for six weeks and are concerned, consider taking a pregnancy test. If the test is negative, it is not necessary to repeat it unless other signs of pregnancy appear.
If you become pregnant while using Jaydess, contact your healthcare provider immediately for removal of the device.
Removal may result in miscarriage. However, if Jaydess remains in place during pregnancy, not only is the risk of miscarriage higher, but so is the risk of preterm delivery. If Jaydess cannot be removed, discuss with your healthcare provider the benefits and risks of continuing the pregnancy. If you decide to continue the pregnancy, you will be closely monitored throughout, and you must contact your healthcare provider immediately if you experience cramping abdominal pain, stomach pain or fever.
Jaydess contains a hormone called levonorgestrel, and isolated cases of effects on the external genitalia of female fetuses have been observed when exposed to levonorgestrel-releasing intrauterine devices during intrauterine life.
If you wish to become pregnant, contact your healthcare provider to have Jaydess removed.

Ectopic pregnancy
(pregnancy outside the uterus)
It is uncommon for a woman to become pregnant while using Jaydess. However, if you do become pregnant while using Jaydess, the risk that the pregnancy develops outside the uterus (ectopic or extrauterine pregnancy) is increased. Women who have previously had an ectopic pregnancy, tubal surgery or a pelvic infection are at higher risk. Ectopic pregnancy is a serious condition requiring immediate medical intervention (see section 2, “Warnings and precautions” for signs and symptoms) and may affect future fertility.

Breastfeeding
You may use Jaydess while breastfeeding. Levonorgestrel (the active ingredient in Jaydess) has been found in small amounts in breast milk. However, no negative effects on the growth or development of breastfed infants or on the quantity or quality of breast milk have been observed.

Fertility
Fertility returns to normal levels after Jaydess is removed.

Driving and using machines
Jaydess does not affect the ability to drive or use machines.

3. How to use Jaydess

Starting to use Jaydess

• Before Jaydess is inserted, it must be confirmed that you are not pregnant.
• Jaydess should be inserted within 7 days from the start of menstruation. If Jaydess is inserted within this time frame, it will work immediately and prevent pregnancy right away.
• If Jaydess cannot be inserted within 7 days from the start of menstruation, or if your menstrual cycle is irregular, it may be inserted on any other day. In this case, you must not have had unprotected sexual intercourse since your last menstrual period and must have a negative pregnancy test before insertion. In addition, Jaydess may not provide reliable contraceptive protection immediately. Therefore, you must use a barrier contraceptive method (such as condoms) or abstain from vaginal intercourse during the first 7 days after Jaydess insertion.
• Jaydess is not intended for use as emergency contraception (post-coital contraception).

Starting to use Jaydess after childbirth

• Jaydess may be inserted after childbirth only once the uterus has returned to its normal size, but not earlier than 6 weeks after delivery (see section 4 “Possible side effects – Perforation”).
• See also “Starting to use Jaydess” for information on 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 work immediately.

Replacing Jaydess

• Jaydess may be replaced with a new Jaydess at any time during the menstrual cycle. The new Jaydess will work immediately.

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

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

Placement of Jaydess

The healthcare provider’s examination before insertion may include:

• a cervical smear (Pap test)
• a breast examination
• other tests, for example, to diagnose possible infections, including sexually transmitted infections, and a pregnancy test if necessary. The healthcare provider will also perform a gynecological examination to determine the position and size of the uterus.

After the gynecological examination:

• A device called a speculum is inserted into the vagina, and the cervix may be cleaned with an antiseptic solution. Jaydess is inserted into the uterus using a thin, flexible plastic tube (the inserter). Local anaesthesia of the cervix may be administered before insertion.
• Some women may feel dizzy or faint during or after Jaydess insertion or removal.
• Pain and bleeding may occur during or immediately after insertion.

After Jaydess placement, your doctor will give you a patient reminder card for follow-up visits. Keep this card and bring it with you to every scheduled appointment.

Follow-up visit and when to seek medical advice:

Jaydess should be checked 4–6 weeks after insertion and thereafter at least once a year. Your doctor will determine the frequency and type of follow-up examinations required in your particular case. Always bring your patient reminder card to every scheduled appointment. In addition, you should contact your doctor if you experience any of the symptoms described in section 2 “Warnings and precautions”.

Removal of Jaydess

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

Jaydess can be removed at any time by a healthcare provider; after removal, pregnancy is possible. Some women may feel dizzy or faint during or after removal of Jaydess. Pain and bleeding may occur 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 unless you use another contraceptive method (e.g. condoms) for at least 7 days before removal of the IUS.

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

A new Jaydess device may be inserted immediately after removal of the previous one; in this case, no additional contraceptive protection is needed. If you do not wish to continue with the same method, consult your doctor about other reliable contraceptive options.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately if you notice any of the following symptoms:

• allergic reactions including skin rash, hives, and angioedema (characterised, for example, by sudden swelling of the eyes, mouth, or throat). See also section 2 for information on when to contact your doctor immediately.

The following list reports possible side effects according to their frequency:
Very common side effects: may affect more than 1 in 10 people

• headache
• abdominal/pelvic pain
• acne/oily skin
• menstrual disorders such as increased or decreased menstruation, spotting, infrequent periods, or absence of menstruation (see also the section below on irregular and infrequent bleeding)
• ovarian cyst (see also the section below on ovarian cysts)
• inflammation of the 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
• painful menstruation
• breast pain/discomfort
• expulsion of the device (complete or partial) – (see the section below on expulsion)
• genital discharge
• weight gain

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

• dizziness
• increased body hair growth
• uterine perforation (see also the section below on perforation)

Description of some possible side effects
Irregular or infrequent bleeding
Jaydess is likely to alter your menstrual cycle. Periods may occur as spotting (light bleeding), bleeding of shorter or longer duration, lighter or heavier bleeding, or even complete absence of menstruation.
Bleeding or spotting between periods may occur, especially during the first 3–6 months. Occasionally, periods may initially be heavier than usual.
Overall, the amount and duration (in days) of menstrual bleeding are likely to gradually decrease each month. In some women, menstruation may stop completely.
The lining of the uterus cannot undergo monthly thickening due to the hormonal action, and therefore there is no tissue to be shed during menstruation. This does not necessarily mean that you are in menopause or pregnant. Your hormone levels generally remain normal.
After removal of the system, menstruation should return to normal soon.

Pelvic infection
The Jaydess inserter and the Jaydess device are sterile. Nevertheless, the risk of pelvic infection (infections of the lining of the uterus or fallopian tubes) is increased at the time of insertion and during the first 3 weeks afterwards.
Pelvic infections in users of IUS are often due to sexually transmitted infections. The risk of infection is higher if you or your partner have multiple sexual partners or if you have previously had pelvic inflammatory disease (PID).
Pelvic infections must be treated promptly.
Pelvic infections such as PID can have serious consequences, impair fertility, and increase the risk of future ectopic pregnancy (pregnancy outside the uterus). In extremely rare cases, severe infections or sepsis may occur shortly after insertion (severe infections can be fatal).
Jaydess must be removed in case of recurrent PID or if the infection is severe or does not respond to treatment.

Expulsion
Uterine muscle contractions during menstruation may sometimes shift or expel the IUS device. This is more likely to occur if you are overweight at the time of intrauterine system insertion or if you have a history of heavy periods. If the intrauterine system is misplaced, it may not function properly, thereby increasing the risk of pregnancy. If the intrauterine system is expelled, protection against pregnancy is lost.
Possible symptoms of expulsion include pain and abnormal bleeding, but Jaydess may be expelled without your awareness. Since Jaydess causes a reduction in menstrual flow, an increase in bleeding may indicate expulsion. It is recommended to check the threads with your fingers, for example when showering. See also section 2 “Warnings and precautions” for instructions on how to check whether Jaydess is correctly positioned. If you notice signs suggestive of expulsion or can no longer feel the threads, you should use another contraceptive method (e.g. condom) and consult your healthcare provider.

Perforation
During insertion of Jaydess, penetration or perforation of the uterine wall may occur, although perforation may only be detected some time later. If Jaydess is located outside the uterine cavity, it will not prevent pregnancy and must 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 and in women in whom Jaydess is inserted up to 36 weeks after childbirth, and may also be increased in women with a fixed and retroverted uterus (fixed retroverted uterus). If you suspect perforation, seek immediate medical advice and inform the doctor that you have Jaydess inserted, especially if this is not the person who inserted it.

Ovarian cyst
Since the contraceptive action of Jaydess is primarily due to local effects in the uterus, ovulation (release of an egg) normally continues during use of Jaydess. Occasionally, an ovarian cyst may develop. In most cases, women do not experience any symptoms.
An ovarian cyst may require medical treatment, and more rarely surgery, but usually resolves spontaneously.

Reporting of side effects
If you experience any possible side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Jaydess

This medicinal product does not require any special storage conditions.
Keep this medicinal product out of the sight and reach of children.
Do not open the blister. Only the doctor or nurse is authorized to do so.
Do not use this medicinal product after the expiry date stated on the carton and on the blister after Exp. The expiry date refers to the last day of that month.

6. Package contents and other information

What Jaydess contains
The active substance is levonorgestrel. The intrauterine release system contains 13.5 mg of levonorgestrel.
The other components are:

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

Description of the appearance of Jaydess and contents of the pack
Jaydess is a T-shaped intrauterine system (IUS). The vertical arm of the T-shaped body contains a
reservoir holding the medicinal substance levonorgestrel. Two removal threads are attached to the loop at the lower end of the vertical arm. Additionally, the vertical support contains a silver ring located near the horizontal arms, visible on ultrasound.
Pack sizes:

• 1x1 intrauterine release system
• 5x1 intrauterine release system. Not all pack sizes may be marketed.

Marketing Authorization Holder
Bayer S.p.A., Viale Certosa n.130, 20156 Milan, Italy
Manufacturer
Bayer Oy, Pansiontie 47, 20210 Turku, Finland
This medicinal product is authorised in the European Economic Area Member States 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

Other sources of information
Detailed and up-to-date information about this medicinal product is available by scanning the
QR code on the package leaflet, the outer carton, and the reminder card using a
smartphone. The same information is also available at the following URL: www.pi.bayer.com/jaydess/it and on the AIFA website (https://www.aifa.gov.it/home)
[QR code to be inserted at national level on the package leaflet]

The following information is intended exclusively for healthcare professionals

INSERTION INSTRUCTIONS
Jaydess 13.5 mg intrauterine delivery system
Insertion must be performed by a healthcare professional under aseptic conditions.
Jaydess is supplied with an inserter in a sterile package that should not be opened until the time of insertion. Do not re-sterilize. Jaydess 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."
Unused medicine and waste material from this medicine should be disposed of in accordance with local regulations.
Jaydess is supplied with a patient reminder card in the outer packaging. Complete the patient reminder card and give it to the patient after insertion.

Preparation for insertion

• Evaluate the patient to rule out contraindications to Jaydess insertion (see section 4.3 and section 4.4 Medical examination/consultation in the Summary of Product Characteristics).
• Insert a speculum, visualize the cervix, and 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 clamp or other clamp to stabilize the uterus. If the uterus is retroverted, it may be preferable to grasp the posterior lip of the cervix. Apply gentle traction on the clamp to straighten the cervical canal. Throughout the entire insertion procedure, the clamp must remain in place and gentle counter-traction on the cervix must be maintained.
• Advance a uterine sound through the cervical canal to the uterine fundus to measure uterine depth, confirm uterine cavity direction, and rule out intrauterine abnormalities (e.g. septum, submucosal fibroids) or a previously inserted intrauterine contraceptive device not removed. In case of difficulty, consider the possibility of cervical dilation. If cervical dilation is required, consider using analgesics and/or a paracervical block.

Insertion

1. First, fully open the sterile package. Perform the procedure under aseptic conditions using sterile gloves.

2. Push the

slider forward,
in the direction of
the arrow, to the
furthest position,
to load Jaydess
into the insertion
tube.
IMPORTANT! Do not pull the slider downward, as this will cause premature release of Jaydess. Once released, Jaydess cannot be reloaded.

3. While keeping the slider in the furthest position, set the upper edge of the flange at the level corresponding to the uterine depth measured by the sound.
4. While keeping the slider in the furthest position, gently advance the inserter into the cervix until the flange is approximately 1.5–2.0 cm from the cervix.

IMPORTANT! Do not force the inserter. If necessary, dilate the cervical canal.

5. Holding the inserter steady, pull the slider down to the mark to open the horizontal arms of Jaydess. Wait 5–10 seconds to allow the horizontal arms to fully deploy.
6. Gently advance

the inserter
toward the
uterine fundus until
the flange touches
the cervix.
Jaydess is now
positioned at the
uterine fundus.

7. While keeping

the inserter in place,
release Jaydess by
pulling the slider fully
downward. While
keeping the slider
down, gently remove
the inserter by pulling
it out. Cut the threads,
leaving approximately
2–3 cm protruding
from the cervix.
IMPORTANT! If there is any suspicion that the device is not correctly positioned, verify its location (e.g. by ultrasound). Remove the device if it is not correctly positioned within the uterine cavity. Once removed, the device must not be reinserted.

Removal/replacement
For removal/replacement, refer to the Summary of Product Characteristics for Jaydess.

To remove
Jaydess, gently
pull the threads
with a clamp.
Immediately after
removal, a new
Jaydess system
may be inserted.
After removal of
Jaydess, the device
should be examined
to ensure its
integrity and confirm
complete removal.
[QR code to Summary of Product Characteristics to be inserted at national level]
Summary of Product Characteristics for Jaydess available online at www.pi.bayer.com/jaydess/it