JAYDESS 13.5 мг Вагинальное решение

Содержание инструкции

1. Jaydess 13,5 mg intrauterine releasing system
   1. What is Jaydess and what is it 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

Jaydess 13,5 mg intrauterine releasing system

Levonorgestrel
Medicinal product subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects experienced
while taking this medicine. See the end of section 4 for information on how
to report adverse effects.

Read this leaflet carefully before using this medicine as 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 only for you. Do not give it to other people.
• If any side effects occur, including those not listed in this leaflet, tell 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 is Jaydess and what is it used for

Jaydess is indicated for pregnancy prevention (contraception) for up to three years.

Jaydess is an intrauterine releasing system (IUS) in the shape of a T which, once inserted into the uterus, slowly releases a small quantity of the hormone levonorgestrel.
Jaydess reduces the monthly growth of the uterine lining and makes cervical mucus thicker. In this way it prevents contact between spermatozoa and the ovum and therefore the fertilization of the ovum by the spermatozoa.

2. What you need to know before using Jaydess

General considerations
Before you can start using Jaydess, the healthcare professional will ask you some questions about your medical history
including those in which the reliability of Jaydess may be reduced. In such circumstances, you should not have sexual intercourse
or 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 emergency contraception (post-coital contraception).

DO NOT use Jaydess

• if you are pregnant (see section “Pregnancy, breastfeeding and fertility”)
• if you suffer from pelvic inflammatory disease (PID; infection of the female reproductive organs) or have suffered from it several times in the past
• if you suffer from disorders associated with an increased susceptibility to pelvic infections
• if you have a lower genital tract infection (an infection of the vagina or cervix [uterine neck])
• if you have had an infection of the uterus after childbirth, after a termination of pregnancy or after an abortion in the last 3 months.
• if you currently have abnormalities of the cervical cells
• if you have confirmed or suspected malignant tumor of the cervix or uterus
• if you have tumors whose growth is sensitive to progestogenic hormones (e.g., breast cancer)
• if you have vaginal bleeding of unknown origin
• if you have abnormalities of the cervix or uterus, including fibroids, that deform the uterine cavity
• if you have active liver disease or a liver tumor
• if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

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

• you have diabetes. Generally, it is not necessary to modify antidiabetic therapy during the use of Jaydess but the healthcare professional may need to monitor the treatment.
• you suffer from epilepsy. A seizure may occur during the insertion or removal of the device.
• you have had an ectopic or extrauterine pregnancy in the past (a pregnancy outside the uterus).

In addition, talk to your healthcare professional if any of the following conditions apply to you, before you start to
use Jaydess or if they occur for the first time while you are using Jaydess:

• migraine with visual disturbances or other symptoms that may be signs of transient cerebral ischemia (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 be indicative of an ectopic pregnancy and therefore you should contact
your healthcare professional immediately (see also section “Pregnancy, breastfeeding and fertility”):

• Your periods have stopped and you subsequently experience persistent bleeding or pain
• You experience severe or persistent lower abdominal pain
• You have the normal signs of pregnancy but also vaginal bleeding and dizziness
• The pregnancy test is positive

Contact your healthcare professional immediately if any of the following conditions occur (see
also section 4) and remind them that you have the Jaydess system, especially if it is not the person who placed it:

• severe pain (similar to menstrual cramps) or heavy bleeding after placement or if you have pain/bleeding that persists for more than a few weeks. For example, this may be a sign of infection, perforation or may mean that Jaydess is not in the correct position.
• you no longer feel the threads in the vagina. This may be a sign of expulsion or perforation. You can gently check by inserting a finger into the vagina and feeling 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 contraceptive methods (such as a condom) until your healthcare professional has checked that the intrauterine device is still in place.
• you or your partner feel the lower end of Jaydess. Avoid sexual intercourse until your healthcare professional has checked that the intrauterine system 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 unusual vaginal discharge, which may be a sign of infection. Infections must be treated immediately.
• you experience pain or discomfort during sexual intercourse, which may be, for example, a sign of infection, ovarian cyst or may mean that Jaydess is not in the correct position.
• your menstrual characteristics change suddenly (e.g., if your periods are scarce or absent and subsequently you experience 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 tampons is recommended. If you use tampons or menstrual cups, you should change them
taking particular care not to remove the threads of Jaydess. If you think that Jaydess may have
moved from its position (see the list above for possible signs) avoid intercourse or use a barrier
contraceptive method (such as a condom) and contact your doctor.
Psychiatric disorders
Some women using hormonal contraceptives including Jaydess have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience
mood changes and depressive symptoms, see your doctor as soon as possible for further medical advice
.

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

Other medicines and Jaydess
Tell your healthcare professional if you are taking, have recently taken or may take any other
medicines.

Pregnancy, breastfeeding and fertility

Pregnancy
Jaydess should not be used during pregnancy.
During the use of Jaydess, some women may stop having periods altogether. The absence of
menstruation is not necessarily a sign of pregnancy. If you do not have your periods and have other symptoms of
pregnancy, undergo a medical examination and a pregnancy test.
If you have not had your periods for six weeks and are concerned, consider taking a pregnancy test. If the test is negative, you do not need to repeat it unless other signs of
pregnancy appear.
If pregnancy occurs while using Jaydess, contact your healthcare professional immediately to have
the device removed.
Removal may cause abortion. However, if Jaydess remains in place during pregnancy, not only is the
risk of abortion higher, but also the risk of preterm labor. If Jaydess cannot be removed,
discuss with your healthcare professional the benefits and risks associated with continuing the pregnancy. If you decide to
continue the pregnancy you will be closely monitored during the
pregnancy and must contact your healthcare professional as soon as you experience cramp-like abdominal pains,
stomach pains and fever.
Jaydess contains a hormone called levonorgestrel and isolated cases of effects on the external genitals of female fetuses have been observed if exposed to levonorgestrel intrauterine devices during intrauterine life.
If you want to become pregnant, contact your healthcare professional 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 become pregnant
while using Jaydess, the risk that the pregnancy develops outside the uterus (ectopic or extrauterine pregnancy) is increased. Women who have already had an ectopic pregnancy, surgery
on the fallopian tubes or a pelvic infection are at greater risk. Ectopic pregnancy is a
serious condition that requires immediate medical attention (see section 2, “Warnings and
precautions” for signs and symptoms) and may have consequences for future fertility.

Breastfeeding
You can use Jaydess during breastfeeding. Levonorgestrel (the active ingredient of Jaydess) has been
found in small amounts in breast milk. However, no adverse effects on the
growth or development of the breastfed child or on the amount or quality of breast milk have been observed.

Fertility
Fertility returns to its usual level after Jaydess has been removed.

Driving and operating machinery
Jaydess does not impair the ability to drive or operate machinery.

3. How to use Jaydess

Starting to use Jaydess

• Before Jaydess is inserted, it is necessary to ensure that you are not pregnant.
• Jaydess must be inserted within 7 days of the start of your menstrual period. If Jaydess is inserted during these days, Jaydess will work immediately and will prevent you from becoming pregnant.
• If it is not possible for Jaydess to be inserted within 7 days of the start of your menstrual period or if your menstrual cycle 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 must have a negative pregnancy test before insertion. Also, Jaydess may not prevent pregnancy reliably immediately. Therefore, you must use a barrier method of contraception (such as condoms) or abstain from vaginal intercourse for the first 7 days after the insertion of Jaydess.
• Jaydess is not intended for use as emergency contraception (post-coital contraception).

Starting to use Jaydess after childbirth

• Jaydess can be inserted after childbirth, only when the uterus has returned to its normal size, but not before 6 weeks have elapsed since childbirth (see section 4 “Possible side effects - Perforation”).
• See also "Starting to use Jaydess" for what you need to know about the timing of insertion.

Starting to use Jaydess after an abortion
Jaydess can be inserted immediately after an abortion if the pregnancy lasted less than 3 months, provided that you do not have genital infections. Jaydess will work immediately.

Replacing Jaydess
Jaydess can be replaced with a new Jaydess at any time during your menstrual cycle. Jaydess will work immediately.

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

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

Placement of Jaydess
The visit made by the healthcare professional before insertion may include:

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

After the gynecological examination:

• An instrument called a speculum is inserted into the vagina and the cervix may be cleaned with an antiseptic solution. Jaydess is inserted into the uterus through a thin, flexible plastic tube (insertion tube). Local anesthesia of the cervix may be performed before insertion.
• Some women experience dizziness or fainting during or after the insertion of Jaydess or after its removal.
• Pain and bleeding may occur during or immediately after insertion.

After the placement of Jaydess, you will receive a patient reminder card from your doctor for follow-up visits. Bring it with you to each scheduled appointment.
Follow-up visit and when to seek medical advice:
Jaydess must be checked 4–6 weeks after insertion and, subsequently, at least once a year. The doctor may determine the frequency and type of checks necessary in your specific case.
Bring with you the patient reminder card you received from your doctor to each scheduled appointment. Also, you should contact your doctor if any of the symptoms described in section 2 “Warnings and precautions” occur.

Removing Jaydess
Jaydess must be removed no later than the end of the third year of use.
Jaydess can be removed at any time by the healthcare professional; after its removal, you may become pregnant. Some women experience dizziness or fainting during or after the removal of Jaydess. Pain and bleeding may occur during the removal of Jaydess.

Continuing contraception after removal
If you do not want to become pregnant, Jaydess should not be removed after the seventh day of your menstrual cycle, unless you use other methods of contraception (e.g., condoms) for at least 7 days before the removal of the IUS.
If you have irregular periods or do not have periods, you should use a barrier method of contraception 7 days before removal.
A new Jaydess device can be inserted immediately after removal of the previous one; in this case, no further protective measures are necessary. If you do not want to continue using the same method, ask your doctor for advice on other reliable methods of contraception.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, throat) See also section 2 for when to contact your doctor immediately.

The following list reports 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 bleeding such as increased and decreased bleeding, spotting, infrequent periods and absent periods (see also the following section on irregular and infrequent bleeding)
• ovarian cyst (see also the following section 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 periods
• breast pain/discomfort
• device expulsion (complete and partial) - (see the following section on expulsion)
• genital discharge
• weight increase

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

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

Description of some possible side effects
Irregular or infrequent bleeding
Jaydess is likely to change your menstrual cycle. Your periods may occur as spotting
(light bleeding), bleeding of shorter or longer duration, or lighter or heavier flow, or
even complete absence of periods.
Bleeding and spotting may occur between periods, especially during the first 3-6 months. Sometimes,
at the beginning, periods may be heavier than usual.
Overall, the amount and duration of your periods are likely to decrease
gradually each month. In some women, periods may stop completely.
The lining of the uterus may not thicken monthly due to the hormonal action and
therefore there is no material to shed with menstruation. This does not necessarily mean that
you are in menopause or pregnant. Your hormone levels generally remain normal.
After removal of the system, your periods 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 uterine lining or fallopian tubes) is increased at the time of insertion and
during the first 3 weeks afterwards.
Pelvic infections in IUS users are often due to sexually transmitted diseases. The
risk of infection is higher if you or your partner have multiple sexual partners or if you have had
a pelvic inflammatory disease (PID) in the past.

Pelvic infections must be treated promptly.
Pelvic infections such as PID can have serious consequences, impair fertility and increase the
risk of a future ectopic pregnancy (pregnancy outside the uterus). In extremely rare cases, you may
experience serious infections or sepsis immediately after insertion (serious 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 contractions during menstruation can sometimes move or expel the
IUS device. This is more likely to happen if you are overweight at the time of insertion of the
intrauterine system or if you have a history of being overweight. If the intrauterine system is in the wrong position,
it may not work properly and the risk of pregnancy increases. If the intrauterine system
is expelled, protection against pregnancy is lost.
Possible symptoms of expulsion are pain and abnormal bleeding, but Jaydess can also be expelled
without you noticing. Because Jaydess reduces menstrual flow, an increase in it
may be a sign of expulsion. It is recommended to check the threads with your fingers, for example when you are showering. See also section 2 “Warnings and precautions” for how to check if Jaydess
is positioned correctly. If you have signs indicating expulsion or no longer feel the threads, you should use
another method of contraception (e.g. a condom) and consult your healthcare professional.

Perforation
During the insertion of Jaydess, penetration or perforation of the uterine wall may occur, but
it may be some time before the perforation is detected. If Jaydess ends up outside
the uterine cavity, it is not effective in preventing pregnancy and must be removed as soon as possible.
Surgery may be needed 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 be increased in women who have a fixed and tilted backwards uterus (fixed retroverted
uterus). If you suspect a perforation, seek medical advice immediately and remind them that you have
Jaydess inserted, especially if it is not the person who inserted it.

Ovarian cyst
Because the contraceptive action of Jaydess is due mainly to local effects in the uterus, ovulation
(release of an egg) normally continues during the use of Jaydess. Sometimes an ovarian cyst
may develop. In most cases, the woman does not experience any symptoms.
An ovarian cyst may require medical care, more rarely surgery, but generally
disappears spontaneously.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly through 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 medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not open the blister pack. Only the doctor or nurse are authorized to do so.
Do not use this medicine after the expiry date which is stated on the pack and on the blister pack after Exp. The
expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Jaydess contains
The active substanceis levonorgestrel. The intrauterine releasing system contains 13.5 mg of levonorgestrel.
The other ingredientsare:

• 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 an intrauterine releasing system (IUS) in the shape of a T. The vertical arm of the T-body contains a
reservoir containing the medicine levonorgestrel. Two threads intended for removal of the device are attached
to the eyelet at the end of the lower vertical arm. In addition, the vertical support contains a silver ring in
proximity to the horizontal arms, visible on ultrasound.
Packs:

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

Marketing Authorisation Holder
Bayer S.p.A, Viale Certosa n.130, 20156 Milan

Manufacturer
Bayer Oy, Pansiontie 47, 20210 Turku, Finland

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:

• 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 updated information regarding this medicine is available by scanning the
QR code on the package leaflet, on the outer packaging and on the reminder card using a
smartphone. The same information is available at the following URL: www.pi.bayer.com/jaydess/it and on
the AIFA website (https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/)
[QR code to the package leaflet to be inserted at national level]
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The following information is intended exclusively for healthcare professionals

INSTRUCTIONS FOR INSERTION
Jaydess 13.5 mg intrauterine releasing system
Insertion by a healthcare professional under aseptic conditions.
Jaydess is supplied with an inserter in a sterile pack which must not be opened until the time of
insertion. Do not resterilize. Jaydess is for single use only. Do not use if the blister pack is
damaged or open. Do not insert after the expiry date stated on the pack and on the blister pack after Exp..
Unused medicine and waste materials derived from such 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

• Visit the patient to exclude contraindications to the insertion of Jaydess (see section 4.3 and section 4.4 Medical examination/consultation of the Summary of Product Characteristics).
• Insert a speculum, visualise the cervix and carefully cleanse the cervix and vagina with a suitable antiseptic solution.
• Enlist the help of an assistant, if necessary.
• Grasp the anterior lip of the cervix with tenaculum forceps or other forceps, to stabilise the uterus. If the uterus is retroverted, it may be appropriate to grasp the posterior lip of the cervix. Gentle traction on the forceps may be applied to straighten the cervical canal. During the entire insertion procedure, the forceps must remain in position and gentle counter-traction on the cervix must be maintained.
• Advance a uterine sounding through the cervical canal to the fundus to measure the depth, confirm the direction of the uterine cavity and exclude the presence of intrauterine anomalies (e.g. septum, submucous fibroids) or a previously inserted intrauterine contraceptive that has not been removed. If difficulties are encountered, consider the possibility of dilating the canal. If dilation of the cervical canal is necessary, consider the possibility of using analgesics and/or a paracervical block.

Insertion

• 1. First, open the sterile pack completely. Operate 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 inserter tube.

IMPORTANT!Do not pull the slider downwards, as this would cause premature release of Jaydess. Once released, Jaydess cannot be reloaded.

• 3. Keeping the slider in the furthest position, set the upperedge of the flange to the uterine depth measured with the sounding.

• 4. Keeping the slider in the furthestposition, 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 firmly, pullthe slider down to themarkingto open the horizontal arms of Jaydess. Wait 5–10 seconds for the horizontal arms to fully deploy.

• 6. Gently advance the inserter towards the uterine fundus untilthe flangetouches the cervix. Jaydess is now in the vicinity of the uterine fundus.

• 7. Keeping the inserter in place, release Jaydess by pulling the slider all the way down. Keeping the slider down, gently remove the inserter by pulling it out. Cutthe threadsleaving approximately 2–3 cm protruding from the cervix .

IMPORTANT!If there is suspicion that the system is not in the correct position,
check its position (e.g. by ultrasound). Remove the system if it is not positioned
correctly in the uterine cavity. Once removed, the system should not be reinserted.

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

To remove
Jaydess, gently pull
on the threads
with forceps.
Immediately after
removal, a new
Jaydess system can be
inserted.
After removal of
Jaydess, the system
must be
examined to ensure
that it is
intact and has been
completely
removed.
[QR code to the Summary of Product Characteristics to be inserted at national level]
Summary of Product Characteristics for Jaydess online at www.pi.bayer.com/jaydess/it