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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD.
For further information call emc accessibility on
0800 198 5000.
The product code(s) for this leaflet is: PL00010/0587.
Jaydess 13.5 mg intrauterine delivery system
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Jaydess 13.5 mg intrauterine delivery system
levonorgestrel
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects, you may get. See the end of section 4 for how to report side effects.
1. What Jaydess is and what it is used for
2. What you need to know before you use Jaydess
3. How to use Jaydess
4. Possible side effects
5. How to store Jaydess
6. Contents of the pack and other information
Jaydess is used for the prevention of pregnancy (contraception) for up to three years.
Jaydess is a T-shaped intrauterine delivery system (IUS) which after placement inside the womb slowly releases a small amount of the hormone levonorgestrel.
Jaydess works by reducing the monthly growth of the lining of the womb and thickening the cervical mucus. These actions prevent the sperm and egg from coming into contact and so prevent fertilization of an egg by sperm.
Before you can begin using Jaydess, your healthcare professional will ask you some questions about your personal health history.
In this leaflet, several situations are described where Jaydess should be removed, or where the reliability of Jaydess may be decreased. In such situations you should either not have intercourse or you should use a condom or another barrier method.
Jaydess, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Jaydess is not suitable for use as an emergency contraceptive (postcoital contraceptive).
Talk to your healthcare professional before using Jaydess if you:
In addition, also talk to your healthcare professional if any of the following conditions exist before you use Jaydess or appear for the first time while using Jaydess:
The following signs and symptoms could mean that you may have an extrauterine pregnancy and you should see your healthcare professional immediately (see also section “Pregnancy, breast-feeding and fertility”):
Contact your healthcare professional promptly if any of the following occur (see also section 4) and remind them that you have a Jaydess device, especially if they were not the person who inserted it:
Use of sanitary pads is recommended. If tampons or menstrual cups are used, you should change them with care so as not to pull the threads of Jaydess. If you think you may have pulled Jaydess out of place (see list above for possible signs), avoid intercourse or use a barrier contraceptive (such as condoms), and contact your healthcare professional.
Psychiatric disorders
Some women using hormonal contraceptives including Jaydess have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
Jaydess is not indicated for use before the first menstrual bleeding (menarche).
Tell your healthcare professional if you are taking, have recently taken or might take any other medicines.
Pregnancy
Jaydess must not be used during pregnancy.
Some women may not have their periods while using Jaydess. Not having a period is not necessarily a sign of pregnancy. If you do not have your period and have other symptoms of pregnancy you should see your healthcare professional for an examination and have a pregnancy test.
If you have not had a period for six weeks and are concerned, then consider having a pregnancy test. If this is negative, there is no need to carry out another test unless you have other signs of pregnancy.
If you become pregnant with Jaydess in place, you should see your healthcare professional immediately to have Jaydess removed. The removal may cause a miscarriage. However, if Jaydess is left in place during pregnancy, not only is the risk of having a miscarriage higher, but also the risk of preterm labour. If Jaydess cannot be removed, talk with your healthcare professional about the benefits and risks of continuing the pregnancy. If the pregnancy is continued, you will be closely monitored during your pregnancy and you should contact your healthcare professional right away if you experience stomach cramps, pain in your stomach or fever.
Jaydess contains a hormone, called levonorgestrel, and there have been isolated reports of effects on the genitalia of female babies if exposed to levonorgestrel intra-uterine devices while in the womb.
If you want to become pregnant you should contact your healthcare professional to have Jaydess removed.
Extrauterine pregnancy
(pregnancy outside the womb)
It is uncommon to become pregnant while using Jaydess. However, if you become pregnant while using Jaydess, the risk that the pregnancy could develop outside the womb (have an extrauterine or ectopic pregnancy) is increased. Women who have already had an extrauterine pregnancy, surgery of the fallopian tubes or a pelvic infection carry a higher risk for this type of pregnancy. An extrauterine pregnancy is a serious condition which calls for immediate medical attention (see section 2, “Warnings and precautions” for signs and symptoms) and may impact future fertility.
Breast-feeding
You can use Jaydess during breast-feeding. Levonorgestrel (the active ingredient in Jaydess) has been identified in small quantities in the breast milk of breast-feeding women. However, no negative effects have been seen on infant growth and development or the amount or the quality of the breast milk.
Fertility
Your usual level of fertility will return after Jaydess is removed.
Jaydess has no influence on the ability to drive or use machines.
Starting to use Jaydess
Starting to use Jaydess after giving birth
Starting to use Jaydess after an abortion
Jaydess can be inserted immediately after an abortion, if the pregnancy was less than 3 months along provided that there are no genital infections. Jaydess will then work right away.
Replacing Jaydess
Jaydess can be replaced by a new Jaydess at any time of your menstrual cycle. Jaydess will then work right away.
Examination by your healthcare professional before placement may include:
After a gynaecological examination:
After placement of Jaydess you should receive a patient reminder card from your doctor for follow-up examinations. Bring this with you to every scheduled appointment.
Follow-up examination and when to seek advice from your doctor:
You should have your Jaydess checked 4-6 weeks after placement, and thereafter regularly, at least once a year. Your doctor may determine how often and what kinds of check-ups are required in your particular case. Bring the patient reminder card you have received from your doctor to every scheduled appointment. In addition, you should contact your doctor if any of the symptoms described in section 2 "Warnings and precautions" occur.
Jaydess should be removed no later than the end of the third year of use.
Jaydess can be easily removed at any time by your healthcare professional, after which pregnancy is possible. Some women feel dizzy or faint during or after Jaydess is removed. You may experience some pain and bleeding during removal of Jaydess.
If pregnancy is not desired, Jaydess should not be removed after the seventh day of the menstrual cycle (monthly period) unless you use other methods of contraception (e.g. condoms) for at least 7 days before the IUS removal.
If you have irregular periods (menses) or no periods, you should use a barrier method of contraception for 7 days before removal.
A new Jaydess can also be placed immediately after removal, in which case no additional protection is needed.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your healthcare professional immediately if you notice any of the following symptoms:
See also section 2 for when to contact your healthcare professional promptly.
The following is a list of possible side effects by how common they are:
Very common side effects: may affect more than 1 in 10 people
Common side effects: may affect up to 1 in 10 people
Uncommon side effects: may affect up to 1 in 100 people
Description of selected possible side effects:
Jaydess is likely to affect your menstrual cycle. It can change your menstrual periods so that you have spotting (a small amount of bleeding), shorter or longer periods, lighter or heavier bleeding, or no bleeding at all.
You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first.
Overall, you are likely to have a gradual reduction in the amount and number of days of bleeding each month. Some women eventually find that periods stop altogether.
The monthly thickening of the lining of the womb may not happen due to the effect of the hormone and therefore there is nothing to come or shed away as a menstrual period. It 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 soon return to normal.
The Jaydess inserter and Jaydess itself are sterile. Despite this, there is an increased risk of pelvic infection (infections in the lining of the womb or the fallopian tubes) at the time of placement and during the first 3 weeks after the placement.
Pelvic infections in IUS users are often related to the presence of sexually transmitted diseases. The risk of infection is increased if you or your partner have multiple sexual partners or if you have had pelvic inflammatory disease (PID) before.
Pelvic infections must be treated promptly.
Pelvic infections such as PID may have serious consequences and it may impair fertility and increase the risk of a future extrauterine pregnancy (pregnancy outside the womb). In extremely rare cases severe infection or sepsis (very severe infection, which may be fatal) can occur shortly after insertion.
Jaydess must be removed if you experience recurring PID or if an infection is severe or does not respond to treatment.
The muscular contractions of the womb 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 have a history of heavy periods. If the IUS is out of place, it may not work as intended and therefore, the risk of pregnancy is increased. If the IUS is expelled, you are not protected against pregnancy anymore.
Possible symptoms of an expulsion are pain and abnormal bleeding but Jaydess may also come out without you noticing. As Jaydess decreases menstrual flow, increase of menstrual flow may be indicative of an expulsion.
It is recommended that you check for the threads with your finger, for example while having a shower. See also section 2 “Warnings and precautions” for how to check if Jaydess is in place. If you have signs indicative of an expulsion or you cannot feel the threads, you should use another contraceptive (such as condoms), and consult your healthcare professional.
Penetration or perforation of the wall of the womb may occur during placement of Jaydess, although the perforation may not be detected until sometime later. If Jaydess becomes lodged outside the cavity of the womb, it is not effective at preventing pregnancy and it must be removed as soon as possible. You may need surgery to have Jaydess removed. The risk of perforation is increased in breast-feeding women and in women who have insertion up to 36 weeks after birth, and may be increased in women with the uterus fixed and leaning backwards (fixed retroverted uterus). If you suspect you may have experienced a perforation, seek prompt advice from a healthcare provider and remind them that you have Jaydess inserted, especially if they were not the person who inserted it.
Since the contraceptive effect of Jaydess is mainly due to its local effect in the womb, ovulation (release of the egg) usually continues while using Jaydess. Sometimes an ovarian cyst may develop. In most cases there are no symptoms.
An ovarian cyst may require medical attention, or more rarely surgery, but it usually disappears on its own.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not open the blister. Only your doctor or nurse should do this.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
The active substance is levonorgestrel. The intrauterine delivery system contains 13.5 mg levonorgestrel.
The other ingredients are:
Jaydess is a T-shaped intrauterine delivery system (IUS). The vertical arm of the T-body carries a drug reservoir containing levonorgestrel. Two removal threads are tied to the loop at the lower end of the vertical arm. In addition, the vertical stem contains a silver ring located close to the horizontal arms, which is visible under ultrasound examination.
Pack size:
Not all pack sizes may be marketed.
This leaflet was last revised in June 2022.
Other souces of information
Detailed and updated information on this medicine is available by scanning the QR Code included in the package leaflet, outer carton and patient reminder card with a smartphone. The same information is also available on the following URL: www.pi.bayer.com/jaydess/uk and on the website of MHRA (https://www.gov.uk/pil-spc).
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