13.5 mg intrauterine insert
levonorgestrel

What Jaydess is and what it is used for

Jaydess is used to prevent pregnancy (contraception) for up to three years.

Jaydess is a T-shaped uterine insert that after insertion into the uterus slowly releases a small amount of the hormone et levonorgestrel.

Jaydess works by reducing the monthly growth of the uterine lining and by thickening the secretions in the cervix. These measures prevent sperm and egg from coming into contact with each other and thus prevent the egg from being fertilized by sperm.

What you need to know before using Jaydess

General notes

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Before you can start using your Jaydess, qualified healthcare professionals will ask some questions about your medical history.
This leaflet describes several situations where Jaydess should be taken out or when Jaydess’s reliability may be impaired. In such situations, you should either refrain from having intercourse or using a condom or any other barrier method.
Like other hormonal contraceptives, Jaydess does not protect against HIV ( AIDS ) or other sexually transmitted diseases.
Jaydess is not suitable for use as an emergency contraceptive (postcoital contraceptive).

DO NOT use Jaydess if you:

  • is pregnant (see section for “Pregnancy, breast-feeding and fertility”)
  • have pelvic inflammatory disease (PID, infection of the female reproductive organs) or have previously had this disease repeatedly
  • have a condition that can lead to increased susceptibility to infection in your pelvis
  • have an infection of the lower genitals, e.g. an infection of the vagina or cervix (cervix)
  • have had an infection in the womb after childbirth, abortion or miscarriage in the last three months
  • have cell changes in the cervix
  • have cancer or suspected cancer of the cervix or uterus
  • have tumors that are sensitive to progestogen hormones to grow, e.g. breast cancer
  • have unexplained bleeding from the uterus
  • a malformation of the cervix or uterus including uterine fibroids (muscle fibroids) this affects the uterine cavity
  • have an ongoing liver disease or liver tumor
  • is allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to a qualified healthcare professional before using Jaydess if you

  • have diabetes . It is not usually necessary to change your diabetes treatment when using Jaydess, but this may need to be checked by a qualified healthcare professional.
  • have epilepsy . A seizure may occur during insertion or withdrawal
  • previously had an ectopic pregnancy or ectopic pregnancy (ectopic pregnancy).

Also, talk to a qualified healthcare professional if you have any of the following conditions or if any of the following conditions occur for the first time when using Jaydess:

  • migraine , with visual disturbances or other symptoms that may be signs of transient cerebral ischemia (temporary blockage of the blood supply to the brain)
  • very severe headache
  • jaundice (skin, whites of the eyes and / or nails turn yellow)
  • sharp rise in blood pressure
  • severe vascular disease such as stroke or heart attack

The following signs and symptoms may indicate that you have an ectopic pregnancy and should contact a qualified healthcare professional immediately (see also the section on “Pregnancy, breast-feeding and fertility”):

  • Your period has stopped and you then have a persistent bleeding or pain
  • You have severe or persistent pain in the lower abdomen
  • You have normal pregnancy symptoms, but you also have bleeding and dizziness
  • You have a positive pregnancy test

Contact a qualified healthcare professional immediately if any of the following occur (see also section 4) and notify them that you have a Jaydes uterine insert, especially if none of them inserted it:

  • you experience severe pain (such as menstrual cramps) or heavy bleeding after insertion or if you have pain / bleeding that continues for more than a few weeks. This could be a sign of infection , perforation or that Jaydess is not in the right position
  • you no longer feel the threads in the vagina. This may be a sign of ejection or perforation. You can check if the threads are in place by gently inserting a finger into the vagina and feeling the threads in the back of the vagina near the opening to the uterus (cervix). Do not pull the threads because then you can accidentally pull out Jaydess. Use a barrier method as a contraceptive (such as a condom) until the qualified healthcare professional has checked that the insert is still in the correct position
  • you or your partner may feel the lower part of Jaydes. Avoid intercourse until qualified healthcare professionals have checked that the insert is still in the correct position
  • your partner knows the excerpts during intercourse
  • you think you may be pregnant
  • you have persistent abdominal pain, fever or abnormal discharge from the vagina, which may be a sign of infection . Infection must be treated immediately.
  • you feel pain or discomfort during intercourse, which for example may be a sign of infection , ovarian cyst or that Jaydess is not in the right position
  • you get sudden changes in your bleeding pattern (eg if you normally have little or no menstrual bleeding and you instead start to have persistent bleeding or pain, or start bleeding heavily), which may be a sign that Jaydess is not in the right position or has been rejected

The use of sanitary napkins is recommended. If tampons or menstrual cups are used, you should change them carefully so that you do not pull on Jaydes’ threads. If you think you have pulled Jaydess out of position (see the list above with possible signs), avoid intercourse or use a barrier method as a contraceptive (such as a condom) and contact a qualified healthcare professional.

Mental disorders

Some women who use hormonal contraceptives, including Jaydess, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.

Children and young people

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

Other drugs and Jaydess

Tell your healthcare provider if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Jaydess must not be used during pregnancy.

Some women do not menstruate when they use Jaydess. It does not have to mean that you are pregnant if you do not get your period. If you do not get your period and have other signs of pregnancy, you should consult a qualified healthcare professional for an examination, and do a pregnancy test.

If you have not had a period in six weeks and are worried, then consider doing a pregnancy test. If the test is negative, there is no need to do a new test, unless you have other signs of pregnancy.

If you become pregnant with Jaydess on the spot, you should immediately consult a qualified healthcare professional to remove Jaydess. Taking out Jaydess can cause a miscarriage. However, if Jaydess is left in place during pregnancy, not only does the risk of miscarriage increase but also the risk of premature birth. If Jaydess can not be taken, talk to a qualified healthcare professional about the benefits and risks of continuing the pregnancy, and the effects the hormone can have on the baby’s development.

If you would like to become pregnant, please contact a qualified healthcare professional to have Jaydess withdrawn.

Excessive pregnancy

(ectopic pregnancy)

It is uncommon to get pregnant while using Jaydess. If you still become pregnant while using Jaydess, the risk of the pregnancy developing outside the womb increases (ectopic pregnancy or ectopic pregnancy). Women who have previously had an ectopic pregnancy performed surgery on the fallopian tubes or had a genital infection are at greater risk of getting an ectopic pregnancy. Ectopic pregnancy is a serious condition that requires immediate medical attention (see section 2, “Warnings and Precautions” for signs and symptoms) and that may affect future fertility.

Breast-feeding

Jaydess can be used during breastfeeding. Levonorgestrel (the active substance in Jaydess) has been identified in small amounts in breast milk in breastfeeding women. However, no negative effects have been seen on the baby’s growth and development, or on the amount or quality of breast milk.

Fertility

Your fertility level will return to normal after Jaydess is removed.

Driving and using machines

Jaydess has no known effects affecting the ability to drive or use machines.

How to use Jaydess

Deposit by Jaydess

Jaydess can either be inserted:

  • within seven days after starting menstrual bleeding (your monthly period)
  • immediately after an abortion in the first trimester, if genital infections can be ruled out
  • when the uterus has returned to its normal size after delivery, and not earlier than 6 weeks after delivery (see section 4 “Possible side effects – Perforation”).

Examination of qualified healthcare professionals before deployment may include:

  • cell sampling
  • examination of the breasts
  • other tests, e.g. for infection , including sexually transmitted diseases. Qualified healthcare professionals will also perform a gynecological examination to determine the location and size of the uterus.

After a gynecological examination:

  • An instrument called a speculum is inserted into the vagina and the cervix is ​​wiped with a bactericidal solution. Jaydess is then inserted into the uterus with a thin, flexible plastic tube (insertion tube). Local anesthesia can be applied to the cervix before insertion.
  • Some women experience dizziness or fainting during the deposit or after Jaydess is inserted or removed.
  • You may experience some pain and bleeding during or shortly after insertion.

After Jaydess is inserted, you will receive a patient card from your doctor/midwife for future examinations. Bring this card for all return visits.

Follow-up examination and when to seek advice from a doctor/midwife:

Jaydess should be checked 4-6 weeks after the deposit, and thereafter regularly, at least once a year. Your doctor/midwife will decide how often and what type of check-ups are required in your case. Bring the patient card that you received from your doctor/midwife for all return visits. You should also contact your doctor/midwife if you experience any of the symptoms described in section 2 “Warnings and precautions”.

Selection of Jaydess

Jaydess should be taken out by the end of the third year of use at the latest.

Jaydess can be easily removed by a qualified healthcare professional at any time and it is then possible for you to become pregnant. Some women experience dizziness or fainting during or after Jaydess is removed. You may experience some pain and bleeding during the withdrawal.

If you want to avoid pregnancy, Jaydess should not be taken after the seventh day of the menstrual cycle (monthly period) unless another contraceptive is used (eg a condom) for at least 7 days before withdrawal.

If you have irregular menstruation (menstruation) or no menstruation, you should use a barrier method as a contraceptive for 7 days before withdrawal.

A new Jaydess can also be inserted immediately after the old one is removed. In such cases, no additional protection is required.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a qualified healthcare professional immediately if you notice any of the following symptoms:

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

See also section 2 for information on when to contact qualified healthcare professionals immediately.

Below is a list of possible side effects according to how common they are:

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

  • headache
  • abdominal and pelvic pain
  • acne / fat hy
  • changes in the bleeding pattern such as increased or decreased menstrual bleeding, spotting, prolonged interval between bleedings or no bleeding at all (see also next section on irregular and long-term bleeding)
  • ovarian cysts (see also next section on ovarian cysts)
  • inflammation of the external genitalia or vagina (vulvovaginitis)

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

  • depression
  • decreased sex drive
  • migraine
  • feeling sick (nausea)
  • hair loss
  • upper genital infection
  • painful menstruation
  • chest pain / discomfort
  • ejection of the post (in whole or in part) – (see next section on ejection)
  • relocations
  • weight gain

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

  • dizziness
  • strong body hair
  • perforation of the uterus (see also the next section on perforation / damage to the uterine wall)

Description of selected possible side effects:

Irregular bleeding and bleeding at long intervals

Jaydess is likely to affect your menstrual cycle. Menstruation can be changed so that you get splashing bleeding (small bleeding), a shorter or longer menstrual cycle, reduced or increased bleeding, or no bleeding at all.

You may experience bleeding and splashing between periods, especially during the first 3-6 months. Sometimes the bleeding is greater than usual in the beginning.

You will probably have a gradual decrease in the amount of blood and the number of bleeding days each month. For some women, menstruation eventually disappears completely.

As a result of the effect of the hormone, the monthly thickening of the uterine lining may not occur, and therefore there is nothing that can come out or be expelled through a menstrual period. This does not necessarily mean that you have reached menopause or are pregnant. Your hormone levels usually remain normal.

Once the post is removed, your period should soon return to normal.

Pelvic infections / Abdominal infections

Both Jaydess and its depositors are sterile. Despite this, there is an increased risk of pelvic infection / genital infection ( infection of the uterine lining or fallopian tubes) at the time of insertion and during the first 3 weeks after insertion.

Pelvic infection / genital infection in users of uterine inserts is often related to the occurrence of sexually transmitted diseases. The risk of infection increases if you or your partner has several sexual partners or if you have previously had the pelvic inflammatory disease.

Pelvic infections / genital infections must be treated as soon as possible.

Pelvic infections / genital infections such as Pelvic inflammatory disease can have serious consequences and can affect fertility and increase the risk of a future ectopic pregnancy (ectopic pregnancy). In extremely rare cases, severe infection or sepsis may occur shortly after insertion (very serious infection, which can be fatal).

Jaydess must be taken out if you get a recurrent pelvic inflammatory disease or if an infection is severe or if treatment does not help.

Ejection

Muscle contractions in the uterus during menstruation can sometimes displace the insert or repel it completely. This is more likely to occur if you are overweight at the time of insertion or if you have had heavy periods in the past. If the insert is displaced, it may not work as intended and therefore the risk of pregnancy is higher. If the post is rejected, you are no longer protected against pregnancy.

Any signs of expulsion are pain and abnormal bleeding, but Jaydess can also be expelled without you noticing. Because Jaydess usually decreases the amount of menstruation over time, and increased menstrual bleeding may be a sign that Jaydess has been expelled. See section 2 “Warnings and Precautions” for information on how to check if Jaydess is in place and what to do if you suspect that Jaydess is no longer in place.

Perforation / Damage to the uterine wall

Damage to the uterine wall can occur when inserting Jaydess. An injury is sometimes not discovered until after a while. If Jaydess gets stuck outside the uterine cavity, it does not effectively protect against pregnancy and must be removed as soon as possible. You may need surgery to remove Jaydess.

The risk of damage to the uterine wall is increased in breastfeeding women and in women where the insertion is made up to 36 weeks after delivery, and may be increased in women where the uterus is fixed and bent backward (retro-reflected uterus). If you suspect you have an injury to the uterine wall, contact a qualified healthcare professional immediately for advice and remind them that you have a Jaydess inmate, especially if it is not the same person who inserted it.

Cysts on the ovaries

Because the preventive effect of Jaydess is mainly due to its local effect in the womb, ovulation (ovulation) usually continues when you use Jaydess. Sometimes a cyst can form on the ovary. In most cases, it gives no symptoms.

A cyst on the ovary can sometimes require medical attention, or more rarely surgery, but usually disappears by itself.

How to store Jaydess

This medicine does not require any special storage instructions.

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

Do not open the blister. Only qualified healthcare professionals should do this.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is levonorgestrel. The intrauterine insert contains 13.5 mg of levonorgestrel.

Other ingredients are:

  • polydimethylsiloxane elastomer
  • silica, colloidal , anhydrous
  • polyethylene
  • barium sulphate
  • black iron oxide (E 172)
  • silver

What the medicine looks like and contents of the pack

Jaydess is a T-format intrauterine post. The vertical arm of the T-body has a medicine container that contains levonorgestrel. Two removal threads are attached to the loop on the lower part of the vertical arm. In addition, the vertical arm contains a silver ring that sits close to the horizontal arms, and it is visible on an ultrasound examination.

Pack size:

-1×1 intrauterine post

-5×1 intrauterine post

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Bayer AB

Box 606

169 26 Solna

Sweden

Manufacturer

Bayer Oy

Pansiovägen 47

20210 Turku

Finland

This medicinal product is authorized under the European Economic Area under the names:

  • Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: Jaydess
  • Estonia, Latvia, Lithuania:

Muhammad Nadeem

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