Jaydess 13.5 mg.

What you should know before using Jaydess
General comments
Before you start using Jaydess, your healthcare professional will ask you some questions about your medical history.
In this leaflet described several situations where Jaydess must be removed or in which the reliability of Jaydess can be reduced. In such situations you should not have sex or you should use a condom or other barrier method.
Jaydess, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Jaydess is not suitable for use as an "emergency" contraception (pill after intercourse).

Do not use Jaydess if:
you are pregnant (see section "Pregnancy, lactation and fertility");
currently have pelvic inflammatory disease (PID, an infection of the female reproductive organs) or have had this condition many times in the past;
have conditions associated with increased susceptibility to infections, pelvic;
you have an infection in the lower divisions of genital tract infection (infection of the vagina or cervix [cervical]);
you had infections of the uterus after childbirth, after abortion or miscarriage after the last 3 months;
currently have cell abnormalities in the cervix;
have cancer or suspected cancer of the cervix or uterus;
have tumors whose growth is sensitive to hormones progestogen, e.g., breast cancer;
have unspecified vaginal bleeding;
have an abnormality of the cervix or of the uterus, including fibroids that distort the uterine cavity;
you have active liver disease or liver tumor;
you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor before using Jaydess if:
have diabetes. Usually no need to change its scheme of treatment for diabetes while using Jaydess, but this should be checked by your healthcare professional;
have epilepsy. Convulsions (seizures) may occur during insertion or removal of the system;
you have previously had an ectopic or tubal pregnancy (pregnancy outside the uterus).
In addition, talk to your doctor also if you have any of the following conditions before using Jaydess or if any of them appear for the first time during the use of Jaydess:
migraine with visual disturbances or other symptoms that may constitute signs of transient cerebral ischemia (temporary blockage of blood flow to the brain);
extremely severe headache;
jaundice (yellowing of the skin, whites of the eyes and / or nails);
significant increases in blood pressure;
severe disease of arteries such as stroke or heart attack.
The following signs and symptoms may mean that you may have an ectopic pregnancy and you should consult your doctor immediately:
Your menstrual periods have stopped and then you started to have prolonged bleeding or pain;
Have pain in the lower abdomen that is severe or prolonged;
You have normal signs of pregnancy, but you also have bleeding and feel dizzy;
If you have a positive pregnancy test.
Contact your doctor immediately if you get any of the following conditions (see section 4):
severe pain (like menstrual cramps) or severe bleeding after insertion or have pain / bleeding that lasts more than a few weeks. This may be for example a sign of infection, perforation or signal that Jaydess not in the correct position;
no longer can feel the threads in your vagina. This may be a sign of disposal. You can check by gently inserting a finger into your vagina and feel the threads at the end of your vagina near the opening of the uterus (cervix). Do not pull the threads because you may accidentally remove Jaydess. Avoid sexual intercourse or use a barrier method (such as condoms) until your doctor check that the Navy is still in the right position;
You or your partner can feel the lower end of Jaydess. Avoid intercourse until your doctor check if the Navy is still in the right position;
Your partner feel the threads during intercourse;
think you may be pregnant;
you have persistent stomach pain, fever or abnormal vaginal discharge, which may be a sign of infection. Infections should be treated immediately;
feel pain or discomfort during sexual intercourse, which may be the evidence of infection, ovarian cyst, or a signal that Jaydess not in the correct position;
there are sudden changes in your menstrual cycles (for example, if you have sparse or no menstrual bleeding and then start continuous bleeding or pain or start bleeding), which may be a sign that Jaydess not in the right position or is discarded.
The use of sanitary napkins. If you use tampons, you should change them carefully, so as not to pull the threads of Jaydess.

Children and adolescents
Using Jaydess in women under 18 years of age has not been studied. Jaydess is not indicated for use before the first menstrual period (menarche).

Other medicines and Jaydess
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, lactation and fertility
pregnancy
Jaydess should not be used in pregnancy.
It is possible that some women cycle to stop while using Jaydess. The absence of menstruation is not necessarily a sign of pregnancy occurred. If you do not cycle and you have other symptoms of pregnancy, you should visit your doctor for an examination and to take a pregnancy test.
If you have not cycle for six weeks, and you are worried, think to take a pregnancy test. If it is negative, no need to do another test, unless you have other signs of pregnancy.
If you become pregnant with inserted Jaydess should immediately visit your doctor to be removed Jaydess. Risk of miscarriage if Jaydess not be removed during pregnancy.
If during pregnancy Jaydess remain in place, increasing the risk of miscarriage, infection or preterm birth. Discuss with your doctor the risks of continuing the pregnancy.
If you want to become pregnant, you should contact your doctor to remove Jaydess.

Ectopic pregnancy (pregnancy outside the uterus)
It is unusual to get pregnant while using Jaydess. However, if you become pregnant while using Jaydess risk of possible development of pregnancy outside the uterus (ectopic or have an ectopic pregnancy) increases. Women who have previously had an ectopic pregnancy, tubal surgery or pelvic infection have a higher risk for this type of pregnancy. An 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.

breastfeeding
You can use Jaydess during lactation. It is the availability of levonorgestrel (the active ingredient in Jaydess) in small amounts in breast milk of lactating women. However, there were no negative effects on growth and development of the baby or the quantity or quality of breast milk.

Fertility
After removal of Jaydess will restore your normal childbearing potential.

Driving and using machines
Jaydess not affect your ability to drive or operate machinery.

3. How to use Jaydess
Placing Jaydess
Jaydess can be placed:
within seven days of your menstrual bleeding (your monthly cycle);
immediately after abortion in the first trimester, with the proviso that no genital infections;
after birth, only after the uterus has regained its normal size and not earlier than six weeks after birth.
Examination by your doctor before setting may include:
Pap smear;
breast exam;
Other tests, eg. infections including Sexually transmitted disease, if necessary. Your doctor will perform a pelvic examination and to determine the position and size of your uterus.
After gynecological examination:
Instrument called a speculum is placed in the vagina and cervix can be cleaned with an antiseptic solution. Then Jaydess is placed in the uterus using a thin, flexible plastic tube (insertion tube). It is possible prior to insertion into the cervix to apply a local anesthetic;
Some women feel dizzy or faint during or after insertion or removal of Jaydess;
You may experience pain and bleeding during or after installation.
Subsequent control:
You should check your Jaydess 4-6 weeks after insertion and then regularly, at least once a year.

Remove Jaydess
Jaydess must be removed no later than the end of the third year of use.
Jaydess can be easily removed at any time by your doctor, after which pregnancy is possible. Some women feel dizzy or faint during or after removal of Jaydess. You may experience pain and bleeding during removal of Jaydess.
If pregnancy is unwanted, Jaydess should not be removed after the seventh day of the menstrual cycle (monthly period), unless you use other methods of contraception (eg. Condoms) for at least seven days prior to removal of the Navy.
If you do not cycle (Menses), you should use a barrier method of contraception for seven days before removal.
You can also put a new Jaydess immediately after the removal of the old, which does not require additional precautions.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Below is a list of possible side effects by frequency:

Very common side effects may affect more than 1 in 10 people:
headache;
abdominal / pelvic pain;
acne / oily skin;
changes in bleeding, including enhanced and reduced menstrual bleeding, spotting, uncommonly bleeding and lack of bleeding (see the next section and irregular bleeding and uncommon);
ovarian cyst (also see the next section for ovarian cyst);
inflammation of the vulva and vagina (vaginitis).
Common side effects may affect up to 1 in 10 people:
depressed mood / depression;
migraine;
nausea;
infection of the upper genital tract;
painful menstruation;
pain / discomfort in the chest;
Disposal of the device (full and partial) - (see next section for spontaneous discharge of the device);
hair loss;
genital discharge.
Uncommon side effects may affect up to 1 in every 100 people:
excessive body hair.
Rare side effects may affect up to 1 in 1000 people:
perforation of the uterus (see also next section perforation).
Description of selected possible side effects:
There are reports of allergic reactions including rash, hives (urticaria) and angioedema (characterized by sudden swelling as the eyes, mouth, throat) for use of such products.
Irregular bleeding or uncommonly
Jaydess likely to affect your menstrual cycle. It can change your menstrual cycle so that you have spotting (light bleeding), shorter or longer cycles, scanty or profuse bleeding or no bleeding.
You may have bleeding and spotting between periods, especially during the first 3 to 6 months. Sometimes initial bleeding is more abundant than usual.
Overall, it is likely that you may have a gradual reduction of the number of days of bleeding every month. In some women, eventually menstruation may stop completely.
You may not occur monthly thickening of the lining of the uterus due to the hormone, so there is nothing to be discharged in the form of menstruation. This does not necessarily mean that you have reached menopause or are pregnant. Generally, the levels of your own hormones remain normal level.
When the system is removed, your period should soon be normalized.

Infection pelvic
The insertion tube for Jaydess itself Jaydess sterile. However, there is an increased risk of infection, pelvic infection (infection of the lining of the uterus or fallopian tubes) at the time of placement and during the first 3-4 weeks after placement.
Infections in the pelvis in women using the Navy, are often associated with diseases, sexually transmitted. The risk of infection is increased if you or your partner have multiple sexual partners or if you have had pelvic inflammatory disease.
Infections in the pelvic area should be treated promptly.
Infections in the pelvic area as PID can have serious consequences and can negatively affect fertility and increase the risk of ectopic pregnancy (pregnancy outside the womb) in the future. In extremely rare cases, a little after insertion may occur severe infection or sepsis (a very severe infection that can be fatal).
Jaydess must be removed if you have recurrent PID or if an infection is very severe or does not respond to treatment.

spontaneous discharge
Occasionally muscle contractions of the uterus during menstruation to push the Navy from its place or to push out. It happens rarely, but it is possible Jaydess be shed during your menstrual cycle, without you noticing it.
It is also possible Jaydess only be partially ejected from the uterus, which means that it is misaligned, but is not fully discharged (You and your partner may notice this during sexual intercourse). If Jaydess is fully or partially discharged, will not be protected from pregnancy.

perforation
Rarely during the placement of Jaydess may occur penetration or perforation of the uterine wall, although the perforation be established only later. If Jaydess shifted outside the uterine cavity, it is not effective for preventing pregnancy. You may need surgery to remove Jaydess.

The risk of perforation is increased in lactating women and may be increased:
if Jaydess placed shortly after birth (see section 3 "Installing Jaydess");
a woman with back located uterus (womb in retroverzno fixed position).
Ovarian Cyst
Since the contraceptive effect of Jaydess is mainly due to local effects on the uterus, usually ovulation (release of eggs) continues during the use of Jaydess. Sometimes it is possible to develop an ovarian cyst. In most cases there are no symptoms.

5. How to store Jaydess
This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not open the blister. Only your doctor or nurse should do so.
Do not use this medicine after the expiry date stated on the carton and on the blister after "EXP" / "EXP". The expiry date refers to the last day of that month.

6. Contents of the pack and other information
What Jaydess
The active substance is levonorgestrel. Intrauterine delivery system containing 13,5 mg levonorgestrel.

Other ingredients are:
polydimethylsiloxane elastomer;
silica colloidal anhydrous;
polyethylene;
barium sulfate;
black iron oxide (E172);
silver.
Jaydess looks like and contents of the pack
Jaydess is a T-shaped intrauterine delivery system (CPA). The vertical arm of the T-shaped body having a drug reservoir containing levonorgestrel. To the loop at the bottom of the vertical arm are attached two support removal threads. In addition, the vertical arm contains silver ring located near the horizontal arms, which can be seen in ultrasound.