JAYDESS 13.5 MG INTRAUTERINE DELIVERY SYSTEM

Active substance: LEVONORGESTREL

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83931523

Package leaflet:
Information for the user
Patient's name:
Doctor's name:
Doctor's phone number:
Date of insertion:
Date of removal:
First check-up visit:
Next visits:
1.
2.
3.

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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.
Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
OOKeep this leaflet. You may need to read it
again.
OOIf you have any further questions, ask
your doctor or nurse.
OOThis medicine has been prescribed for you
only. Do not pass it on to others.
OO If you get any side effects, talk to your
doctor or nurse. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
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

1. What Jaydess is and what it is used for
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.
2. What you need to know before you use
Jaydess
General notes
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 sex or you should
use a condom or another barrier method.
Jaydess, like other hormonal contraceptives,
does not protect against HIV infection (AIDS)

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or any other sexually transmitted disease.
Jaydess is not suitable for use as an
emergency contraceptive (postcoital
contraceptive).
Do NOT use Jaydess if you:
OO re pregnant (see section "Pregnancy,
a
breast-feeding and fertility")
OOcurrently have a pelvic inflammatory
disease (PID; infection of the female
reproduction organs) or have had this
condition multiple times in the past
OOhave conditions associated with increased
susceptibility to pelvic infections
OOhave an infection in the lower genital
tract (an infection in the vagina or the
cervix [neck of the womb])
OOhave had an infection of the womb after
delivery of a child, after an abortion
or after miscarriage during the past 3
months
OOcurrently have cell abnormalities in the
cervix
OOhave cancer or suspected cancer of the
cervix or womb
OOhave tumors which are sensitive to
progestogen hormones to grow, e.g.
breast cancer
OOhave unexplained vaginal bleeding
OOhave an abnormality of the cervix or
womb including fibroids that distort the
cavity of the womb

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OOhave

an active liver disease or liver tumor
allergic to levonorgestrel or any of
the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
OOare

Talk to your healthcare professional
before using Jaydess if you:
OOhave diabetes. There is generally no need
to alter your diabetic medication while
using Jaydess, but this may need to be
checked by your healthcare professional
OOhave epilepsy. A fit (seizure) can occur
during placement or removal
OOhave had an ectopic or extrauterine
pregnancy (pregnancy outside the womb)
in the past.
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:
OOmigraine, with visual disturbances or
other symptoms which may be signs of
a transient cerebral ischemia (temporary
blockage of the blood supply to the
brain)
OOexceptionally severe headache
OOjaundice (a yellowing of the skin, whites
of the eyes and/or nails)
OOmarked increase of blood pressure
OOsevere disease of the arteries such as
stroke or heart attack.

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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”):
OOYour menstrual periods have stopped and
then you start having persistent bleeding
or pain
OOYou have pain in your lower abdomen
that is severe or persistent
OOYou have normal signs of pregnancy, but
you also have bleeding and feel dizzy.
OOYou have a positive pregnancy test.
Contact your healthcare professional
promptly if any of the following occur
(see also section 4):
OOsevere pain (like menstrual cramps) or
heavy bleeding after placement or if you
have pain/bleeding which continues for
more than a few weeks. This may be for
example a sign of infection, perforation
or that Jaydess is not in the correct
position.
OOyou no longer feel the threads in your
vagina. This may be a sign of expulsion.
You can check by gently putting a finger
into your vagina and feeling for the
threads at the end of your vagina near
the opening of your womb (cervix). Do
not pull the threads because you may
accidentally pull out Jaydess. Avoid
intercourse or use a barrier contraceptive

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(such as condoms) until your healthcare
professional has checked that the IUS is
still in position.
OOyou or your partner can feel the lower
end of Jaydess. Avoid intercourse until
your healthcare professional has checked
that the IUS is still in position.
OOyour partner feels the removal threads
during intercourse.
OOyou think you may be pregnant
OOyou have persistent abdominal pain,
fever, or unusual discharge from the
vagina, which may be a sign of infection.
Infections must be treated immediately.
OOyou feel pain or discomfort during sexual
intercourse, which may be for example
a sign of infection, ovarian cyst or that
Jaydess is not in the correct position.
OOthere are sudden changes in your
menstrual periods (for example, if you
have little or no menstrual bleeding, and
then you start having persistent bleeding
or pain, or you start bleeding heavily),
which may be a sign of Jaydess not being
in the correct position or expelled.
Use of sanitary pads is recommended. If
tampons are used, you should change them
with care so as not to pull the threads of
Jaydess.

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

If you leave Jaydess in place during
pregnancy, the risk of having a miscarriage,
infection or preterm labour will be increased.
Talk with your healthcare professional about
the risks of continuing the pregnancy.

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

If you want to become pregnant you should
contact your healthcare professional to
have Jaydess removed.

Pregnancy, breast-feeding and fertility
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. There is a risk of spontaneous
miscarriage if Jaydess is removed during
pregnancy.

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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 breastfeeding women. However, no negative
effects have been seen on infant growth
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and development or the amount or the
quality of the breast milk.
Fertility
Your usual level of fertility will return after
Jaydess is removed.
Driving and using machines
Jaydess has no influence on the ability to
drive or use machines.
3. How to use Jaydess
Placement of Jaydess
Jaydess can either be placed:
OOwithin seven days from the start of your
menstrual bleed (your monthly period)
OOimmediately after a first trimester
abortion provided that there are no
genital infections
OOafter giving birth only after the womb
has returned to its normal size, and not
earlier than 6 weeks after delivery.
Examination by your healthcare provider
before placement may include:
OOa cervical smear test (Pap smear)
OOexamination of the breasts
OO other tests, e.g. for infections, including
sexually transmitted diseases, as necessary.
Your healthcare professional will also do
a gynecological examination to determine
the position and size of the womb.
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After a gynaecological examination:

OO an instrument called a speculum is placed

into the vagina, and the cervix may be
cleansed with an antiseptic solution.
Jaydess is then placed into the womb using
a thin, flexible plastic tube (the placement
tube). Local anaesthesia may be applied to
the cervix prior to placement
OO some women feel dizzy or faint during
placement or after Jaydess is placed or
removed.
OO you may experience some pain and
bleeding during or just after placement.
Follow-up control
You should have your Jaydess checked 4-6
weeks after placement, and thereafter
regularly, at least once a year.
Removal of Jaydess
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
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(e.g. condoms) for at least seven days
before the IUS removal.
In the case you do not have periods
(menses), you should use a barrier method
of contraception for seven days before
removal.
A new Jaydess can also be placed
immediately after removal, in which case
no additional protection is needed.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them. 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
OOdepressed

mood / depression

OOmigraine
OOfeeling

sick (nausea)
genital tract infection
OOpainful menstruation
OObreast pain / discomfort
OOdevice expulsion (complete and partial) (see also following section on expulsion)
OOhair loss
OOgenital discharge
OOupper

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

body hair

OOheadache

OOabdominal

/ pelvic pain
/ greasy skin
OObleeding changes including increased
and decreased menstrual bleeding,
spotting, infrequent periods and absence
of bleeding (see also following section on
irregular or infrequent bleeding)
OOovarian cyst (see also following section
on ovarian cyst)
OOinflammation of the external genital
organs and vagina (vulvovaginitis)
OOacne

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Rare side effects: may affect up to 1 in
1,000 people
OOperforation

of the womb (see also
following section on perforation)

Description of selected possible side
effects:
OOallergic reactions including rash, hives
(urticaria) and angioedema (characterised
by sudden swelling of e.g. the eyes,
mouth, throat) have been reported with
similar products
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Irregular or infrequent bleeding
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.

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.

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.

Pelvic infections must be treated promptly.

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.

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.

When the system is removed, your period
should soon return to normal.

Expulsion
The muscular contractions of the womb
during menstruation may sometimes push
the IUS out of place or expel it. It is rare but
possible for Jaydess to come out during your
menstrual period without you noticing.

Pelvic Infection
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.

It is also possible for your Jaydess to
partially expel from your womb, meaning
that it is displaced but not completely
expelled (you and your partner may notice
this during sexual intercourse). If Jaydess
is completely or partially expelled, you will
not be protected from pregnancy.

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Perforation
Penetration or perforation of the wall of the
womb may occur rarely during placement
of Jaydess, although the perforation may
not be detected until some time later.
If Jaydess becomes lodged outside the
cavity of the womb, it is not effective
at preventing pregnancy. You may need
surgery to have Jaydess removed.
The risk of perforation is increased in
breast-feeding women, and may be
increased:
OOif Jaydess is placed shortly after giving
birth (see section 3 "Placement of
Jaydess")
OOin women with the uterus leaning
backwards (fixed retroverted uterus)
Ovarian cyst
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.
Reporting of side effects
If you get any side effects, talk to your
doctor or nurse. This includes any possible
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side effects not listed in this leaflet. You
can also report side effects directly (see
details below). By reporting side effects, you
can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme
Website:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website:
www.medicinesauthority.gov.mt
e-mail:
postlicensing.medicinesauthority@gov.mt
5. How to store Jaydess
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.

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6. Contents of the pack and other
information
What Jaydess contains
The active substance is levonorgestrel.
The intrauterine delivery system contains
13.5 mg levonorgestrel.
The other ingredients are:
OOpolydimethylsiloxane elastomer
OOsilica, colloidal anhydrous
OOpolyethylene
OObarium sulfate
OOiron oxide, black (E172)
OOsilver
What Jaydess looks like and contents of
the pack
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:
OO1x1 intrauterine delivery system.
OO5x1 intrauterine delivery system.
Not all pack sizes may be marketed.
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Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire, RG14 1JA
Manufacturer
Bayer Oy,
Pansiontie 47,
20210 Turku, Finland.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
- Austria, Belgium, Bulgaria, Czech
Republic, Denmark, Finland, France,
Germany, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, The Netherlands,
Norway, Poland, Portugal, Romania, Slovak
Republic, Slovenia, Spain, Sweden, United
Kingdom: Jaydess
- Estonia, Latvia, Lithuania: Fleree
This leaflet was last revised in
February 2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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