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LEVOSERT 20 MICROGRAM/24 HOURS INTRAUTERINE DELIVERY SYSTEM

Active substance(s): LEVONORGESTREL

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Levosert

20 micrograms/24 hours
Intrauterine Delivery System

Levonorgestrel
Package leaflet:
Information for the user

Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.
• Keep this leaflet. You may
need to read it again.
• If you have any further
questions, ask your doctor or
pharmacist.
• If you get any side effects, talk
to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Levosert® is and what it
is used for
2. What you need to know
before you use Levosert®
3. How to use Levosert®
4. Possible side effects
5. How to store Levosert®
6. Contents of the pack and
other information
1. What Levosert® is and what it
is used for
Levosert® is an intrauterine
delivery system (IUS) for insertion
in the womb. It can be used in
the following ways:
- As an effective method of
contraception (prevention of
pregnancy).
- For heavy menstrual bleeding
(heavy periods).
Levosert® prevents pregnancy
by controlling the monthly
development of the womb lining
so that it is not thick enough for
you to become pregnant; by
making the normal mucus in
the opening to the womb (the
cervical canal) thicker so that the
sperm cannot get through to
fertilise the egg; by preventing
the release of eggs (ovulation) in
some women.

There are also local effects on
the lining of the womb caused
by the presence of the T-shaped
frame.
Levosert® is also useful for
reducing menstrual blood
flow, so it can be used if you
suffer from heavy menstrual
bleeding (periods). This is called
menorrhagia. The hormone in
Levosert® acts by controlling the
monthly development of the
womb lining, making it thinner,
so that there is less bleeding
every month.
Levosert® is placed inside
the uterus (womb) where it
slowly releases the hormone
levonorgestrel over a period of 3
years or until it is removed.
2. What you need to know
before you use Levosert®
Do not use Levosert®:
Before you have Levosert®
fitted, your doctor or nurse will
carry out some tests to make
sure that Levosert® is suitable
for you to use. This will include
a pelvic examination and may
also include other examinations
such as a breast examination, if
your doctor or nurse feels this is
appropriate.
Genital infections will need to be
successfully treated before you
can have Levosert® fitted.
If you have epilepsy, tell the
doctor or nurse fitting Levosert®
because, although rare, a fit can
occur during insertion. Some
women might feel faint after the
procedure. This is normal and
your doctor or nurse will tell you
to rest for a while.

Not all women can use
Levosert®. Do not use Levosert®
and tell your doctor if you:
• are pregnant, suspect that
you are pregnant or are breast
feeding
• have an unusual vaginal
bleeding pattern
• have an abnormal womb or
fibroids
• have an unusual or unpleasant
vaginal discharge, or vaginal
itching
• have or have had pelvic
inflammatory disease
• have or have had
inflammation of the lining of
your womb following delivery
of your baby
• have or have had an infection
of the womb after delivery or
after abortion during the past
3 months
• have or have had
inflammation of the cervix
(neck of your womb)
• have or have had an abnormal
smear test (changes in the
cervix)
• have had a stroke, heart attack
or any heart problems
• have or have had liver
problems
• have any condition which
makes you susceptible to
infections. A doctor will have
told you if you have this
• have or have had any type of
cancer, suspected cancer or
leukaemia (blood cancer)
• have or have had
trophoblastic disease (the
trophoblast provides nutrients
to the foetus). A doctor will
have told you if you have this
• are allergic (hypersensitive)
to the levonorgestrel or any
of the other ingredients this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before using
Levosert® if you:
• are diabetic (too high blood
glucose level), have high
blood pressure or abnormal
blood lipid levels
• have fits (epilepsy)
• have a history of blood clots
(thrombosis)

• a
 re on long term steroid
therapy
• are taking any other medicines
as some medicines may
stop Levosert® from working
properly
• have or develop migraine,
dizziness, blurred vision,
unusually bad headaches or
if you have headaches more
often than before
• have ever had an ectopic
pregnancy (development of
the foetus outside the womb)
or a history of ovarian cysts
• have yellowing of the skin or
whites of the eyes
• cancer affecting your blood
(including leukaemia) which is
now in remission
• have had a stroke or heart
attack, or if you have heart
problems
• disease of your arteries
Your doctor will decide if you
can use Levosert® if you have
or have had some of the above
conditions.
You must also tell your doctor
if any of these conditions occur
for the first time whilst you have
Levosert® in place.
You must see a doctor or nurse
as soon as possible if you develop
painful swelling in your leg,
sudden chest pain or difficulty in
breathing as these may be a sign
of a blood clot. It is important
that any blood clots are treated
promptly.
You must also see a doctor
without delay if you develop
persistent lower abdominal
pain, fever, pain during sexual
intercourse or abnormal
bleeding. If you get severe pain
or fever shortly after Levosert®
has been inserted, you may have
a severe infection which must be
treated immediately.
Levosert® and smoking
Women are advised to give up
smoking. Smoking increases the
risk of developing a heart attack,
stroke, or blood clot.

Levonorgestrel (Levosert) 20mg-24hrs PIL - UK
item no: AAAG7629

dimensions: 210x297

print proof no: 10

pharmacode:

origination date: 07-04-14

min pt size: 9pt

Pregnancy, breast-feeding and
fertility
Can I become pregnant whilst
using Levosert®?
It is very rare for women to
become pregnant with Levosert®
in place.
Missing a period may not mean
that you are pregnant. Some
women may not have periods
whilst using the system.
If you have not had a period for
6 weeks 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, e.g.
sickness, tiredness or breast
tenderness.
If you become pregnant with
Levosert® in place, please contact
your doctor as soon as possible
so that ectopic pregnancy can be
excluded and Levosert® removed
to reduce the risk of spontaneous
miscarriage.
What if I want a baby?
If you want a baby, ask your
doctor to remove Levosert®. Your
usual level of fertility will return
very quickly after the system is
removed.
Can I breast feed while using
Levosert®?
Very small amounts of the
hormone in Levosert® are found in
breast milk but the levels are lower
than with any other hormonal
contraceptive method.

colours/plates:
1. Black
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originated by: BW
approved for print/date

Other medicines and Levosert®
Tell your doctor if you are
taking or have recently taken or
might take any other medicines
including medicines obtained
without a prescription.
The effect of hormonal
contraceptives such as Levosert®
may be reduced by medicines that
increase the amounts of enzymes
made by the liver. Please tell your
doctor or nurse if you are taking:
• Phenobarbital, primidone,
phenytoin or carbamazepine
(to treat epilepsy)
• Griseofulvin (an antifungal)
• Rifampicin or rifabutin
(antibiotics)
• Nevirapine or efavirenz (for
HIV)

revision date: 04/09/14

Technical Approval

revised by: C.Grant

date sent: 07-04-14

supplier: IL/Uteron

technically app. date: 29-07-14

Non Printing Colours
1.
2.
3.

No risk for the new-born is to be
expected. If you want to breast
feed your baby, you should
discuss this with your doctor.
Driving and using machines
There are no known effects
on the ability to drive or use
machines.
Levosert® contains barium
sulphate
The T-frame of Levosert®
contains barium sulphate so that
it can be seen on X-rays.
3. How to use Levosert®
Only a doctor or specially trained
nurse can fit the system (see
special instructions for insertion
in the package).
They will:
• give you a pelvic examination
to find the position and size of
your womb
• place a speculum (an
instrument to help the doctor
see the cervix) into your
vagina
• clean your vagina and cervix
• place a thin flexible tube
containing the device into
your vagina and then through
the cervix into the womb. At
this point you might feel a little
discomfort
• withdraw the tube leaving the
device in place
• trim the threads to a suitable
length for easy removal.
During insertion procedure,
a slight discomfort might be
encountered. Inform your doctor
about any pain you feel.
The device should be inserted
either during your period or
within seven days from the
beginning of your period. If you
already have the device and it is
time to replace it with a new one,
you do not need to wait until
your period.
If you have just had a baby, you
should wait at least 6 weeks
before having Levosert® fitted.
Levosert® can sometimes be
fitted immediately after you have
had an abortion, provided that
you have no genital infections.

If you have fits (epilepsy), tell
the doctor or nurse fitting the
Levosert® because, although rare,
a seizure (fit) can occur during
insertion.
Some women might feel faint
after the device is fitted. This is
normal and your doctor will tell
you to rest for a while.
In very rare cases during fitting,
part or all of the device could
penetrate the wall of the womb.
If this happens the device is
removed.
How quickly should Levosert®
work?
Contraception:
You are protected from
pregnancy as soon as the
system is fitted. The possibility
of becoming pregnant is
approximately 2 in 1,000 per year.
The failure rate may increase in
case of Levosert® coming out by
itself or perforation.
Heavy menstrual bleeding:
Levosert® usually achieves a
significant reduction in menstrual
blood loss in 3 to 6 months of
treatment.
How often should I have the
system checked?
You should have the system
checked usually 6 weeks after
it is fitted, again at 12 months
and then once a year until it is
removed.
What happens if the system
comes out by itself?
If the system comes out either
completely or partially, you
may not be protected against
pregnancy. It is rare but possible
for this to happen without you
noticing during your menstrual
period. An unusual increase in the
amount of bleeding during your
period might be a sign that this
has happened. Tell your doctor or
clinic if there are any unexpected
changes in your bleeding pattern.
How can I tell whether the
system is in place?
After each menstrual period, you
can feel for the two thin threads
attached to the lower end of the
system. Your doctor will show you
how to do this.

Do not pull the threads because
you may accidentally pull it out. If
you cannot feel the threads, go to
your doctor.
You should also go to your doctor
if you can feel the lower end of the
device itself or you or your partner
feel pain or discomfort during
sexual intercourse.
If you stop taking Levosert®
Your doctor can remove the system
at any time. The removal is very
easy. Unless you plan to have a new
system or an intrauterine device
fitted immediately, it is important to
use another form of contraception
in the week leading up to the
removal. Intercourse during this
week could lead to pregnancy after
Levosert® is removed.
How will Levosert® affect my
periods?
Levosert® will affect your menstrual
cycle. You might experience
spotting, shorter or longer periods,
painful periods, lighter periods or
no periods at all.
For all users of Levosert®:
Many women have spotting (a
small amount of blood loss) for the
first 3-6 months after the system is
fitted. Others will have prolonged
or heavy bleeding. You may have
an increase in bleeding however,
usually in the first 2 to 3 months,
before a reduction in blood loss is
achieved. Overall you are likely to
have fewer days bleeding in each
month and you might eventually
have no periods at all. This is due
to the effect of the hormone
(levonorgestrel) on the lining of the
womb.
If you have had Levosert® fitted for
heavy menstrual bleeding:
Levosert® usually achieves a
significant reduction in menstrual
blood loss in 3 to 6 months of
treatment. You may have an
increase in bleeding however,
usually in the first 2 to 3 months,
before a reduction in blood loss is
achieved.
If a significant reduction in blood
loss is not achieved after 3 to 6
months, alternative treatments
should be considered.

If you have had Levosert® fitted
for quite a long time and then
start to have bleeding problems,
contact your doctor or clinic for
advice.
If you have any further questions
on the use of this medicine, ask
your doctor.
Moreover, see a doctor as soon
as possible if you get:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing
Because these may be signs of a
blood clot.
Perforation
In rare cases it is possible that the
womb or the neck of the womb
is pierced, most commonly
during insertion of Levosert®. This
may be associated with severe
pain and continued bleeding.
If perforation is suspected the
system should be removed as
soon as possible. Contact your
doctor immediately if you cannot
feel the threads.
The risk of perforation may be
increased in insertions following
delivery, in lactating women and
in women with a fixed retroverted
(bent backwards) uterus.
4. Possible side effects
Like all medicines, this medicine
can cause side effects, although
not everybody gets them.
With Levosert®, side effects are
most common during the first
months after the system is fitted
and decrease as time goes on.
Very common (affects more than
1 in 10 women) side effects can
include:
• menstrual changes. You might
experience spotting, shorter
or longer periods, painful
periods. Though Levosert®
usually achieves a significant
reduction in menstrual blood
loss in 3 to 6 months of
treatment, you may have an
increase in bleeding, usually in
the first 2 to 3 months, before
a reduction in blood loss is
achieved.

Periods can totally disappear. If
a significant reduction in blood
loss is not achieved after 3 to 6
months, alternative treatments
should be considered.
• ovarian cysts. They are fluidfilled sacs in the ovary.
Common (may affect up to 1
in 10 women) side effects can
include:
• bloating or swelling of your
legs or ankles;
• weight gain;
• depression, nervousness or
other mood changes;
• headache;
• abdominal, pelvic or back
pain;
• feeling sick (nausea);
• spots (acne);
• painful periods;
• increased vaginal discharge;
• inflammation of the neck of
the womb (cervicitis);
• tender, painful breasts; or
• Levosert® coming out by
itself.
Uncommon (may affect up to 1
in 100 women) side effects can
include:
• genital infections that may
cause: vaginal itching; pain
on passing urine; or lower
abdominal (tummy) pain from
inflammation of the womb,
ovaries or fallopian tubes;
• increased growth of hair on
the face and body;
• hair loss; or
• itchy skin (pruritus).

You should tell your doctor if you
have lower abdominal (tummy)
pain especially if you also have
a fever or have missed a period
or have unexpected bleeding.
This might be a sign of ectopic
pregnancy.
If you think you are reacting
badly to Levosert® or are having
any other problems, please tell
your doctor or clinic.
Reporting of side effects
If you get any side effects, talk to
your doctor or pharmacist. 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
By reporting side effects you can
help provide more information
on the safety of this medicine.
5. How to store Levosert®
Store in the original package. Do
not open the Levosert® pack.
Only your doctor or clinic should
do this.
This medicinal product does not
require any special temperature
storage conditions.

Rare (may affect up to 1 in 1000
women) side effects can include:
• reduced sex drive;
• migraine;
• bloated abdomen;
• rashes, itching, eczema; or
• the wall of the womb torn
when the Levosert® is fitted.

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

Ovarian cysts and pelvic
inflammatory disease have been
reported. So tell your doctor if
you have lower abdominal pain
or if you experience painful or
difficult sex. This is important
as pelvic infections can reduce
your chances of having a baby
and can increase the risk of
ectopic pregnancy (development
of a foetus outside the womb).

Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to throw away
medicines you no longer use.
These measures will help protect
the environment.

Levonorgestrel (Levosert) 20mg-24hrs PIL - UK
item no: AAAG7629

dimensions: 210x297

print proof no: 10

pharmacode:

origination date: 07-04-14

min pt size: 9pt

Do not use the device after the
expiry date which is stated on
the label and the outer pack after
EXP. The expiry date refers to the
last day of that month.

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: BW
approved for print/date

Ectopic pregnancy is possible
with Levosert® but highly unlikely.
The risk of this happening is
lower than for women using
no contraception or a copper
intrauterine device.

revision date: 04/09/14

Technical Approval

revised by: C.Grant

date sent: 07-04-14

supplier: IL/Uteron

technically app. date: 29-07-14

Non Printing Colours
1.
2.
3.

6. Contents of the pack and
other information
What Levosert® contains
• Levosert® consists of a small
T-shaped frame made from
a plastic called polyethylene.
This carries 52 mg of
levonorgestrel, the active
substance, a hormone used
in many contraceptive pills
and hormone replacement
therapy preparations. The
hormone is contained
within a substance called
polydimethylsiloxane.
This is surrounded by a
membrane (skin) also made of
polydimethylsiloxane.
• The T-shaped frame also
contains barium sulphate so
that it can be seen on X-rays.
• This structure provides a
device for releasing the
hormone gradually into the
uterus (womb).
• There are two fine threads,
made of polyethylene and
copper phtalocyanine blue,
attached to the bottom of
the frame. These allow easy
removal and allow you or
your doctor to check that the
device is in place.
What Levosert® looks like and
contents of the pack
Each pack contains one
Levosert®.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Odyssea Pharma SA
Rue du Travail 16
4460 Grâce Hollogne
Belgium
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
This leaflet was last revised in
August 2014
The following information
is intended for medical or
healthcare professionals only
See special instruction leaflet
enclosed in the pack. AAAG7629

b

4001008

Prescriber Check List

Ask yourself the following questions before prescribing/inserting
Levosert®:

Description
a Levonorgestrel containing cylinder

• I have checked that the patient’s needs meet the indications of

b Lateral arms

• I have checked that the patient doesn’t reach any

c Threads

contraception or heavy menstrual bleeding?

The following information is intended for medical
or healthcare professionals only

For healthcare professionals

a

contra-indication:
Known or suspected pregnancy
Current or recurrent pelvic inflammatory disease
Current genital infection
Postpartum endometritis
Infected abortion during the past three months
Cervicitis, Cervical dysplasia
Suspected or confirmed uterine or cervical malignancy
Liver tumour or other acute or severe liver disease
Congenital or acquired abnormality of the uterus including
fibroids if they distort the uterine cavity
Undiagnosed abnormal genital bleeding
Conditions associated with increased susceptibility
to infections
Active or previous severe arterial disease, such as stroke or myocardial
infarction
Current or suspected hormone dependent tumours such as
breast cancer
Hypersensitivity to the active constituents of the preparation
Acute malignancies affecting the blood or leukaemias except
when in remission
Recent trophoblastic disease while hCG levels remain elevated

c
f

d Knobs

e

e Flange

Insertion
tube

f Scale
g Thickened mark
g

h First indent

Plunger

i Second indent

j

j Ring

h
i

Preparation for insertion

1

5
6
7
8
9

Introduce the
plunger and the IUD
in the insertion tube

closed
blister

Instructions for use and handling

Levonorgestrel

20 micrograms/24 hours Intrauterine Delivery System

Levosert

®

Partly open the blister (about
1/3 from the bottom) and
introduce the plunger in the
insertion tube. Extricate the
threads from the flange. Pull
the thread to introduce the
IUD into the tube. The arms
of the IUD must stay in an
horizontal plan, parallel to
the flat side of the flange.

5
6
7
8

Conditions for use

1. In women of fertile age, Levosert® is inserted within seven
days of the onset of menstruation. It can be replaced by a new
system at any time of the cycle.
2. It is recommended that Levosert® should only be inserted by
physicians/health care professionals who have undergone
sufficient training and have read carefully these instructions
before Levosert® insertion.
3. Levosert® is supplied in a sterile pack. Do not use if the inner
package is damaged or open.
4. Determine the position (anteversion, retroversion) and size of
the uterus by a gynaecological examination. Exclude pregnancy
and contra-indications.
5. Place a speculum, use appropriate antiseptic solution to clean
the vagina and cervix.
6. Use cervical dilators if cervical stenosis is diagnosed. Do not
force to overcome resistance.
7. Grasp the cervix with a Tenaculum forceps and apply a gentle
traction in order to straighten alignment of the cervical canal
and uterine cavity.
8. Determine the uterine depth by hysterometry. If uterine depth
is < 5.5 cm discontinue the procedure.

d

IUD

9

Position the lower
edge of the flange
at the sounded value

2
5
5
6
7
8
9

6
7
8

hysterometer
value

Position the blue flange so
as the lower edge of the flange
indicates the value found by
hysterometry. The flat sides of
the flange must always remain
parallel to the arms. This will
allow the arms to open correctly
in the uterine cavity.

zoom 1

Adjust the position
of the IUD in the
insertion tube

3
5

5
6

Push the IUD against
the fundus

7

6

8
9

Hold the plunger firmly while
pulling the thread and moving
the tube to adjust the IUD´s
position. The knobs of the lateral
arms must be closely opposed
to each other, slightly above the
upper extremity of the insertion
tube (see zoom 1) and the distal
edge of the tube must be aligned
with the first indent of the plunger
(see zoom 2). If the tube is not
aligned with the first indent of the
plunger you must pull the thread
more firmly.

6
7
8
9

zoom 2

To position the IUD in the uterine
cavity, push the insertion tube
simultaneously with the plunger,
until the blue flange is again in
contact with the cervix. Levosert®
is then correctly placed in the
uterine cavity.

7

Release the IUD from
the tube into the
uterine cavity

5
6
7
8
9

Insertion

Introduce the device
in the cervical canal
until the blue flange
is in contact with the
cervix

5
6

4

7
8
9

STOP !

Take the whole device out of
the blister, by holding firmly the
plunger and tube together in the
correctly adjusted position.
Introduce the assembly into the
cervical canal until the blue flange
is in contact with the cervix.

8

3 cm

6
7
8
9

Remove sequentially
the inserter
components and
cut the threads
Remove sequentially, first the
plunger, then the insertion tube.
Cut the threads at around 3 cm
from the cervix.

Release the arms
of the intrauterine
device

5

Without moving the plunger, pull
the insertion tube down to the ring
of the plunger. A slight resistance
marks the passage of the bulge
of the plunger. Nevertheless pull
down the tube to the ring of the
plunger. Levosert® is then released
completely from the insertion tube.

IMPORTANT!

Hold the plunger, release the
thread and pull the insertion tube
down until its lower extremity
reaches the second indent of
the plunger.

In case of difficult insertion and/or exceptional pain or bleeding during or after insertion, physical
examination and ultrasound should be performed immediately to exclude perforation of the uterine body
or cervix. If necessary remove the system and insert a new, sterile system.
Please report to our pharmacovigilance department any case of uterine perforation or insertion difficulties:
Actavis Group PTC ehf. E-mail: medinfo@actavis.co.uk Phone: 01271 385257.
Instructions for use and handling was last revised in Aug 2014
AAAG7630

Levonorgestrel 20mcg-24hrs PIL (Professionals) - UK
item no: AAAG7630

dimensions: 210x297

print proof no: 7

pharmacode:

origination date: 07-04-14

min pt size: 8pt

1. Black
2.
3.
4.
5.
6.

originated by: BW
approved for print/date

colours/plates:

revision date: 05/09/14

Technical Approval

revised by: BW

date sent: 07-04-14

supplier: IL/Uteron

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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