Skip to Content

LEVOSERT 20 MICROGRAM/24 HOURS INTRAUTERINE DELIVERY SYSTEM

Active substance(s): LEVONORGESTREL / LEVONORGESTREL / LEVONORGESTREL

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET

1

Package leaflet: Information for the user
Levosert 20 micrograms/24 hours Intrauterine Delivery System
Levonorgestrel
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 (uterus), where it slowly
releases the hormone levonorgestrel.
It is used for:
1. Contraception
Levosert is an effective, long-term and reversible method of contraception. Levosert prevents
pregnancy by thining the lining of your womb (uterus), by making the normal mucus in the opening of
the womb (cervical canal) thicker, so that the sperm cannot get through to fertilise the egg and 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.
2. Treating heavy menstrual bleeding
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 thining the
lining of your uterus, so that there is less bleeding every month.
Levosert is used for contraception and heavy menstrual bleeding over a period of 3 years or until it is
removed.
Children and adolescents.
Levosert is not indicated for use before the first menstrual bleeding (menarche).

2.

What you need to know before you 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 successully treated before you can have Levosert fitted.

2

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 if you :
-

are pregnant or suspect that you may be pregnant
have or have had pelvic inflammatory disease
have an unusual or unpleasant vaginal discharge, or vaginal itching, as this may indicate an
infection
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 or have had liver problems
have an abnormal womb, including uterine fibroids, especially for those what distort the uterine
cavity
have an abnormal vaginal bleeding pattern
have any condition which makes you susceptible to infections. A doctor will have told you if you
have this
have or have had hormone dependent cancer, such as breast cancer
have or have had any type of cancer or suspected cancer including blood (leukaemia), uterine and
cervical cancer, unless in remission
have or have had trophoblastic disease. A doctor will have told you if you have this
are allergic (hypersensitive) to levonorgestrel or any of the other ingredients this medicine (listed
in section 6).

Warnings and precautions
Levosert, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any
other sexually transmitted disease (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis
B and syphilis). You will need condoms to protect yourself from these diseases.
Levosert should not be used as a post-coital contraceptive (after unprotected sexual intercourse).
Talk to your doctor before using Levosert if you:
have or develop migraine, dizziness, blurred vision, unusually bad headaches or if you have
headaches more often than before
have yellowing of the skin or whites of the eyes (jaundice)
are diabetic (too high blood glucose level), have high blood pressure or abnormal blood lipid
levels
have had cancer affecting your blood (including leukaemia) which is now in remission
are on long term steroid therapy
have ever had an ectopic pregnancy (development of the foetus outside the womb) or a history
of ovarian cysts
have had or have severe arterial disease, such as heart attack, or stroke
have a history of blood clots (thrombosis)
are taking any other medicines as some medicines may stop Levosert from working properly
have irregular bleedings
have fits (epilepsy)
Your doctor will decide if you can use Levosert if you have or have had some of the above conditions.

3

You must also tell your doctor if any of these conditions occur for the first time whilst you have
Levosert in place.
The following signs and symptoms could mean that you may have an extrauterine pregnancy
(pregnancy outside the uterus) and you should see your healthcare professional immediately (see also
section “Pregnancy, breast-feeding and fertility”):





Your menstrual periods have stopped and then you start having persistent bleeding or pain
You have pain in your lower abdomen that is severe or persistent
You have normal signs of pregnancy, but you also have bleeding and feel dizzy.
You have a positive pregnancy test

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.
You must see a doctor promptly if you 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 Levosert. Avoid intercourse or use a barrier contraceptive (such as condoms)
until your healthcare professional has checked that the IUS is still in position.
Levosert and smoking
Women are advised to give up smoking. Smoking increases the risk of developing a heart attack,
stroke, or blood clot.
Other medicines and Levosert
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, phenytoin or carbamazepine (to treat epilepsy)
 Griseofulvin (an antifungal)
 Rifampicin or rifabutin (antibiotics)
 Nevirapine or efavirenz (for HIV)
Tell your doctor if you are taking or have recently taken or might take any other medicines. Levosert
should not be taken simultaneously with another hormonal contraceptive method.
Pregnancy, breast-feeding and fertility
Levosert should not be used during pregnancy or if you may suspect that you are pregnant
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 the device 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?

4

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. 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 explain the fitting procedure and any risks associated with its usage. You will then be
examined by your doctor or nurse before Levosert is fitted. If you have any concerns over its usage
you should discuss it with them.
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 suffer from 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 in the first 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.

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.

5

Do not pull the threads because you may accidentally pull it out. If you cannot feel the threads,
contact your doctor or nurse as soon as possible and in the meantime avoid intercourse or use a barrier
contraceptive (such as condoms). The threads may have simply drawn up into the womb or cervical
canal. If the threads still cannot be found by your doctor or nurse, they may have broken off, or
Levosert may have come out by itself, or in rare cases it may have perforated the wall of your womb
(uterine perforation, see section 4).
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.
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 healthcare provider if there are any unexpected changes in your bleeding pattern.
If you stop using 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 intra-uterine 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?
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 healthcare provider 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.

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.

6

If you experience any of the following serious side effects please contact your doctor or nurse
immediately:
 Severe pain or fever developing shortly after insertion may mean that you have a severe
infection which must be treated immediately. In rare cases very severe infection (sepsis) can
occur.


Severe pain and continued bleeding as this might be a sign of damage or tear in the wall of
the womb (perforation). Perforation is rare, but occurs most often during the fitting of the
Levosert, although the perforation may not be detected until sometime later. If this happens
the Levosert will be removed; very rarely this may require surgery. The risk of perforation is
low, but is increased in breastfeeding women and in women who have had a baby up to 36
weeks before insertion.
Possible signs and symptoms of perforation may include:
- severe pain (like menstrual cramps) or more pain than expected
- heavy bleeding (after insertion)
- pain or bleeding which continues for more than a few weeks
- sudden changes in your periods
- pain during sex
- you can no longer feel the Levosert threads (see section 3 ”How to use Levosert How can I tell whether the system is in place?").



Lower abdominal pain especially if you also have a fever or have missed a period or have
unexpected bleeding, as this might be a sign of ectopic pregnancy. The absolute risk of
ectopic pregnancy in Levosert users is low. However, when a woman becomes pregnant with
Levosert in place, the relative likelihood of ectopic pregnancy is increased.



Lower abdominal pain or experience painful or difficult sex as this might be a sign of ovarian
cysts or pelvic inflammatory disease. This is important as pelvic infections can reduce your
chances of having a baby and can increase the risk of ectopic pregnancy.

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 fluid-filled sacs in the ovary.
Common (may affect up to 1 in 10 women) side effects can include:
depression, nervousness or other mood changes;
reduced sex drive;
headache;
abdominal, pelvic or back pain;
feeling sick (nausea);
spots (acne);
painful periods;
increased vaginal discharge;
tender, painful breasts; or
Levosert coming out by itself;
weight gain.
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;
migraine;
bloated abdomen;
7

-

eczema
inflammation of the neck of the womb (cervicitis);
bloating or swelling of your legs or ankles;
increased growth of hair on the face and body;
hair loss;
itchy skin (pruritus); or
skin discolouration or increased skin pigment, especially on the face (chloasma).

Rare (may affect up to 1 in 1000 women) side effects can include:
rashes, itching, or
perforation of the wall of the uterus
Severe pain or fever developing shortly after insertion may mean that you have a severe infection
which must be treated immediately. In rare cases very severe infection (sepsis) can occur.

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 Yellow Card Scheme; Website:
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. Keep the pouch in the outer carton in order to protect from light. Do not
open the Levosert pack. Only your doctor or healthcare provider should do this.
This medicinal product does not require any special temperature storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use the system 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.
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.

6.

Contents of the pack and other information

What Levosert contains
-

Levosert contains 52 mg of levonorgestrel, the active substance. The hormone is contained
within a substance called polydimethylsiloxane. This is surrounded by a membrane (skin) also
made of polydimethylsiloxane.

What Levosert looks like and contents of the pack
-

Levosert consists of a small T-shaped frame made from a plastic called polyethylene. This
structure provides a device for releasing the hormone gradually into the uterus (womb).
There are two fine threads, made of polypropylene 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.

Each pack contains one Levosert.

8

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Manufacturer
Odyssea Pharma SA
Rue du Travail 16
4460 Grâce Hollogne
Belgium
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
This medicinal product is authorised in the Member States of the EEA under the following
names:
Levosert
Donasert

This leaflet was last revised in June 2017.

The following information is intended for medical or healthcare professionals only
See special instruction leaflet enclosed in the pack.

9

Instructions for use and handling
Levosert 20 micrograms/24 hours Intrauterine Delivery System
Levonorgestrel
The following information is intended for medical or healthcare professionals only

Prescriber Check List
Ask yourself the following questions before prescribing/inserting Levosert:
I have checked that the patient’s needs meet the indications of contraception or heavy menstrual
bleeding and for duration of use of up to three years?
I have completed the patient card included in the pack and given this to the patient as a reminder (any
insertions of more than three years in duration should be reported as off label use)?
Please read the following instructions for use carefully as there may be some difference in the type of
inserter device compared with other IUDs you have used previously:

10

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 strongly 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 which should not be opened until required for insertion.
The exposed product should be handled with aseptic precautions. 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 contraindications.
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.

11

Description

12

Preparation for insertion

Introduce the plunger and the IUD in the
insertion tube
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.

Position the lower edge of the flange at the
sounded 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.

13

Adjust the position of the IUD in the
insertion tube
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.

Insertion

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

14

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

Push the IUD against
the fundus
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.

15

Release the IUD from the tube into the
uterine cavity
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.

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.

16

IMPORTANT!
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:
Women’s Health Division of Gedeon Richter (UK) Ltd
Email: drugsafety.uk@gedeonrichter.eu
Phone: 0207 604 8806

17

Expand Transcript

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.

Hide