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LEVOSERT 20 MICROGRAM/24 HOURS INTRAUTERINE DELIVERY SYSTEM

Active substance(s): LEVONORGESTREL

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Package leaflet: Information for the user

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.

–– 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.

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?
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.

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?

–– 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.

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
Can I breast feed while using Levosert?
first 2 to 3 months, before a reduction in blood loss is achieved. Overall you are likely to have fewer days
Uncommon (may affect up to 1 in 100 women) side effects can include:
Levosert should not be used as a post-coital contraceptive (after unprotected sexual intercourse).
Very small amounts of the hormone in Levosert are found in breast milk but the levels are lower than with any
bleeding in each month and you might eventually have no periods at all. This is due to the effect of the hormone –– genital infections that may cause: vaginal itching; pain on passing urine; or lower abdominal (tummy) pain
other hormonal contraceptive method. No risk for the new-born is to be expected. If you want to breast feed your (levonorgestrel) on the lining of the womb.
from inflammation of the womb, ovaries or Fallopian tubes;
Talk to your doctor before using Levosert if you:
baby, you should discuss this with your doctor.
–– migraine;
–– have or develop migraine, dizziness, blurred vision, unusually bad headaches or if you have headaches more
If you have had Levosert fitted for heavy menstrual bleeding:
–– bloated abdomen;
What is in this leaflet:
often than before
Driving and using machines
Levosert usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment. You may have –– eczema;
1. What Levosert is and what it is used for
–– have yellowing of the skin or whites of the eyes (jaundice)
There are no known effects on the ability to drive or use machines.
an increase in bleeding however, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. If a
–– inflammation of the neck of the womb (cervicitis);
2. What you need to know before you use Levosert
–– are diabetic (too high blood glucose level), have high blood pressure or abnormal blood lipid levels
significant reduction in blood loss is not achieved after 3 to 6 months, alternative treatments should be considered.
–– bloating or swelling of your legs or ankles;
3. How to use Levosert
–– have had cancer affecting your blood (including leukaemia) which is now in remission
Levosert contains barium sulphate.
–– increased growth of hair on the face and body;
4. Possible side effects
–– are on long term steroid therapy
If you have had Levosert fitted for quite a long time and then start to have bleeding problems, contact your
–– hair loss;
The T-frame of Levosert contains barium sulphate so that it can be seen on X-rays.
5. How to store Levosert
–– have ever had an ectopic pregnancy (development of the foetus outside the womb) or a history of ovarian
–– itchy skin (pruritus); or
doctor or healthcare provider for advice.
6. Contents of the pack and other information
cysts
–– skin discolouration or increased skin pigment, especially on the face (chloasma).
–– have had or have severe arterial disease, such as heart attack, or stroke
3. How to use Levosert
If you have any further questions on the use of this medicine, ask your doctor.
–– have a history of blood clots (thrombosis)
Rare (may affect up to 1 in 1000 women) side effects can include:
1. What Levosert is and what it is used for
–– are taking any other medicines as some medicines may stop Levosert from working properly
–– rashes, itching, or
Only a doctor or specially trained nurse can fit the system (see special instructions for insertion in the package). Moreover, see a doctor as soon as possible if you get:
–– have irregular bleedings
–– perforation of the wall of the uterus.
–– painful swelling in your leg
They will explain the fitting procedure and any risks associated with its usage. You will then be examined by
Levosert is an intrauterine delivery system (IUS) for insertion in the womb (uterus), where it slowly releases the hormone
–– have fits (epilepsy).
your doctor or nurse before Levosert is fitted. If you have any concerns over its usage you should discuss it with –– sudden chest pain
levonorgestrel.
Severe pain or fever developing shortly after insertion may mean that you have a severe infection which must be
them.
–– difficulty breathing
Your doctor will decide if you can use Levosert if you have or have had some of the above conditions.
Because these may be signs of a blood clot.
treated immediately. In rare cases very severe infection (sepsis) can occur.
It is used for:
During insertion procedure, a slight discomfort might be encountered. Inform your Doctor about any pain you
1. Contraception
You must also tell your doctor if any of these conditions occur for the first time whilst you have Levosert in place. feel.
Reporting of side effects
Levosert is an effective, long-term and reversible method of contraception. Levosert prevents pregnancy by
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
4. Possible side effects
thining the lining of your womb (uterus), by making the normal mucus in the opening of the womb (cervical
The following signs and symptoms could mean that you may have an extrauterine pregnancy (pregnancy The device should be inserted either during your period or within seven days from the beginning of your
leaflet. You can also report side effects directly via Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard. By
canal) thicker, so that the sperm cannot get through to fertilise the egg and by preventing the release of eggs
reporting side effects you can help provide more information on the safety of this medicine.
period. If you already have the device and it is time to replace it with a new one, you do not need to wait Like all medicines, this medicine can cause side effects, although not everybody gets them.
(ovulation) in some women. There are also local effects on the lining of the womb caused by the presence of the outside the uterus) and you should see your healthcare professional immediately (see also section
“Pregnancy, breast-feeding and fertility”):
until your period.
T-shaped frame.
If you have just had a baby, you should wait at least 6 weeks before having Levosert fitted. Levosert can
With Levosert, side effects are most common during the first months after the system is fitted and decrease as
•• Your menstrual periods have stopped and then you start having persistent bleeding or pain.
5. How to store Levosert
sometimes be fitted immediately after you have had an abortion, provided that you have no genital infections.
time goes on.
2. Treating heavy menstrual bleeding
•• You have pain in your lower abdomen that is severe or persistent.
Levosert is also useful for reducing menstrual blood flow, so it can be used if you suffer from heavy menstrual bleeding
If you suffer from fits (epilepsy), tell the doctor or nurse fitting the Levosert because, although rare, a seizure (fit) If you experience any of the following serious side effects please contact your doctor or nurse
Store in the original package. Keep the pouch in the outer carton in order to protect from light. Do not open the
(periods). This is called menorrhagia. The hormone in Levosert acts by thining the lining of your uterus, so that there is less •• You have normal signs of pregnancy, but you also have bleeding and feel dizzy.
•• You have a positive pregnancy test.
can occur during insertion.
immediately:
Levosert pack. Only your doctor or healthcare provider should do this.
bleeding every month.
Some women might feel faint after the device is fitted. This is normal and your doctor will tell you to rest for a
•• Severe pain or fever developing shortly after insertion may mean that you have a severe infection which This medicinal product does not require any special temperature storage conditions.
You must see a doctor or nurse as soon as possible if you develop painful swelling in your leg, sudden while.
must be treated immediately. In rare cases very severe infection (sepsis) can occur.
Levosert is used for contraception and heavy menstrual bleading over a period of 3 years or until it is
chest pain or difficulty in breathing as these may be a sign of a blood clot. It is important that any blood In very rare cases during fitting, part or all of the device could penetrate the wall of the womb. If this happens the
Keep this medicine out of the sight and reach of children.
removed.
clots are treated promptly.
device is removed.
•• 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
Do not use the system after the expiry date which is stated on the label and the outer pack after EXP. The expiry
Children and adolescents.
You must also see a doctor without delay if you develop persistent lower abdominal pain, fever, pain during
How quickly should Levosert work?
perforation may not be detected until sometime later. If this happens the Levosert will be removed; very rarely date refers to the last day of that month.
Levosert is not indicated for use before the first menstrual bleeding (menarche).
sexual intercourse or abnormal bleeding. If you get severe pain or fever shortly after Levosert has been inserted, Contraception:
this may require surgery. The risk of perforation is low, but is increased in breastfeeding women and in women
you may have a severe infection which must be treated immediately.
You are protected from pregnancy as soon as the system is fitted. The possibility of becoming pregnant is
who have had a baby up to 36 weeks before insertion.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
approximately 2 in 1,000 in the first year. The failure rate may increase in case of Levosert coming out by
Possible signs and symptoms of perforation may include:
medicines you no longer use. These measures will help protect the environment.
2. What you need to know before you use Levosert
You must see a doctor promptly if you no longer feel the threads in your vagina. This may be a sign of
itself or perforation.
–– severe pain (like menstrual cramps) or more pain than expected
expulsion. You can check by gently putting a finger into your vagina and feeling for the threads at the
–– heavy bleeding (after insertion)
Before you have Levosert fitted, your doctor or nurse will carry out some tests to make sure that Levosert is
Heavy menstrual bleeding:
–– pain or bleeding which continues for more than a few weeks
6. Contents of the pack and other information
suitable for you to use. This will include a pelvic examination and may also include other examinations such as a 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
Levosert usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment.
–– sudden changes in your periods
breast examination, if your doctor or nurse feels this is appropriate.
your healthcare professional has checked that the IUS is still in position.
–– pain during sex
What Levosert contains
How often should I have the system checked?
–– you can no longer feel the Levosert threads (see section 3 “How to use Levosert - How can I tell whether the system
Genital infections will need to be successully treated before you can have Levosert fitted.
Levosert and smoking
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 in place?”).
–– Levosert contains 52 mg of levonorgestrel, the active substance. The hormone is contained within
Women are advised to give up smoking. Smoking increases the risk of developing a heart attack, stroke, or blood clot. is removed.
a substance called polydimethylsiloxane. This is surrounded by a membrane (skin) also made of
If you have epilepsy, tell the doctor or nurse fitting Levosert because, although rare, a fit can occur during
•• Lower abdominal pain especially if you also have a fever or have missed a period or have unexpected polydimethylsiloxane.
insertion. Some women might feel faint after the procedure. This is normal and your doctor or nurse will tell you
Other medicines and Levosert
How can I tell whether the system is in place?
bleeding, as this might be a sign of ectopic pregnancy. The absolute risk of ectopic pregnancy in Levosert
to rest for a while.
The effect of hormonal contraceptives such as Levosert may be reduced by medicines that increase the
After each menstrual period, you can feel for the two thin threads attached to the lower end of the system. Your
users is low. However, when a woman becomes pregnant with Levosert in place, the relative likelihood of
What Levosert looks like and contents of the pack
amounts of enzymes made by the liver. Please tell your doctor or nurse if you are taking:
doctor will show you how to do this.
ectopic pregnancy is increased.
Not all women can use Levosert.
•• Phenobarbital, phenytoin or carbamazepine (to treat epilepsy)
Do not pull the threads because you may accidentally pull it out. If you cannot feel the threads, contact
–– Levosert consists of a small T-shaped frame made from a plastic called polyethylene. This structure provides a
•• Griseofulvin (an antifungal)
your doctor or nurse as soon as possible and in the meantime avoid intercourse or use a barrier
•• Lower abdominal pain or experience painful or difficult sex as this might be a sign of ovarian cysts or
device for releasing the hormone gradually into the uterus (womb).
Do not use Levosert if you:
•• Rifampicin or rifabutin (antibiotics)
contraceptive (such as condoms). The threads may have simply drawn up into the womb or cervical
pelvic inflammatory disease. This is important as pelvic infections can reduce your chances of having a baby –– There are two fine threads, made of polypropylene and copper phtalocyanine blue, attached to the
•• Nevirapine or efavirenz (for HIV).
canal. If the threads still cannot be found by your doctor or nurse, they may have broken off, or Levosert and can increase the risk of ectopic pregnancy.
bottom of the frame. These allow easy removal and allow you or your doctor to check that the device
–– are pregnant or suspect that you may be pregnant
may have come out by itself, or in rare cases it may have perforated the wall of your womb (uterine
is in place.
–– have or have had pelvic inflammatory disease
Tell your doctor if you are taking or have recently taken or might take any other medicines. Levosert should not perforation, see section 4).
Very common (affects more than 1 in 10 women) side effects can include:
–– have an unusual or unpleasant vaginal discharge, or vaginal itching, as this may indicate an infection
be taken simultaneously with another hormonal contraceptive method.
–– menstrual changes. You might experience spotting, shorter or longer periods, painful periods. Though Levosert usually Each pack contains one Levosert.
–– have or have had inflammation of the lining of your womb following delivery of your baby
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 achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment, you may have an increase in
–– have or have had an infection of the womb after delivery or after abortion during the past 3 months
Pregnancy, breast-feeding and fertility
or discomfort during sexual intercourse.
bleeding, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. Periods can totally disappear. If a Marketing Authorisation Holder and Manufacturer
–– have or have had inflammation of the cervix (neck of your womb)
Levosert should not be used during pregnancy or if you may suspect that you are pregnant
significant reduction in blood loss is not achieved after 3 to 6 months, alternative treatments should be considered.
–– have or have had an abnormal smear test (changes in the cervix)
What happens if the system comes out by itself?
–– ovarian cysts. They are fluid-filled sacs in the ovary.
Marketing Authorisation Holder
–– have or have had liver problems
Can I become pregnant whilst using Levosert?
If the system comes out either completely or partially, you may not be protected against pregnancy. It is rare but possible
Gedeon Richter Plc.
–– have an abnormal womb, including uterine fibroids, especially for those what distort the uterine cavity
It is very rare for women to become pregnant with Levosert in place.
for this to happen without you noticing during your menstrual period. An unusual increase in the amount of bleeding during Common (may affect up to 1 in 10 women) side effects can include:
Gyömrői út 19-21.
–– have an abnormal vaginal bleeding pattern
Missing a period may not mean that you are pregnant. Some women may not have periods whilst using the
your period might be a sign that this has happened. Tell your doctor or healthcare provider if there are any unexpected
–– depression, nervousness or other mood changes;
1103 Budapest
–– have any condition which makes you susceptible to infections. A doctor will have told you if you have this
system.
changes in your bleeding pattern.
–– reduced sex drive;
Hungary
–– have or have had hormone dependent cancer, such as breast cancer

LEVOSERT 0.02mg/24h

K-26224-1.1

UK

RG_198

v_01

Helvetica Neue LT Com (9 pt) [10,8 pt]

P 3155

2017.06.13.

UTAS-2

720 × 300/72 × 300 mm

PIL_Z_Fold_72x300_720x300

/Page1

2017.02.23.

Manufacturer
Odyssea Pharma SA
Rue du Travail 16
4460 Grâce Hollogne
Belgium

Description

Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

Adjust the position of the IUD in the insertion tube

Push the IUD against the fundus

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.

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.

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

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.
Insertion

See special instruction leaflet enclosed in the pack.
Instructions for use and handling

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

Preparation for insertion
Introduce the plunger and the IUD in the insertion tube

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:

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.

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.

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.

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)?

Release the arms of the intrauterine device

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:

Position the lower edge of the flange at the sounded
value

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.

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.

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

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.

K-26224-1.1, 00000000

LEVOSERT 0.02mg/24h

K-26224-1.1

UK

RG_198

v_01

Helvetica Neue LT Com (9 pt) [10,8 pt]

P 3155

2017.06.13.

UTAS-2

720 × 300/72 × 300 mm

PIL_Z_Fold_72x300_720x300

/Page2

2017.02.23.

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