Levosert easy

Package leaflet: Information for the user

Levosert Easy, 20 micrograms/24 h, intrauterine delivery system
Levonorgestrelum
Please read all of this leaflet carefully before 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 experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Levosert Easy is and what it is used for
2. Important information before using Levosert Easy
3. How to use Levosert Easy
4. Possible side effects
5. How to store Levosert Easy
6. Contents of the pack and other information

1. What Levosert Easy is and what it is used for

Levosert Easy is an intrauterine delivery system (IUS) designed to be placed in the uterine cavity, where it gradually releases a hormone called levonorgestrel.
It may be used in the following cases:

Contraceptive method
The Levosert Easy system is an effective, long-term and reversible (temporary) contraceptive method. The Levosert Easy system prevents pregnancy by inhibiting the growth of the endometrium (uterine lining), thickening cervical mucus (in the cervical canal), which prevents sperm from reaching the egg, and by suppressing ovulation in some women. There may also be a local effect on the endometrium due to the presence of the T-shaped intrauterine delivery system.

Treatment of heavy menstrual bleeding
The Levosert Easy system is also used to reduce the amount of menstrual blood loss and may be used in the treatment of heavy menstrual bleeding (periods), known as menorrhagia. The hormone contained in the Levosert Easy system suppresses the monthly development of the endometrium, resulting in lighter menstrual bleeding each month.

Levosert Easy is effective for 8 years for contraception (prevention of pregnancy) and for 5 years for the treatment of heavy menstrual bleeding. To ensure continued contraceptive protection, Levosert Easy must be removed before the end of the eighth year and immediately replaced with a new Levosert Easy system if continued use is required. If a new system is inserted immediately, no additional contraceptive protection is needed. For the indication of heavy menstrual bleeding, Levosert Easy should be replaced before the end of the fifth year. If symptoms have not returned by the end of the fifth year of use, continued use beyond five years may be considered. The system must be removed or replaced no later than after 8 years.

Children and adolescents
Levosert Easy is not indicated for use before the onset of first menstrual bleeding (menarche).

2. Important information before using Levosert Easy

Before insertion of the Levosert Easy system, your doctor or nurse may order several examinations to ensure that the Levosert Easy therapeutic system is suitable for you. This includes a pelvic examination, and possibly other tests such as a breast examination, if your doctor or nurse considers it appropriate.

Patients must be effectively treated for any genital infections before insertion of the Levosert Easy system.

Inform your doctor or nurse if you have epilepsy, as although rarely, a seizure may occur during insertion of the Levosert Easy system. Some women may feel faint after the insertion procedure. This is normal, and your doctor or nurse will advise you to rest for a while.

Not all women can use the intrauterine therapeutic system Levosert Easy.

Do not use the intrauterine therapeutic system Levosert Easy if you:

• are pregnant or suspect you may be pregnant;
• have current or past pelvic inflammatory disease;
• have unusual or unpleasant vaginal discharge or vaginal itching, which may indicate an infection;
• have current or past endometritis (infection of the uterine lining) after childbirth;
• have current or past uterine infections following childbirth or abortion within the last 3 months;
• have current or past cervicitis (inflammation of the cervix);
• have current or past abnormal Pap smear results (cervical cell changes);
• have current or past liver tumors or other acute or severe liver diseases;
• have uterine abnormalities, including fibroids, especially if they distort the uterine cavity;
• have irregular vaginal bleeding;
• have any condition that makes you more susceptible to infections. Your doctor will inform you if this applies to you;
• have current or past hormone-dependent tumors, such as breast cancer;
• have current or past any type of cancer or suspected cancer, including blood cancer (leukemia), cervical or endometrial cancer, unless you are in remission;
• have current or past trophoblastic disease. Your doctor will inform you if this applies to you;
• are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

The Levosert Easy system, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted infections (e.g. chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B virus, syphilis). Only the use of condoms can provide protection against these infections.

The Levosert Easy system must not be used as emergency contraception (after unprotected sexual intercourse).

Before starting to use the intrauterine therapeutic system Levosert Easy, discuss with your doctor if you:

• have migraines, dizziness, vision disturbances, unusually severe headaches, or headaches that have become more frequent;
• have jaundice (yellowing of the skin or whites of the eyes);
• have high blood pressure;
• have diabetes (high blood glucose levels) or abnormal blood lipid levels;
• have blood cancer (including leukemia) currently in remission;
• are on long-term steroid therapy;
• have ever had an ectopic pregnancy (pregnancy outside the uterus) or ovarian cysts;
• have current or past severe cardiovascular disease, such as heart attack or stroke, or have any heart problems;
• have had blood clots (thrombosis) in the past;
• are taking any other medicines, as some medicines may reduce the effectiveness of Levosert Easy;
• have irregular bleeding;
• have seizures (epilepsy).

If any of the above conditions are present or have occurred in the past, your doctor will decide whether Levosert Easy can be used.

If, while using Levosert Easy, you develop any of the conditions listed above for the first time, you should also inform your doctor.

The following symptoms may indicate an ectopic pregnancy (pregnancy developing outside the uterus), and in such cases, you should contact your doctor immediately (see also section "Pregnancy, breastfeeding and fertility"):

• Menstrual bleeding has stopped, followed by persistent bleeding or pain.
• You experience severe or persistent lower abdominal pain.
• You have typical signs of pregnancy but also experience bleeding and dizziness.
• A pregnancy test is positive.

If you experience painful leg swelling, sudden chest pain, or difficulty breathing, seek medical attention from your doctor or nurse as quickly as possible, as these may be symptoms of a blood clot. It is important that any blood clots are treated as soon as possible.

You should also contact your doctor immediately if you experience persistent lower abdominal pain, fever, pain during sexual intercourse, or abnormal bleeding. If you develop sudden severe pain or fever shortly after insertion of Levosert Easy, this may indicate a serious infection that requires immediate treatment.

Spontaneous expulsion

Uterine contractions during menstrual bleeding may sometimes cause displacement or expulsion of the system. This is more likely if the woman is overweight at the time of insertion or has had heavy menstrual bleeding in the past. If the system is not in the correct position, it may not work as intended, increasing the risk of pregnancy. Expulsion of the system results in loss of contraceptive protection.

Possible signs of expulsion include vaginal bleeding or lower abdominal pain, but the Levosert Easy system may also be expelled unnoticed. Since Levosert Easy reduces menstrual flow, an increase in bleeding may be a sign of expulsion or displacement.

It is recommended to check with your fingers (e.g. during bathing) whether the threads are in place. See also section 3 "How to use Levosert Easy – Self-checking the correct position of the Levosert Easy system". If symptoms suggest expulsion or if the threads cannot be felt at the cervical opening, use alternative contraceptive methods (such as condoms) and consult your doctor.

Psychiatric disorders

Some women using hormonal contraceptives, including Levosert Easy, have reported depression or mood changes. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.

Levosert Easy and smoking

Women should stop smoking. Smoking increases the risk of heart attack, stroke, or blood clots.

Use of tampons and menstrual cups

It is recommended to use sanitary pads. If you use tampons or menstrual cups, change them carefully to avoid pulling on the Levosert Easy threads.

Levosert Easy and other medicines

Because the mechanism of action of Levosert Easy is primarily local, taking other medicines should not increase the risk of pregnancy during use of Levosert Easy. However, you should inform your doctor about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines. This includes the following medicines:

• medicines used to treat epilepsy (such as lamotrigine, barbiturates, phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate)
• medicines used to treat tuberculosis (such as rifampicin, rifabutin)
• medicines used to treat HIV and hepatitis C virus infection (such as nevirapine, efavirenz, ritonavir, nelfinavir)
• medicines used to treat fungal infections (such as griseofulvin, itraconazole, ketoconazole)
• medicines used to treat bacterial infections (such as clarithromycin, erythromycin)
• medicines used to treat certain heart conditions and high blood pressure (such as verapamil, diltiazem)
• herbal products containing St John's wort (Hypericum perforatum)
• grapefruit juice

Levosert Easy should not be used simultaneously with other hormonal contraceptive methods.

Pregnancy, breastfeeding and fertility

Do not use Levosert Easy during pregnancy or if pregnancy is suspected.

Can you become pregnant while using Levosert Easy?

Pregnancy in women using Levosert Easy is very rare.

The absence of menstrual bleeding does not necessarily mean you are pregnant. Some women may not have periods while using an intrauterine system. If you miss your period for 6 weeks, consider taking a pregnancy test. If the result is negative, there is no need to repeat the test unless other symptoms of pregnancy occur, such as nausea, fatigue, or breast tenderness.

If you become pregnant with Levosert Easy in place, contact your doctor immediately for removal of the system. Removal may cause miscarriage. However, leaving the Levosert Easy in place during pregnancy may increase not only the risk of miscarriage but also the risk of premature delivery. If the Levosert Easy cannot be removed, discuss the benefits and risks of continuing the pregnancy with your doctor. If the pregnancy continues, it should be closely monitored by your doctor, and you should contact your doctor immediately if you experience abdominal cramps, abdominal pain, or fever.

Levosert Easy contains a hormone called levonorgestrel, and there have been isolated reports of effects on the genital organs of female infants exposed to levonorgestrel released from an intrauterine device remaining in the uterine cavity.

What should you do if you want to have a baby?

If you wish to become pregnant and have a child, ask your doctor to remove the Levosert Easy system. Fertility returns quickly after removal.

Can you breastfeed while using Levosert Easy?

Very small amounts of the hormone in Levosert Easy have been detected in breast milk, but at lower concentrations than with other hormonal contraceptive methods. There is no significant risk to the newborn. If you wish to breastfeed, discuss this with your doctor.

Driving and using machines

The effect on the ability to drive and use machines is unknown.

Levosert Easy contains barium sulfate.

The T-shaped frame of the Levosert Easy system contains barium sulfate and is therefore visible on X-ray imaging.

3. How to use Levosert Easy

The system must be inserted only by a doctor or a specially trained nurse (see:
special insertion instructions included in the package).
These healthcare professionals will explain the insertion procedure and any risks associated with its use.
Before insertion of the Levosert Easy system, the patient will be examined by a doctor or nurse.
If the patient has any concerns regarding the use of the system, she should discuss them with her
doctor or nurse.
During the insertion procedure, the patient may experience mild discomfort. Any pain felt should be reported
to the doctor.

Starting use of the Levosert Easy system

• Before inserting the Levosert Easy system, it must be confirmed that the patient is not pregnant.
• The Levosert Easy system should be inserted within 7 days of the onset of menstruation. When inserted during this period, the Levosert Easy will be effective immediately and will prevent pregnancy.
• If insertion of the Levosert Easy cannot be performed within 7 days after the start of menstruation, or if menstruation occurs at an unpredictable time, the Levosert Easy system may be inserted on any other day. In such cases, unprotected intercourse must be avoided since the last menstrual period, and a negative pregnancy test must be obtained before insertion. Additionally, the Levosert Easy may not provide immediate contraceptive protection. Therefore, a barrier method of contraception (e.g., condoms) must be used, or sexual intercourse should be avoided during the first 7 days after insertion of the Levosert Easy system.
• The Levosert Easy is not intended for use as emergency contraception (post-coital contraception).

Starting use of the Levosert Easy system after childbirth

• The Levosert Easy system may be inserted after childbirth once the uterus has returned to its normal size, but not earlier than 6 weeks after delivery (see section 4 "Possible side effects – Perforation").
• For further information on the timing of insertion, refer to the section "Starting use of Levosert Easy" above.

Starting use of the Levosert Easy system after miscarriage
The Levosert Easy system may be inserted immediately after a miscarriage if the pregnancy lasted less than 3
months, provided there are no genital tract infections. The Levosert Easy will then be effective immediately.
Replacing the Levosert Easy system
The Levosert Easy system may be replaced with a new Levosert Easy system at any time during the menstrual
cycle. The Levosert Easy will then be effective immediately.
Switching from another contraceptive method (such as combined hormonal contraceptives, implant)

• The Levosert Easy system may be inserted immediately if there is sufficient certainty that the patient is not pregnant.
• If more than 7 days have passed since the onset of menstrual bleeding, sexual intercourse should be avoided or an additional contraceptive method should be used for the following 7 days.

Insertion of the Levosert Easy system
Examination by a healthcare provider prior to insertion may include:

• Cervical smear test (Pap smear)
• Breast examination
• Other tests if necessary, e.g., for infections including sexually transmitted infections, and a pregnancy test. The healthcare provider will also perform a gynecological examination to determine the position and size of the uterus.

After the gynecological examination

• A speculum is inserted into the vagina, and the cervix may be cleaned with an antiseptic solution. The Levosert Easy system is then placed into the uterus using a thin, flexible plastic tube (insertion tube). Local anesthesia may be applied before inserting the tube into the cervix.
• Some women may experience dizziness or fainting during or after insertion or removal of the Levosert Easy system.
• Pain and bleeding may occur during or immediately after insertion.

After insertion of the Levosert Easy system, the patient should receive from the doctor a card reminding her of
follow-up examinations. This card should be brought to every scheduled visit.
After insertion of the Levosert Easy system, the patient should receive from the doctor a reminder card for
follow-up examinations. The patient should bring the reminder card to every scheduled follow-up visit.
How quickly does the Levosert Easy system start working?
Contraception
If the Levosert Easy system is inserted during menstruation or within 7 days of its onset, or if the patient already has a system in place and it is time to replace it with a new one, or if the patient has just had a miscarriage, protection against pregnancy is immediate upon insertion of the intrauterine system. The likelihood of pregnancy is approximately 2 cases per
1000 women during the first year of use. The failure rate may increase if spontaneous expulsion of the Levosert Easy system or perforation occurs.
Excessive menstrual bleeding
After insertion of the Levosert Easy system, menstrual bleeding usually decreases significantly within 3 to 6 months of therapy.
How often should the system be checked?
An examination of the Levosert Easy system should be performed 4 to 6 weeks after insertion,
and then regularly at least once a year, until the system is removed. The doctor may determine how often and what type of examinations are required in individual cases. The patient should bring
the reminder card she received from the doctor to every scheduled follow-up visit.
Additionally, the patient should contact her doctor if any of the symptoms described in section 2 "Warnings and precautions" occur.
Furthermore, the patient should contact her doctor as soon as possible if she experiences:

• Painful swelling of the leg,
• Sudden chest pain,
• Difficulty breathing, as these may be symptoms of thrombosis.

How can you tell if the system is in place?
After each menstrual period, a woman may check for the presence of two threads attached to the lower edge of the system. The doctor will show how to do this.
Do not pull on the threads, as this may accidentally remove the device. If the woman cannot feel the threads, she should see a doctor or nurse as soon as possible, and in the meantime should avoid sexual intercourse or use barrier contraception (such as condoms). The threads may have retracted into the uterus or cervix. If the threads are still not found by the doctor or nurse, they may have broken, or the Levosert Easy system may have been spontaneously expelled, or in rare cases may have perforated the uterine wall (uterine perforation, see section 4).
The patient should also see a doctor if she feels the lower edge of the device, or if she or her partner feel pain or discomfort during intercourse.
What happens if the system is spontaneously expelled?
If the system is completely or partially expelled, it will not provide protection against pregnancy.
Spontaneous expulsion rarely occurs during menstruation and may go unnoticed by the patient, but it is possible. A symptom may be an unusual increase in menstrual flow. The patient should inform her doctor or clinic staff if any unexpected changes in bleeding pattern occur.
Removal of the Levosert Easy system
The Levosert Easy system should be removed or replaced after 8 years of use for contraception and after 5 years of use in cases of heavy menstrual bleeding, or earlier if heavy or bothersome menstrual bleeding returns. If symptoms have not returned by the end of the fifth year of use, continued use beyond five years may be considered. The system must be removed or replaced within a maximum of 8 years.
The doctor can easily remove the system at any time, after which pregnancy is possible. Some women may experience dizziness or fainting during or after removal of the Levosert Easy system. Pain and bleeding may occur during removal of the Levosert Easy system.
Continuation of contraception after removal
If the patient does not plan to become pregnant, the Levosert Easy system should not be removed after the seventh day of the menstrual cycle (menstruation), unless the patient uses another contraceptive method (e.g., condoms) for at least 7 days before removal of the intrauterine system.
In cases of irregular or absent menstruation, barrier contraception should be used for 7 days before removal of the system.
A new Levosert Easy system may also be inserted immediately after removal of the previous one, in which case additional protection is not necessary. If the patient does not wish to continue with the same
method, she should consult her doctor for advice on other effective contraceptive methods.
How does the Levosert Easy system affect menstrual bleeding?
For all patients using the Levosert Easy system
In many women, spotting (small amounts of blood) occurs during the first 3–6 months after insertion. In some women, menstrual bleeding may be prolonged or heavier.
Patients may experience heavier bleeding, usually during the first 2 to 3 months, before blood loss decreases. The number of bleeding days may gradually decrease each month, and eventually menstruation may stop altogether. This is due to the effect of the hormone (levonorgestrel) on the endometrium.
If the patient has the Levosert Easy system inserted to reduce excessive menstrual bleeding
Levosert Easy usually significantly reduces the heaviness of menstrual bleeding within 3 to 6
months after starting treatment. However, before the bleeding volume decreases, bleeding may be heavier during the first 2 to 3 months of treatment. If there is no significant reduction in bleeding after 3 to 6
months, alternative treatment methods should be considered.
If the Levosert Easy system was inserted some time ago and bleeding disturbances have occurred since then, the patient should consult her doctor or other healthcare provider.
If the patient has any questions about the use of this medicine, she should consult her doctor.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
Adverse effects with the Levosert Easy system most commonly occur during the first months after
insertion and decrease over time.
If any of the following serious adverse effects occur,
you should contact your doctor or nurse immediately:

• Severe pain or fever occurring soon after insertion may indicate that a serious infection has developed, which requires immediate treatment. In rare cases, a very severe infection (sepsis) may occur.
• Severe pain and persistent bleeding, as these may be symptoms of injury or perforation of the uterine wall. Perforation is uncommon, but most often occurs during insertion of the Levosert Easy system, although it may not be diagnosed until some time later. A Levosert Easy system located outside the uterine cavity is not effective in preventing pregnancy and must be removed as quickly as possible; very rarely, surgery may be required. The risk of perforation is low, but increases in breastfeeding women and in women who have given birth within 36 weeks prior to insertion, and may also be increased in women with a persistently retroverted uterus (retroversion of the uterus). If a patient suspects uterine perforation, she should contact her doctor as soon as possible and inform them that she has a Levosert Easy system in place, particularly if this is not the doctor who performed the insertion. Possible subjective and objective symptoms of perforation may include:
• severe pain (resembling menstrual cramps) or pain more intense than expected,
• heavy bleeding (occurring after insertion),
• pain or bleeding lasting longer than a few weeks,
• sudden changes in menstrual pattern,
• pain during sexual intercourse,
• inability to feel the Levosert Easy system threads (see section 3 “How to use Levosert Easy – How to check if the system is in place?”).
• Pain in the lower abdomen, especially if the patient has fever or has not had menstrual bleeding or has experienced unexpected bleeding, as this may indicate an ectopic pregnancy. The overall risk of ectopic pregnancy in women using the Levosert Easy system is small. However, if a woman becomes pregnant while using the Levosert Easy system, the relative likelihood of ectopic pregnancy increases.
• Pain in the lower abdomen or pain or discomfort during sexual intercourse, as this may indicate an ovarian cyst or pelvic inflammatory disease. This is important because pelvic infections may reduce the chances of having a child and may increase the risk of ectopic pregnancy.

Very common (may occur in more than 1 in 10 women) adverse effects:

• changes in menstruation. Spotting, shorter or longer menstrual bleeding, or painful periods may occur. Although significant reduction in menstrual blood loss is observed within 3 to 6 months of using the Levosert Easy system, during the first 2 to 3 months menstrual bleeding may initially increase before blood loss decreases. Menstrual bleeding may cease completely. If there is no significant reduction in blood loss within 3 to 6 months, alternative treatments should be considered;
• ovarian cysts. These are fluid-filled sacs in the ovary;
• bacterial or fungal infections of the vagina or external genital organs (vulva);
• skin eruptions (acne);
• pain or bleeding during insertion.

Common (occurring in no more than 1 in 10 women) adverse effects:

• depression, nervousness, or other mood changes;
• decreased libido;
• headache;
• migraine;
• feeling of weakness (pre-syncope);
• dizziness;
• abdominal, pelvic, or back pain;
• abdominal discomfort;
• nausea;
• bloating;
• vomiting;
• painful menstruation;
• excessive vaginal mucus discharge;
• vulvovaginitis;
• breast tenderness, breast pain;
• pain during sexual intercourse;
• uterine cramps;
• spontaneous expulsion of the intrauterine Levosert Easy therapeutic system;
• weight gain.

Uncommon (occurring in no more than 1 in 100 women) adverse effects:

• genital tract infections, which may cause: vaginal itching, pain during urination, or lower abdominal pain (abdominal pain) associated with inflammation of the uterus, ovaries, or fallopian tubes;
• fainting;
• skin rash;
• cervical inflammation;
• swelling or edema of legs or ankles;
• increased growth of facial and body hair;
• hair loss;
• skin itching (pruritus);
• skin discoloration or increased pigmentation, especially on the face (chloasma);
• ectopic pregnancy;
• perforation (puncture) of the uterine wall (see above “serious adverse effects”).

Rare (occurring in no more than 1 in 1000 women) adverse effects:

• rash, itching.

Severe pain or fever occurring soon after insertion may indicate that a serious infection has developed, which must be treated immediately. In rare cases, a very severe infection (sepsis) may occur.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Levosert Easy

Store in the original packaging. There are no special requirements regarding storage temperature.
Keep the sealed tray inside the outer packaging to protect it from light. Keep the packaging tightly closed.
The sealed tray should only be opened by a doctor or clinic staff.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the label and outer packaging following „EXP”.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Levosert Easy contains

• The active substance in this medicine is 52 mg of levonorgestrel. The hormone is contained within a substance called polydimethylsiloxane (PDMS). This is surrounded by a membrane also made of polydimethylsiloxane (PDMS).

What Levosert Easy looks like and contents of the pack

• Levosert Easy consists of a small T-shaped frame made of LDPE containing 20–24% barium sulphate. This system design enables gradual release of the hormone into the uterine cavity.
• The system also includes two thin threads made of PE, coloured blue with copper phthalocyanine. The threads are attached to the lower part of the frame. They allow the doctor to easily remove the system and enable the doctor or patient to check whether the system is in the correct position.

Levosert Easy, intrauterine therapeutic system with insertion device, is packed in a thermoformed, transparent, plastic tray with a removable HDPE lid. The sterile tray is packaged in a cardboard box containing a patient information leaflet and a patient reminder card.
Pack sizes:
The pack contains one intrauterine therapeutic system.
The multipack contains 5 packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturers
Odyssea Pharma SRL
Rue du Travail 16
4460 Grâce-Hollogne
Belgium
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

For further information about this medicinal product, please contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel. +48 (22) 755 96 48
[email protected]

This medicinal product is authorised in the European Economic Area under the following names:
Hungary: Levosert Single-Handed Inserter
Bulgaria: Донасертон 20 микрограма/24 часа вътрематочна лекарстводоставяща система / Donasertone 20 micrograms/24 hours Intrauterine Delivery System
Czech Republic: Levosert SHI
Latvia: Levosert SHI 20 mikrogramu/24 stundās intrauterīna sistēma
Lithuania: Levosert Single-Handed Inserter 20 mikrogramų/24 valandų vartojimo į gimdos ertmę sistema
Poland: Levosert Easy
Romania: Donasertone 20 micrograme/24 ore sistem cu cedare intrauterină
Slovakia: Levosert SHI

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The following information is intended exclusively for healthcare professionals

See: special instructions included in the package
Instructions for use and storage
Levosert Easy 20 micrograms/24 hours intrauterine system
Levonorgestrelum
Prescriber checklist
Before prescribing and (or) inserting the Levosert Easy system, ensure that:

• The patient meets all indications for contraception or has heavy menstrual bleeding, and also meets the criteria regarding duration of treatment, which is eight or five years.
• The patient card included in the package has been completed and handed to the patient (any case of using the device for longer than eight years for contraception and (or) for treatment of heavy menstrual bleeding should be reported as off-label use).

Instructions for insertion of the system
Please carefully read the following instructions, as there may be differences related to the type of system compared to other previously used intrauterine devices:
For insertion by healthcare personnel using an aseptic technique.
It is recommended that the Levosert Easy system be inserted only by healthcare professionals experienced in inserting intrauterine systems (IUS) and (or) who have undergone appropriate training in the insertion of the Levosert Easy system and have thoroughly familiarized themselves with this instruction prior to insertion.

The Levosert Easy system is supplied in a sterile package, which should not be opened until the time of use. Do not re-sterilize. The system may be used only once. The unpacked system should be inserted under aseptic conditions. If the sterile package is damaged, the system must be discarded (see section 6.6 of the Summary of Product Characteristics). Do not use if the inner packaging is damaged or open. Do not use after the expiry date stated on the cardboard box and tray after EXP. The expiry date refers to the last day of the stated month.

Further information regarding the timing of insertion can be found in the Summary of Product Characteristics, section 4.2.

The Levosert Easy system is supplied with a reminder card for follow-up examinations for the patient, contained in the outer packaging. The reminder card for the patient should be completed and handed to the patient after insertion of the system.

Preparation for insertion of the system

• Examine the patient to exclude contraindications to insertion of the Levosert Easy system (see section 4.3 and section 4.4 in the section titled "Medical examination").
• Insert a speculum, visualize the cervix, and thoroughly clean the cervix and vagina with an appropriate antiseptic solution.
• If necessary, assistance from a nurse or assistant may be used.
• Grasp the anterior lip of the cervix with a tenaculum or other forceps to stabilize the uterus. If the uterus is retroverted, grasping the posterior lip of the cervix may be more appropriate. Gently pull the cervix with forceps to straighten the cervical canal. The forceps should remain in place, and gentle traction on the cervix should be maintained throughout the insertion procedure.
• Insert a sound through the cervical canal to the fundus of the uterus to measure uterine depth. If uterine depth is < 5.5 cm, discontinue insertion. Confirm correct uterine cavity position and exclude any signs of intrauterine abnormalities (e.g. septum, submucosal fibroids) or a previously inserted intrauterine contraceptive device that has not been removed. If difficulties are encountered, consider cervical dilation. If cervical dilation is necessary, consider using analgesics and (or) cervical block.

Description
Figure 1a: Intrauterine system Levosert Easy

T-shaped plastic frame
Hormone-containing reservoir with membrane
Blue removal threads

Figure 1b: Intrauterine system Levosert Easy with applicator
Intrauterine system Levosert Easy

Insertion tube
Stopper ring
BLUE slider
GREEN slider
Handle
Slit
Threads
The intrauterine system Levosert Easy is partially loaded into the applicator. The threads pass through the insertion tube and exit through the slit opening in the handle.
The applicator handle contains a BLUE slider marked number 1 and a GREEN slider marked number 2. The handle is marked number 3. The sliders are marked 1 and 2, and the handle is marked 3 to assist in the insertion process (Figure 2).
Moving the sliders allows achieving the position required to complete the insertion process.

Figure 2: Applicator sliders

NUMBER 1
NUMBER 2

• The applicator handle contains a BLUE slider marked number 1 and a GREEN slider marked number 2 to assist in the insertion process.
• Moving the sliders allows achieving the position required to complete the insertion process.

Preparation for insertion of the system
Open the sterile package of the Levosert Easy system

• Remove the sealed inner package containing the Levosert Easy system from the box.
• Check the integrity of the inner package; if the inner package, applicator, or intrauterine system is damaged, do not use the product.
• Place the inner package on a flat surface with the peelable lid facing upwards.
• Remove the lid.

Loading the Levosert Easy system into the applicator

• To remove the applicator from the inner package, grasp the handle below the sliders and gently twist (Figure 3).
• WARNING: Do not remove the applicator by pulling on the insertion tube.

Figure 3: Removing the applicator from the inner package

Ensure that both sliders (marked 1 and 2) are fully advanced forward (Figure 4):
Figure 4: Sliders fully advanced forward, ready for loading Levosert Easy.

NUMBER 1
NUMBER 2

• The BLUE slider (marked number 1) has a single line mark that aligns with the single line mark on the handle.
• The GREEN slider (marked number 2) has a double line mark that aligns with the double line mark on the handle.
• Hold the handle, placing your thumb or finger in the depression of the BLUE slider (above number 1) and push forward, ensuring that both sliders are fully advanced forward.

Loading the Levosert Easy system into the applicator:

• Ensure that the arms of the intrauterine system are in a horizontal position (aligned with the horizontal plane of the handle and stopper ring); if necessary, adjust the rotation of the intrauterine system using the flat, sterile surface of the inner package.
• While maintaining forward pressure on the BLUE slider, gently pull the threads straight backward to load the Levosert Easy system into the insertion tube. Ensure that both threads are evenly tensioned during pulling, and pull them upward or downward to lock the threads into the slit at the bottom of the handle (Figure 5); lock the threads in the slit to prevent the intrauterine system from protruding from the upper part of the insertion tube. Once the threads are locked in the slit, release the threads.

Figure 5: Locking the threads in the slit

• After loading the intrauterine system, maintain forward pressure on the BLUE slider to keep the hemispherical bulge formed by the ends of the intrauterine system arms.
• After proper loading, the intrauterine system is completely inside the insertion tube, and the ends of the arms form a hemispherical bulge at the top of the tube (Figure 6).

Figure 6: Close-up of the hemispherical bulge at the end of the tube.

• If the intrauterine system is not properly loaded, do not attempt insertion.
• To reload the Levosert Easy system:
• Pull the BLUE slider backward with your thumb until the depression aligns with the GREEN slider to release the intrauterine system.
• Manually pull the threads out of the slit.
• Push the BLUE slider forward and repeat the loading procedure.
• Adjust the stopper ring to the measured uterine depth based on sounding. To adjust the stopper ring, place the flat side of the ring into the cut-out of the inner package (Figure 7) or against a sterile edge inside the package. If necessary, slide the insertion tube to move the stopper ring to the correct position. Ensure that the flat sides of the stopper ring are in the same horizontal plane as the handle. If at

any stage it is necessary to touch the stopper ring or other sterile surface,
sterile gloves should be used.
Figure 7: Adjusting the stopper ring

Cut-out in the inner
package

• If curvature correction of the insertion tube is necessary to adapt to the anatomical position of the uterus, the insertion tube may be bent or straightened without touching it above the stopper ring, unless sterile gloves are used. When bending the tube, avoid sharp bends to prevent kinking.
• After proper adjustment of the stopper ring, avoid contact between the stopper ring and objects that may change its position (e.g. inner packaging, speculum, forceps, etc.).

Insertion of the Levosert Easy system into the uterine cavity

• Gently pull the forceps and continue applying forward pressure on the BLUE slider while inserting the loaded insertion tube through the cervical os. Slide the tube until the upper edge of the stopper ring is 1.5–2 cm from the external cervical os (Figure 8). Maintain forward pressure on the BLUE slider throughout the insertion process.
• At this point, the stopper ring must not be moved toward the cervix.
• Do not use force with the applicator. If necessary, dilate the cervical canal.

Figure 8: Sliding the insertion tube until the stopper ring is 1.5 to 2 cm from the cervical os

• Using the thumb or finger, gently move only the BLUE slider backward. Initially, slight resistance will be felt before moving the BLUE slider from its starting position. Continue moving the BLUE slider backward until slight resistance is again felt, as the BLUE and GREEN sliders will join, forming a common depression. Do not move the BLUE slider further than necessary to create the depression. Hold the GREEN slider steady so that the double line marks on the slider and handle remain aligned (Figure 9). This will allow the arms of the intrauterine system to open in the lower part of the uterus. Do not move the sliders further, as this may cause premature release of the intrauterine system in an incorrect location.

Figure 9: Releasing and opening the arms of the intrauterine system

• Wait 10–15 seconds to allow full opening of the arms of the intrauterine system.
• Without moving the sliders, advance the applicator until the stopper ring touches the cervix. If

resistance is encountered, do not continue advancing. The Levosert Easy system is now in the correct position (Figure 10).

• Note: Proper positioning of the system within the uterine cavity is essential to prevent expulsion.

Figure 10: Advancing the Levosert Easy system to the fundus of the uterus

Releasing the Levosert Easy system and completing the insertion procedure

• Holding the applicator stationary, maintaining its position relative to the cervix, move both sliders (BLUE and GREEN) downward together, keeping the common slider depression directed toward number 3 on the handle (Figure 11), until a click is heard and the GREEN indicator at the bottom of the handle becomes visible (Figure 12).

Figure 11: Releasing the Levosert Easy system from the insertion tube

• Look at the slit to ensure that the threads have been properly released (Figure 12); if they have not been released or if no click was heard, grasp the threads and gently pull them out of the slit.

Figure 12: Visible green indicator and threads released from the slit

• Remove the applicator from the uterine cavity.
• Using blunt-tipped scissors, cut the intrauterine threads perpendicularly to their orientation, leaving approximately 3 cm outside the cervix (Figure 13). Note: Do not cut the threads at an angle, as this may leave sharp ends.
• During cutting, do not pull or tension the threads to avoid displacing the intrauterine system.

Figure 13: Cutting the threads approximately 3 cm from the cervix

The insertion process of the intrauterine system Levosert Easy is complete.
Important considerations during or after insertion:

• If there is suspicion that the intrauterine system is not in the correct position:
• Check the position using ultrasound or another appropriate radiological test.
• If incorrect positioning is suspected, the Levosert Easy intrauterine system should be removed. Do not reinsert the same Levosert Easy intrauterine system after removal.

IMPORTANT!
In case of difficulty during insertion and (or) severe pain or bleeding during or after insertion, consider the possibility of perforation and take appropriate steps, such as physical examination and ultrasonography. If necessary, remove the system and insert a new, sterile one.
After insertion, patients should be re-examined after 4 to 6 weeks to check the threads and confirm that the system is in the correct position. Physical examination alone (including thread check) may not be sufficient to exclude partial perforation.
All cases of uterine perforation or difficulty with insertion must be reported via the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Removal/replacement
To remove the Levosert Easy system, gently pull on the threads with forceps. If the threads are not visible, but the system is detected in the uterine cavity during ultrasound examination, narrow forceps may be used. This method may require cervical dilation or surgical intervention. After removal of the Levosert Easy system, check whether the system has been damaged.
During particularly difficult removal procedures, isolated cases have been reported of the hormone-containing cylinder moving above the horizontal arms and becoming hidden together inside the cylinder. This situation does not require further intervention, provided the intrauterine system (IUS) remains intact. The bulges of the horizontal arms usually prevent complete detachment of the cylinder from the T-shaped frame.