Benilexa

Package leaflet: Information for the user

Benilexa

20 micrograms/24 hours intrauterine delivery system
Levonorgestrel
Please 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 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.

Contents of this leaflet:

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

1. What Benilexa is and what it is used for

Benilexa is a hormonal intrauterine system (IUS) inserted into the uterus, where it slowly releases the hormone levonorgestrel.
It is indicated for:
Contraception
Benilexa is an effective, long-term and non-permanent (reversible) method of contraception. Benilexa prevents pregnancy by thinning the lining of your uterus, thickening the typical mucus in the initial part of the uterus (cervical canal) so that sperm cannot pass through to fertilize the egg, and in some women, by preventing the release of oocytes (ovulation). In addition, the presence of the T-shaped part of the device causes certain local effects on the uterine lining. Benilexa must be removed after 8 years of use when used for contraception.
Treatment of heavy menstrual bleeding
Benilexa is also useful in reducing blood flow during the menstrual cycle, and therefore can be used if you suffer from heavy menstrual bleeding (menstrual cycles). This condition is called menorrhagia. The hormone in Benilexa acts by thinning the lining of your uterus, thereby reducing monthly bleeding.
Benilexa must be removed or replaced after 8 years of use, or earlier if heavy or troublesome menstrual bleeding recurs.
Children and adolescents
Benilexa is not indicated for use before the first menstrual period (menarche).

2. What you need to know before using Benilexa

Before you can start using Benilexa, your doctor or nurse will ask you some questions to ensure that using Benilexa is suitable for you. This will include a pelvic examination and may also include other checks such as a breast examination, if your doctor or nurse considers it necessary.
Any genital infections must be successfully treated before Benilexa is inserted.
If you have epilepsy, inform the doctor or nurse who will insert Benilexa, as seizures, although rare, may occur during insertion. After the procedure, some women may feel faint. This is normal, and the doctor or nurse will advise you to rest for a while.

Not all women can use Benilexa.
Do not use Benilexa if:

• you are pregnant or suspect you may be pregnant;
• you have or have had pelvic inflammatory disease;
• you have unusual or unpleasant vaginal discharge or vaginal itching, which may indicate an infection;
• you have or have had an infection of the lining of the uterus after giving birth;
• you have or have had an infection of the uterus after childbirth or abortion within the last 3 months;
• you have or have had inflammation of the cervix (neck of the womb);
• you have or have had abnormal results on a Pap test (changes in the cervix);
• you have or have had liver problems;
• you have a liver tumour;
• you have an abnormal uterus, including uterine fibroids, especially those distorting the uterine cavity;
• you have abnormal vaginal bleeding;
• you have any condition that makes you more susceptible to infections. Your doctor will tell you if this applies to you;
• you have or have had a tumour whose growth is sensitive to hormones, such as breast cancer;
• you have or have had any type of tumour or suspected tumour, including blood cancer (leukemia), cancer of the uterus or cervix, unless you are in remission;
• you have or have had trophoblastic disease. Your doctor will tell you if this applies to you;
• you are allergic (hypersensitive) to levonorgestrel or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before using Benilexa, your doctor or nurse will ask you some questions to ensure that using Benilexa is suitable for you. This will include a pelvic examination and may also include other checks such as a breast examination, if your doctor or nurse considers it necessary.
Any genital infections must be successfully treated before Benilexa is inserted.
If you have epilepsy, inform the doctor or nurse who will insert Benilexa, as seizures, although rare, may occur during insertion. Some women may feel faint after the procedure. This is normal, and the doctor or nurse will advise you to rest.
Benilexa may not be suitable for all women.
Like other hormonal contraceptives, Benilexa does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs) such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, or syphilis. You should use a condom to protect yourself from these infections.
Benilexa must not be used as a post-coital (after unprotected sex) contraceptive.

Talk to your doctor before using Benilexa if you:

• have or develop migraines, dizziness, blurred vision, unusually severe headaches, or if you experience headaches more frequently than usual;
• have yellowing of the skin or whites of the eyes (jaundice);
• have diabetes (high blood sugar levels), high blood pressure, or abnormal blood fat levels;
• have had a blood cell tumour (including leukaemia) that is now in remission;
• are receiving long-term steroid therapy;
• have ever had an ectopic pregnancy (pregnancy outside the uterus) or a history of ovarian cysts;
• have or have had severe arterial disease, such as heart attack or stroke, or if you have had certain heart problems;
• have a history of blood clots (thrombosis);
• are taking other medicines, as some drugs may interfere with the proper functioning of Benilexa;
• have irregular bleeding;
• have seizures (epilepsy).
  If you have or have had any of the conditions listed above, your doctor will decide whether you can use Benilexa. You must also inform your doctor if any of these conditions occur for the first time while Benilexa is in place.

Expulsion
Uterine muscle contractions during menstruation may sometimes displace the device or cause its expulsion. This is more likely if you are overweight at the time of intrauterine system insertion or if you have a history of heavy menstrual bleeding. If the intrauterine system is misplaced, it may not work properly, increasing the risk of pregnancy. If the intrauterine system is expelled, protection against pregnancy is lost. Possible symptoms of expulsion include pain and abnormal bleeding, but Benilexa may also be expelled without you noticing. Since Benilexa reduces menstrual flow, an increase in bleeding may indicate expulsion. It is recommended to check the threads with your fingers, for example when showering. See also section 3 “How to use Benilexa – How can I tell if Benilexa is correctly inserted?” If you notice signs of expulsion or can no longer feel the threads, you should use another contraceptive method (e.g. a condom) and consult a healthcare professional.

Psychiatric disorders
Some women using hormonal contraceptives, including Benilexa, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts.
If you experience mood changes or depressive symptoms, consult your doctor as soon as possible for further medical advice.

Benilexa and smoking
Women are advised to stop smoking. Smoking increases the risk of heart attack, stroke, or blood clots.

Use of tampons and menstrual cups
The use of sanitary pads is recommended. If you use tampons or menstrual cups, you must change them carefully to avoid pulling on the Benilexa threads.

Other medicines and Benilexa
The effectiveness of hormonal contraceptives such as Benilexa may be reduced by medicines that increase the levels of liver enzymes. Inform your doctor if you are taking:

• phenobarbital, phenytoin, or carbamazepine (for treating epilepsy);
• griseofulvin (an antifungal);
• rifampicin or rifabutin (antibiotics);
• nevirapine or efavirenz (for HIV).

Inform your doctor if you are using, have recently used, or might use any other medicines. Benilexa must not be used at the same time as other hormonal contraceptive methods.

Pregnancy, breastfeeding and fertility

Benilexa must not be used during pregnancy or if you suspect you may be pregnant.

Can I become pregnant while using Benilexa?
It is very rare for women to become pregnant while Benilexa is in place.
The absence of menstruation is not necessarily a sign of pregnancy. Some women may not have periods while using the device.
If you have not had a period for 6 weeks, consider taking a pregnancy test. If the test is negative, there is no need to repeat it unless you develop other symptoms of pregnancy, such as nausea, fatigue, or breast tenderness.
If you become pregnant while Benilexa is in place, contact a healthcare professional immediately to have Benilexa removed. Removal may cause miscarriage. However, if Benilexa remains in place during pregnancy, not only is the risk of miscarriage higher, but there is also an increased risk of preterm delivery. If Benilexa cannot be removed, discuss with a healthcare professional the benefits and risks of continuing the pregnancy. If you continue the pregnancy, you will be closely monitored, and you must contact your doctor immediately if you experience cramping abdominal pain, stomach pain, or fever.

Benilexa contains a hormone called levonorgestrel, and isolated cases of effects on the genitals of female infants have been observed when exposed in utero to levonorgestrel-releasing intrauterine devices.

What should I do if I want to become pregnant?
If you wish to become pregnant, ask your doctor to remove Benilexa. Your normal fertility levels will tend to return very quickly once the device has been removed.

Can I breastfeed while using Benilexa?
Very small amounts of levonorgestrel, the hormone in Benilexa, have been found in breast milk, but levels are lower than those observed with other hormonal contraceptives. No risk has been observed for newborns. If you wish to breastfeed 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 machinery.

Benilexa contains barium sulfate
The T-shaped part of Benilexa contains barium sulfate to make it visible on X-rays.

3. How to use Benilexa

Only a doctor or nurse who is properly trained may insert the device (see the Instructions for Use and Handling enclosed in the package). They will explain to you the insertion procedure and the risks associated with its use. You will therefore be examined by a doctor or nurse before Benilexa is inserted. If you experience any problems during use, you must discuss them with your healthcare provider.

The device should be inserted during menstruation or within seven days of the start of menstruation. If you already have a device in place and it is time to replace it with a new one, it is not necessary to wait for menstruation.

If you have recently given birth, you must wait at least 6 weeks before Benilexa is inserted. Sometimes Benilexa may be inserted immediately after an abortion, provided you do not have genital infections.

How quickly does Benilexa work?
Contraception
As soon as the system is inserted, you are protected against pregnancy.

Treatment of heavy menstrual bleeding (menorrhagia)
Benilexa generally leads to lighter menstrual periods after 3–6 months of treatment.

How will Benilexa affect my menstrual cycle?
Many women experience spotting (light bleeding) for the first 3–6 months after insertion of the system. Others may have heavy or prolonged bleeding. However, you may experience an increase in vaginal bleeding, usually during the first 2–3 months, before a reduction in vaginal bleeding occurs. Overall, you are likely to have fewer days of menstrual bleeding each month, and eventually you may stop having periods altogether. This is due to the effect of the hormone (levonorgestrel) on the lining of the uterus. If after 3–6 months there is no significant reduction in vaginal bleeding, alternative treatments should be considered.

If you have used Benilexa for a prolonged period and then start experiencing vaginal bleeding problems, contact your doctor or healthcare provider for advice.

How often should I check the system?
You should generally check the system 6 weeks after insertion, again at 12 months, and thereafter once a year until it is removed.

How can I tell if Benilexa is correctly in place?
After each menstrual period, you may feel the two thin threads attached to the lower end of the system. Your doctor will show you how to do this.

Do not pull on the threads, as you might accidentally remove the device. If you cannot feel the threads, contact your doctor or nurse as soon as possible and, in the meantime, avoid sexual intercourse or use a barrier contraceptive (e.g. condoms). The threads may simply have retracted into the uterus or cervical canal.

If your doctor or nurse has difficulty locating the threads, they may have broken, or Benilexa may have been spontaneously expelled, or in rare cases may have perforated the wall of your uterus (uterine perforation, see section 4).

You should also see your doctor if you can feel the lower end of the device itself, or if you or your partner experience pain or discomfort during sexual intercourse.

What happens if the system is expelled spontaneously?
If the system is completely or partially expelled, you may not be protected against pregnancy. This is rare, but it could happen during a menstrual period without your knowledge. An unusual increase in menstrual bleeding may be a sign that this has occurred. Contact your doctor or healthcare provider if you notice unexpected changes in vaginal bleeding.

If you stop using Benilexa
Your doctor can remove the system at any time. Removal is very simple. Unless you plan to immediately insert a new system or intrauterine device, it is important to use another method of contraception during the week before removal. Sexual intercourse during this week may result in pregnancy after Benilexa has been removed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
With Benilexa, side effects are more common during the first few months after
insertion and decrease over time.
If you experience any of the following serious side effects, contact your doctor or nurse immediately:

• Severe pain or development of fever shortly after insertion may indicate a serious infection requiring immediate treatment. In rare cases, a very severe infection (sepsis) may occur.
• Severe pain and continuous bleeding could be a sign of damage or tearing of the uterine wall (perforation). Perforation is uncommon, but occurs more frequently during insertion of Benilexa, although it may not be detected until some time later. Benilexa placed outside the uterine cavity is not effective in preventing pregnancy and should be removed as soon as possible; very rarely, this may require surgical intervention. The risk of perforation is low, but is increased in women who are breastfeeding and in women who have given birth within 36 weeks prior to insertion, and may also be increased in women with a fixed and retroverted uterus (fixed retroverted uterus). If you suspect you have experienced perforation, seek immediate medical advice and remind the healthcare provider that you have Benilexa inserted, especially if it is not the person who inserted it. Possible signs and symptoms of perforation may include:
  • severe pain (like menstrual cramps) or more pain than expected
  • severe bleeding (after insertion)
  • pain or bleeding that continues for more than a few weeks
  • sudden changes in menstrual cycle
  • pain during sexual intercourse
  • you can no longer feel the threads of Benilexa (see section 3 "How to use Benilexa – How can I tell if Benilexa is correctly inserted?" in section 3).
• Lower abdominal pain, especially if you also have fever, missed a menstrual period, or have unexpected bleeding, as this could indicate an ectopic pregnancy (fetus developing outside the uterus). The absolute risk of ectopic pregnancy in users of Benilexa is low. However, when a woman becomes pregnant while Benilexa is in place, the relative likelihood of ectopic pregnancy is increased.
• Lower abdominal pain or experiencing pain or difficulty during sexual intercourse, as this could indicate ovarian cysts or pelvic inflammatory disease. This is important because pelvic infections can reduce the chance of having a child and may increase the risk of ectopic pregnancy.

Other side effects
Very common side effects (may affect more than 1 in 10 women) may include:

• absent, light, or infrequent menstrual periods (see "How will Benilexa affect my menstrual cycle?" in section 3);
• vaginal bleeding, including spotting;
• bacterial or fungal infections of the vagina and external genitalia (vulva);
• acne.

Common side effects (may affect up to 1 in 10 women) may include:

• depression, nervousness, or other mood changes;
• reduced sexual desire;
• headache;
• migraine;
• feeling faint (presyncope);
• dizziness;
• abdominal, pelvic, or back pain;
• abdominal discomfort;
• feeling unwell (nausea);
• bloated abdomen;
• vomiting;
• painful menstruation;
• increased vaginal discharge;
• tender and painful breasts;
• painful sexual intercourse;
• uterine spasm;
• spontaneous expulsion of Benilexa;
• weight gain.

Uncommon side effects (may affect up to 1 in 100 women) may include:

• genital infections that may cause: vaginal itching, pain when passing urine; or lower abdominal (stomach) pain due to inflammation of the uterus, ovaries, or fallopian tubes;
• fainting;
• eczema;
• inflammation of the cervix (cervicitis);
• swelling and numbness in the legs or ankles;
• increased growth of facial and body hair;
• hair loss;
• skin itching;
• changes in skin colour or increased skin pigmentation, especially on the face (chloasma).

Rare side effects (may affect up to 1 in 1,000 women) may include:

• skin rashes, itching.

The onset of severe pain or fever shortly after insertion may mean you have a serious infection that must be treated immediately. In rare cases, very severe infections (sepsis) may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Benilexa

Keep in the original packaging. Keep the pouch inside the outer packaging to
protect the medicine from light. Do not open the Benilexa package. Only the doctor or
healthcare professional should do so.
Keep this medicine out of the sight and reach of children.
Do not use this product after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Benilexa contains

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

Description of the appearance of Benilexa and contents of the
package

• Benilexa consists of a small T-shaped body made of a plastic called polyethylene. This structure allows for a device that releases the hormone gradually into the uterus.
• There are two thin threads, made of polypropylene and blue copper phthalocyanine, attached to the lower end of the structure. These allow for easy removal of the device and enable you and your doctor to check that the device is in place.

Pack sizes:
1 intrauterine system with insertion device.
5 intrauterine systems with insertion device.
Not all pack sizes may be marketed.

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 164460
Grâce Hollogne
Belgium
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria      Levosert
Cyprus        Levosert
Germany      Levosert
Denmark       Levosert
Spain         Levosert 0,02 mg cada 24 horas sistema de liberación intrauterino
Ireland        Levosert 52 mg Intrauterine Delivery System
Iceland        Levosert 20 míkrógrömm/24 klst. Leginnlegg
Italy           Benilexa
Malta          Levosert
Norway        Levosert
Sweden        Levosert
Slovenia       Levosert 20 mikrogramov/24 ur intrauterini dostavni sistem
United Kingdom Benilexa
(Northern Ireland)

The following information is intended for doctors or healthcare professionals only

See the special instructions leaflet included in the package.

Instructions for use and handling

Benilexa 20 micrograms/24 hours intrauterine system
Levonorgestrel

The following information is intended exclusively for physicians or healthcare professionals

Prescriber Checklist
Ask yourself the following questions before prescribing/inserting Benilexa:
Have I confirmed that the patient’s needs are consistent with the indications for contraception and heavy menstrual bleeding (menorrhagia), and for use for up to eight years?
Have I completed the patient card included in the package and provided it to the patient as a reminder (any insertion intended to last longer than eight years must be documented as off-label use)?
Read carefully the following instructions for use, as there may be differences in the insertion device compared to other intrauterine devices previously used.

Conditions for Use:

1. In women of reproductive age, Benilexa must be inserted within 7 days of the onset of menstruation. It may be replaced with a new system at any time during the cycle.
2. It is strongly recommended that Benilexa be inserted only by physicians/healthcare providers who have been adequately trained and who have carefully read these instructions prior to insertion.
3. Benilexa is supplied in a sterile package that must not be opened until the time of insertion. The product must be handled under aseptic conditions. Do not use if the inner packaging is damaged or opened.
4. Perform a gynecological examination to determine uterine position (anteversion, retroversion) and size. Exclude pregnancy and contraindications.
5. Insert a speculum and clean the vagina and cervix with a suitable antiseptic solution.
6. Use cervical dilators if cervical stenosis is diagnosed. Do not force passage against resistance. If cervical dilation is required, consider using analgesics and/or a paracervical block.
7. Stabilize the cervix with a tenaculum clamp and apply gentle traction to align the cervical canal with the uterine cavity.
8. Determine the depth of the uterine cavity by sounding. If uterine depth is < 5.5 cm, discontinue the procedure.

Description

a) reservoir containing levonorgestrel with membrane
b) horizontal arms
c) threads (strings)
d) protrusions
e) flange
f) graduated scale
g) thickened point
h) first marking
i) second marking
j) eyelet

Preparation for Insertion

Load the plunger and intrauterine system (IUS) into the insertion tube
Partially open the blister pack (approximately one-third from the bottom end) and insert the plunger into the insertion tube.
Release the threads from the flange. Pull the thread to load the intrauterine device into the tube. The arms of the IUS must lie horizontally, parallel to the flat side of the flange.

Position the lower edge of the flange at the measured sounding length
Position the blue flange so that its lower edge aligns with the length determined by sounding. The flat sides of the flange must always remain parallel to the arms. This ensures proper opening of the arms within the uterine cavity.

Adjust the position of the intrauterine device within the insertion tube.
While holding the plunger steady, pull the thread and move the tube to adjust the position of the IUS.
The protrusions on the lateral arms must be close together, opposite each other, slightly above the upper end of the insertion tube (see zoom 1), and the distal end of the tube must align with the first mark on the plunger (see zoom 2). If the tube is not aligned with the first mark on the plunger, pull the thread more firmly.

Insertion

Insert the device into the cervical canal until the blue flange contacts the cervix
Remove the entire device from the blister, firmly holding the plunger and tube in the correctly adjusted position.
Insert the assembly into the cervical canal until the blue flange is in contact with the cervix.

Release the arms of the intrauterine device
While holding the plunger steady, release the thread and pull the insertion tube until its lower end reaches the second mark on the plunger.

Advance the intrauterine device to the fundus
To position the IUS in the uterine cavity, simultaneously push the insertion tube and plunger until the blue flange is again in contact with the cervix.
Benilexa is now correctly placed in the uterine cavity.

Release the intrauterine device from the tube into the uterine cavity
Without moving the plunger, withdraw the insertion tube toward the plunger’s eyelet.
A slight resistance indicates passage of the plunger’s thickened point. Despite this, continue pulling the tube down toward the plunger’s eyelet.
Benilexa is then fully released from the insertion tube.

Remove the inserter components sequentially and trim the threads
Sequentially remove first the plunger, then the insertion tube.
Trim the threads to approximately 3 cm from the cervix.
Insertion of Benilexa is now complete.

Important considerations during or after insertion:

• If you suspect the IUS is not correctly positioned:
  • Confirm placement using ultrasound or another appropriate radiological method.
  • If incorrect placement is suspected, remove Benilexa. Do not reinsert the same Benilexa IUS after removal.

IMPORTANT!
In case of insertion difficulty and/or unusual pain or bleeding during or after insertion, a medical examination and ultrasound must be performed immediately to rule out uterine or cervical perforation. A clinical examination alone (including checking the threads) may not be sufficient to exclude partial perforation. If necessary, remove the system and insert a new sterile system.
Healthcare professionals are reminded to report all cases of uterine perforation or insertion difficulties through the national pharmacovigilance system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

How to remove Benilexa
Benilexa is removed by gently pulling the threads with forceps. Excessive force or use of sharp instruments during removal may cause device breakage. If the threads are not visible and the device is not visible within the uterine cavity, it may be removed using fine forceps or a specialized intrauterine thread retrieval tool. Cervical dilation may be necessary.

In women of reproductive age, if pregnancy is not desired, removal should be performed during menstruation, provided a menstrual period is occurring.
If the device is removed mid-cycle and the woman has had sexual intercourse during the week prior to removal, she is at risk of pregnancy. To ensure continuous contraceptive protection, a new device should be inserted immediately or an alternative contraceptive method must be used.

After removal of Benilexa, the device should be examined to confirm its integrity and complete removal. In isolated cases during difficult removals, it has been reported that the hormone-containing cylinder has slipped over the horizontal arms, concealing them inside. Once device integrity is confirmed, no further action is required. The protrusions on the horizontal arms usually prevent complete detachment of the cylinder from the T-body.

Package leaflet: Information for the user

Benilexa

20 micrograms/24 hours intrauterine delivery system
levonorgestrel
Please read 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 questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Benilexa is and what it is used for

Benilexa is a hormonal intrauterine system (IUS) inserted into the uterus, where it slowly releases the hormone levonorgestrel.
It is indicated for:
Contraception
Benilexa is an effective, long-term and non-permanent (reversible) method of contraception. Benilexa prevents pregnancy by thinning the lining of your uterus, thickening the typical mucus in the initial part of the uterus (cervical canal) so that sperm cannot pass through to fertilize an egg, and in some women, by preventing the release of eggs (ovulation). In addition, the presence of the T-shaped part of the device causes local effects on the uterine lining. Benilexa must be removed after 8 years of use when used for contraception.
Treatment of heavy menstrual bleeding
Benilexa is also useful in reducing blood flow during the menstrual cycle and can therefore be used if you suffer from heavy menstrual bleeding (menstrual cycles). This condition is called menorrhagia. The hormone in Benilexa acts by thinning the inner lining of the uterus, thereby reducing monthly bleeding.
Benilexa must be removed or replaced after 8 years of use, or earlier if heavy or troublesome menstrual bleeding recurs.
Children and adolescents
Benilexa is not indicated for use before the first menstruation (menarche).

2. What you should know before using Benilexa

Do not use Benilexa if:

• you are pregnant or suspect you may be pregnant;
• you have or have had pelvic inflammatory disease;
• you have unusual and unpleasant vaginal discharge or vaginal itching, which may indicate an infection;
• you have or have had an infection of the uterine lining after giving birth;
• you have or have had a uterine infection after childbirth or abortion within the last 3 months;
• you have or have had inflammation of the cervix (neck of the womb);
• you have or have had abnormal results on a Pap test (cervical changes);
• you have or have had liver problems;
• you have a liver tumour;
• you have an abnormal uterus, including uterine fibroids, especially those distorting the uterine cavity;
• you have abnormal vaginal bleeding;
• you have any condition that makes you more susceptible to infections. Your doctor will advise you if this applies to you;
• you have or have had a tumour whose growth is sensitive to hormones, such as breast cancer;
• you have or have had any type of tumour or suspected tumour, including blood cancer (leukaemia), uterine or cervical cancer, unless in remission;
• you have or have had trophoblastic disease. Your doctor will advise you if this applies to you;
• you are allergic (hypersensitive) to levonorgestrel or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before inserting Benilexa, your doctor or nurse will perform certain examinations to ensure that Benilexa is suitable for you. This will include a pelvic examination and may also include a breast examination, if your doctor or nurse considers it necessary.
Any genital infections must be successfully treated before Benilexa is inserted.
If you suffer from epilepsy, inform the doctor or nurse inserting Benilexa, as although rare, a seizure may occur during insertion. Some women may feel faint after the procedure. This is normal, and the doctor or nurse will advise you to rest.
Benilexa may not be suitable for all women.
Like other hormonal contraceptives, Benilexa does not protect against HIV (AIDS) infection or other sexually transmitted infections (STIs) such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, or syphilis. Benilexa must not be used as a post-coital (emergency) contraceptive (after unprotected sexual intercourse).

Talk to your doctor before using Benilexa if you:

• have or develop migraine, dizziness, blurred vision, unusually severe headaches, or experience headaches more frequently than usual;
• have yellowing of the skin or whites of the eyes (jaundice);
• have diabetes (high blood sugar levels), high blood pressure, or abnormal levels of fats in the blood;
• have had a blood cell tumour (including leukaemia) that is now in remission;
• are on long-term steroid therapy;
• have ever had an ectopic pregnancy (pregnancy developing outside the uterus) or a history of ovarian cysts;
• have or have had severe arterial disease, such as heart attack or stroke, or other heart problems;
• have a history of blood clots (thrombosis);
• are taking other medicines, as some drugs may interfere with the proper functioning of Benilexa;
• have irregular bleeding;
• have epileptic seizures (epilepsy).

If you have or have had any of the conditions listed above, your doctor will decide whether you can use Benilexa.
You must also inform your doctor if any of these conditions occur for the first time while Benilexa is in place.

Expulsion
Uterine muscle contractions during menstruation may sometimes displace the device or cause its expulsion. This is more likely if you are overweight at the time of intrauterine system insertion or if you have a history of heavy menstrual bleeding. If the intrauterine system is displaced, it may not work properly, increasing the risk of pregnancy. If the system is expelled, protection against pregnancy is lost. Possible signs of expulsion include pain and abnormal bleeding, but Benilexa may also be expelled without you noticing. Since Benilexa reduces menstrual flow, an increase in bleeding may indicate expulsion.
It is recommended to check the threads with your fingers, for example when showering. See also section 3 “How to use Benilexa – How can I tell if Benilexa is correctly inserted?”
If you notice signs suggesting expulsion or can no longer feel the threads, you should use another contraceptive method (e.g. a condom) and consult a healthcare professional.

Psychiatric disorders
Some women using hormonal contraceptives, including Benilexa, have reported depression or depressed mood. 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.

Benilexa and smoking
Women are advised to stop smoking. Smoking increases the risk of heart attack, stroke, or blood clots.

Use of tampons and menstrual cups
The use of sanitary pads is recommended. If you use tampons or menstrual cups, you must change them carefully to avoid pulling on the Benilexa threads.

Other medicines and Benilexa
The effectiveness of hormonal contraceptives such as Benilexa may be reduced by medicines that increase the levels of liver enzymes. Inform your doctor if you are taking:

• phenobarbital, phenytoin, or carbamazepine (for epilepsy);
• griseofulvin (an antifungal);
• rifampicin or rifabutin (antibiotics);
• nevirapine or efavirenz (for HIV).

Inform your doctor if you are currently using, have recently taken, or might take any other medicine. Benilexa must not be used at the same time as another hormonal contraceptive method.

Pregnancy, breastfeeding and fertility

Benilexa must not be used during pregnancy or if you suspect you are pregnant.

Can I become pregnant while using Benilexa?
It is very rare for women to become pregnant while Benilexa is in place.
The absence of menstruation is not necessarily a sign of pregnancy. Some women may not have periods while using the device.
If you have missed your period for 6 weeks, consider taking a pregnancy test. If the test is negative, there is no need to repeat it unless you develop other signs of pregnancy, such as nausea, fatigue, or breast tenderness.
If you become pregnant while Benilexa is in place, contact a healthcare professional immediately for removal of Benilexa. Removal may cause miscarriage. However, if Benilexa remains in place during pregnancy, not only is the risk of miscarriage higher, but there is also an increased risk of preterm delivery. If Benilexa cannot be removed, discuss with a healthcare professional the benefits and risks of continuing the pregnancy. If the pregnancy continues, you will be closely monitored, and you must contact your doctor immediately if you experience cramp-like abdominal pain, stomach pain, or fever.

Benilexa contains a hormone called levonorgestrel, and isolated cases of effects on the genitals of female infants have been observed when exposed in utero to levonorgestrel-releasing intrauterine devices.

What should I do if I want to become pregnant?
If you wish to become pregnant, ask your doctor to remove Benilexa. Your normal fertility levels will tend to return very quickly after removal of the device.

Can I breastfeed while using Benilexa?
Very small amounts of the hormone contained in Benilexa have been found in breast milk. No risk is expected for newborns/infants. Breastfeeding can be continued during use of Benilexa.

Driving and using machines
There are no known effects on the ability to drive or operate machinery.

Benilexa contains barium sulfate
The T-shaped part of Benilexa contains barium sulfate, making it visible on X-rays.

3. How to use Benilexa

Only a doctor or a properly trained nurse may insert the device (see the special instructions for insertion in the package).
They will explain to you the insertion procedure and the risks associated with its use. You will therefore be examined by a doctor or nurse before Benilexa is inserted. If you have any problems during use, you should discuss them with your healthcare provider.
The device should be inserted during menstruation or within seven days of the start of menstruation. If you already have a device in place and it is time to replace it with a new one, there is no need to wait for menstruation.
If you have recently given birth, you must wait at least 6 weeks before Benilexa is inserted. Sometimes Benilexa may be inserted immediately after an abortion, provided you do not have genital infections.

How quickly does Benilexa work?
Contraception
As soon as the system is inserted, you are protected against pregnancy.
Treatment of heavy menstrual bleeding (menorrhagia)
Benilexa generally leads to lighter menstrual periods after 3–6 months of treatment.

How will Benilexa affect my menstrual cycle?
Many women experience spotting (light bleeding) for the first 3–6 months after insertion of the system. Others may experience heavy or prolonged bleeding. However, you may experience an increase in vaginal bleeding, usually during the first 2–3 months, before vaginal bleeding decreases. Overall, you are likely to have fewer days of menstrual bleeding each month, and eventually you may stop having periods altogether. This is due to the effect of the hormone (levonorgestrel) on the lining of the uterus. If after 3–6 months there is no significant reduction in vaginal bleeding, contact your doctor or healthcare provider for advice.
If you have used Benilexa for a prolonged period and then start experiencing vaginal bleeding problems, contact your doctor or healthcare provider for advice.

How often should I check the system?
You should generally check the system 6 weeks after insertion, again at 12 months, and thereafter once a year until it is removed.

How can I tell if Benilexa is correctly in place?
After each menstruation, you may feel the two thin threads attached to the lower end of the system. Your doctor will show you how to do this.
Do not pull on the threads, as you might accidentally remove the device. If you cannot feel the threads, contact your doctor or nurse as soon as possible and, in the meantime, avoid sexual intercourse or use a barrier contraceptive (e.g., condoms). The threads may simply have retracted into the uterus or cervical canal.
If your doctor or nurse cannot locate the threads, they may have broken, or Benilexa may have been expelled spontaneously, or in rare cases may have perforated the wall of your uterus (uterine perforation, see section 4).
You should also see your doctor if you can feel the lower end of the device itself, or if you or your partner experience pain or discomfort during sexual intercourse.

What happens if the system is expelled spontaneously?
If the system is completely or partially expelled, you may no longer be protected against pregnancy. This is rare, but it may occur during menstruation without your noticing. An unusual increase in the amount of menstrual bleeding may be a sign that this has occurred. Contact your doctor or healthcare provider if you notice unexpected changes in vaginal bleeding.

If you stop using Benilexa
Your doctor can remove the system at any time. Removal is very simple. Unless you are planning to immediately insert a new system or intrauterine device, it is important to use another method of contraception during the week before removal. Sexual intercourse during this week may result in pregnancy after Benilexa has been removed.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
With Benilexa, side effects are more common during the first months after insertion and decrease over time.
If you experience any of the following serious side effects, contact your doctor or nurse immediately:

• Severe pain or development of fever shortly after insertion may mean you have a serious infection that needs immediate treatment. In rare cases, a very severe infection (sepsis) may occur.
• Severe pain and continuous bleeding could be a sign of injury or tearing of the uterine wall (perforation). Perforation is not common, but it occurs more often during insertion of Benilexa, although it may not be detected until some time later. Benilexa placed outside the uterine cavity is not effective in preventing pregnancy and should be removed as soon as possible; very rarely, this may require surgical intervention. The risk of perforation is low, but increases in women who are breastfeeding and in women who have given birth within 36 weeks prior to insertion, and may also increase in women with a fixed and backward-tilted uterus (fixed retroverted uterus). If you suspect you have experienced a perforation, seek immediate medical advice and remind the healthcare provider that you have Benilexa inserted, especially if it is not the same person who inserted it. 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 that continues for more than a few weeks
• sudden changes in your menstrual cycle
• pain during sexual intercourse
• you can no longer feel the threads of Benilexa (see "How can I tell if Benilexa is correctly inserted?" in section 3).
• Lower abdominal pain, especially if you also have fever, have missed a menstrual period, or have unexpected bleeding, as this could be a sign of ectopic pregnancy (fetus developing outside the uterus). The absolute risk of ectopic pregnancy in users of Benilexa is low. However, when a woman becomes pregnant while Benilexa is in place, the relative likelihood of ectopic pregnancy is increased.
• Lower abdominal pain or pain or difficulty during sexual intercourse, as this could be a sign of ovarian cysts or pelvic inflammatory disease. This is important because pelvic infections can reduce the chance of becoming pregnant and may increase the risk of ectopic pregnancy.

Other side effects
Very common (may affect more than 1 in 10 women) may include:

• Absent, light or infrequent menstrual periods (see “How will Benilexa affect my menstrual cycle?” in section 3),
• vaginal bleeding including spotting;
• bacterial or fungal infections of the vagina and external genitals (vulva);
• acne.
  Common (may affect up to 1 in 10 women) may include:
• depression, nervousness or other mood changes;
• reduced sexual desire;
• headache;
• migraine;
• feeling faint (presyncope);
• back pain;
• abdominal discomfort;
• feeling unwell (nausea);
• bloated abdomen;
• vomiting;
• painful menstruation;
• increased vaginal discharge;
• tender and painful breasts;
• uterine cramping;
• spontaneous expulsion of Benilexa;
• weight gain.
  Uncommon (may affect up to 1 in 100 women) may include:
• fainting;
• eczema;
• inflammation of the cervix (cervicitis);
• swelling or puffiness of the legs or ankles;
• increased growth of facial and body hair;
• hair loss;
• itchy skin (pruritus);
• changes in skin color or increased skin pigmentation, especially on the face (chloasma).
  Rare (may affect up to 1 in 1,000 women) may include:
• skin rashes, sensation of itching.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Benilexa

Store in the original packaging. This medicine does not require any special storage temperature. Keep the blister sealed within the outer packaging to protect the medicine from light. Do not open the Benilexa packaging—only the doctor or healthcare professional should do so.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Benilexa contains

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

Description of the appearance of Benilexa and package contents

• Benilexa consists of a small T-shaped body made of a plastic called polyethylene. This structure provides a device that gradually releases the hormone into the uterus.
• There are two thin threads made of polypropylene and copper phthalocyanine blue attached to the lower end of the structure. These allow for easy removal of the device and enable you or your doctor to check that the device is in place. Benilexa IUS with the insertion device is packaged in a thermoformed plastic tray (PETG) with a removable lid (TYVEK-polyethylene). The sterile trays are packed in a folding carton.

Pack sizes:
One Intrauterine System with insertion device.
Multipack containing five packs, each with one intrauterine system and insertion device.
Not all pack sizes may be marketed.

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 European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Levosert One
Cyprus Levosert One
Germany Levosert One
Denmark Levosert One
Spain LEVOSERT ONE 0,02 MG CADA 24 HORAS SISTEMA DE LIBERACION INTRAUTERINO
Ireland Levosert SHI
Iceland Levosertone
Italy Benilexa
Malta Levosert One
Norway Levosertone
Sweden Levosertone
Slovenia Levosert SHI 20 mikrogramov/ 24 ur intrauterini dostavni sistem
United Kingdom Benilexa One Handed
(Northern Ireland)

The following information is intended exclusively for doctors or healthcare professionals

Instructions for Use and Handling

Prescriber Checklist
Please ask yourself the following questions before prescribing/inserting Benilexa:
Have I confirmed that the patient's needs are consistent with the indications for
contraception or heavy menstrual bleeding (menorrhagia), and for use for up to eight years?
Have I completed the patient card included in the package and handed it to the
patient as a reminder?

Conditions for Use:

1. In women of fertile age, Benilexa should be inserted within 7 days of the onset of menstruation. It may be replaced with a new system at any time during the cycle.
2. It is strongly recommended that Benilexa be inserted only by physicians/healthcare providers who have been adequately trained and who have carefully read these instructions before inserting Benilexa.
3. Benilexa is supplied in a sterile package that must not be opened until the time of insertion. The product must be handled under aseptic conditions. Do not use if the inner package is damaged or opened.
4. Perform a gynecological examination to determine uterine position (anteversion, retroversion) and size. Exclude pregnancy and contraindications.
5. Insert a speculum and use an appropriate antiseptic solution to clean the vagina and cervix.
6. Use cervical dilators if cervical stenosis is diagnosed. Do not force passage against resistance. If cervical dilation is required, consider using analgesics and/or a paracervical block.
7. Stabilize the cervix with a Tenaculum clamp and apply gentle traction to align the cervical canal with the uterine cavity.
8. Determine the depth of the uterine cavity by sounding (uterine sounding). If uterine depth is < 5.5 cm, discontinue the procedure.

Description
Figure 1a: Benilexa Intrauterine System (IUS)

T-shaped plastic body
Hormone reservoir
Blue removal threads

Figure 1b: Benilexa Intrauterine System (IUS) with inserter

Benilexa IUS
Insertion tube
Slit
Flange
BLUE slider
GREEN slider
Handle
Threads

Figure 2: Inserter sliders

• Benilexa is partially preloaded within the inserter. The threads are passed through the insertion tube and exit through an opening in the handle at the slit.
• The inserter handle contains a BLUE slider marked with number 1, a GREEN slider marked with number 2, and the handle itself marked with number 3 to facilitate the insertion process.
  • Moving the sliders achieves the required positions to complete the insertion process.

Preparation for Insertion
Step 1: Open the sterile Benilexa package

• Remove the sealed tray containing Benilexa from the box.
• Inspect the sealed tray and do not use the product if the packaging, inserter, or IUS is damaged.
• Place the tray on a flat surface with the removable lid facing upwards.
• Remove the lid.

Step 2: Remove the inserter from the tray (Figure 3)
Figure 3

• To remove the inserter from the tray, grasp the handle below the sliders and gently rotate (Figure 3).
  NOTE: Do not attempt to remove the inserter by pulling on the tube.

Step 3: Move sliders fully forward to load Benilexa (Figure 4)
Figure 4

• The BLUE slider (marked with number 1) has a single marking line that will align with the single marking line on the handle.
• The GREEN slider (marked with number 2) has a double-line marking that will align with the double-line marking on the handle.
• Hold the handle, placing your thumb or finger in the groove of the BLUE slider (above number 1), and apply forward pressure, ensuring both sliders are fully advanced forward.

Step 4: Load Benilexa into the inserter:

• Ensure the IUS arms are horizontal (aligned with the horizontal plane of the handle and flange); adjust the rotation of the IUS as needed using the sterile flat surface of the tray.
• While maintaining forward pressure on the BLUE slider, gently pull the threads straight backward to load Benilexa into the insertion tube. Ensure even tension is applied to both threads during pulling. Pull the threads upward or downward to secure the threads into the slit at the bottom end of the handle (Figure 5). It is essential to secure the threads in the slit to prevent the IUS from shifting out of the top of the insertion tube. Once the threads are secured in the slit, stop holding the threads.

Figure 5: Securing the threads in the slit

• After loading the IUS, continue to maintain forward pressure on the BLUE slider to keep the IUS in the correct position.
• If correctly loaded, the IUS will be completely inside the insertion tube, with the arm tips forming a hemispherical dome at the top of the tube (Figure 6, Zoom 1).

Figure 6: Position of the IUS in the insertion tube
Zoom 1

The side arm knobs must be
closely opposed to each other,
slightly above the upper end of
the insertion tube (Zoom 1).
Zoom 2  If the IUS is not correctly loaded (Zoom

2), do not attempt insertion.

• To reload Benilexa:
• Pull the BLUE slider backward with your thumb until the groove aligns with the GREEN slider to release the IUS.
• Manually remove the threads from the slit.
• Return the BLUE slider to the forward position and repeat the loading steps.

Step 5: Adjusting the flange (Figure 7)
Figure 7

• Adjust the flange to the uterine depth measured by sounding. To adjust the flange, place the flat side of the flange against the notch in the tray (Figure 7) or against a sterile edge inside the tray. Slide the insertion tube as needed to move the flange to the correct measurement. Ensure the flat sides of the flange are in the same horizontal plane as the handle.

• If adjustment of the curvature of the insertion tube is needed to match the anatomical orientation of the uterus,
  the insertion tube may be bent or straightened. When bending the tube, avoid sharp bends to prevent kinking.

• Once the flange is correctly positioned, avoid contact between the flange and objects that could alter its position (e.g., tray, speculum, tenaculum, etc.).

Note: If at any stage contact with the flange or another sterile surface is necessary, sterile gloves must be used.
Step 6: Insertion of Benilexa into the uterus (Figure 8)
Figure 8

• Apply gentle traction on the

tenaculum and continue applying forward pressure on the BLUE slider while inserting the loaded insertion tube through the cervical os. Advance the tube until the upper edge of the flange is 1.5–2 cm from the external os (Figure 8). Maintain forward pressure on the BLUE slider throughout the insertion process.

• Do not advance the flange toward the cervix at this stage.
• Do not force the inserter. If necessary, dilate the cervical canal.

Step 7: Release and opening of the IUS arms
Figure 9

• Using your thumb or finger, gently slide only the BLUE slider backward until resistance is felt. The BLUE and GREEN sliders will merge together to form a common recess for the sliders. Do not move the BLUE slider further than necessary to create the recess. Keep the GREEN slider in place so that the double-line markings on the slider and the inserter handle remain aligned (Figure 9). This allows the IUS arms to open in the lower uterine segment. Do not pull the sliders further back, as this could cause premature release of the IUS in the wrong position.
  Wait 10–15 seconds to allow the IUS arms to fully open.

Figure 10: Moving Benilexa to the fundal position

• Without moving the sliders, advance the inserter until the flange touches the cervix. If resistance is encountered at the fundus, do not continue advancing. Benilexa is now in the fundal position (Figure 10).

Note: The fundal position is important to prevent expulsion.
Step 8: Release of Benilexa and completion of the procedure
Figure 11: Release of Benilexa from the inserter tube

• While holding the inserter steady and maintaining its position relative to the cervix, move both sliders (BLUE and GREEN) together, keeping the common slider recess facing downward toward number 3 on the handle (Figure 11), until a click is heard and the GREEN indicator on the bottom of the handle becomes visible (Figure 12).

Figure 12: Green indicator visible and threads released from the slit

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

Figure 13: Cut the threads to approximately 3 cm from the cervix

• Withdraw the inserter from the uterus.
• Use sharp scissors with blunt tips to cut the IUS threads perpendicularly to the thread length, leaving approximately 3 cm outside the cervix (Figure 13). Note: Do not cut the threads at an angle to avoid sharp ends. Do not apply tension or pull on the threads during cutting to avoid displacing the IUS.

Insertion of Benilexa is now complete.
Important considerations during or after insertion:

• If incorrect IUS placement is suspected:
  o Confirm placement with ultrasound or another appropriate radiological test.
  o If incorrect placement is suspected, remove Benilexa. Do not reinsert the same Benilexa IUS after removal.

IMPORTANT!
In case of insertion difficulty and/or unusual pain or bleeding during or after
insertion, a medical examination and ultrasound must be performed immediately to
exclude uterine body or cervical perforation. A clinical examination alone (including thread check) may not be sufficient to exclude partial perforation. If necessary, remove the system and insert a new sterile system.
Please report all cases of uterine perforation or insertion difficulties via the national pharmacovigilance system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

How to remove Benilexa
Benilexa is removed by gently pulling on the threads with a clamp. Excessive force or sharp instruments during removal may cause device breakage. If the threads are not visible and the device is located within the uterine cavity, it may be removed using a narrow tenaculum or an intrauterine thread retrieval device. This may require cervical canal dilation.
In women of fertile age, if pregnancy is not desired, device removal should be performed during menstruation, provided there is a menstrual cycle.
If the device is removed mid-cycle and the woman has had sexual intercourse during the week prior to removal, she is at risk of pregnancy. To ensure continuous contraceptive protection, a new device should be inserted immediately or an alternative contraceptive method should be used.
After removal of Benilexa, the device should be inspected to ensure it is intact and has been completely removed. In isolated cases during difficult removals, it has been reported that the hormone-containing cylinder has slipped over the horizontal arms, concealing them inside. Once device integrity is confirmed, no further action is required. The protrusions of the horizontal arms usually prevent complete detachment of the cylinder from the T-body.