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Luadei

Package leaflet: Information for the user


Luadei 13.5 mg intrauterine delivery system


levonorgestrel


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This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects, you may get. See the end of section 4 for how to report side effects.


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What is in this leaflet:

1. What Luadei is and what it is used for

2. What you need to know before you use Luadei

3. How to use Luadei

4. Possible side effects

How to store Luadei

6. Contents of the pack and other information


What Luadei is and what it is used for


Luadei is used for the prevention of pregnancy (contraception) for up to three years.

Luadei is a T‑shaped intrauterine delivery system (IUS) which after placement inside the womb slowly releases a small amount of the hormone levonorgestrel.

Luadei works by reducing the monthly growth of the lining of the womb and thickening the cervical mucus. These actions prevent the sperm and egg from coming into contact and so prevent fertilization of an egg by sperm.

What you need to know before you use Luadei


General notes

Before you can begin using Luadei, your healthcare professional will ask you some questions about your personal health history.


In this leaflet, several situations are described where Luadei should be removed, or where the reliability of Luadei may be decreased. In such situations you should either not have sex or you should use a condom or another barrier method.


Luadei, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.


Luadei is not suitable for use as an emergencycontraceptive (postcoital contraceptive).


Do NOT use Luadei if you:

are pregnant (see section “Pregnancy, breast-feeding and fertility”)

- currently have a pelvic inflammatory disease (PID; infection of the female reproduction organs) or have had this condition multiple times in the past.

- have conditions associated with increased susceptibility to pelvic infections

- have an infection in the lower genital tract (an infection in the vagina or the cervix [neck of the womb])

- have had an infection of the womb after delivery of a child, after an abortion or after miscarriage during the past 3 months

- currently have cell abnormalities in the cervix

- have cancer or suspected cancer of the cervix or womb

- have tumours which are sensitive to progestogen hormones to grow, e.g, breast cancer

- have unexplained vaginal bleeding

- have an abnormality of the cervix or womb including fibroids that distort the cavity of the womb

- have an active liver disease or liver tumour

- are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).


Warnings and precautions


Talk to your healthcare professional before using Luadei if you


In addition, also talk to your healthcare professional if any of the following conditions exist before you use Luadei or appear for the first time while using Luadei:


- migraine, with visual disturbances or other symptoms which may be signs of a transient cerebral ischemia (temporary blockage of the blood supply to the brain)

- exceptionally severe headache

- jaundice (a yellowing of the skin, whites of the eyes and/or nails)

- marked increase of blood pressure

- severe disease of the arteries such as stroke or heart attack.


The following signs and symptoms could mean that you may have an extrauterine pregnancy and you should see your healthcare professional immediately (see also section “Pregnancy, breast-feeding and fertility”):


Contact your healthcare professional promptly if any of the following occur (see also section 4):

- severe pain (like menstrual cramps) or heavy bleeding after placement or if you have pain/bleeding which continues for more than a few weeks. This may be for example a sign of infection, perforation or that Luadei is not in the correct position.

- you no longer feel the threads in your vagina . This may be a sign of expulsion or perforation. You can check by gently putting a finger into your vagina and feeling for the threads at the end of your vagina near the opening of your womb (cervix). Do not pull the threads because you may accidentally pull out Luadei.Avoid intercourse or use a barrier contraceptive (such as condoms) until your healthcare professional has checked that the IUS is still in position.

- you or your partner can feel the lower end of Luadei. Avoid intercourse until your healthcare professional has checked that the IUS is still in position.

- your partner feels the removal threads during intercourse.

- you think you may be pregnant

- you have persistent abdominal pain, fever, or unusual discharge from the vagina, which may be a sign of infection. Infections must be treated immediately.

- you feel pain or discomfort during sexual intercourse, which may be for example a sign of infection, ovarian cyst or that Luadei is not in the correct position.

- there are sudden changes in your menstrual periods (for example, if you have little or no menstrual bleeding, and then you start having persistent bleeding or pain, or you start bleeding heavily), which may be a sign of Luadei not being in the correct position or expelled.


Use of sanitary pads is recommended. If tampons are used, you should change them with care so as not to pull the threads of Luadei.


Children and adolescents


Luadei is not indicated for use before the first menstrual bleeding (menarche).


Other medicines and Luadei


Tell your healthcare professional if you are taking, have recently taken or might take any other medicines.


Pregnancy, breast-feeding and fertility


Pregnancy

Luadei must not be used during pregnancy.


Some women may not have their periods while using Luadei. Not having a period is not necessarily a sign of pregnancy. If you do not have your period and have other symptoms of pregnancy you should see your healthcare professional for an examination and have a pregnancy test.


If you have not had a period for six weeks and are concerned, then consider having a pregnancy test. If this is negative, there is no need to carry out another test unless you have other signs of pregnancy.


If you become pregnant with Luadei in place, you should see your healthcare professional immediately to have Luadei removed. There is a risk of spontaneous miscarriage if Luadei is removed during pregnancy.


If you leave Luadei in place during pregnancy, the risk of having a miscarriage, infection or preterm labour will be increased. Talk with your healthcare professional about the risks of continuing the pregnancy.


If you want to become pregnant you should contact your healthcare professional to have Luadei removed.


Extrauterine pregnancy
(pregnancy outside the womb)

It is uncommon to become pregnant while using Luadei. However, if you become pregnant while using Luadei, the risk that the pregnancy could develop outside the womb (have an extrauterine or ectopic pregnancy) is increased. Women who have already had an extrauterine pregnancy, surgery of the fallopian tubes or a pelvic infection carry a higher risk for this type of pregnancy. An extrauterine pregnancy is a serious condition which calls for immediate medical attention (see section 2, “Warnings and precautions for signs and symptoms) and may impact future fertility.



Breast-feeding

You can use Luadei during breast-feeding. Levonorgestrel (the active ingredient in Luadei) has been identified in small quantities in the breast milk of breast-feeding women. However, no negative effects have been seen on infant growth and development or the amount or the quality of the breast milk.


Fertility

Your usual level of fertility will return after Luadei is removed.


Driving and using machines


Luadei has no influence on the ability to drive or use machines.


How to use Luadei


Placement of Luadei


Luadei can either be placed:


Examination by your healthcare professional before placement may include:


After a gynaecological examination:


Follow-upexamination:

You should have your Luadei checked 4-6 weeks after placement, and thereafter regularly, at least once a year. Your doctor may determine how often and what kinds of check-ups are required in your particular case.


Removal of Luadei


Luadei should be removed no later than the end of the third year of use.

Luadei can be easily removed at any time by your healthcare professional, after which pregnancy is possible. Some women feel dizzy or faint during or after Luadei is removed. You may experience some pain and bleeding during removal of Luadei.

If pregnancy is not desired, Luadei should not be removed after the seventh day of the menstrual cycle (monthly period) unless you use other methods of contraception (e.g. condoms) for at least seven days before the IUS removal.

In the case you do not have periods (menses), you should use a barrier method of contraception for seven days before removal.

A new Luadei can also be placed immediately after removal, in which case no additional protection is needed.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them. The following is a list of possible side effects by how common they are:


Very common side effects:may affect more than 1 in 10 people


Common side effects: may affect up to 1 in 10 people


Uncommon side effects: may affect up to 1 in 100 people

excessive body hair



Rare side effects: may affect up to 1 in 1,000 people

perforation1 of the womb (see also following section on perforation)



Description of selected possible side effects:

Allergic reactions including rash, hives (urticaria) and angioedema (characterized by sudden swelling of e.g. the eyes, mouth, throat) have been reported with similar products.


Irregular or infrequent bleeding

Luadei is likely to affect your menstrual cycle. It can change your menstrual periods so that you have spotting (a small amount of bleeding), shorter or longer periods, lighter or heavier bleeding, or no bleeding at all.

You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first.

Overall, you are likely to have a gradual reduction in the amount and number of days of bleeding each month. Some women eventually find that periods stop altogether.

The monthly thickening of the lining of the womb may not happen due to the effect of the hormone and therefore there is nothing to come or shed away as a menstrual period. It does not necessarily mean that you have reached menopause or are pregnant. Your own hormone levels usually remain normal.

When the system is removed, your period should soon return to normal.


Pelvic Infection


The Luadei inserter and Luadei itself are sterile. Despite this, there is an increased risk of pelvic infection (infections in the lining of the womb or the fallopian tubes) at the time of placement and during the first 3 weeks after the placement.

Pelvic infections in IUS users are often related to the presence of sexually transmitted diseases. The risk of infection is increased if you or your partner have multiple sexual partners or if you have had pelvic inflammatory disease (PID) before.

Pelvic infections must be treated promptly.

Pelvic infections such as PID may have serious consequences and it may impair fertility and increase the risk of a future extrauterine pregnancy (pregnancy outside the womb). In extremely rare cases severe infection or sepsis (very severe infection, which may be fatal) can occur shortly after insertion.


Luadei must be removed if you experience recurring PID or if an infection is severe or does not respond to treatment.


Expulsion


The muscular contractions of the womb during menstruation may sometimes push the IUS out of place or expel it. It is rare but possible for Luadei to come out during your menstrual period without you noticing.

It is also possible for your Luadei to partially expel from your womb, meaning that it is displaced but not completely expelled (you and your partner may notice this during sexual intercourse). If Luadei is completely or partially expelled, you will not be protected from pregnancy.


Perforation


Penetration or perforation of the wall of the womb may occur during placement of Luadei, although the perforation may not be detected until some time later. If Luadei becomes lodged outside the cavity of the womb, it is not effective at preventing pregnancy. You may need surgery to have Luadei removed.

The risk of perforation is increased in breast-feeding women and in women who have insertion up to 36 weeks after birth, and may be increasedin women with the uterus leaning backwards (fixed retroverted uterus).


Ovarian cyst


Since the contraceptive effect of Luadei is mainly due to its local effect in the womb, ovulation (release of the egg) usually continues while using Luadei. Sometimes an ovarian cyst may develop. In most cases there are no symptoms.

An ovarian cyst may require medical attention, or more rarely surgery, but it usually disappears on its own.



Reporting of side effects



If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. [To be completed nationally]


5. How to store Luadei


This medicinal product does not require any special storage conditions.


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


Do not open the blister. Only your doctor or nurse should do this.


Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.


6. Contents of the pack and other information


What Luadei contains


The active substance is levonorgestrel. The intrauterine delivery system contains 13.5 mg levonorgestrel.


The other ingredients are:

- polydimethylsiloxane elastomer

- silica, colloidal anhydrous

- polyethylene

- barium sulfate

- iron oxide, black (E172)

- silver


What Luadei looks like and contents of the pack


Luadei is a T‑shaped intrauterine delivery system (IUS). The vertical arm of the T-body carries a drug reservoir containing levonorgestrel. Two removal threads are tied to the loop at the lower end of the vertical arm. In addition, the vertical stem contains a silver ring located close to the horizontal arms, which is visible under ultrasound examination.


Pack size:

  • 1x1 intrauterine delivery system.

  • 5x1 intrauterine delivery system.

Not all pack sizes may be marketed.


Marketing Authorisation Holder


<[To be completed nationally]>


{Name and address}

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Manufacturer


Bayer OY

Pansiontie 47

20210 Turku

Finland


This medicinal product is authorised in the Member States of the EEA under the following names:


Austria, France, Germany, The Netherlands, Spain, Sweden, United Kingdom: Luadei


This leaflet was last revised in 2015-05-13


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The following information is intended for healthcare professionals only:


INSERTION INSTRUCTIONS


Luadei 13.5 mg intrauterine delivery system


To be inserted by a healthcare provider using aseptic technique.


Luadei is supplied within an inserter in a sterile package, which should not be opened until needed for insertion. Do not resterilize. As supplied, Luadei is for single use only. Do not use if the blister is damaged or open. Do not insert after the expiry date which is stated on the carton and the blister after EXP.


Any unused product or waste material should be disposed of in accordance with local requirements.


Preparation for insertion


- Examine the patient to establish the size and position of the uterus, in order to detect any signs of acute genital infections or other contraindications for the insertion of Luadei. If there is any doubt regarding pregnancy, a pregnancy test should be performed.

- Insert a speculum, visualize the cervix, and then thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.

- Employ an assistant as necessary.

- Grasp the anterior lip of the cervix with a tenaculum or other forceps to stabilize the uterus. If the uterus is retroverted, it may be more appropriate to grasp the posterior lip of the cervix. Gentle traction on the forceps can be applied to straighten the cervical canal. The forceps should remain in position and gentle counter traction on the cervix should be maintained throughout the insertion procedure.

- Advance a uterine sound through the cervical canal to the fundus to measure the depth and confirm the direction of the uterine cavity and to exclude any evidence of intrauterine abnormalities (e.g., septum, submucous fibroids) or a previously inserted intrauterine contraceptive which has not been removed. If difficulty is encountered, consider dilatation of the canal. If cervical dilatation is required, consider using analgesics and/or a paracervical block.


Insertion


1. First, open the sterile package completely. Then use aseptic technique and sterile gloves.

Figure 1

Luadei

Flange

Mark

Slider

Handle with threads inside

Insertion tube with plunger and scale