Package leaflet: Information for the user

Luadei 13.5 mg intrauterine delivery system

levonorgestrel

Patient’s name: <….>

Doctor’s name: <….>

Doctor’s phone number: <….>

Date of insertion: <….>

Date of removal: <….>

First check-up visit: <….>

Next visits:

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.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others.

• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

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

6. Contents of the pack and other information

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.

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:

- 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

• have diabetes. There is generally no need to alter your diabetic medication while using Luadei, but this may need to be checked by your healthcare professional

• have epilepsy. A fit (seizure) can occur during placement or removal

• have had an ectopic or extrauterine pregnancy (pregnancy outside the womb) in the past.

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”):

• Your menstrual periods have stopped and then you start having persistent bleeding or pain

• You have pain in your lower abdomen that is severe or persistent

• You have normal signs of pregnancy, but you also have bleeding and feel dizzy.

• You have a positive pregnancy test

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.

Placement of Luadei

Luadei can either be placed:

• within seven days from the start of your menstrual bleed (your monthly period)

• immediately after a first trimester abortion provided that there are no genital infections

• after giving birth only after the womb has returned to its normal size, and not earlier than 6 weeks after delivery (see section 4 “Possible side effects – Perforation”).

Examination by your healthcare professional before placement may include:

• a cervical smear test (Pap smear)

• examination of the breasts

• other tests, e.g. for infections, including sexually transmitted diseases, as necessary. Your healthcare professional will also do a gynaecological examination to determine the position and size of the womb.

After a gynaecological examination:

• An instrument called a speculum is placed into the vagina, and the cervix may be cleansed with an antiseptic solution. Luadei is then placed into the womb using a thin, flexible plastic tube (the placement tube). Local anaesthesia may be applied to the cervix prior to placement.

• Some women feel dizzy or faint during placement or after Luadei is placed or removed.

• You may experience some pain and bleeding during or just after placement.

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

• headache

• abdominal/pelvic pain

• acne/greasy skin

• bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent periods and absence of bleeding (see also following section on irregular and infrequent bleeding)

• ovarian cyst (see also following section on ovarian cyst)

• inflammation of the external genital organs and vagina (vulvovaginitis)

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

• depressed mood/depression

• migraine

• feeling sick (nausea)

• upper genital tract infection

• painful menstruation

• breast pain/discomfort

• device expulsion (complete and partial) - (see the following section on expulsion)

• hair loss

• genital discharge

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

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