PACKAGE LEAFLET: INFORMATION FOR THE USER

Tresovelle 20 micrograms/24 hours Intrauterine Delivery System

Levonorgestrel

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

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

-    If you have any further questions, ask your doctor or pharmacist.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Tresovelle is and what it is used for

2.    What you need to know before you use Tresovelle

3.    How to use Tresovelle

4.    Possible side effects

5.    How to store Tresovelle

6.    Contents of the pack and other information

1.    WHAT Tresovelle IS AND WHAT IT IS USED FOR

Tresovelle is an intrauterine delivery system (IUS) for insertion in the womb. It can be used in the following

ways:

-    As an effective method of contraception (prevention of pregnancy).

-    For heavy menstrual bleeding (heavy periods).

Tresovelle prevents pregnancy by controlling the monthly development of the womb lining so that it is not thick enough for you to become pregnant; by making the normal mucus in the opening to the womb (the cervical canal) thicker so that the sperm cannot get through to fertilise the egg; by preventing the release of eggs (ovulation) in some women. There are also local effects on the lining of the womb caused by the presence of the T-shaped frame.

Tresovelle is also useful for reducing menstrual blood flow, so it can be used if you suffer from heavy menstrual bleeding (periods). This is called menorrhagia. The hormone in Tresovelle acts by controlling the monthly development of the womb lining, making it thinner, so that there is less bleeding every month.

Tresovelle is placed inside the uterus (womb) where it slowly releases the hormone levonorgestrel over a period of 3 years or until it is removed.

Children and adolescents

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

2.    WHAT YOU NEED TO KNOW BEFORE YOU USE Tresovelle Do not use Tresovelle:

Before you have Tresovelle fitted, your doctor or nurse will carry out some tests to make sure that Tresovelle is suitable for you to use.

This will include a pelvic examination and may also include other examinations such as a breast examination, if your doctor or nurse feels this is appropriate.

Genital infections will need to be successfully treated before you can have Tresovelle fitted.

If you have epilepsy, tell the doctor or nurse fitting Tresovelle because, although rare, a fit can occur during insertion. Some women might feel faint after the procedure. This is normal and your doctor or nurse will tell you to rest for a while.

Not all women can use Tresovelle. Do not use Tresovelle and tell your doctor if you :

-    are pregnant, suspect that you are pregnant or are breast feeding

-    have an unusual vaginal bleeding pattern

-    have an abnormal womb or fibroids

-    have an unusual or unpleasant vaginal discharge, or vaginal itching

-    have or have    had    pelvic inflammatory disease

-    have or have    had    inflammation of the lining of your womb following delivery of your baby

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

-    have or have    had    inflammation of the cervix (neck of your womb)

-    have or have    had    an abnormal smear test (changes in the cervix)

-    have had a stroke, heart attack or any heart problems

-    have or have had liver problems

-    have any condition which makes you susceptible to infections. A doctor will have told you if you have this

-    have or have had any type of cancer, suspected cancer or leukaemia (blood cancer)

-    have or have had trophoblastic disease (the trophoblast provides nutrients to the foetus). A doctor will have told you if you have this

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

Warnings and precautions

Talk to your doctor before using Tresovelle if you:

-    are diabetic (too high blood glucose level), have high blood pressure or abnormal blood lipid levels

-    have fits (epilepsy)

-    have a history of blood clots (thrombosis)

-    are on long term steroid therapy

-    are taking any other medicines as some medicines may stop Tresovelle from working properly

-    have or develop migraine, dizziness, blurred vision, unusually bad headaches or if you have headaches more often than before

-    have ever had an ectopic pregnancy (development of the foetus outside the womb) or a history of ovarian cysts

-    have yellowing of the skin or whites of the eyes

-    have cancer affecting your blood (including leukaemia) which is now in remission

-    have had a stroke or heart attack, or if you have heart problems

-    have disease of your arteries

Your doctor will decide if you can use Tresovelle if you have or have had some of the above conditions.

You must also tell your doctor if any of these conditions occur for the first time whilst you have Tresovelle in place.

You must see a doctor or nurse as soon as possible if you develop painful swelling in your leg, sudden chest pain or difficulty in breathing as these may be a sign of a blood clot. It is important that any blood clots are treated promptly.

You must also see a doctor without delay if you develop persistent lower abdominal pain, fever, pain during sexual intercourse or abnormal bleeding. If you get severe pain or fever shortly after Tresovelle has been inserted, you may have a severe infection which must be treated immediately. In rare cases very severe infection (sepsis) can occur (see Section 4 Possible Side Effects).

Tresovelle and smoking

Women are advised to give up smoking. Smoking increases the risk of developing a heart attack, stroke, or blood clot.

Other medicines and Tresovelle

Tell your doctor if you are taking or have recently taken or might take any other medicines including medicines obtained without a prescription.

The effect of hormonal contraceptives such as Tresovelle may be reduced by medicines that increase the amounts of enzymes made by the liver. Please tell your doctor or nurse if you are taking:

•    Phenobarbital, primidone, phenytoin or carbamazepine (to treat epilepsy)

•    Griseofulvin (an antifungal)

•    Rifampicin or rifabutin (antibiotics)

•    Nevirapine or efavirenz (for HIV)

Pregnancy, breast-feeding and fertility

Can I become pregnant whilst using Tresovelle?

It is very rare for women to become pregnant with Tresovelle in place.

Missing a period may not mean that you are pregnant. Some women may not have periods whilst using the system.

If you have not had a period for 6 weeks then consider having a pregnancy test. If this is negative there is no need to carry out another test, unless you have other signs of pregnancy, e.g. sickness, tiredness or breast tenderness.

If you beome pregnant with Tresovelle in place, please contact your doctor as soon as possible so that ectopic pregnancy can be excluded and Tresovelle removed to reduce the risk of spontaneous miscarriage.

What if I want a baby?

If you want a baby, ask your doctor to remove Tresovelle. Your usual level of fertility will return very quickly after the system is removed.

Can I breast feed while using Tresovelle?

Very small amounts of the hormone in Tresovelle are found in breast milk but the levels are lower than with any other hormonal contraceptive method. No risk for the new-born is to be expected. If you want to breast feed 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 machines.

Tresovelle contains barium sulphate.

The T-frame of Tresovelle contains barium sulphate so that it can be seen on X-rays.

3. HOW TO USE Tresovelle

Only a doctor or specially trained nurse can fit the system (see special instructions for insertion in the package).

They will:

- give you a pelvic examination to find the position and size of your womb

- place a speculum (an instrument to help the doctor see the cervix) into your vagina

-    clean your vagina and cervix

-    place a thin flexible tube containing the device into your vagina and then through the cervix into the womb. At this point you might feel a little discomfort

-    withdraw the tube leaving the device in place

-    trim the threads to a suitable length for easy removal.

During insertion procedure, a slight discomfort might be encountered. Inform your Doctor about any pain you feel.

The device should be inserted either during your period or within seven days from the beginning of your period. If you already have the device and it is time to replace it with a new one, you do not need to wait until your period.

If you have just had a baby, you should wait at least 6 weeks before having Tresovelle fitted (see section 4 “Possible side effects”). Tresovelle can sometimes be fitted immediately after you have had an abortion, provided that you have no genital infections.

If you have fits (epilepsy), tell the doctor or nurse fitting the Tresovelle because, although rare, a seizure (fit) can occur during insertion.

Some women might feel faint after the device is fitted. This is normal and your doctor will tell you to rest for a while.

In very rare cases during fitting, part or all of the device could penetrate the wall of the womb. If this happens the device is removed.

How quickly should Tresovelle work?

Contraception:

You are protected from pregnancy as soon as the approximately 2 in 1,000 per year. The failure rate perforation (see section 4 “Possible side effects”).

Heavy menstrual bleeding:

Tresovelle usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment.

How often should I have the system checked?

You should have the system checked usually 6 weeks after it is fitted, again at 12 months and then once a year until it is removed.

What happens if the system comes out by itself?

If the system comes out either completely or partially, you may not be protected against pregnancy. It is rare but possible for this to happen without you noticing during your menstrual period. An unusual increase in the amount of bleeding during your period might be a sign that this has happened. Tell your doctor or clinic if there are any unexpected changes in your bleeding pattern.

How can I tell whether the system is in place?

After each menstrual period, you can feel for the two thin threads attached to the lower end of the system. Your doctor will show you how to do this.

Do not pull the threads because you may accidentally pull it out. If you cannot feel the threads, go to your doctor. The threads may have simply drawn up into the womb or cervical canal. If the threads still cannot be found by your doctor or nurse, they may have broken off, or the system may have come out by itself, or in rare cases it may have perforated the wall of your womb (uterine perforation, see section 4). It may be necessary for you to have an ultrasound scan or x-ray to locate the system.

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

If you stop taking Tresovelle

Your doctor can remove the system at any time. The removal is very easy. Unless you plan to have a new system or an intra-uterine device fitted immediately, it is important to use another form of contraception in the week leading up to the removal. Intercourse during this week could lead to pregnancy after Tresovelle is removed.

How will Tresovelle affect my periods?

Tresovelle will affect your menstrual cycle. You might experience spotting, shorter or longer periods, painful periods, lighter periods or no periods at all.

For all users of Tresovelle:

Many women have spotting (a small amount of blood loss) for the first 3-6 months after the system is fitted. Others will have prolonged or heavy bleeding. You may have an increase in bleeding however, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. Overall you are likely to have fewer days bleeding in each month and you might eventually have no periods at all. This is due to the effect of the hormone (levonorgestrel) on the lining of the womb.

If you have had Tresovelle fitted for heavy menstrual bleeding:

Tresovelle usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment. You may have an increase in bleeding however, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. If a significant reduction in blood loss is not achieved after 3 to 6 months, alternative treatments should be considered.

If you have had Tresovelle fitted for quite a long time and then start to have bleeding problems, contact your doctor or clinic for advice.

If you have any further questions on the use of this medicine, ask your doctor.

Moreover, see a doctor as soon as possible if you get:

-    painful swelling in your leg

-    sudden chest pain

-    difficulty breathing

Because these may be signs of a blood clot.

Perforation

In rare cases it is possible that the womb or the neck of the womb is pierced, most commonly during insertion of Tresovelle. This may be associated with severe pain and continued bleeding. If perforation is suspected the system should be removed as soon as possible. Contact your doctor immediately if you cannot feel the threads.

The risk of perforation may be increased in insertions following delivery, in lactating women and in women with a fixed retroverted (bent backwards) uterus.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

With Tresovelle, side effects are most common during the first months after the system is fitted and decrease as time goes on.

Severe pain or fever developing shortly after insertion may mean that you have a severe infection which must be treated immediately. In rare cases very severe infection (sepsis) can occur. Contact your doctor immediately if you experience such side effects (see Section 2 Warnings and Precautions)

Severe pain and continued bleeding might be a sign of damage or tear in the wall of the womb (perforation). Perforation is rare, but occurs most often during the fitting of the Tresovelle, although the perforation may not be detected until sometime later. If this happens the system will be removed; very rarely this may require surgery. The risk of perforation is low, but is increased in breastfeeding women and in women who have had a baby up to 36 weeks before insertion. 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 which continues for more than a few weeks

-    sudden changes in your periods

-    pain during sex

-    you can no longer feel the threads (see section 3 ”How to use Tresovelle - How can I tell whether the system is in place?").

Very common (affects more than 1 in 10 women) side effects can include:

-    menstrual changes. You might experience spotting, shorter or longer periods, painful periods. Though Tresovelle usually achieves a significant reduction in menstrual blood loss in 3 to 6 months of treatment, you may have an increase in bleeding, usually in the first 2 to 3 months, before a reduction in blood loss is achieved. Periods can totally disappear. If a significant reduction in blood loss is not achieved after 3 to 6 months, alternative treatments should be considered.

-    ovarian cysts. They are fluid-filled sacs in the ovary.

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

-    bloating or swelling of your legs or ankles;

-    weight gain;

-    depression, nervousness or other mood changes;

-    headache;

-    abdominal, pelvic or back pain;

-    feeling sick (nausea);

-    spots (acne);

-    painful periods;

-    increased vaginal discharge;

-    inflammation of the neck of the womb (cervicitis);

-    tender, painful breasts; or

-    Tresovelle coming out by itself.

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

-    genital infections that may cause: vaginal itching; pain on passing urine; or lower abdominal (tummy) pain from inflammation of the womb, ovaries or Fallopian tubes;

-    increased growth of hair on the face and body;

-    hair loss; or

-    itchy skin (pruritus).

Rare (may affect up to 1 in 1000 women) side effects can include:

-    reduced sex drive;

-    migraine;

-    bloated abdomen;

-    rashes, itching, eczema; or

-    the wall of the womb torn when the Tresovelle is fitted (uterine perforation - see above*).

* The perforation rate is higher (>1/1000 to <1/100) in women who are breastfeeding or have an insertion up to 36 weeks after delivery.

Ovarian cysts and pelvic inflammatory disease have been reported. So tell your doctor if you have lower abdominal pain or if you experience painful or difficult sex. This is important as pelvic infections can reduce your chances of having a baby and can increase the risk of ectopic pregnancy (development of a foetus outside the womb). Ectopic pregnancy is possible with Tresovelle but highly unlikely. The risk of this happening is lower than for women using no contraception or a copper intrauterine device.

You should tell your doctor if you have lower abdominal (tummy) pain especially if you also have a fever or have missed a period or have unexpected bleeding. This might be a sign of ectopic pregnancy.

If you think you are reacting badly to Tresovelle or are having any other problems, please tell your doctor or clinic.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRESOVELLE

Store in the original package in order to protect from light. Do not open the Tresovelle pack. Only your doctor or clinic should do this.

This medicinal product does not require any special temperature storage conditions.

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

Do not use the device after the expiry date which is stated on the label and the outer pack after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tresovelle contains

-    Tresovelle consists of a small T-shaped frame made from a plastic called polyethylene. This carries 52 mg of levonorgestrel, the active substance, a hormone used in many contraceptive pills and hormone replacement therapy preparations. The hormone is contained within a substance called polydimethylsiloxane. This is surrounded by a membrane (skin) also made of polydimethylsiloxane.

-    The T-shaped frame also contains barium sulphate so that it can be seen on X-rays.

-    This structure provides a device for releasing the hormone gradually into the uterus (womb).

-    There are two fine threads, made of polyethylene and copper phtalocyanine blue, attached to the bottom of the frame. These allow easy removal and allow you or your doctor to check that the device is in place.

What Tresovelle looks like and contents of the pack

Each pack contains one Tresovelle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Mithra Pharmaceuticals S.A.

Rue Saint Georges, 5 4000 Liege Belgium

infomed@mithra.com

Manufacturer Odyssea Pharma S.A.

Rue du Travail 16 4460 Grace Hollogne Belgium

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

Belgium Luxembourg United Kingdom

This leaflet was last revised in 06/2016.

The following information is intended for medical or healthcare professionals only

See special instruction leaflet enclosed in the pack.

9