Nexplanon 68 mg implant for subdermal use

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Your doctor will give you a Patient Alert Card that contains important information you need to be aware of. Store the card in a safe place, and show it to your healthcare professional at any visits related to the use of your implant.

1. What Nexplanon is and what it is used for
2. What you need to know before you use Nexplanon
3. How to use Nexplanon
4. Possible side effects
5. How to store Nexplanon
6. Contents of the pack and other information
7. Information for the health care professional

The implant is inserted just below the skin. The active compound, etonogestrel, works in two ways:

• It prevents the release of an egg cell from the ovaries.
• It causes changes in the cervix that make it difficult for sperm to enter the womb.

As a result, Nexplanon protects you against pregnancy for a period of three years, but if you are overweight the doctor may advise you to replace the implant earlier. Nexplanon is one of several means of preventing pregnancy. Another frequently used birth control method is the combined Pill. In contrast to combined Pills, Nexplanon can be used by women who may not, or do not want to use oestrogens. When you use Nexplanon you do not have to remember to take a pill every day. This is one of the reasons that Nexplanon is very reliable (over 99 % effective). If in rare cases the implant is not inserted correctly or is not inserted at all, you may not be protected against pregnancy. When you are using Nexplanon, your menstrual bleeding may change and become absent, irregular, infrequent, frequent, prolonged, or rarely heavy. The bleeding pattern that you experience during the first three months generally indicates your future bleeding pattern. Painful periods may improve.

You may stop using Nexplanon at any time (see also “ When you want to stop using Nexplanon” ).

Do not use Nexplanon if you have any of the conditions listed below. If any of these conditions apply to you, tell your doctor before Nexplanon is inserted. Your doctor may advise you to use a non-hormonal method of birth control.

• if you are allergic to etonogestrel or any of the other ingredients of this medicine (listed in section 6).
• if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel [for example in the legs (deep venous thrombosis) or the lungs (pulmonary embolism)].
• if you have or have had jaundice (yellowing of the skin), severe liver disease (when the liver is not functioning properly), or a liver tumour.
• if you have (had) or if you may have cancer of the breast or of the genital organs.
• if you have any unexplained vaginal bleeding.

If any of these conditions appear for the first time while using Nexplanon, consult your doctor immediately.

Talk to your doctor, pharmacist or nurse before using Nexplanon.

If Nexplanon is used in the presence of any of the conditions listed below, you may need to be kept under close observation. Your doctor can explain to you what to do. If any of these apply to you, tell your doctor before Nexplanon is inserted. Also if the condition develops or gets worse while you are using Nexplanon you must tell your doctor.

• you have had cancer of the breast;
• you have or have had a liver disease;
• you have ever had a thrombosis;
• you have diabetes;
• you are overweight;
• you suffer from epilepsy;
• you suffer from tuberculosis;
• you have high blood pressure;
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so avoid too much exposure to the sun or ultraviolet radiation.

Cancer

The information presented below has been obtained in studies with women who daily take an oral combined contraceptive containing two different female hormones (“the Pill”). It is not known whether these observations are also applicable to women who use a different hormonal contraceptive, such as implants containing only a progestagen.

Breast cancer has been found slightly more often in women using oral combined pills, but it is not known whether this is caused by the treatment. For example, it may be that tumours are found more in women on combined pills because they are examined by the doctor more often. The increased occurrence of breast cancer becomes gradually less after stopping the combined pill. It is important to regularly check your breasts and you should contact your doctor if you feel any lump in your breasts. You should also tell your doctor if a close relative has or ever had breast cancer.

In rare cases, benign and even more rarely malignant liver tumours have been reported in women using the Pill. If you experience severe abdominal pain, you should contact your doctor immediately.

Thrombosis

A blood clot in a vein (known as a ‘venous thrombosis’) can block the vein. This can happen in veins in the leg, the lung (a lung embolus), or other organs. A blood clot in an artery (known as ‘arterial thrombosis’) can block the artery. For example, a blood clot in an artery may cause a heart attack, or in the brain may cause a stroke.

Using any combined hormonal contraceptive increases a woman’s risk of developing such clots compared with a woman not taking any combined hormonal contraceptive. The risk is not as high as the risk of developing a blood clot during pregnancy. The risk with progestagen-only methods like Nexplanon, is believed to be lower than in users of Pills that also contain oestrogens. There have been reports of blood clot formation like lung emboli, deep vein thrombosis, heart attacks and strokes in women using etonogestrel implants; however, available data do not suggest an increase in risk of these events in women using the implant.

If you suddenly notice possible signs of a thrombosis, you should see your doctor immediately. (see also “When should you contact your doctor?").

Menstrual bleeding pattern changes

Like with other progestagen-only contraceptives, your menstrual bleeding pattern may change when using Nexplanon. You may experience a change in frequency (absent, less frequent, more frequent or continuous), intensity (reduced or increased) or in duration. Absence of bleeding was reported in about 1 of 5 women while another 1 of 5 women reported frequent and/or prolonged bleeding. Occasionally heavy bleeding has been observed. In clinical trials, bleeding changes were the most common reason for stopping treatment (about 11 %). The bleeding pattern that you experience during the first three months generally indicates your future bleeding pattern.

A changing bleeding pattern does not mean that Nexplanon does not suit you or is not giving you contraceptive protection. In general, you do not need to take any action. You should consult your doctor if menstrual bleeding is heavy or prolonged.

Insertion and removal related events

The implant may move from the original insertion site in the arm, if incorrectly inserted or due to external forces (e.g. manipulation of the implant or contact sports). In rare cases implants have been found in the blood vessels of the arm or in the pulmonary artery (a blood vessel in the lung). In cases where the implant has migrated from the original insertion site, localisation of the implant may be more difficult and removal may require a larger incision or surgical removal in the hospital.

If the implant cannot be found in the arm your healthcare professional may use x-rays or other imaging methods on the chest. If the implant is located in the chest, surgery may be needed. If the implant cannot be found, and there is no evidence it has been expelled, contraception and the risk of progestagen-related undesirable effects may last longer than you want.

If at any time the implant cannot be felt, you should contact your doctor as soon as possible.

Psychiatric disorders

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

Ovarian cysts

During the use of all low-dose hormonal contraceptives, small fluid-filled sacs may develop in the ovaries. These are called ovarian cysts. They usually disappear on their own. Sometimes they cause mild abdominal pain. Only rarely, they may lead to more serious problems.

Broken or bent implant

If the implant breaks or bends while in your arm, how the implant works should not be affected. Breakage or bending may occur due to external forces. The broken implant may move from the insertion site. If you have questions, contact your healthcare provider.

Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you use Nexplanon. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or, whether the use of another medicine you need must be changed.

Some medicines

• can have an influence on the blood levels of Nexplanon
• can make it less effective in preventing pregnancy
• can cause unexpected bleeding.

These include medicines used for the treatment of

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
• tuberculosis (e.g. rifampicin),
• HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz),
• Hepatitis C Virus infection (e.g. boceprevir, telaprevir),
• other infectious diseases (e.g. griseofulvin),
• high blood pressure in the blood vessels of the lungs (bosentan),
• depressive moods (the herbal remedy St. John’s wort (Hypericum perforatum)).

Nexplanon may influence the effect of other medicines, e.g.

• medicines containing ciclosporin
• the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)

Ask your doctor or pharmacist for advice before taking any medicine.

There are no indications of any effect of food and drink on the use of Nexplanon.

You must not use Nexplanon if you are pregnant, or think you may be pregnant. In case you doubt whether you are pregnant or not, you should perform a pregnancy test before starting using Nexplanon.

Nexplanon may be used while you are breast-feeding. Although a small amount of the active substance of Nexplanon passes over into the breast milk, there is no effect on the production or the quality of breast milk, nor on the growth and development of the child.

If you are breast-feeding, ask your doctor for advice before using this medicine.

The safety and efficacy of Nexplanon in adolescents under the age of 18 have not been studied.

There are no indications of any effect of the use of Nexplanon on alertness and concentration.

Regular check-ups

Before Nexplanon is inserted, your healthcare professional will ask you some questions about your personal health history and that of your close relatives. The healthcare professional will also measure your blood pressure, and depending on your personal situation, may also carry out some other tests. When you are using Nexplanon, your healthcare professional may ask you to return for a (routine) medical check-up sometime after insertion of the implant. The frequency and nature of further check-ups will depend on your personal situation. Your healthcare professional should palpate the implant at each check-up visit.

Contact your doctor as soon as possible if:

• you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also “Do not use Nexplanon” and “Warnings and precautions”; do not forget about the items related to your immediate family);
• you notice possible signs of thrombosis such as severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially if you cough up blood;
• you have a sudden, severe stomach ache or look jaundiced;
• you feel a lump in your breast (see also “Cancer”);
• you have a sudden or severe pain in the lower part of your belly or stomach;
• you have unusual, heavy vaginal bleeding;
• you are to be immobilised (for example being confined to bed) or are to have surgery (consult your doctor at least four weeks in advance);
• you suspect that you are pregnant;
• the implant is not palpable after insertion or at any time.

Nexplanon should be inserted and removed only by a healthcare professional who is familiar with procedures as described on the other side of this leaflet. The healthcare professional will decide in consultation with you the most suitable time for insertion. This depends on your personal situation (for example on the birth control method that you are currently using). Unless you are switching from another hormonal contraceptive method, the insertion should be performed on day 1-5 of your spontaneous menstrual bleeding to rule out pregnancy. If the implant is placed after the fifth day of menses then you should use an additional contraceptive method (such as a condom) for the first 7 days after insertion.

Before inserting or removing Nexplanon, your healthcare professional will give you a local anaesthetic. Nexplanon is inserted directly under the skin, on the inside of your upper non-dominant arm (the arm that you do not write with). A description of the insertion and the removal procedure of Nexplanon is shown below.

• Insertion of Nexplanon should only be performed by a qualified healthcare professional who is familiar with the procedure.
• To facilitate the insertion of the implant, you should lie on your back, with your arm bent at the elbow and with your hand underneath your head (or as close as possible).

• The implant will be inserted at the inner side of your upper non-dominant arm (the arm that you do not write with).
• The insertion site will be indicated on the skin, and the site is disinfected and anaesthetised.
• The skin is stretched and the needle is inserted, directly under the skin. Once the tip is inside the skin the needle is completely inserted in a movement parallel to the skin.

• The purple slider is unlocked to retract the needle. The implant will remain in the upper arm when the needle is withdrawn.

• The presence of the implant should be verified by feeling it (palpation) immediately following insertion. A correctly inserted implant can be felt between thumb and finger by both the healthcare professional and by you. It should be realised that palpation is not suitable for 100 % verification of the presence of the implant.

• In case the implant cannot be palpated or when its presence is doubtful other methods must be used to confirm the presence of the implant.
• Once the healthcare professional has located the implant that was not palpable, it should be removed.
• Until the presence of the implant has been verified you may not be protected against pregnancy and a contraceptive barrier method (e.g. condoms) must be used.
• A small adhesive bandage will be placed over the insertion site and a pressure bandage will be placed to minimise bruising. You may remove the pressure bandage in 24 hours and the small adhesive bandage over the insertion site in 3-5 days.
• After insertion of the implant, the healthcare professional will give you a Patient Alert Card with on it the insertion site, insertion date and the latest date on which the implant has to be removed or replaced. Put it in a safe place, since the information on the card may facilitate removal later on.

At the end of the insertion procedure, the healthcare professional will ask you to palpate the implant (feel the implant under your skin). A correctly inserted implant should be clearly palpable by the healthcare professional as well as by you, and you should be able to feel both ends between your thumb and finger. It should be realised that palpation is not suitable for 100 % verification of the presence of the implant. If the implant cannot be palpated immediately after insertion, or at any time, the implant may not have been inserted, may have been inserted deeply, or may have migrated from the place it was inserted.

Therefore, it is important to occasionally gently palpate the implant to be sure that you know its location. If at any time you cannot feel the implant, contact your doctor as soon as possible.

In case of the slightest doubt you have to use a barrier method (e.g. a condom) until the healthcare professional and you are absolutely sure that the implant has been inserted. The healthcare professional may have to use X-rays, ultrasound or magnetic resonance imaging, or may have to take a blood sample, to make sure that the implant is inside your arm. If the implant cannot be found in the arm after a thorough search, your healthcare professional may use x-rays or other imaging methods on your chest. Once the healthcare professional has located the implant that was not palpable, it should be removed.

Nexplanon should be removed or replaced no more than three years after insertion.

To help you remember when and where Nexplanon was inserted, and when Nexplanon must be removed at the latest, your healthcare professional will give you a Patient Alert Card that shows this information. The Patient Alert Card also contains instructions to occasionally gently palpate the implant to be sure that you know its location. If at any time you cannot feel the implant, contact your doctor as soon as possible. Store the card in a safe place! Show the Patient Alert Card to your healthcare professional at any visits related to the use of your implant. In case you would like to have Nexplanon replaced, a new implant may be inserted immediately after the old implant is removed. The new implant may be inserted in the same arm and at the same site as the previous implant as long as the site is in the correct location. Your healthcare professional will advise you.

You can ask your healthcare professional to remove the implant at any time you want.

If the implant cannot be localised by palpation, the healthcare professional may use X-rays, ultrasound or magnetic resonance imaging to locate the implant. Depending on the exact position of the implant removal may be difficult and may require surgery.

If you do not want to become pregnant after removal of Nexplanon, ask your healthcare professional about other reliable methods of birth control.

If you stop using Nexplanon because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you to work out when the baby will be due.

• The implant should only be removed by a qualified healthcare professional who is familiar with the procedure.
• The implant is removed at your request or -at the latest- three years after insertion.
• The location of the insertion site of the implant is indicated on the Patient Alert Card.
• The healthcare professional will locate the implant. If the implant cannot be located the healthcare professional may have to use X-ray, CT, ultrasound or magnetic resonance imaging techniques.
• To facilitate the removal of the implant, you should lie on your back, with your arm bent at the elbow and with your hand underneath your head (or as close as possible).
• Your upper arm will be disinfected and anaesthetised.
• A small incision will be made along the arm just below the tip of the implant.
• The implant is gently pushed towards the incision and removed with a forceps.
• Occasionally, the implant may be surrounded by hard tissue. If this is the case, a small cut needs to be made into the tissue before the implant can be removed.
• If you want your healthcare professional to replace Nexplanon with another implant, the new implant may be inserted using the same incision as long as the site is in the correct location.
• The incision will be closed by a sterile adhesive wound closure.
• A pressure bandage will be placed to minimise bruising. You may remove the pressure bandage in 24 hours and the sterile adhesive wound closure over the insertion site in 3-5 days.

These pictograms are only meant to illustrate the insertion and removal procedures for the woman who will be receiving the implant.

Note: The exact procedures for the insertion and removal of Nexplanon by the qualified healthcare professional are described in the Summary of product characteristics and in section 7 on the other side of this user package leaflet.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Each applicator contains one implant with

• The active substance is: etonogestrel (68 mg)
• The other ingredients are: ethylene vinyl acetate copolymer, barium sulphate and magnesium stearate.

Nexplanon is a subdermal long acting hormonal contraceptive. It consists of a radiopaque progestagen-only implant preloaded in an innovative, ready-for-use, user-friendly, disposable applicator. The off-white implant is 4 cm in length and 2 mm in diameter and contains etonogestrel and barium sulphate. The applicator has been designed to facilitate the insertion of the implant just below the skin of your inner upper (non dominant) arm. The implant is to be inserted and removed by a healthcare professional who is familiar with the procedures. For uncomplicated removal it is necessary that the implant is inserted just below the skin (see other side of the leaflet). Local anaesthetic should be used before inserting or removing the implant. The risk of complications is small if the provided instructions are followed.

Pack sizes: Carton box with 1 blister pack, carton box with 5 blister packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

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

Austria, Belgium, Germany, Ireland, Luxembourg, Malta, the Netherlands, Slovakia, Poland, Portugal, Spain: Implanon NXT

Denmark, Estonia, Finland, France, Iceland, Italy, Norway, Romania, Sweden, United Kingdom (Northern Ireland): Nexplanon