What Etonogestrel is and what it is used for: Etonogestrel is a contraceptive implant preloaded in a disposable applicator. Safety and efficacy have been established in women between 18 and 40 years of age. The implant is a small, soft, flexible, plastic rod, 4 cm in length and 2 mm in diameter, which contains 68 milligrams of the active substance, etonogestrel. The applicator allows the healthcare professional to insert the implant just under the skin of your upper arm. Etonogestrel is a synthetic female hormone resembling progesterone. A small amount of etonogestrel is continuously released into the bloodstream. The implant itself is made of ethylene vinyl acetate copolymer, a plastic that will not dissolve in the body. It also contains a small amount of barium sulfate which renders it visible under X-ray. Etonogestrel is used to prevent pregnancy. How does Etonogestrel work: 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, Etonogestrel 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. Etonogestrel is one of several means of preventing pregnancy. Another frequently used birth control method is the combined Pill. In contrast to combined Pills, Etonogestrel can be used by women who may not, or do not want to use estrogens. When you use Etonogestrel you do not have to remember to take a pill every day. This is one of the reasons that Etonogestrel 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 Etonogestrel, 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 Etonogestrel at any time What you need to know before you use Etonogestrel : Do not use Etonogestrel : Tell your doctor: If you are allergic to etonogestrel or any of the other ingredients of this medicine 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. Warnings and precautions: You should let your doctor know if: 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. Other medicines and Etonogestrel : Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. These include medicines used for the treatment of: Epilepsy (e.g.Primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate); Tuberculosis (e.g.Rifampicin); HIV infection (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). Etonogestrel ring 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) How to use Etonogestrel : Etonogestrel 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 Etonogestrel, your healthcare professional will give you a local anaesthetic. Etonogestrel is inserted directly under the skin, on the inside of your upper non-dominant arm (the arm that you do not write with). Etonogestrel should be removed or replaced no more than three years after insertion. Possible side effects: Stop using the product and seek immediate medical attention if you have noticed: Signs of deep vein thrombosis: swelling of one leg or along a vein in the leg or foot especially when accompanied by pain or tenderness in the leg which may be felt only when standing or walking; increased warmth in the affected leg; change in colour of the skin on the leg e.g.Turning pale, red or blue. Signs of a pulmonary embolism: sudden unexplained breathlessness or rapid breathing; sudden cough without an obvious cause, which may bring up blood; sharp chest pain which may increase with deep breathing; severe light headedness or dizziness; rapid or irregular heartbeat; severe pain in your stomach. Signs of retinal vein thrombosis (blood clot in the eye): symptoms most commonly occur in one eye: immediate loss of vision or painless blurring of vision which can progress to loss of vision. Signs of heart attack: chest pain, discomfort, pressure, heaviness; sensation of squeezing or fullness in the chest, arm or below the breastbone; Signs of a stroke: sudden weakness or numbness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; sudden, severe or prolonged headache with no known cause; loss of consciousness or fainting with or without seizure. Signs of blood clots blocking other blood vessels: swelling and slight blue discolouration of an extremity; severe pain in your stomach (acute abdomen). Signs of a severe allergic reaction: swelling of the face, lips, mouth, tongue or throat. Signs of breast cancer: dimpling of the skin; changes in the nipple; any lumps you can see or feel. Signs of cancer of the cervix: vaginal discharge that smells and contains blood; unusual vaginal bleeding; pelvic pain; painful sex. Signs of severe liver problems: severe pain in your upper abdomen; yellow skin or eyes (jaundice). How to store Etonogestrel : Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton. Store in the original blister package. 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 to protect the environment. This medicinal product does not require any special storage conditions.

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