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.