Implanon Implant 68mg

Implanon(R) implant

Etonogestrel

Consumer Medicine Information

Before administration of this medicine please read this leaflet carefully. On the back of this leaflet you will find more information about Implanon as well as some general advice on using medicines. If you have any questions or worries, ask your doctor or pharmacist.

What is in this leaflet

  • 1.About Implanon
  • 2.What Implanon is used for
  • 3.Before you use Implanon
  • 4.Using Implanon
  • 5.While you are using Implanon
  • 6.Side effects
  • 7.After using Implanon
  • 8.Product Description
  • 1. About Implanon

    The name of your medicine is Implanon. It is a single small non-biodegradable semi-rigid rod, 4 cm in length and 2 mm in diameter, made of plastic (ethylene vinylacetate copolymer). It contains 68 mg etonogestrel, a hormone that is slowly released into the bloodstream for three years. Although Implanon may be removed at any time, it must be removed after three years. Implanon is placed directly under the skin of the inner part of your upper arm in the groove between the biceps and the triceps.

    Implanon is a contraceptive.

    The etonogestrel in Implanon prevents the release of an egg cell from the ovaries (ovulation). In addition, Implanon causes changes to cervical mucus that make it difficult for sperm to enter the womb.

    A doctor`s prescription is required to obtain this medicine.

    Before you have Implanon inserted or removed, confirm that your doctor is familiar with the technique. For uncomplicated removals, it is necessary that Implanon be inserted directly under the skin. Incorrect insertion may lead to complicated removals that may result in scarring.

    Implanon has several important advantages:

  • It is one of the most reliable birth control methods. However, there is no birth control method that is 100% effective.
  • It does not interfere with having sex.
  • Once you stop using it you can expect your previous fertility to return quickly.
  • Implanon is one of several means of preventing pregnancy. Another frequently used birth control method is the combined Pill. Implanon differs from combined Pills in that it contains no oestrogen and does not have to be swallowed.

    Furthermore, compared to the combined Pill, Implanon has some additional advantages, but also some disadvantages:

    Advantages

  • You do not have to worry about taking a tablet each day; Implanon need only be replaced every 3 years.
  • Implanon can be used by women who do not tolerate oestrogens.
  • Implanon may, in some circumstances, be used by lactating women (check with your doctor, as the safety of the use of Implanon when breastfeeding is still being investigated).
  • Disadvantages

  • Vaginal bleeding may occur at irregular intervals during the use of Implanon. You also may not have any bleeding at all. It is important to have regular medical check ups, because while irregular bleeding is a common side effect of Implanon, it may rarely be caused by other medical conditions.
  • On rare occasions, Implanon moves from its original position. This may complicate removal.
  • Implanon must be inserted and removed by a doctor. A small scar may remain.
  • 2. What Implanon is used for

    Implanon is used for contraception.

    How Implanon works

    Implanon works by preventing the release of an egg cell from the ovaries. In addition, it causes changes to cervical mucus that make it difficult for sperm to enter the womb.

    3. Before you use Implanon

    Your doctor can tell you whether Implanon is suitable for you or not. For certain medical reasons you may be advised to use another birth control method. Therefore, before your doctor inserts Implanon, you should inform your doctor if the answer is yes to any of the following questions:

  • Are you or do you think that you may be pregnant?
  • Have you recently had abnormal bleeding from your vagina?
  • Have you ever had an allergic reaction to sex hormones or plastics?
  • Caution: Before using Implanon it is also important to tell your doctor or family planning counsellor if you have or have had:

  • Cancer of the breast, ovary or womb;
  • A disturbed liver function, a liver tumour or gall-stones;
  • Blood clots;
  • Diabetes
  • Appearance or worsening of the following conditions during pregnancy or previous use of hormones: jaundice or itching, porphyria (a metabolic disease); herpes (itching of vesicles of the skin); chorea (a neurological disorder); systemic lupus erythematosus (SLE; an autoimmune disease affecting many parts of the body); haemolytic uraemic syndrome (a disorder of blood coagulation causing failure of the kidneys); otosclerosis (a certain form of deafness).
  • During the use of Implanon, you should return to your doctor for regular check-ups.

    Consult your doctor promptly if you have:

  • a sudden, severe stomach-ache or yellowing of the skin (indicating possible liver problems or gall stones);
  • a lump in your breast;
  • a sudden or severe pain in the lower abdomen or stomach area (this could indicate ectopic pregnancy or an ovarian cyst, see below);
  • to take other medicines (see below);
  • any other complaints that you cannot explain but think might be related to Implanon.
  • As with all contraceptive medicines, Implanon does not protect against HIV infection (AIDS) or any other sexually transmissible infection. Only condoms and safe sex practices can protect you from these diseases. Your doctor may suggest the additional use of condoms in certain circumstances to reduce risk of such transmission.

    Vaginal bleeding may occur at irregular intervals during the use of Implanon. This may be just slight staining which may not even require a pad, or a heavier so called `breakthrough` bleeding, which looks like a light period and requires sanitary protection. You also may not have any bleeding at all. This does not mean that Implanon does not suit you or is not giving you contraceptive protection. In general, you do not need to take any action. If, however, vaginal bleeding is heavy or prolonged, consult your doctor or family planning counsellor.

    When you are using low-dose hormonal contraceptives, small sacs of fluid (follicles) may develop in the ovaries. In the absence of Implanon these follicles would release an egg. Sometimes they may grow to an unusually large size, and are then called ovarian cysts. They usually disappear without treatment and only rarely cause problems.

    Ectopic pregnancy is a pregnancy outside the womb. Because Implanon effectively protects you against pregnancy for 3 years it can also protect you against having a pregnancy outside the womb. Failure to remove and, if appropriate, reinsert Implanon after 3 years may increase your risk of an ectopic pregnancy.

    Chloasma (yellowish-brown patches of the skin, particularly in the face) may occasionally occur, especially if this occurred during previous pregnancy or previous use of female hormones. If this applies to you, it is best to avoid direct exposure to natural and artificial sunlight.

    OTHER MEDICINES, such as those used for the treatment of epilepsy and tuberculosis and St. Johns Wort could reduce the protection against pregnancy offered by Implanon. Therefore, ask your doctor or family planning counsellor for advice on taking extra contraceptive precautions (condom or cap plus spermicide) if you are taking (or intend to take) other medicines while using Implanon (also if these medicines are prescribed by another doctor or dentist).

    If you are pregnant, or think you may be pregnant, do not use Implanon.

    If you are breast-feeding you may be able to use Implanon. Check with your doctor for advice.

    4. Using Implanon

    How and when to use Implanon.

    Implanon should only be inserted and removed by a doctor who is familiar with the technique. It is placed directly under the skin inside the upper non-dominant arm. The insertion of Implanon is generally not painful if performed with an anaesthetic and only takes the time required for an injection.

    Make sure your doctor shows you how to gently feel the implant in your arm after insertion. If you cannot feel the implant in your arm after insertion you should tell your doctor and use a back up method of contraception until the presence of the rod is confirmed. Avoid manipulating the rod after insertion to prevent it from moving from its original position.

    Implanon should be removed or replaced no later than three years after insertion. Failure to do so may increase your risk of ectopic pregnancy. Removal requires a 2mm incision under local anaesthetic. Occasionally removal may be complicated because the rod has moved from its original position or was inserted too deeply.

    WHEN TO INSERT IMPLANON

    No additional contraception is necessary when Implanon is inserted at the right time in your cycle:

    *NO PRECEDING HORMONAL CONTRACEPTIVE USE

    Implanon should be inserted on day 1-5 of your natural cycle (day 1 being the first day of menstrual bleeding).

    *CHANGING FROM A COMBINED ORAL CONTRACEPTIVE (COC)

    Implanon should be inserted preferably on the next day following the last active tablet of the COC. At the latest it should be inserted on the day following the usual active tablet-free interval or last sugar tablet of the COC.

    *CHANGING FROM A PROGESTAGEN-ONLY-METHOD (MINIPILL, OR INJECTABLE)

    Implanon may be inserted on any day when switching from a minipill (from an injectable when the next injection would be due).

    *FOLLOWING MISCARRIAGE OR ABORTION

    Consult your doctor or Family Planning adviser before insertion of Implanon.

    If you want to stop using Implanon

    You can stop using Implanon at any time: ask a doctor who is familiar with the technique to remove the device.

    If your implant is not easy to feel under the skin, removal should be performed by someone who is skilled in removal of deeply inserted Implanon.

    If you do not wish to get pregnant, you should start using another reliable birth control method on the same day that Implanon is removed: ask your doctor for advice.

    If you want to have a baby, it is helpful to wait until you have had one period after Implanon has been removed before you try to get pregnant. In this way, it is easier to work out when the baby is due.

    5. While you are using Implanon

    When you are using Implanon, you should arrange for regular check-ups by your doctor. He or she should pay special attention to your blood pressure and your breasts and give you a regular examination of the pelvic organs (including a cervical smear).

    Consult your doctor promptly if any of the following happen:

  • If you have any of the signs of a blood clot, as below:
  • Sudden severe pain in the chest, whether it reaches to the arm or not.
  • If you suddenly become breathless.
  • If you suddenly lose vision, partially or completely, or if you see double.
  • If you have an unusual, severe or prolonged headache.
  • If your speech is abnormal.
  • If you experience dizziness.
  • If you have a fainting attack or you collapse.
  • If one side or part of your body suddenly becomes very weak or numb.
  • If you suffer severe pain in one of your calves.
  • If you develop a sudden stomach ache or develop yellowing of the skin.
  • If you can feel a lump in your breast.
  • If you have persistent vomiting or diarrhoea
  • If you have any other complaints that you cannot explain but think might be related to Implanon.
  • If you plan to use other medicines.
  • If having stopped using Implanon you wish to restart.
  • If you wish to change your method of contraception.
  • Ability to drive or operate machinery.

    As far as is known, Implanon has no effect on alertness and concentration.

    If you are unsure of any of the aspects of this product, please discuss with your doctor or pharmacist.

    6. Side Effects of Implanon

    Various undesirable effects that have been associated with the hormones used for birth control are similar to those that may occur during pregnancy. The reason for this is the similarity between these hormones and the natural hormones produced in extra large amounts during pregnancy. These effects can also occur during the use of Implanon but are not necessarily caused by Implanon.

    Serious undesirable effects

    See `Before Using Implanon`

    Other possible undesirable effects:

    Headache; migraine; nausea; vomiting; breast tenderness, pain, changes in libido or mood swings; various skin disorders; weight gain.

    Tell your doctor or family planning counsellor if any side effect becomes troublesome or continues. It is also important to tell them if you experience any other unusual or unexpected symptoms during the use of Implanon.

    7. After Using Implanon

    Disposal

    Your doctor will arrange disposal of Implanon upon removal of the old implant.

    8. Product Description

    What it looks like.

    The name of your medicine is Implanon. It is a single small non-biodegradable semi-rigid rod, 4 cm in length and 2 mm in diameter, made of plastic (ethylene vinylacetate copolymer). It contains 68 mg etonogestrel, a hormone, which is slowly released into the bloodstream. The rod is provided in a sterile, preloaded applicator. Do not be alarmed by the size of the box or the applicator. Implanon is placed directly under the skin.

    Make sure your doctor shows you how to gently feel the implant in your arm after insertion.

    Storage of Implanon

    Your doctor will not use Implanon after the expiry date, which is the last date for insertion, if the packaging is worn or torn, or if the product does not look quite right. Do not open the plastic box containing the applicator.
    When dispensed, store Implanon in a safe dry place below 30 degrees C and do not freeze prior to handing it to your physician.

    Manufacturer

    NV Organon, Oss, The Netherlands.

    Supplier

  • Organon (Australia) Pty Limited
  • 31-33 Sirius Rd, Lane Cove NSW 2066
  • The leaflet was prepared in February 2003.
  • Australian Registration No. AUST R 70855
  • The information supplied relates only to Implanon and should not be used in relation to any other product that may also contain the same active ingredients.

    ENQUIRE

    1800 200 736