Thank you for choosing JADELLE® implants birth control. They are one of the most effective reversible contraceptive methods offering both convenience and a high degree of reliability for up to five years.
Your doctor has already discussed JADELLE® with you. This leaflet will help you to remember the important points. Please read the following information carefully, before you start using JADELLE®.
JADELLE® is an effective, reversible contraceptive that protects you for up to five years. Two thin, flexible rods filled with a synthetic progestin are inserted just under the skin of your upper arm.
JADELLE® implants release continuously low doses of a synthetic hormone, levonorgestrel.
Pregnancy is prevented by a combination of mechanisms. The most important of these are inhibition of ovulation and thickening of the cervical mucus, which thus becomes impermeable to sperm. JADELLE® contains no estrogen.
JADELLE® is one of the most effective forms of reversible contraception available. It is at least as effective as the combined contraceptive pill but, unlike most other reversible methods of contraception, you do not need to remember it every day.
JADELLE® may be used by all healthy women who do not wish to get pregnant. It is a good method for women who are seeking continuous contraception or want to space their children, who do not want to be sterilised, who desire a method that is convenient, who cannot use IUDs or who cannot use methods that contain estrogen.
JADELLE® should not be used if you have: active thrombophlebitis or thromboembolic disorder, undiagnosed abnormal genital bleeding, acute liver disease, benign or malignant liver tumor, known or suspected breast cancer or other hormone dependent cancer or if you are pregnant. If you become pregnant while using the implants, they must be removed immediately.
To make sure that you are not pregnant, the implants should be inserted within 7 days after the onset of menstrual bleeding, or immediately or within 7 days after abortion. If they are inserted at any other time, you will need to use an additional non-hormonal (barrier) method for the following 7 days.
JADELLE® will provide contraceptive protection for up to five years. Before the end of the fifth year, when the implants should be removed, a new set may be inserted for continued protection.
After the anaesthetic wears off, you will probably experience some tenderness at the insertion site for the first few days. There may also be some swelling, bruising or bleeding.
Keep the insertion area dry for 2-3 days to prevent infection. The protective gauze may be removed after 24 hours and the sterile skin closure as soon as the incision wound has healed, i.e. normally after 3-5 days.
You can resume your normal daily activities immediately following the insertion of JADELLE®. However, you should not lift any heavy objects and you should try to avoid hitting the insertion site for a few days. After the incision has healed, you do not have to worry about hitting the area or putting pressure on it. The implants are flexible and cannot break inside the arm. They will stay where they are placed and not move around. Insertion or removal of the implants leaves a small scar on the arm, which is not noticeable in most women.
Certain medicines may interfere with the hormone delivered by JADELLE®, making it less effective in preventing pregnancy. Reduced contraceptive efficacy has been reported in JADELLE® users taking some medicines used to treat epilepsy, tuberculosis or fungal infections. The herbal preparation St John´s Wort may also make JADELLE® less effective. Don’t worry about medicines, your doctor will screen you to make sure that there are no medical reasons why you should not use JADELLE®. Whenever a new medicine is prescribed for you in the future, always tell the doctor that you are using JADELLE®.
Studies have shown no significant harmful effects on the growth or health of infants whose mothers began to use JADELLE® six weeks after childbirth. There is no data to support the use of the implants earlier than six weeks after childbirth.
JADELLE® is likeyly to alter your bleeding pattern, although the situation usually stabilizes during the first year of use. The type of bleeding pattern you will experience with JADELLE® cannot be predicted. Menstrual irregularities may vary from woman to woman and may include prolonged bleeding during the first few months of use, untimely bleeding or spotting, no bleeding at all for several months, or a combination of these patterns. Despite the increased frequency of bleeding in some women, the monthly blood loss is usually less than that of normal menstruation. Most women who experience some change in their bleeding pattern are not bothered by it.
If you have regular periods after having the implants inserted and they suddenly stop for six weeks or more, you should confirm that you are not pregnant. If you are, JADELLE® implants must be removed immediately.
Sometimes women are concerned about amenorrhea, i.e. about having no monthly bleeding at all. If you do not have your periods while using JADELLE®, it does not harm your health or future fertility.
Most other side effects are rare, occurring in about ten percent of users and similar to those sometimes found with other progestogen-only methods of contraception, such as the mini pill. You should be aware of the following conditions even though you may not experience any of them: headache, nervousness, nausea, acne, vaginal discharge, pelvic pain, weight changes and skin complaints. You may also experience irregular menstrual bleeding and spotting.
If you are worried about possible side effects with JADELLE® you should discuss this with your doctor or nurse.
No. They will remain under the skin where they are placed. They are flexible and cannot break in your arm. They will become naturally surrounded by a protective layer of fibrous tissue.
You should contact your doctor or clinic right away if you have: severe lower abdominal pain; heavy vaginal bleeding; arm pain; pus or bleeding at the insertion site, indicating infection; expulsion of an implant; episodes of migraine, repeated severe headaches or blurred vision; or delayed menstrual cycle after a long time of having regular cycles. Failure to have periods after regular cycles may be a sign of pregnancy.
You are advised to return to follow-up at least once a year, preferably as part of your annual gynaecological check-up. Your doctor or clinic will advise you.
JADELLE® implants must be removed at the end of five years. However, they can be removed at any time before that, for either personal or medical reasons.
If you wish to continue using JADELLE®, a new set of implants can be inserted at the same time as the old set is removed.
Once the implants are removed, the contraceptive effect wears off quickly and you can become pregnant as rapidly as women who have used no contraceptive at all.
JADELLE® is a contraceptive. It is not intended to protect against sexual y transmitted diseases (STDs) including AIDS. If there is a risk of infection in your sexual activities, you should use a condom as well as JADELLE®.
JADELLE is a long-acting (up to 5 years) progestogen-only contraceptive implant. It consists of two flexible white rods 43mm x 2.5mm in diameter each containing 75mg levonorgestrel.
JADELLE must not be used if you are pregnant or if you have an acute blood clotting disorder, abnormal liver function or vaginal bleeding or sex-hormone dependent cancers or if you are sensitive to any of the ingredients of JADELLE. Careful consideration of the risks and benefits of JADELLE is required where there is a history of blood clots, heart attacks, stroke, pancreatitis, high blood cholesterol, diabetes with blood vessel damage or severe migraine.
Use strictly as directed and discontinue on medical advice if any of the following occur, development or worsening of migraine, jaundice, depression or visual disturbances. Inform your doctor immediately if you have severe abdominal pain together with no menstrual bleeding (an indication of an ectopic pregnancy), a rod is expelled, you have pus or bleeding at the injection site, you have a lump in your breast or a blood clot (possible warning signs are severe pain in the chest or breathlessness or severe pain or swelling in one of your legs).
Side effects that may occur include headache, nervousness, vaginal discharge, changes to your menstrual pattern, weight changes, nausea, acne, skin complaints and pain or bleeding at the injection site.
Read the package insert carefully. In all situations where the reliability of JADELLE is reduced (such as missing rod) additional contraceptive precautions are required.
You will need to pay for JADELLE and doctor’s charges apply. Additional information is available from Bayer Schering Pharma on 0800 80 45 45 or from www.medsafe.govt.nz. Bayer New Zealand Limited PO Box 2825, Shortland Street Auckland.
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