Description NovaT 380 Cu380Ag A medical device in the form of an intrauterine device containing copper. Product to be fitted only by qualified medical personnel. Composition Copper, silver, polyethylene, barium sulfate, iron oxide (E 172). Action A medical device, the NovaT 380 Cu380Ag IUD has contraceptive properties. It acts locally, inside the uterus, preventing fertilization. Thanks to its copper content, the IUD inhibits sperm, the egg, and the eggs transport to the fallopian tube. It is approved for use for up to five years. NOTE: The IUD provides protection from the moment it is inserted, but pregnancy can occur after it is removed. How to use a medical device The NovaT 380 Cu380Ag contraceptive device is inserted into the uterus. This procedure can only be performed by a doctor! For additional information, consult your doctor and read the package leaflet. During the entire period of use of the product, follow the doctors recommendations. Contraindications and precautions The NovaT 380 Cu380Ag intrauterine device should not be used: If pregnancy is confirmed or suspected. In case of inflammation of the reproductive organs, or at a high risk of their occurrence. In case of congenital or acquired uterine defect, including fibroids, if they distort the uterine cavity. In untreated cervical dysplasia. In untreated malignant tumor of the uterus. In case of inflammation of the uterus within three months after childbirth, miscarriage or termination of pregnancy. In case of copper allergy. In case of coagulation disorders. In Wilsons disease. During genital bleeding, if the cause is unknown. Contraindications to the use of the insert may also include: Heavy periods. Anemia. Uterine fibroids. Consult your doctor in the following cases: For regular check-ups. For pain and cramps in the lower abdomen. In case of fainting. When infection is suspected (it may manifest itself as pain, fever, vaginal discharge). If your period is delayed or you suspect pregnancy. If the IUD has shifted or you cannot feel the IUD threads in your vagina. For heavy or unusual bleeding or changes in menstrual flow. Possible side effects of a medical device After inserting the NovaT 380 Cu380Ag IUD, some women may experience headaches and dizziness. If these symptoms persist after half an hour, a doctor should check that the IUD is properly inserted. In the first few weeks after insertion, you may experience period-like pain and spotting. If these symptoms persist or become more severe, consult your doctor. You may experience heavier menstrual bleeding when using an IUD. Rarely, the IUD may fall out. If you suspect this, contact your doctor. Comments Before use, please read the instructions for use or the label/ Fragile product, do not bend or crush! The product does not protect against sexually transmitted diseases! Pregnancy and breastfeeding The NovaT 380 Cu380Ag insert must not be used during pregnancy. Impact on fertility The product has a contraceptive effect, preventing fertilization.