9
– Very rarely, directly after the insertion of copper-containing coils (such
as MelbeaGold), the patient may experience pain and dizziness.
If these symptoms persist after a 30-minute rest period, it is possible
that the position of the product inside the uterus is not suitable. In such
cases, the position of the IUD has to be checked and if it is not suitable,
the device must be removed.
It is recommended that you stay in the waiting room of your gynaecologist
or healthcare service provider for half an hour. You might be asked to
lay down until you feel better and to get up slowly afterwards. If you do
not experience these symptoms, feel free to leave the waiting room.
– Women may use the MelbeaGold product for contraception while
breastfeeding.
However, an increased risk of perforation was shown in the case of
breastfeeding women. If the device is inserted directly after childbirth,
the chance of the partial or complete perforation of the uterine wall is
higher due to the uterine wall being softer.
– MelbeaGold may trigger allergic reactions in hypersensitive individuals.
Before insertion, it is recommended to perform a test to confirm that you
are not allergic to copper, nickel, or plastics.
– You may use tampons while wearing the MelbeaGold device.
– The warnings related to the use of medications, other devices, and medical
treatments while wearing the MelbeaGold device are included in Section 8.
– Your doctor will inform you how you can check the presence of the
indicator string in your vagina; further details are included in Section 11.
– The warnings related to the possible side effects you may experience
while wearing the MelbeaGold device are included in Section 14.
8. WHAT POTENTIAL INTERACTIONS AND INCOMPATIBILITIES
ARE KNOWN BETWEEN MELBEAGOLD AND OTHER MEDICAL
TREATMENTS AND MEDICATIONS?
8.1. Interactions with medications and other devices
The MelbeaGold device and the equivalent Goldlily device have not undergone
an interaction study to identify possible interactions between the medical
devices and other treatments, medications, and devices.
Experience and the relevant scientific literature have shown that a reduction
in the effectiveness of copper-containing IUDs as a result of the use of
medication is unlikely.
However, notices contain information about a reduction in the effectiveness
of copper-containing IUDs as a result of the long-term use of non-steroidal
anti-inflammatory drugs (acetylsalicylic acid in particular) as well as
corticosteroids.
It appears that the
short-term use
of corticosteroids for the treatment of
period pain (dysmenorrhea) does not affect the contraceptive effectiveness
of copper-containing IUD.
8.2. Potential interactions and incompatibilities with other medical
treatments
– Short-wave diathermy of the pelvic region must not be performed while
the device is in place!
Medical devices generating high doses of radio frequency (RF) energy,
such as diathermy devices, may cause undesirable health effects in
the case of women wearing copper-containing IUDs, including the
MelbeaGold device, due to the heating of the tissues.