Mirena Allergic Skin Reactions, Ovarian Follicles, Pelvic Inflammatory Disease, Method Failure, Menstrual Periods
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Serious side effects
If a pregnancy occurs in the case of method failure, the risk that it may be ectopic (located outside the womb) is increased. This requires immediate medical attention (see symptoms listed in the section "What else you should know"). Pelvic inflammatory disease, which may be serious, can occur during the use of the IUS. Enlarged ovarian follicles may require medical attention. MIRENA may pierce the wall of the womb. In addition, cases of breast cancer have been reported (frequency unknown).
Other possible side effects
It is perfectly normal for you to experience changes in menstrual bleeding patterns during the use of MIRENA. The changes may include spotting, shorter or longer menstrual periods, irregular bleeding, prolonged interval of bleeding or no bleeding at all, heavy flow and menstrual pain.
Ovarian cysts have been detected in 12% of women during the use of MIRENA.
Allergic skin reactions may be due to the IUS.
In addition, the following undesirable effects that may be associated with MIRENA have been reported. These side effects have been listed by the parts of the body that they may affect and how common they are.
The following definitions apply when the words "common", "uncommon" and "rare" appear in this leaflet relating to adverse effects:
"very common" means more than 1 in every 10 patients may experience these.
"common" means between 1 and 10 in every 100 patients may experience these.
"uncommon" means between 1 and 10 in every 1,000 patients may experience these.
"rare" means between 1 and 10 in every 10,000 patients may experience these.
Nervous System and Psychiatric Disorders
Common - headache
- decreased libido
Uncommon - migraine
- altered mood
Common -abdominal pain
- nausea (feeling sick)
Uncommon - abdominal bloating
Skin and Subcutaneous Disorders
Common - acne
Uncommon - excessive body hair (hirsuitism)
- hair loss
- severe itching (pruritis)
- inflammation of the skin (eczema)
Rare - rash
- hives (urticaria)
Musculoskeletal, Connective Tissue and Bone Disorders
Common - back pain
Reproductive System Disorders
Very Common - uterine or vaginal bleeding including spotting, infrequent periods
(oligomenorrhea), and absence of bleeding (amenorrhea)
- benign ovarian cysts (see the section called "Enlarged ovarian follicles")
Common - pelvic pain
- painful menstruation (dysmenorrhea)
- vaginal discharge
- inflammation of the external genital organs or vagina (vulvovaginitis)
- breast tenderness
- breast pain
- expulsion of MIRENA
Uncommon - pelvic inflammatory disease (infection of the female upper genital tract, the female structures above the neck of the womb)
- inflammation of the lining of the womb (endometritis)
- inflammation of the neck of the womb (cervicitis/Papanicalaou smear normal, class II)
Rare - perforation of the womb
Common - weight gain
Uncommon - swelling (edema)
Similar side effects have been reported when MIRENA has been used for hormone replacement therapy in combination with estrogen preparations.
These side effects are more common during the first months after insertion, and subside during prolonged use.
If you are concerned about any of these side effects or notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Do not use after the expiry date stated on the package.
Store all medicines properly and keep them out of reach of children.
active substances (per implant)
levonorgestrel (52 mg)
polydimethylsiloxane elastomer, silica (colloidal anhydrous), polyethylene, barium sulphate, iron oxide
If you have any further questions please consult your doctor or pharmacist.
This leaflet was last revised on 29th May 2007