Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Undesirable effects are more common during the first months after the insertion, and subside during prolonged use.

Very common undesirable effects (occurring in more than 10% of users) include uterine/vaginal bleeding including spotting, oligomenorrhoea, amenorrhoea (see section 5.1).

The f requency of benign ovarian cysts depends on the diagnostic method used (see section 4.4) but has been estimated from clinical trial data to occur in 7% of users.

Table 2: Adverse Drug Reactions

System Organ        Common            Uncommon                 Rare         Unknown Class
≥ 1/100 to <      ≥ 1/1000 to < 1/100      ≥ 1/10,000
1/10                                       to <
1/1000
Immune system                                                               Hypersensitivity disorders                                                                   including rash, urticaria and angioedema
Psychiatric         Depressed disorders           mood/
Depression

Nervousness

Decreased libido
Nervous system Headache disorders
Migraine
Vascular            Dizziness disorders
Gastrointestinal Abdominal pain Abdominal distension disorders
Nausea
Skin and         Acne                 Alopecia                 Rash subcutaneous tissue disorders Hirsutism            Pruritus
Eczema
Chloasma/Skin
Hyperpigmentation
Musculoskeletal, Back pain connective tissue and bone disorders
Reproductive     Ovarian cysts        Uterine perf oration* system and breast disorders Pelvic pain          Pelvic inflammatory disease
Dysmenorrhoea
Endometritis
Vaginal discharge         Cervicitis/Papanicolaou smear normal, class II
Vulvovaginitis

Breast tenderness

Breast pain
General             Intrauterine    Oedema disorders and       contraceptive administration      device expelled site conditions
Investigations      Weight                                                 Blood pressure increase                                               increased

* This f requency is based on a large prospective comparative non-interventional cohort study in IUS/IUD users which showed that breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth are independent risk factors for perforation (see section 4.4). In clinical trials with Mirena that excluded breastfeeding women the f requency of perforation was "rare".

Cases of sepsis (including group A streptococcal sepsis) have been reported following IUD insertion (see section 4.4).

When a woman becomes pregnant with Mirena in situ, the relative risk of ectopic pregnancy is increased (see sections 4.4 and 4.6)

Cases of breast cancer have been reported in Mirena users (see section 4.4).

The f ollowing adverse reactions have been reported in connection with the insertion or removal procedure of Mirena: pain, bleeding and insertion-related vasovagal reaction with dizziness or syncope (see section 4.4). The procedure may also precipitate a seizure in patients with epilepsy.

The removal threads may be felt by the partner during intercourse.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
 https://sideeffects.health.gov.il