Adverse reactions : תופעות לוואי

4.8    Undesirable effects
Summary of the safety profile
The majority of women experience changes in menstrual bleeding pattern after insertion of Janess. Over time, the frequency of amenorrhoea and infrequent bleeding increases, and the frequency of prolonged, irregular and frequent bleeding decreases. The following bleeding patterns were observed in clinical trials: 

Table 2: Bleeding patterns reported with Janess in clinical trials

Janess                                    Second 90
First 90 days                      End of year 1   End of year 3 days
Amenorrhea                 <1%                3%                6%             12% Infrequent
8%               19%               20%             22% bleeding
Frequent bleeding          31%               12%                8%             4% Irregular bleeding*        39%               25%               18%             15% Prolonged
55%               14%                6%             2% bleeding*

*Subjects with irregular bleeding and prolonged bleeding may also be included in one of the other categories (excluding amenorrhea)


Tabulated summary of adverse events
The frequencies of Adverse Drug Reactions (ADRs) reported with Janess are summarised in the table below. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥ 1/10),
common (≥ 1/100 to < 1/10),
uncommon (≥ 1/1,000 to < 1/100),
rare (≥ 1/10,000 to < 1/1,000),
very rare (< 1/10,000).


System Organ            Very Common             Common                Uncommon Class


Psychiatric                                     Depressed mood/ disorders                                       Depression
Decreased libido
System Organ              Very Common               Common                     Uncommon Class


Nervous system            Headache                  Migraine disorders
Vascular disorders                                                             Dizziness 

Gastrointestinal          Abdominal/pelvic          Nausea disorders                 pain
Skin and                  Acne/ Seborrhoea          Alopecia                   Hirsutism subcutaneous tissue disorders

Reproductive              Bleeding changes          Upper genital tract        Uterine perforation** system and breast         including increased       infection disorders                 and decreased             Dysmenorrhea menstrual bleeding,       Breast spotting, infrequent      pain/discomfort bleeding and              Device expulsion amenorrhea                (complete and
Ovarian cyst*             partial)
Vulvovaginitis            Genital discharge

Investigations                                      Increased weight

* In clinical trials ovarian cysts had to be reported as AEs if they were abnormal, non- f unctional cysts and/or had a diameter > 3 cm on ultrasound examination.
** This f requency is based on a large prospective comparative non-interventional cohort study with women using another LNG-IUS and copper IUDs, which showed that breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth are independent risk f actors for perforation (see section 4.4 under Perforation). In clinical trials with Janess that excluded breastfeeding women the frequency of perforation was “rare”.


Description of selected adverse reactions
With the use of LNG-IUS, cases of hypersensitivity including rash, urticaria and angioedema have been reported.
If a woman becomes pregnant while using Janess, the relative likelihood of this pregnancy being ectopic is increased (see section 4.4 under Ectopic Pregnancy).
The removal threads may be felt by the partner during intercourse.
The following ADRs have been reported in connection with the insertion or removal procedure of Janess: Procedural pain, procedural bleeding, insertion-related vasovagal reaction with dizziness or syncope. The procedure may precipitate a seizure in an epileptic patient.
Cases of sepsis (including group A streptococcal sepsis) have been reported following IUD insertion (see section 4.4 under Pelvic Infection).


Paediatric population
The safety profile of Janess observed in a study of 304 adolescents was consistent with that in the adult population.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 f orm https://sideeffects.health.gov.il /