Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post- marketing surveillance by system organ class and frequency. Adverse reactions identified from post- marketing experience are included in italics. The frequency grouping is defined using the following convention: 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); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1. Adverse Reactions
System Organ         Very        Common         Uncommon            Rare           Very      Frequency Not Class               Common       ≥1/100 to      ≥1/1 000 to      ≥1/10 000 to      Rare      Known (Cannot ≥1/10        <1/10           <1/100           <1/1000       <1/10 000    Be Estimated From Available
Data)
Blood and                                                        Disseminated lymphatic                                                        intravascular system disorders                                                 coagulation* Immune system                                                                                Hypersensitivity, disorders                                                                                    Anaphylactic reaction,
Anaphylactic shock,
Anaphylactoid reaction
Cardiac                                                                                      Cardiac arrest disorders
Vascular                                                                                     Hypertension∗∗ disorders
Respiratory,                                                                                 Asthma∗∗, thoracic and                                                                                 Bronchospasm∗∗ mediastinal disorders
Gastrointestinal    Vomiting   Nausea                                                        Diarrhoea disorders
Skin and                                                                                     Rash subcutaneous tissue disorders
Musculoskeletal                Back pain and connective tissue disorders
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System Organ            Very             Common            Uncommon              Rare              Very            Frequency Not Class                  Common            ≥1/100 to         ≥1/1 000 to        ≥1/10 000 to         Rare           Known (Cannot ≥1/10             <1/10              <1/100             <1/1000          <1/10 000          Be Estimated From Available
Data)
Pregnancy,                            Uterine                                                                    Uterine rupture, Puerperium and                        hypertonus,                                                                Premature Perinatal                             Foetal distress                                                            separation of conditions                            syndrome,                                                                  placenta, Uterine                                                                    Anaphylactoid contractions                                                               syndrome of abnormal                                                                   pregnancy∗∗, Rapid cervical dilatation,
Neonatal distress,
Death neonatal††,
Stillbirth†, Foetal death
Reproductive                          Vulvovaginal                                                               Irritation, Pain system and                            burning breast disorders                      sensation
General                               Pyrexia disorders and administration site conditions
Investigations        Foetal                                                                                     Apgar score low heart rate abnormal†
* Reported during post marketing surveillance
∗∗ Maternal adverse events that have been reported only with use of the vaginal tablets.
† Foetal adverse events that have been reported with use of the cervical gel, intravaginal gel and vaginal tablets.
†† Foetal adverse event has only been reported with vaginal tablets.



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