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        <1/1 000       <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            <1/1 000          <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 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/