Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most frequently reported adverse drug reactions during treatment with Prolutex during clinical trial are administration site reactions, breast and vulvo-vaginal disorders.
The table below displays the main adverse drug reactions in women treated with Prolutex in the pivotal clinical trial. Data is expressed by system organ class (SOC) and frequency.


System Organ Class        Very common         Common                   Uncommon (SOC)                     (≥ 1/10)            (≥ 1/100 to< 1/10)       (≥ 1/1000 to < 1/100) 
Psychiatric disorders                                                  Mood altered Nervous system                                Headache                 Dizziness, disorders                                                              Somnolence Gastrointestinal                              Abdominal distension     Gastrointestinal disorders                                     Abdominal pain           disturbances Nausea
Vomiting
Constipation
Skin and subcutaneous                                                  Pruritus tissue disorders                                                       Rash Reproductive system       Uterine spasm       Breast tenderness        Breast disorders and breast disorders      Vaginal             Breast pain haemorrhage         Vaginal discharge
Vulvo-vaginal pruritus
Vulvo-vaginal discomfort
Vulvo-vaginal inflammation
OHSS
General disorders and     Administration      Injection site           Feeling hot, administration site        site reactions*        haematoma                  Malaise conditions                                        Injection site             Pain induration
Fatigue
*Administration site reactions, such as irritation, pain, pruritus and swelling.

Class effects
The following disorders although not reported by patients in clinical studies using Prolutex have been described with other drugs in this class of medicines.

System Organ Class (SOC)
Psychiatric disorders                             Depression
Nervous system disorders                          Insomnia
Hepatobiliary disorders                           Jaundice
Reproductive system and breast disorders          Menstrual disturbances Premenstrual like syndrome
Skin and subcutaneous tissue disorders            Urticaria, Acne, Hirsutism, Alopecia General disorders and administration site         Weight gain conditions                                        Anaphylactoid reactions 
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/.