Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile:
The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea.

Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.

Tabulated list of adverse reactions:

The adverse reactions reported in the phase III program of 2,637 women are provided in the table below.

Adverse reactions listed below are classified according to frequency and system organ class 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).



MedDRA                      Adverse reactions (frequency)
System Organ Class          Common                Uncommon                           Rare 
Infections and                                       Influenza infestations
Immune system disorders                                                              hypersensitivity reactions including rash, urticaria,
angioedema**
Metabolism and nutrition                             Appetite disorders disorders
Psychiatric disorders    Mood disorders              Emotional disorder              Disorientation Anxiety
Insomnia
Hyperactivity disorder
Libido changes
Nervous system              Headache                 Somnolence                      Tremor disorders                   Dizziness                Migraine                        Disturbance in attention Dysgueusia
Syncope
Eye disorders                                        Visual disturbance              Abnormal sensation in eye
Ocular hyperaemia
Photophobia
Ear and labyrinth                                                                    Vertigo disorders
Respiratory, thoracic and                                                            Dry throat mediastinal disorders
Gastrointestinal disorders Nausea*                   Diarrhoea
Abdominal pain*           Dry mouth
Abdominal                 Dyspepsia discomfort                Flatulence
Vomiting*
Skin and subcutaneous                                Acne tissue disorders                                     Skin lesion
Pruritus
Musculoskeletal and         Myalgia connective tissue           Back pain disorders
Reproductive system and     Dysmenorrhea             Menorrhagia                     Genital pruritus breast disorders            Pelvic pain              Vaginal discharge               Dyspareunia Breast tenderness        Menstrual disorder              Ruptured ovarian cyst Metrorrhagia                    Vulvovaginal pain
Vaginitis                       Hypomenorrhea*
Hot flush
Premenstrual syndrome
General disorders and       Fatigue                  Chills                          Thirst administration site                                  Malaise conditions                                           Pyrexia
*Symptoms which could also be related to an undiagnosed pregnancy (or related complications) **Adverse reaction from spontaneous reporting

Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see section 4.2).


Post-marketing experience: the adverse reactions spontaneously reported in post-marketing experience were similar in nature and frequency to the safety profile described during the phase III program.

Description of selected adverse reactions:
The majority of women (74.6%) in the phase III studies had their next menstrual period at the expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses. The delay was greater than 20 days in 4 % of the women.

A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days. In a majority of cases (88.2%), this bleeding was reported as spotting. Among the women who received Ella in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.

In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of Ella (73 women enrolled twice and 9 enrolled three times). There were no safety differences in these subjects in terms of incidence and severity of adverse reactions, change in duration or volume of menses or incidence of intermenstrual bleeding.

Reporting of suspected adverse reactions:
Reporting of 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