Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
Six multi-centre clinical trials of up to one- year duration were used to evaluate safety of Zoely. In total 3,434 women, aged 18-50, were enrolled and completed 33,828 cycles.
Most commonly reported adverse reactions in these clinical trials were acne (15.4%) and withdrawal bleeding irregular (9.8%).
An increased risk for venous and arterial thromboembolism, causative of serious adverse events has been observed with the use of CHCs (see section 4.4).

Tabulated list of adverse reactions

Possibly related adverse reactions that have been reported in clinical trials or during post- marketing use with Zoely are listed in the table below.
Adverse reactions are listed according to the MedDRA system organ class and ranked under frequency groupings using the following convention; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).

Table: List of adverse reactions
Adverse reaction in MedDRA Term1
System organ class      Very common      Common           Uncommon              Rare 

Metabolism and                                          increased         decreased nutrition disorders                                     appetite, fluid   appetite retention
Psychiatric disorders                  decreased                          increased libido libido,
depression/ depressed mood, mood altered
Nervous system                         headache,                          cerebrovascular disorders                              migraine                           accident, transient ischaemic attack,
disturbance in attention
Eye disorders                                                             contact lens intolerance/dry eye
Vascular disorders                                      hot flush         venous thromboembolis m
Gastrointestinal                       nausea           abdominal         dry mouth disorders                                               distension
Hepatobiliary                                                             cholelithiasis, disorders                                                                 cholecystitis Skin and                acne                            hyperhydrosis,    chloasma, subcutaneous tissue                                     alopecia,         hypertrichosis disorders                                               pruritus, dry skin, seborrhea
Musculoskeletal and                                     sensation of connective tissue                                       heaviness disorders
Reproductive            abnormal       metrorrhagia,    hypomenorrho      vaginal odour, system and breast       withdrawal     menorrhagia,     ea, breast        vulvovaginal disorders               bleeding       breast pain,     swelling,         discomfort pelvic pain      galactorrhoea,
uterine spasm,
premenstrual syndrome,
breast mass,
dyspareunia,
vulvovaginal dryness

Adverse reaction in MedDRA Term1
System organ class        Very common         Common           Uncommon                  Rare 

General disorders                                              irritability,      hunger and administration                                             oedema site conditions
Investigations                              weight             hepatic increased          enzyme increased
1The  most appropriate MedDRA term to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.

In addition to the above-mentioned adverse reactions, hypersensitivity reactions have been reported in Zoely users (frequency unknown).
Description of selected adverse reactions
An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4.

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