Adverse reactions : תופעות לוואי

4.8    Undesirable Effects
Summary of the safety profile
The most commonly reported adverse reactions with Gynera are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. They occur in ≥1% of users.
Serious adverse reactions are arterial and venous thromboembolism.

System Organ          Adverse events reported in clinical trials               Adverse events Class                                                                          reported post marketing
Common      Uncommon                Rare
(≥ 1/100)   (≥ 1/1000, < 1/100)     (<1/1000)
Eye disorders                                             contact lens intolerance
Gastrointestinal      nausea,   vomiting, diarrhea                             Ulcerative colitis disorders             abdominal pain
Immune system                                             hypersensitivity     Exacerbation of disorders                                                                      symptoms of hereditary and acquired angioedema
Investigations        weight                              weight decreased increased
Metabolism and                    fluid retention nutrition disorders
Nervous system        headache    migraine                                     exacerbation of disorders                                                                      chorea Vascular system                                           Venous thromboembolism
(VTE), Arterial thromboembolism
(ATE)
Hepatobiliary                                                                  liver function disorders                                                                      disturbances Psychiatric           depressed libido decreased          libido increased disorders             mood,
mood altered
Reproductive          breast     breast hypertrophy       vaginal discharge,   reduced menstrual system and breast     pain,                               breast discharge     flow, spotting, disorders             breast                                                   breakthrough tenderness                                               bleeding and missed withdrawal bleeding, post pill amenorrhoea
Skin and                          rash, urticaria         erythema             chloasma subcutaneous tissue                                       nodosum,
disorders                                                 erythema
multiforme

Description of selected adverse reactions
An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4.

The following serious adverse events have been reported in women using COCs, which are discussed in section 4.4 ‘Special warnings and precautions for use’: 
•   Venous thromboembolic disorders
•   Arterial thromboembolic disorders
•   Strokes (e.g. transient ischemic attack, ischemic stroke, haemorrhagic stroke) •   Hypertension
•   Hypertriglyceridemia
•   Liver tumours (benign and malignant)

The frequency of diagnosis of breast cancer is very slightly increased among COC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown. For further information, see sections 4.3 ‘Contraindications’ and 4.4 ‘Special warnings and precautions for use’.

Conditions reported to deteriorate with pregnancy or previous COC use 
Jaundice and/or pruritus related to cholestasis; gallstone formation; systemic lupus erythematosus; herpes gestationis; otosclerosis-related hearing loss; Crohn's disease, sickle cell anaemia; renal dysfunction; hereditary angioedema; porphyria; cervical cancer.

Changes in glucose tolerance or effect on peripheral insulin resistance have been reported in women using COCs (see section 4.4).


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/