Adverse reactions : תופעות לוואי

4.8    Undesirable Effects
Summary of the safety profile
The most commonly reported adverse reactions with Microgynon 30 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.

The following adverse events have been reported during use of ethinylestradiol / levonorgestrel:

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