Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Description of selected adverse reactions
As with all COCs, changes in vaginal bleeding patterns may occur, especially during the first months of use. These may include changes in bleeding frequency (absent, less, more frequent or continuous), intensity (reduced or increased) or duration.
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.
Possibly related undesirable effects that have been reported in users of Mercilon or CHC users in general are listed in the table below1. All ADRs are listed by system organ class and frequency; common (≥1/100), uncommon (≥1/1,000 to < 1/100), rare (<1/1,000) and not known (cannot be estimated from the available data).
System Organ             Common        Uncommon                      Rare          Not known Class

Immune system                                                Hypersensitivity      Exacerbation disorders                                                                          of symptoms of hereditary and acquired angioedema

Metabolism and                         Fluid retention nutrition disorders

Psychiatric           Depressed        Libido decreased      Libido increased disorders             mood, mood altered

Nervous system        Headache         Migraine disorders

Eye disorders                                                Contact lens intolerance

Vascular disorders                                           Venous thromboembolism2

Arterial thromboembolism2
Gastrointestinal      Nausea,          Vomiting, diarrhoea disorders abdominal pain

Skin and                               Rash, urticaria       Erythema nodosum, subcutaneous                                                 erythema multiforme tissue disorders

Reproductive          Breast pain,     Breast                Vaginal discharge,  system and breast   breast             enlargement           breast discharge disorders           tenderness


Investigations      Weight increased                         Weight decreased 1
The most appropriate MedDRA term (version 11) to describe a certain adverse reaction is listed.
Synonyms or related conditions are not listed, but should be taken into account as well.
2
Incidence in observational cohort studies of ≥1/10000 to 1/1000 women-years.


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)