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 Microdiol 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) and rare (<1/1,000).



4
System Organ Class               Common                     Uncommon          Rare 
Immune system disorders                                                       Hypersensitivity Metabolism and nutrition                                    Fluid retention disorders
Psychiatric disorders            Depressed mood,            Libido            Libido increased mood altered               decreased
Nervous system disorders Headache                           Migraine

Eye disorders                                                                 Contact lens intolerance Vascular disorders                                                            Venous thromboembolism2 Arterial thromboembolism2
Gastrointestinal disorders       Nausea,                    Vomiting, abdominal pain             diarrhoea
Skin and subcutaneous                                       Rash, urticaria Erythema nodosum, tissue disorders                                                            erythema multiforme 
Reproductive system and          Breast pain, breast Breast                   Vaginal discharge, breast disorders                 tenderness          enlargement              breast discharge 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:
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic @moh.health.gov.il).