Adverse reactions : תופעות לוואי

4.8    Undesirable effects
For serious undesirable effects in COC users see also section 4.4.

The following adverse drug reactions have been reported during use of Yasmin: 

System Organ Class                                 Frequency of adverse reactions (MedDRA)                              Common              Uncommon                       Rare ≥ 1/100 to <1/10       ≥ 1/1,000 to           ≥ 1/10,000 to <1/1,000 < 1/100
Immune system disorders                                                      Hypersensitivity, Asthma
Psychiatric disorders          Depressive mood        Libido   increased, Libido decreased
Nervous system disorders       Headache
Ear and labyrinth disorders                                                  Hypoacusis Vascular disorders             Migraine               Hypertension,          Venous Hypotension            thromboembolism
(VTE)

Arterial thromboembolism
(ATE)
Gastrointestinal disorders     Nausea                 Vomiting, Diarrhoea Skin and subcutaneous                                 Acne,                  Erythema nodosum, tissue disorders                                      Eczema,                Erythema multiforme Pruritus,
Alopecia
Reproductive system      and   Menstrual disorders,   Breast                 Breast discharge breast disorders               Intermenstrual         enlargement,
bleeding,              Vaginal infection
Breast pain,
Breast tenderness,
Vaginal discharge,
Vulvovaginal candidiasis
General disorders and                                 Fluid retention, administration site                                   Weight increased, conditions                                            Weight decreased 

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;
−   Hypertension;
−   Liver tumours;
−   Occurrence or deterioration of conditions for which association with COC use is not conclusive: Crohn’s disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice; −   Chloasma;
−   Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
−   In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.

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 and 4.4.


Interactions
Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see section 4.5).

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