Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of safety profile
The most commonly reported adverse reactions with Diane 35 are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. They occur in ≥ 1 % of users.
There is an increased risk of thromboembolism for all women who use Diane 35 (see section 4.4).

Tabulated list of adverse events

System Organ        Adverse events reported in clinical trials                       Adverse events Class                                                                                reported post Common              Uncommon           Rare                      marketing (≥ 1/100            (≥ 1/1000 to       (≥1/10,000 to
to <1/10)           <1/100)            < 1/1000)

Eye disorders                                              contact lens 
                                                        intolerance
Gastrointestinal   nausea,           vomiting,
disorders          abdominal pain    diarrhea
Immune system                                           hypersensitivity         exacerbation of disorders                                                                        hereditary angioedema
Investigations     weight                               weight decreased increased
Metabolism and                       fluid retention                             hypertriglyceridemia nutrition
disorders
Nervous system         headache      migraine                                    exacerbation of disorders                                                                        chorea Gastrointestinal                                                                 Crohn's disease, disorders                                                                        ulcerative colitis Hepatobiliary                                                                    liver function disorders                                                                        disturbances Psychiatric       depressed          libido decreased   libido increased disorders         mood,
mood altered
Reproductive      breast pain,       breast             vaginal discharge,       reduced menstrual system and breast breast             hypertrophy        breast discharge         flow, spotting, disorders         tenderness                                                     breakthrough bleeding and missed
withdrawal bleeding,
post pill
amenorrhoea
Skin and                             rash, urticaria    erythema nodosum,        chloasma subcutaneous                                            erythema multiforme tissue disorders
Vascular                                                Thromboembolism          increase in blood Disorders                                                                        pressure 
Description of selected adverse reactions
Post-marketing reports of severe depression (including very rare reports of suicidal ideation or behaviour) in patients using Diane 35 have been received. However, a causal relationship between clinical depression and Diane 35 has not been established.

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 CHCs, 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 oestrogens 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/