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                                                                     symptoms of hereditary and acquired 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.


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/