Adverse reactions : תופעות לוואי

4.8. Undesirable effects

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.

Use of oral CHCs is also associated with an increased risk of:
- intraepithelial cervical neoplasia and cervical cancer;
- diagnosis of breast cancer;
- benign hepatic tumors (eg. Focal nodular hyperplasia, hepatic adenomas) 
See also section 4.4.

The following undesirable effects are listed by frequency grouping as follows: Very common ≥ 1/10
Common         ≥ 1/100, < 1/10
Uncommon       ≥ 1/1000, < 1/100
Rare           ≥ 1/10000, < 1/1000
Very rare      < 1/10000
Not known      (cannot be estimated from the available data)


System/target organ           Undesirable effect
Infections and infestations
Common                        Vaginitis including vaginal candidiasis Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Very rare                     Hepatocellular carcinoma
Immune system disorders
Rare                          Anaphylactic, anaphylactoid reactions, including very rare cases of urticaria, angio-oedema, severe respiratory and circulatory disorders
Very rare                     Exacerbation of systemic lupus erythematosus Not known                     Exacerbation of symptoms of hereditary and acquired angioedema
Metabolism and nutrition disorders
Uncommon                      Increase or decrease in appetite
Rare                          Glucose intolerance
Very rare                     Exacerbation of porphyria
Psychiatric disorders
Common                        Changes in mood and libido, depression
Nervous system disorders
Very common                   Headache, migraine
Common                        Nervousness, dizziness
Very rare                     Exacerbation of chorea


Eye disorders
Rare                              Intolerance of contact lenses
Very rare                         Optic neuritis*
Vascular disorders
Rare                              Venous thromboembolism (VTE), arterial thromboembolism (ATE)

Very rare                         Thrombosis in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries
Aggravation of varicose veins
Gastrointestinal disorders
Common                            Nausea, vomiting, abdominal pain
Uncommon                          Abdominal cramps, bloating
Very rare                         Pancreatitis, ischemic colitis
Not known                         Inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
Hepatobiliary disorders
Rare                              Cholestatic jaundice
Very rare                         Gallstones, cholestasis**
Not known                         Hepatocellular injury (eg. Hepatitis, hepatic function abnormal)
Skin and subcutaneous tissue disorders
Common                            Acne
Uncommon                          Rash, chloasma, possibly persistent, hirsutism, alopecia.
Rare                              Nodular erythema.
Very rare                         Erythema multiforme
Renal and urinary disorders
Very rare                         Uraemic haemolytic syndrome
Reproductive system and breast disorders
Very common                       Withdrawal bleeding/spotting
Common                            Pain and tenderness of the breasts, increase in volume and secretions; dysmenorrhoea; change in vaginal secretions and menstruation, amenorrhoea, uterine ectropion
General disorders and administration site conditions
Common                            Fluid retention, oedema
Investigations
Common                            increase or decrease in body weight 
Uncommon                          Arterial hypertension, change in plasma lipid levels, hypertriglyceridaemia
Rare                              Reduction in serum folate levels*** 
*       Optic neuritis can cause partial or total blindness.
**      Oral CHCs can exacerbate an existing disorder of the gallbladder or activate the development of such a disorder in asymptomatic users.
***     Serum folate levels can be reduced under oral CHCs. This can be of clinical significance if the user rapidly falls pregnant after stopping the pill.

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