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.

The following undesirable effects have been reported in users of COCs: 
For serious adverse effects in COC users see section 4.4.

The occurrence of amenorrhea was reported in 15% of women during clinical trial, see section 4.4.
Some most frequently (greater than 10 %) reported adverse events during phase III studies and postmarketing surveillances in women using Minesse are headache, including migraines, abdominal pain, breast pain, breast tenderness.

Other adverse events have been reported in women taking COC:

System organ         Common              Uncommon               Rare             Not known (cannot class                (1/100 to <1/10)   (1/1,000 to           (1/10,000 to    be estimated from <1/100)                <1/1,000)        the available data)
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System organ       Common              Uncommon              Rare              Not known (cannot class              (1/100 to <1/10)   (1/1,000 to          (1/10,000 to     be estimated from <1/100)               <1/1,000)         the available data)
Infections and     Vaginitis,
Infestations       including candidiasis

Neoplasms                                                                      Hepatocellular benign,                                                                        carcinoma and malignant and                                                                  benign hepatic unspecified                                                                    tumours (e.g. focal (including cysts                                                               nodular and polyps)                                                                    hyperplasia, hepatic adenoma)

Immune system                                                                  Anaphylactic/ disorders                                                                      anaphylactoid reaction, including very rare cases of angioedema, severe reactions with respiratory and circulatory symptoms and urticaria.

Exacerbation of symptoms of hereditary and acquired angioedema.

Metabolism and                         Increased                               Glucose tolerance nutrition                              appetite,                               impaired disorders                              decreased appetite

Psychiatric        Mood altered,
disorders          including depression,
nervousness,
change in libido

Nervous system     Dizziness                                                   Optic neuritis, disorders                                                                      chorea aggravated 
Eye disorders                                                                  Contact lens intolerance

Vascular                               Aggravation of        Venous disorders                              varicose veins        thromboembolism and arterial thromboembolism

Gastrointestinal   Vomiting,                                 Pancreatitis      Colitis ischaemic, Page 13 of 18                                    2022-0081366
System organ        Common              Uncommon              Rare                 Not known (cannot class               (1/100 to <1/10)   (1/1,000 to          (1/10,000 to        be estimated from <1/100)               <1/1,000)            the available data) disorders           nausea, bloating                                               possible aggravation of inflammatory bowel disease,
abdominal cramps

Hepato-biliary                                                Hepatic and          Jaundice disorders                                                     hepatobiliary        cholestatic, disorders (e.g.      cholestasis1 hepatitis, hepatic function abnormal), biliary lithiasis1,
gallbladder disease2

Skin and            Acne, rash,         Chloasma                                   Erythema subcutaneous        alopecia            which may                                  multiforme, tissue disorders                        persist,                                   erythema nodosum hirsutism

Musculoskeletal                                                                    Exacerbation of and connective                                                                     systemic lupus tissue disorders                                                                   erythematosus 
Renal and urinary                                                                  Haemolytic disorders                                                                          uraemic syndrome 
Reproductive        Breakthrough        Breast system and breast   bleeding,           secretion, breast disorders           spotting,           enlargement dysmenorrhoea,
change in menstrual flow,
change in cervical ectroption and secretion

Congenital,                                                                        Exacerbation of familial and                                                                       porphyria genetic disorders

General disorders   Fluid and                 retention/oedema administration

Investigations      Weight              Blood pressure increased, weight   increased, lipids decreased           increased
1
COCs may worsen existing biliary lithiasis and cholestasis
2
COCs may worsen existing gallbladder disease and may accelerate the development of this disease in previously Page 14 of 18                                       2022-0081366
asymptomatic women.

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance.
Website: www.hpra.ie.