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.

For serious adverse effects when taking CHCs, see section 4.4. For lipid disorders, gallbladder diseases, breast cancer, see also section 4.4. The most frequently (greater than 1 in 10) reported adverse events during phase III studies and post marketing surveillance in women using Minulet are headache, including migraines and breakthrough bleeding/spotting.

Use of CHCs has been associated with an increased risk of the following: • Cervical intraepithelial neoplasia and cervical cancer
• Being diagnosed with Breast cancer
• Benign hepatic tumours (e.g. focal nodular hyperplasia, hepatic adenoma) 
Other adverse events have been reported in women taking Minulet:

System organ                         Frequency of adverse events class
Very           Common              Uncommon           Rare          Not Known Common          (1/100 to           (1/1,000 to   (1/10,000 to     (cannot be (1/10)          <1/10)               <1/100)        <1/1,000)     estimated from the available data)
Infections and                    Vaginitis,
infestations                      including candidiasis
Immune system                                                           Anaphylactic/a    Exacerbation disorders                                                               naphylactoid      of symptoms reactions         of hereditary including very    and acquired rare cases of     angioedema urticaria,
angioedema and severe reactions with respiratory and circulatory symptoms
Metabolism and                                           Changes in     Glucose nutrition                                                appetite       intolerance disorders                                                (increase or decrease)
Psychiatric                       Mood changes,
disorders                         including depression;
changes in libido
Nervous system     Headache,      Nervousness;                          Stroke, disorders          including      dizziness                             transient migraine                                             ischaemic attack
Eye disorders                                                           Intolerance to contact lenses
Cardiac                                                                 Myocardial Disorders                                                               infarction Vascular                                                                Arterial disorders                                                               thromboemboli sm, venous thromboemboli sm
Respiratory,                                                            Pulmonary thoracic and                                                            embolism mediastinal disorders
Gastrointestinal                  Nausea,                Abdominal disorders                         vomiting,              cramps,
abdominal pain         bloating
Hepatobiliary                                                           Cholestatic disorder                                                                jaundice Skin and                          Acne                   Rash,          Erythema subcutaneous                                             chloasma       nodosum tissue disorders                                         (melasma) which may persist,
hirsutism,
alopecia
Reproductive       Breakthroug    Breast pain,
system and         h bleeding     tenderness,
breast disorders   and spotting   enlargement,
secretion,
dysmenorrhea,
change in menstrual flow,

                                  change in cervical ectropion and secretion,
amenorrhea
General                           Fluid disorders                         retention/oedem a
Investigations                    Change in              Increase in     Decrease in weight                 blood           serum folate
(increase or           pressure,       levels (serum decrease)              changes in      folate levels serum lipid     may be levels,         depressed by including       CHC therapy) hypertriglyce ridemia

The following adverse events have been classified as very rare adverse events (<1/10,000): • Exacerbation of systemic lupus erythematosus
•   Exacerbation of porphyria
•   Exacerbation of chorea
•   Optic neuritis (optic neuritis may lead to partial or complete loss of vision) •   Aggravation of varicose veins
•   Retinal vascular thrombosis
•   Pancreatitis
•   Ischaemic colitis
•   Hepatic adenomas
•   Hepatocellular carcinomas
•   Gallbladder disease, including gallstones (CHCs may worsen existing gallbladder disease and may accelerate the development of this disease in previously asymptomatic women)
•   Erythema multiforme
•   Haemolytic uremic syndrome

The frequency of the following adverse effects is unknown (cannot be estimated from the available data):
• Hepatocellular injury (e.g. hepatitis, hepatic function abnormal) • Inflammatory bowel disease (Crohn’s Disease, ulcerative colitis).

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/