Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The most frequently reported undesirable effects in the clinical trials with NuvaRing were headache and vaginal infections and vaginal discharge, each reported by 5-6% of the women.

Description of selected adverse reactions
An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4.
Also other undesirable effects have been reported in women using CHCs: these are discussed in more detail in section 4.4.

Adverse drug reactions that have been reported in clinical trials, observational studies, or during postmarketing use with NuvaRing are listed in the Table below. The most appropriate MedDRA term to describe a certain adverse event is listed.

All adverse reactions are listed by system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and not known (cannot be estimated from the available data).

System Organ          Common             Uncommon                Rare          Not known1 Class

Infections and     Vaginal infection   Cervicitis,
infestations                           Cystitis, Urinary tract infection

Immune system                                                                Hypersensitivity disorders                                                                    reactions, including anaphylaxis and exacerbation of symptoms of hereditary and acquired angioedema
Metabolism and                         Increased nutrition                              appetite disorders

Psychiatric        Depression,         Affect lability,
disorders          Libido              Mood altered,
decreased           Mood swings

Nervous system     Headache,           Dizziness,
disorders          Migraine            Hypoaesthesia
Eye disorders                          Visual disturbance

Vascular                               Hot flush           Venous disorders                                                  thromboembolism Arterial thromboembolism
Gastrointestinal   Abdominal pain,     Abdominal disorders          Nausea              distension,
Diarrhoea,
Vomiting,
Constipation

Skin and           Acne                Alopecia,                             Chloasma subcutaneous                           Eczema,
tissue disorders                       Pruritus, Rash
Urticaria
Musculoskeletal                        Back pain,
and connective                         Muscle spasms,
tissue disorders                       Pain in extremity

Renal and                              Dysuria,
urinary disorders                      Micturition urgency,
Pollakiuria

Reproductive        Breast             Amenorrhoea,        Galactorrhoea   Penis disorders system and          tenderness,        Breast breast disorders    Genital pruritus   discomfort,
female,            Breast
Dysmenorrhoea,     enlargement,
Pelvic pain,       Breast mass,
Vaginal            Cervical polyp,
discharge          Coital bleeding,
Dyspareunia,
Ectropion of cervix,
Fibrocystic breast disease,
Menorrhagia,
Metrorrhagia,
Pelvic discomfort,
Premenstrual syndrome,
Uterine spasm,
Vaginal burning sensation,
Vaginal odour,
Vaginal pain,
Vulvovaginal discomfort,
Vulvovaginal dryness

General                                Fatigue,                            Vaginal ring site disorders and                          Irritability,                       tissue administration                         Malaise,                            overgrowth site conditions                        Oedema,
Sensation of foreign body

Investigations      Weight             Blood pressure increased          increased

Injury, poisoning   Vaginal ring       Vaginal ring                        Vaginal injury and procedural      discomfort,        complication                        associated with complications       Vaginal ring                                           ring expelled                                               breakage

Listing of adverse events based on spontaneous reporting.
Hormone-dependent tumours (e.g. liver tumours, breast cancer) have been reported in association with CHC use. For further information see section 4.4.

On very rare occasions NuvaRing has been reported to get disconnected during use (see sections 4.4 and 4.5).

Interactions
Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with hormonal 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