Adverse reactions : תופעות לוואי

4.8 Undesirable effects
In controlled clinical trials involving 759 patients, the most commonly reported ADRs were urogenital (26%) and gastrointestinal (14%).
The following adverse experiences have been reported, and within each system organ class, are ranked by frequency, using the following convention:
Very common (≥1/10)
Common (≥1/100, < 1/10)
Uncommon (≥ 1/ 1,000, < 1/100)
Rare (≥1/10,000, < 1/1,000)
Very rare (<1/10,000), including isolated reports

Infections and infestations
Common: Vaginal candidiasis.

Metabolism and nutrition disorders
Common: Decreased appetite.
Psychiatric Disorders
Uncommon: Depression, difficulty sleeping.

Nervous system disorders
Common: Headache, dizziness.
Uncommon: Paraesthesia, hypoesthesia, dysgeusia
(metallic taste).

Gastrointestinal disorders
Common: GI discomfort/abdominal cramps, vomiting, unpleasant taste/unusual feeling on tongue.
Uncommon: Diarrhoea, constipation, abdominal bloating/noises, nausea, dry mouth.

Skin and subcutaneous tissue disorders
Common: Dry skin, erythema, pruritus, skin discomfort (burning, pain of skin/stinging), skin irritation.
Not known Urticaria.

Musculoskeletal and connective tissue disorders
Uncommon: Cramp.

Renal and urinary disorders
Uncommon: Urine discolouration, urinary tract infection symptoms.
Reproductive system and breast disorders
Common: Vaginal itching/irritation/burning/numbness, pelvic discomfort, vaginal discharge.
Uncommon: Oedema vulva, menstrual discomfort/irregularities, vaginal spotting/bleeding.

General disorders and administration site conditions
Uncommon: Fatigue, irritability.

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.