Adverse reactions : תופעות לוואי

4.8. Undesirable effects:

Oral administration:
The following effects have been seen:
Common            Uncommon              Rare             Very rare
System organ         undesirable       undesirable         undesirable        undesirable class          effects ≥1/100;   effects ≥1/1000;     effects ≥1/10      effects ≤1/10 <1/10             ≤1/100          000; ≤1/1 000           000
-Altered          -Mastodynia
Reproductive       periods system and breast    -Amenorrhoea disorders        -Intercurrent bleeding
-Headaches        -Drowsiness                           -Depression
Central nervous
-Fleeting dizzy system disorders sensations
-Vomiting           -Nausea
Gastrointestinal
-Diarrhoea disorders
-Constipation
Hepatobiliary                       -Cholestatic disorders                         jaundice
Immune system                                                               -Urticaria disorders
Skin and                          -Pruritus                             -Chloasma subcutaneous                         -Acne tissue disorders


Drowsiness and/or fleeting dizzy sensations are seen particularly with concomitant hypoestrogenism. These effects disappear immediately without compromising the benefit of treatment when doses are reduced or oestrogenism is increased.

If the treatment sequence is started too early in the month, particularly before the 15th day of the cycle, the cycle may be shortened or intercurrent bleeding may occur.

Changes in periods, amenorrhoea or intercurrent bleeding have been observed and associated with the use of progesterones in general.

Vaginal administration
Despite the possibility of local irritation may occur (soya lecithin), no significant local intolerance (burning, pruritus or greasy discharge) has been observed during different clinical trials.

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/