Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Cerazette. Since Cerazette causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills. In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent. Information, counselling, and a bleeding diary can improve the woman’s acceptance of the bleeding pattern.

The most commonly reported other undesirable effects in the clinical trials with Cerazette (>2.5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table below.


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

System Organ                                      Frequency of adverse reactions Class                     Common                        Uncommon            Rare               Not known (MedDRA)*
Infections and                                            Vaginal infection infestations
Immune                                                                                          Hypersensitivity system                                                                                          reactions, disorders                                                                                       including angioedema and anaphylaxis
Psychiatric       Mood altered, Depressed mood,
disorders         Libido decreased
Nervous           Headache system disorders
Eye disorders                                             Contact lens intolerance
Gastrointestin- Nausea                                    Vomiting al disorders
Skin and          Acne                                    Alopecia              Rash, subcutaneous                                                                    Urticaria, tissue                                                                          Erythema disorders                                                                       nodosum Reproductive      Breast pain,                            Dysmenorrhoea, system and        Menstruation irregular, Amenorrhoea     Ovarian cyst breast disorders
General                                                   Fatigue disorders and administration site condition
Investigations Weight increased
* MedDRA version 9.0

Breast discharge may occur during use of Cerazette. On rare occasions, ectopic pregnancies have been reported (see section 4.4).In addition, aggravation of hereditary angioedema may occur (see section 4.4).

In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer), and chloasma, some of which are discussed in more detail in section 4.4.

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/