Adverse reactions : תופעות לוואי

4.8         Undesirable effects

The safety of clindamycin vaginal ovules was evaluated in non-pregnant patients in clinical trials.
Frequencies reported are as follows: Common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100).

System Organ Class            Common                      Uncommon
≥ 1/100 to < 1/10           ≥ 1/1,000 to < 1/100

Infections and infestations Fungal infection, candida infection
Nervous system disorders      Headache

Gastrointestinal disorders Abdominal pain, diarrhoea, Vomiting nausea
Skin and subcutaneous      Pruritus (non-applicable   Rash tissue disorders           site)
Musculoskeletal and                                       Flank pain connective tissue disorders

Renal and urinary                                         Pyelonephritis, dysuria disorders
Reproductive system and       Vulvovaginal candidiasis,   Vaginal infection, vaginal breast disorders              vulvovaginal pain,          discharge, menstrual vulvovaginal disorder,      disorder


General disorders and                                     Application site pain, administration site                                       pruritus (topical applicable conditions                                                site), localized oedema, pain, pyrexia



Pseudomembranous colitis is a class event for antibacterials.

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