Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The table below lists the adverse reactions identified through clinical trial experience and post- marketing surveillance by system organ class and frequency. Adverse reactions identified from post- marketing experience are included in italics. The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The safety of clindamycin vaginal cream was evaluated in both non pregnant patients and patients during their second and third trimesters of pregnancy.

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Adverse Drug Reactions Table for Clindamycin Vaginal Cream
System Organ           Very               Common                   Uncommon               Rare         Very Rare       Frequency not Class            Common            ≥ 1/100 to <1/10            ≥ 1/1 000 to       ≥ 1/10, 000 to   < 1/10, 000          known ≥ 1/10                                        <1/100             <1/1 000                         (Cannot be estimated from available data)
Infections and                       Fungal infection,            Bacterial infection                                  Skin candida infestations                         candida infection
Immune System                                                     Hypersensitivity Disorders
Endocrine                                                                                                              Hyperthyroidism disorders
Nervous System                       Headache
Disorders                            Dizziness
Dysgeusia
Ear and labyrinth                                                 Vertigo disorders
Respiratory,                         Upper respiratory            Epistaxis thoracic and                         infection mediastinal disorders
Gastrointestinal                     Abdominal pain               breath odour,                                        Gastrointestinal Disorders                            constipation, diarrhea,      Abdominal                                            disorder, nausea, vomiting             distension                                           Pseudomembranous flatulence                                           colitis* dyspepsia 
Skin and                             Pruritus (non-               Erythema, Subcutaneous                         applicable site), rash       urticaria                                            Rash Tissue Disorders                                                                                                       maculopapular Musculoskeletal                      Back pain and connective tissue disorders
Renal and urinary                                                 Dysuria, disorders                            Urinary tract infection, glycosuria,
proteinuria
Pregnancy,                           Abnormal labour puerperium and perinatal conditions
Reproductive          Vulvovaginal   Vulvovaginitis,              Vulvovaginitis                                       Endometriosis, system and breast     candidiasis    vulvovaginal disorder,       trichomonal, disorders                            Menstrual disorder,          vaginal infection, Vulvovaginal pain,           pelvic pain
Metrorrhagia, Vaginal discharge


General disorders                                                                                                      Pain, and                                                                                                                    inflammation administration site conditions
Investigations                                                    Microbiology test abnormal
* ADRs identified post-marketing.


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/.