Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Approximately 10% of patients can be expected to experience an adverse reaction.
These reactions are typical of irritant dermatitis. The incidence of these is likely to increase if an excess of gel is used. Should irritation occur, the use of moisturiser may be of benefit.

The adverse reactions below have been reported with Zindaclin 1% Gel in clinical trials. They are listed in decreasing order of incidence.

Organ system                      Common                      Uncommon (>1/100, <1/10)             (>1/1000, <1/100)
Skin and subcutaneous             Dry skin                    Painful skin tissue disorder.                  Erythema
Skin burning                Scaly rash
Irritation around eyes
Acne exacerbation
Pruritis

Whilst no case of severe diarrhoea or pseudomembranous colitis has been reported in clinical trials with Zindaclin 1% Gel, and only a small amount of clindamycin is absorbed percutaneously, pseudomembranous colitis has very rarely been reported with the use of other topical clindamycin products. Therefore a theoretical risk of pseudomembranous colitis with Zindaclin 1% Gel exists (please refer to Section 4.4).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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