RESIDERM

Adults and adolescents Apply a thin film of RESIDERM once daily to the affected area. Patient response should be reviewed after 6-8 weeks of treatment and the duration of treatment should be limited to 12 weeks. Children RESIDERM is not indicated for use in children below the age of 12 years.

Cutaneous use.

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 a moisturiser may be of benefit.

The table below shows all adverse reactions reported with RESIDERM in clinical trials. They are listed in decreasing order of incidence. Organ System Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Skin and subcutaneous tissue disorder Dry skin Erythema Skin burning Irritation around eyes Acne exacerbation Pruritis Painful skin Scaly rash Whilst no case of severe diarrhoea or pseudomembranous colitis has been reported in clinical trials with RESIDERM, 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.

4).

Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe pseudomembranous colitis. Topical clindamycin has very rarely been associated with pseudomembranous colitis; however if diarrhoea occurs the product should be discontinued immediately.

Studies indicate a toxin(s) produced by Clostridium difficile is the major cause of antibiotic-associated colitis. Colitis is usually characterised by severe persistent diarrhoea and abdominal cramps. Should antibiotic associated colitis occur appropriate diagnostic and therapeutic measures (such as stopping RESIDERM and, if necessary, antibiotic treatment such as metronidazole or vancomycin treatment) should be taken immediately.

Responses may not be seen for 4-6 weeks. Although the risk of systemic absorption following the administration of RESIDERM is low, the potential for the development of gastrointestinal adverse effects should be taken into account when considering treatment in patients with a previous history of antibiotic-associated colitis, enteritis, ulcerative colitis or Crohn’s disease.

Prolonged use of clindamycin may cause resistance and/or overgrowth of non susceptible bacteria or fungi although this is a rare occurrence. Cross resistance may occur with other antibiotics such as lincomycin and erythromycin. See section

RESIDERM is contra-indicated in patients with a hypersensitivity to the active substance clindamycin or to any of the excipients in the medicinal product. Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that RESIDERM should not be used in patients who have demonstrated lincomycin sensitivity.