ZINDACLIN Gel Ref.[27720] Active ingredients: Clindamycin

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 Zindaclin 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 Zindaclin 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 4.5, Interaction with other medicinal products and other forms of interactions.)

Contact with the eyes or the mucous membranes of the nose and mouth should be avoided. In the event of accidental contact with the eyes or mucous membranes bathe the affected area with copious amounts of cool water.

Zindaclin 1% Gel contains propylene glycol. May cause skin irritation.

The irritation potential of Zindaclin may be increased if the product is used under occlusion.

In vitro, antagonism has been demonstrated between erythromycin and clindamycin, synergy has been shown with metronidazole and both antagonistic and synergistic effects have been observed with aminoglycosides.

For clindamycin applied cutaneously no clinical data on exposed pregnancies are available. Data on a limited number of pregnancies exposed to clindamycin administered by other routes indicate no adverse effects on pregnancy or on the health of the foetus/newborn child. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Orally and parenterally administered clindamycin has been reported to appear in breast milk. It is not known whether clindamycin is excreted in human milk following use of Zindaclin. As a general rule, patients should not breastfeed while taking a drug since many drugs are excreted in human milk.

For use during pregnancy and lactation, benefit and possible risks have to be weighed carefully against each other. Sensitisation and diarrhoea cannot be ruled out in nursed infants.

Not relevant.

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 Zindaclin in clinical trials. They are listed in decreasing order of incidence.

Whilst no case of severe diarrhoea or pseudomembranous colitis has been reported in clinical trials with Zindaclin, 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 exists (please refer to Section 4.4, Special warnings and precautions for use).

Not applicable.