Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided. Application to sensitive areas of skin should be made with caution. In case of accidental contact, rinse well with water. Benzoyl Peroxide 5% & Clindamycin 1% gel should be used with caution in patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis. Benzoyl Peroxide 5% & Clindamycin 1% gel should be used with caution in atopic patients, in whom further skin drying may occur. During the first weeks of treatment, an increase in peeling and reddening will occur in most patients. Depending upon the severity of these side effects, patients can use a non-comedogenic moisturiser, temporarily reduce the frequency of application of Benzoyl Peroxide 5% & Clindamycin 1% gel or temporarily discontinue use; however, efficacy has not been established for less than once daily dosing frequencies. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy may occur, which sometimes may be severe, especially with the use of peeling, desquamating, or abrasive agents. If severe local irritancy (e.g. severe erythema, severe dryness and itching, severe stinging/burning) occurs, Benzoyl Peroxide 5% & Clindamycin 1% gel should be discontinued. As benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sun should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing. If a patient has sunburn, this should be resolved before using Benzoyl Peroxide 5% & Clindamycin 1% gel. If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment with Benzoyl Peroxide 5% & Clindamycin 1% gel should be discontinued immediately, as the symptoms may indicate antibiotic-associated colitis. Suitable diagnostic methods, such as the determination of Clostridium difficile and toxin and, if necessary, colonoscopy should be employed and treatment options for colitis considered. The product may bleach hair or coloured fabrics. Avoid contact with hair, fabrics, furniture or carpeting.Resistance to clindamycin: Patients with a recent history of systemic or topical clindamycin or erythromycin use are more likely to have pre-existing anti-microbial resistant Propionibacterium acnes and commensal flora.Cross-resistance: Cross-resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy.Interaction with other medicinal products and other forms of interaction: No formal drug-drug interaction studies have been performed with Benzoyl Peroxide 5% & Clindamycin 1% gel. Concomitant topical antibiotics, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol and/or astringents, should be used with caution as a cumulative irritant effect may occur. Benzoyl Peroxide 5% & Clindamycin 1% gel should not be used in combination with erythromycin-containing products due to possible antagonism to the clindamycin component. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore caution should be exercised with concomitant use. Concomitant application of Benzoyl Peroxide 5% & Clindamycin 1% gel with tretinoin, isotretinoin and tazarotene should be avoided since benzoyl peroxide may reduce their efficacy and increase irritation. If combination treatment is required, the products should be applied at different times of the day (e.g. one in the morning and the other in the evening). Using topical benzoyl peroxide-containing preparations at the same time as topical sulfonamide-containing products may cause skin and facial hair to temporarily change colour (yellow/orange).
