CLINDAMYCIN + BENZOYL PEROXIDE

For cutaneous use only. Posology Adults and Adolescents (aged 12 years and above) Clindamycin + Benzoyl Peroxide Gel should be applied once daily in the evening, to the entire affected area. Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.

4). The safety and efficacy of Clindamycin + Benzoyl Peroxide Gel has not been studied beyond 12 weeks in acne vulgaris clinical trials. Treatment with this medicine should not exceed more than 12 weeks of continuous use. Paediatric population The safety and efficacy of Clindamycin + Benzoyl Peroxide Gel has not been established in children under 12 years of age, therefore this medicine is not recommended for use in this population.

Elderly patients No specific recommendations. Method of administration Clindamycin + Benzoyl Peroxide Gel should be applied in a thin film after washing gently with a mild cleanser and fully drying. If the gel does not rub into the skin easily, too much is being applied.

Hands should be washed after application.

Adverse drug reactions (ADRs) are summarised below for Clindamycin + Benzoyl Peroxide Gel as a combination including any additional ADRs that have been reported for the single topical active ingredients, benzoyl peroxide or clindamycin , that occurred either during clinical studies or that were spontaneously reported.

Adverse drug reactions are listed by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1,000 and <1/100); rare (≥1/10,000 and <1/1,000) and not known (cannot be estimated from the available data).

MedDRA SOC Very Common Common Uncommon Not known** Immune system disorders Allergic reactions including hypersensitivity and anaphylaxis Nervous system disorders* Headache4 Paraesthesia1 Gastrointestinal disorders Colitis (including pseudomembranous colitis), haemorrhagic diarrhoea, diarrhoea, abdominal pain Skin and subcutaneous tissue disorders* Pruritus, burning sensation, dryness, erythema, peeling (Generally reported as 'slight' in severity.

Frequency relates to data from solicited tolerability assessments during the clinical trial) Dermatitis, photosensitivit y reaction Erythematous rash, worsening of acne Urticaria General disorders and Administration site conditions Application site pain4 Application site reactions including skin discoloration 1At site of application.

2Based on post-marketing reports with topical clindamycin 10 mg/g + benzoyl peroxide 50 mg/g gel. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency however, systemic reactions are rarely seen.

3Reported from studies conducted with topical clindamycin 10 mg/g + benzoyl peroxide 50 mg/g gel. 4Reported from studies conducted with topical clindamycin 10 mg/g foam. Local Tolerability During the pivotal clinical trial with a Clindamycin + Benzoyl Peroxide 10 mg/g + 30 mg/g Gel, patients were assessed for local cutaneous signs and symptoms of erythema, dryness, peeling, itching, and burning/stinging.

The percentage of patients that had symptoms present before treatment, during treatment, and present at week 12 are shown in the next two tables: Percentage of Subjects in the Clindamycin + Benzoyl Peroxide 10 mg/g + 30 mg/g Gel Group (N=327) with Symptoms of Burning/Stinging and Itching (patient assessed) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Slight Mod Strong Slight Mod Strong Slight Mod Strong Burning/ Stinging 15% 4% 0 20% 6% 1% 8% 2% <1% Itching 28% 6% 1% 29% 9% 1% 17% 2% 0 Percentage of Subjects in the Clindamycin + Benzoyl Peroxide 10 mg/g + 30 mg/g Gel Group (N=327) with Signs of Dryness, Erythema and Peeling (investigator assessed) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Slight Mild Mod Severe Slight Mild Mod Severe Slight Mild Mod Severe Dryness 15% 2% 1% 0 24% 7% 2% 0 9% 1% 1% 0 Erythema 19% 11% 5% 0 26% 13% 5% <1% 19% 4% 2% 0 Peeling 10% 2% 0 0 17% 3% 1% 0 4% <1% 0 0 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).

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.

Clindamycin + Benzoyl Peroxide Gel should be used with caution in patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis. This medicine 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 Clindamycin + Benzoyl Peroxide 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. g. severe erythema, severe dryness and itching, severe stinging/burning) occurs, Clindamycin + Benzoyl Peroxide 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 this medicine. If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment with Clindamycin + Benzoyl Peroxide 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. 1). 5).

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