Source: Health Products Regulatory Authority (ZA) Revision Year: 2013 Publisher: GlaxoSmithKline South Africa (Pty) Ltd, 39 Hawkins Avenue, Epping Industria 1, 7460
CLINDOXYL GEL should not be used in patients with known hypersensitivity to clindamycin, lincomycin, benzoyl peroxide or any of the excipients in the formulation.
Contact with the mouth, eyes, skin and mucous membranes and with abraded or eczematous skin should be avoided. Application to sensitive areas of skin should be made with caution. In the event of accidental contact with the eyes, bathe with copious amounts of water.
The product may bleach hair or coloured fabrics.
It is recommended that exposure to sun or sunlamps be minimised.
Patients should be advised that, in some cases, 4-6 weeks of treatment may be required before the full therapeutic effect is observed.
It should be used with caution in atopic patients, in whom further skin drying may occur. The frequency of application should be reduced if excessive irritation or dryness develops.
With long term use of CLINDOXYL GEL resistance may occur. Cross resistance may occur with other antibiotics such as lincomycin and erythromycin when using antibiotic monotherapy.
There have been isolated reports of pseudomembraneous colitis or diarrhoea due to other topical treatments containing clindamycin.
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.
Simultaneous application of CLINDOXYL GEL and topical acne preparations containing vitamin A derivatives should be avoided.
Potential synergism exists between clindamycin and gentamycin.
Safety in pregnancy and lactation has not been established.
CLINDOXYL GEL may cause erythema, peeling, dryness and pruritus at the site of application. Uncommonly, paraesthesia, worsening of acne and contact dermatitis can occur.
Reported frequency in clinical trials are:
Very common (>1/10): Erythema; peeling; dryness
Common (>1/100, <1/10): Burning; pruritus
Uncommon (>1/1000, <1/100): Paraesthesia; worsening of acne.
There have been isolated reports of pseudomembraneous colitis or diarrhoea due to other topical treatments containing clindamycin.
In the post marketing environment there have been isolated instances of allergic reactions which can be sudden and severe.
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