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Epiduo/Epiduo Forte

Epiduo/Epiduo Forte Special Precautions

Manufacturer:

Galderma

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) Gel should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned.
Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) should not come into contact with the eyes, mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with warm water.
This product contains propylene glycol (E1520) that may cause skin irritation. If a reaction suggesting sensitivity to any component of the formula occurs, the use of Epiduo should be discontinued.
Depending upon the severity of local cutaneous adverse reactions, patients should be instructed to use a moisturizer, reduce the frequency of the application of Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) gel, or discontinue use.
As with other topical retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) gel.
Avoid concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
Excessive exposure to sunlight or UV radiation (sunlamps) should be avoided. Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.
Use in Renally Impaired: Pharmacokinetic studies have not been conducted in subjects with a medical condition which might interfere with the absorption, distribution, metabolism, or excretion of Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte), in particular, a history of hepatic or renal disease.
Use in Hepatically Impaired: Pharmacokinetic studies have not been conducted in subjects with a medical condition which might interfere with the absorption, distribution, metabolism, or excretion of Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte), in particular, a history of hepatic or renal disease.
Carcinogenesis/mutagenesis: Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenicity.
Use in Children: Epiduo: The safety and effectiveness of Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) have not been studied in children below 9 years of age.
Epiduo Forte: Safety and effectiveness of Epiduo Forte gel in pediatric patients under the age of 12 have not been established.
Use in the Elderly: The safety and efficacy of Adapalene + Benzoyl Peroxide (Epiduo/Epiduo Forte) in geriatric patients aged 65 years and above have not been established.
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