Description
Aldara 5% Cream Sachets 12’s is indicated for the topical treatment of:• External genital and perianal warts (condylomata acuminata) in adults.• Small superficial basal cell carcinomas (sBCCs) in adults.• Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Qualitative and quantitative composition: -Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %). -100 mg of cream contains 5 mg of imiquimod.
Excipients with known effects: -Methyl hydroxybenzoate (E 218) 2.0 mg/g cream. -Propyl hydroxybenzoate (E 216) 0.2 mg/g cream. -Cetyl alcohol 22.0 mg/g cream. -Stearyl alcohol 31.0 mg/g cream.
How to use
Method of administration
External genital warts: Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes. Only apply to affected areas and avoid any application on internal surfaces. Imiquimod cream should be applied prior to normal sleeping hours. During the 6 to 10 hour treatment period, showering or bathing should be avoided. After this period it is essential that imiquimod cream is removed with mild soap and water. Application of an excess of cream or prolonged contact with the skin may result in a severe application site reaction.
Superficial basal cell carcinoma: -Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly. Sufficient cream should be applied to cover the treatment area, including one centimeter of skin surrounding the tumor. The cream should be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided. After this period it is essential that imiquimod cream is removed with mild soap and water.
Actinic keratosis: -Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly. Sufficient cream should be applied to cover the treatment area. The cream should be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided. After this period it is essential that imiquimod cream is removed with mild soap and water. Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream.
Precautions
Contraindications: Hypersensitivity to the active substance or to any of the excipients listed.