DIFFERIN XP

2 Recommended Dose and Dosage Adjustment DIFFERIN (adapalene) topical cream, gel and lotion, or DIFFERIN XP (adapalene) topical gel should be applied to the affected areas of the face, chest and back once a day before retiring and after washing.

A small amount should be applied to provide a thin film, avoiding eyes, lips and mucous membranes. Ensure that the affected areas are dry before application. DIFFERIN products should not come into contact with the eyes, mouth, angles of the nose or mucous membranes.

If product enters the eye, wash immediately with warm water. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. DIFFERIN®/DIFFERIN XP® – Product Monograph Page 5 of 29 Discontinue treatment if a severe local inflammatory response is experienced.

Reinstitute therapy when the reaction has subsided, initially applying the preparation less frequently. Once daily application may be resumed if it is judged that the patient is able to tolerate the treatment. Clinical improvement is expected to be clearly evident after four to eight weeks of treatment, with further improvement expected with continued use.

Cutaneous safety of DIFFERIN topical gel has been demonstrated over a six-month period of treatment. Cutaneous safety of DIFFERIN XP topical gel has been demonstrated over a 12-month period of treatment. 5 Missed Dose Dosing should continue as per usual the following evening, and the usual amount should be applied.

1 Adverse Reaction Overview Treatment-related adverse reactions typically associated with use of DIFFERIN and DIFFERIN XP include mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, burning and stinging.

DIFFERIN XP results in a slightly greater incidence of these events, as would be expected with the higher concentration of a dapalene. DIFFERIN®/DIFFERIN XP® – Product Monograph Page 9 of 29 These reactions usually occur early in the treatment and tend to resolve after 2 to 4 weeks of therapy (see 7 WARNINGS AND PRECAUTIONS).

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of drug reactions in real-world use. 1%, most of the reactions occurred within two to four weeks of initiation of therapy and were generally observed to resolve with continued use of the product or temporary adjustment of the treatment schedule.

Contact allergy to topical adapalene was not reported during clinical trials. 1% have been reversible upon discontinuation of therapy. DIFFERIN Topical Lotion During two multicentre, active- and vehicle-controlled, Phase III clinical trials, patients with acne vulgaris, 12 years and older, were treated with DIFFERIN Lotion or its vehicle once daily for 12 weeks.

A total of 1068 patients were exposed to DIFFERIN Lotion in these trials . In general, most of the signs and symptoms of cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging) were either mild or moderate in severity and occurred primarily during the first two weeks of treatment, and decreased thereafter.

General For external use only. Avoid contact with the eyes, lips, angles of the nose, mucous membranes and open wounds. Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning or pruritus are associated with the topical application of retinoids and can also be expected with the use of DIFFERIN (adapalene) topical cream, gel or lotion, and with DIFFERIN XP (adapalene) topical gel.

These treatment-related effects generally occur during the first two to four weeks of therapy and usually resolve as the skin undergoes adjustment with continued use. Depending on the degree of the side effects, patients can be directed to use a moisturizer, use the medication less frequently or temporarily discontinue use until the symptoms subside or to discontinue use altogether (see 4 DOSAGE AND ADMINISTRATION).

As with any retinoid, exposure to excessive sunlight, including sunlamps, should be avoided while using the preparation, or a suitably effective sunscreen product and protective clothing over the treated areas is recommended when exposure cannot be avoided.

Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin trea ted with adapalene. Avoid concomitant use of other potentially irritating topical products (abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).

Patients should be advised to use non-comedogenic cosmetics. Colour cosmetics such as blushers and powders are acceptable, however, make-up cosmetics should be water based only. Cosmetics must be removed by thorough cleansing before the area is tr eated.

Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY.

Reproductive Health:

 Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.

 Patients with eczema or seborrheic dermatitis.  Pregnancy  Women planning a pregnancy.