Epiduo Forte 3 mg/g, 25 mg/g Gel

EPIDUO FORTE is indicated for the cutaneous treatment of Acne vulgaris, when comedones, papules and pustules are present in adults, adolescents, and children aged 12 years and above. (See sections 4.2 and 5.1).

Posology S3
EPIDUO FORTE should be applied once a day in the evening on a clean and dry skin to the entire acne affected areas of the face and the trunk. The duration of treatment should be determined by the doctor based on the overall clinical condition and on the therapeutic response to the treatment. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment. If no improvement is observed after 4 - 8 weeks of treatment, the benefit of continued treatment should be reconsidered. A lower strength of EPIDUO FORTE is available (Epiduo 0.1 % / 2.5 % gel) and this concentration should be considered in patients with moderate acne vulgaris (see section 5.1). Doctors may choose between the two concentrations based on the presenting patientu2019s clinical condition and severity.

Special populations
Elderly (u2265 65 years of age)
The safety and efficacy of EPIDUO FORTE in elderly patients have not been established.
Renal and hepatic impairment
EPIDUO FORTE has not been studied in patients with renal and hepatic impairment.
Paediatric population
The safety and efficacy of EPIDUO FORTE have not been studied in children below 12 years of age.

Method of administration
For external cutaneous use only. Apply a thin layer of EPIDUO FORTE to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek), avoiding the eyes and lips (see section 4.4). Patients should be instructed to wash their hands after applying the EPIDUO FORTE. Cosmetics may be applied after EPIDUO FORTE has dried. If irritation occurs, the patient should be directed to apply non-comedogenic moisturisers as needed, to use EPIDUO FORTE less frequently (e.g., every other day), to suspend use temporarily, or to discontinue use altogether.

• Hypersensitivity to the active substances or any of the excipients listed in section 6.1.
• Pregnancy (see section 4.6)
• Women planning a pregnancy (see section 4.6)

EPIDUO FORTE should not be applied to damaged skin, either broken (cuts or abrasions), sunburn or eczematous skin. EPIDUO FORTE should not come into contact with the eyes, lips, mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with warm water. If a reaction suggesting sensitivity to any component of the formula occurs, the use of EPIDUO FORTE should be discontinued. Excessive exposure to sunlight or UV radiation should be avoided. EPIDUO FORTE should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration. The efficacy and safety of EPIDUO FORTE in patients with severe nodular or deep nodulocystic acne have not been studied. As patients with severe nodular /nodulocystic acne are at increased risk of permanent scarring secondary to acne lesions, the use of EPIDUO FORTE in these patients is not recommended due to the risk of insufficient therapeutic response. EPIDUO FORTE contains 40 mg propylene glycol (E1520) per gram, which is equivalent to 40 mg/g (4.0 %) and may cause skin irritation.

Paediatric population
The safety and effectiveness of EPIDUO FORTE has not been studied in children below 12 years of age, therefore, it should not be used in these patients.

No interaction studies have been conducted with EPIDUO FORTE. From previous experience with adapalene and benzoyl peroxide, there are no known interactions with other medicinal products which might be used cutaneously and concurrently with EPIDUO FORTE. However, other retinoids or benzoyl peroxide or medicines with a similar mode of action should not be used concurrently. Caution should be exercised if cosmetics with desquamative, irritant or drying effects, medicated or abrasive soaps and cleansers are used, as they may produce additive irritant effects with EPIDUO FORTE. Absorption of adapalene through human skin is low (see section 5.2), and therefore interaction with systemic medicinal products is unlikely. The percutaneous penetration of benzoyl peroxide in the skin is low and is completely metabolised into benzoic acid which is rapidly eliminated. Therefore, the potential interaction of benzoic acid with systemic medicinal products is unlikely to occur.

Pregnancy
EPIDUO FORTE is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy. Safety in pregnancy has not been established. Animal studies by the oral route have shown reproductive toxicity at high systemic exposure (see section 5.3). If the patient becomes pregnant while taking this drug, treatment should be discontinued.

Lactation
Safety during breastfeeding has not been established. No study on animal or human milk transfer was conducted after cutaneous application of EPIDUO FORTE. EPIDUO FORTE should not be used during breastfeeding, especially in case of acne treatment requiring product application on the chest.

Fertility
No human fertility studies were conducted with EPIDUO FORTE. However, no effects of adapalene or benzoyl peroxide on fertility were found in rats in reproductive studies (see section 5.3).

EPIDUO FORTE has no or negligible effects on the ability to drive and use machines.

Summary of safety profile
Approximately 10 % of patients can be expected to experience adverse skin reactions. Treatment related adverse reactions typically associated with the use of EPIDUO FORTE include mild to moderate application site reactions, such as skin irritation mainly characterized by scaling, dryness, erythema, burning and pain of skin (stinging pain). In such cases, the recommendation is to use a moisturiser, temporarily reduce the application frequency to every other day, or temporarily discontinue its use until once daily schedule can be resumed. These reactions usually occur early in the treatment, and tend to gradually lessen over time.

Tabulated summary of adverse reactions
The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (u2265 1/10), common (u22651/100 to <1/10), uncommon (u22651/1,000 to 1<100), rare (u22651/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data) and were reported with EPIDUO FORTE in vehicle-controlled Phase 3 clinical study (see Table 1).

Symptoms: Refer to section 4.8. EPIDUO FORTE is for once-daily cutaneous use only. Excessive application of EPIDUO FORTE may result in severe irritation. In this event, discontinue use and wait until the skin has recovered. In case of accidental ingestion, appropriate symptomatic measures should be taken.