Australian Doctor Australian Doctor 28th July 2017 | Page 7
Not a real patient. Model used for illustrative purposes only. Individual results may vary.
Please review the full Product Information before prescribing.
Product Information is available from Galderma Medical Information ph: 1800 800 765.
PBS information: This product is not listed on the PBS.
EPIDUO ® FORTE GEL (0.3% adapalene + 2.5% benzoyl peroxide). Indication: Cutaneous treatment of acne vulgaris, when comedones, numerous papules and pustules are present in patients 12 years of age and older and the condition has not responded to fi rst line
treatment. (see clinical trials). Contraindications: Hypersensitivity to the active substances or to any of the excipients. Precautions: For external use only. Should not be applied to damaged, broken or eczematous skin. Avoid contact with eyes, lips, mouth, nostrils or
mucous membranes. Discontinue use if severe irritation or contact allergy occurs. Contains propylene glycol (EI520) that may cause skin irritation. Avoid excessive exposure to sunlight or UV radiation. Avoid contact with any coloured material including hair and dyed
fabrics as this may result in bleaching and discoloration. Refer to full PI. Use in Pregnancy (Cat D): Epiduo Forte should not be used by women who are pregnant or who plan to become pregnant during treatment. In the case of unexpected pregnancy, treatment should be
discontinued. Use in Lactation: Excretion in human milk has not been evaluated. Should be used with caution in breastfeeding women, and only on areas away from the chest. Use in renal or hepatic impairment: Has not been studied in patients with renal or hepatic
impairment, thus caution should be used with these patients. Pediatric Use: Not recommended in children aged less than 12 years. Use in the elderly: Not evaluated in enough subjects aged 65 years and over to determine whether they respond differently from younger
subjects. Interactions: There are no known interactions with other medicinal products. Concomitant use with other retinoids, benzoyl peroxide or drugs with a similar mode of action should be avoided. Use with cosmetics with desquamative, irritant or drying effects
may produce additive irritant effect. Adverse Effects: Common AEs (≥1%): skin irritation, scaling, dryness, erythema, skin burning/stinging sensation. Other common AEs: Nasopharyngitis, headache, upper respiratory tract infection, allergic dermatitis and urticaria.
Uncommon AEs: Erythema of eyelid, paresthesia, pruritus, rash. Post‐marketing experience: Eyelid oedema, conjunctivitis, throat tightness, Pain of skin, allergic contact dermatitis, swelling of face, blister (vesicles), sunburn, pruritus, skin discolouration, rash and eczema.
Dosage and Administration: Apply once a day in the evening to the entire acne affected areas of the face and the trunk on clean and dry skin. A thin fi lm of gel should be applied, with the fi ngertips, avoiding the eyes and lips. Wash hands after application. Cosmetics may
be applied after Epiduo Forte has dried. The duration of treatment should be determined by the Doctor on the basis of the clinical condition. If no improvement is observed after 1-4 weeks treatment, the benefi t of continued treatment should be reconsidered. Additional
systemic treatment or alternative treatments should be considered. Presentation: 15g, 30g, 45g, 60g and 70g bottles with pump and 2g and 5g (sample) tubes. Store below 25°C. Do not refrigerate. S4. Based on approved PI dated 3 March 2017.
REFERENCES: 1. Epiduo Forte Gel Product Information (3 March 2017). 2. Weiss J et al. J Drugs Dermatol 2015; 14: 1427–1435. 3. Stein Gold L et al. Am J Clin Dermatol 2016; 17: 293–303.
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Registered trademark of Galderma Australia Pty Ltd. ABN 12 003 976 930. 13B Narabang Way, Belrose, NSW 2085. Phone 1800 800 765.
EFO17-07-0113b. McCann Health 10803325. Date of preparation July 2017.