Product Description
Skinoren is a medicinal product in the form of a white cream intended for topical (cutaneous) use.
Active Ingredients
Skinoren 200 mg/g cream contains azelalic acid, which exhibits antibacterial effects, inhibits excessive keratinization of the epidermis, and reduces the growth and overactivity of melanocytes. It also decreases the amount of free fatty acids on the skin surface and reduces comedone formation.
Indications
Skinoren 200 mg/g cream (30 g) is indicated in patients from 12 years of age for the treatment of:
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Acne vulgaris
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Skin hyperpigmentation disorders
Composition
1 g of cream contains:
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Active substance: azelaic acid 200 mg
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Excipients: benzoic acid (E 210), cetearyl octanoate + isopropyl myristate (PCL Liquid), glycerol 85%, glyceryl stearate + cetylstearyl alcohol + cetyl palmitate + macrogolglycerol cocoate (CUTINA CBS), propylene glycol, purified water, macrogolglycerol stearate.
Mechanism of Action
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Exhibits antibacterial activity by inhibiting Propionibacterium acnes
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Inhibits abnormal keratinization of the epidermis
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Reduces free fatty acid content on the skin surface
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Decreases comedone formation
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Inhibits excessive activity of abnormal epidermal pigment cells
Dosage and Administration
Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist.
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Skinoren 200 mg/g is for external use only.
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Before application, cleanse the skin thoroughly with water and gently dry (a mild cleanser may be used).
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Unless otherwise directed, apply a thin layer to affected areas twice daily (morning and evening), rubbing the cream in gently.
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A 2.5 cm strip of cream (approx. 0.5 g) is sufficient for the entire face.
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Wash hands after application.
If significant skin irritation occurs, reduce frequency to once daily until symptoms resolve. If needed, interrupt treatment for a few days.
Acne vulgaris
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Clinical improvement is usually observed after approximately 4 weeks of regular use.
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For optimal results, treatment should continue for several months, up to a maximum of 12 months.
Hyperpigmentation
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Use Skinoren for at least 3 months; best results are achieved with continuous treatment.
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Sun exposure may worsen hyperpigmentation, therefore broad-spectrum UVA/UVB protection is required during treatment.
Contraindications
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Hypersensitivity to azelaic acid or any excipient
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Do not use during pregnancy or breastfeeding unless clearly recommended by a physician
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Safety and efficacy have not been established in children under 12 years of age
Storage
Store below 30°C.
Keep out of the sight and reach of children.
Possible Side Effects
Like all medicinal products, Skinoren may cause adverse reactions, although not everybody gets them.
Very common (≥1/10):
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Pruritus
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Burning sensation
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Erythema at application site
Common (≤1/10):
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Skin peeling
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Pain, dryness, depigmentation of skin
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Application site irritation
Uncommon (≤1/100):
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Seborrheic dermatitis
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Acne
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Skin discoloration
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Paresthesia (tingling, pricking sensation)
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Dermatitis
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Discomfort or swelling at application site
Rare (≤1/1000):
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Drug hypersensitivity reactions (may manifest as: angioedema*, contact dermatitis*, periorbital edema*, facial edema*)
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Asthma exacerbation
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Urticaria
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Cheilitis
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Rash, burning, blistering, eczema, ulceration at application site
*Adverse reactions reported after authorization.
Interactions
Inform your doctor or pharmacist about all medications being used, recently taken, or planned for use.
Interaction studies have not been conducted.
Warnings and Precautions
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Avoid contact with eyes, mouth and mucous membranes.
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When applying to the face, ensure the medicine does not enter the eyes.
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In case of accidental contact, rinse immediately with plenty of water and seek medical advice if irritation persists.
Use in Children and Adolescents
Not recommended in children below 12 years of age (lack of safety and efficacy data).
Pregnancy, Breast-feeding, and Fertility
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Consult a doctor before use if pregnant, breastfeeding, planning a pregnancy, or if pregnancy is suspected.
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Do not use during pregnancy or breastfeeding unless clearly recommended.
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Avoid contact between treated skin/ breasts and the infant.