Usage instructions:
Dosage and directions for use:Skinoren gel should be applied to the affected areas of the skin twice a day (morning and evening) and rubbed in gently. Approximately 0,5 g = 2,5 cm of gel is sufficient for the entire facial area.Before Skinoren gel is applied, the skin should be thoroughly cleaned with plain water, and dried. A mild skin-cleansing agent may be used. It is important to use Skinoren gel continuously over the entire period of treatment.The duration of use of Skinoren gel can vary from person to person and also depends on the severity of the skin disorder. In general, an improvement becomes apparent after about 4 weeks. To obtain the best results, however, Skinoren gel should be used continuously over several months.In the event of intolerable skin irritation (see "side effects"), the amount of gel per application should be reduced or the frequency of use of Skinoren gel should be reduced to once a day until the irritation ceases. If required, the treatment should be temporarily interrupted for a few days.Paediatric population:Used in adolescents (12 to 18 years of age) for the treatment of acne vulgaris. Dose adjustment is not required when Skinoren gel is administered to adolescents (12 to 18 years of age).The safety and efficacy of Skinoren gel for the treatment acne vulgaris in children below the age of 12 years have not been established.The safety and efficacy of Skinoren gel for the treatment of papulopustular rosacea in children below the age of 18 years have not been established.Patient information leaflet:Please read this leaflet carefully before you start using Skinoren gel.Keep this leaflet. You may need to read it again.If you have further questions, please ask your doctor or your pharmacist.Skinoren gel has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.How to use Skinoren gel:Do not share medicines prescribed for you with others.Skinoren gel should be applied to the affected area of the skin twice a day (morning and evening) and rubbed in gently.Approximately 0.5g = 2.5 cm of gel is sufficient for the entire facial area.Before Skinoren gel is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used.It is important to use Skinoren gel continuously over the entire period of treatment.The duration of use of Skinoren gel can vary from person to person and also depends on the severity of the skin disorder. In general, an improvement becomes apparent after about 4 weeks.To obtain the best results, however, Skinoren gel should be used continuously over several months.In the event of intolerable skin irritation (see "side effects"), the amount of gel per application should be reduced or the frequency of use of Skinoren gel should be reduced to once a day until the irritation cases. If required, the treatment should be temporarily interrupted for a few days.Paediatric population:Skinoren gel is used in adolescents (12 to 18 years of age) for the treatment of acne vulgaris. No dose adjustment is required.Safety and efficacy of Skinoren gel for the treatment of acne vulgaris in children below the age of 12 years have not been established.The safety and efficacy of Skinoren gel for the treatment of papulopustular rosacea in children below the age of 18 years have not been established.

Storage instructions:
Keep well closed. Store at or below 25 degrees C.Patient information leaflet:Storing and disposing of Skinoren gel:Keep Skinoren gel out of the reach and sight of children.Store at or below 25 degrees C. Keep well closed.Do not use after the expiry date stated on the pack.Return all unused medicine to your pharmacist for safe disposal.Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

Warnings:
Contra-indications:Hypersensitivity to the active substance or to any excipients of the gel.For external use only.Care must be taken when using Skinoren gel to avoid contact with the eyes, mouth and other mucous membrane and patients should be instructed accordingly. In the event of accidental contact, the eyes, mouth and/or affected mucous membrane should be washed with large amounts of water. If eye irritation persists, patients should consult a medical practitioner. The hands should be washed after each application of the Skinoren gel.It is advisable to avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents when using Skinoren gel for treatment of papulopustular rosacea.Benzoic acid is mildly irritant to the skin, eyes and mucous membranes. Propylene glycol may cause skin irritation.Interactions:None are known.Pregnancy and lactation:Safety of Skinoren gel in pregnancy and lactation has not been established.Side effects and special precautions:Side effects:Only cutaneous treatment-related adverse events were reported in clinical studies.In clinical studies, most frequently observed side effects included, application site pruritus, application site burning and application site pain.Frequencies of side effects observed in clinical studies and given in the table below are defined according to MedDRA frequency convention: very common (=1/10); common (=1/100, <1/10); uncommon (=1/1000, < 1/100); rare (=1/10 000, < 1/1000).Acne:System organ class - very common - common - uncommon:Skin and subcutaneous tissue disorder - - - - - contact dermatitis.General disorders and administration site conditions - application site pruritus, application site burning, application site pain - application site dryness, application site rash, application site paraesthesia - application site erythema, application site exfoliation, application site warmth, application site discolouration.Rosacea:System organ class - very common - common - uncommon:Skin and subcutaneous tissue disorders - - - - acne, contact dermatitis.General disorders and administration site conditions - application site burning, application site pain, application site pruritus - application site paraesthesia, application site dryness, application site rash, application site oedema - application site discomfort, application site erythema, application site urticaria.Hypersensitivity and rash has been reported in post-marketing surveillance.Worsening of asthma in patients treated with azelaic acid has been reported during post-marketing surveillance.Paediatric population:Treatment of acne vulgaris in adolescents 12 to 18 years of age: in 4 clinical phase II and II/III studies involving adolescents 12 to 17 years of age (120/383; 31%), overall incidence of adverse events for Skinoren gel was similar for the groups aged 12 to 17 years (40%), aged =18 years (37%) and for the entire patient population (38%). This similarity also applied to the group aged 12 to 20 years (40%).Known symptoms of overdosage and particulars of its treatment:Treatment is supportive and symptomatic.Keep out of reach of children.Patient information leaflet:Before using Skinoren gel:Do not use Skinoren gel:If you are hypersensitive to azelaic acid or any ingredients of the gel.Take special care with Skinoren gel:Skinoren gel is for external use only.Care must be taken when using Skinoren gel to avoid contact with the eyes, mouth and other mucous membranes. If it does, the eyes, mouth and/or affected mucous membrane should be washed with large amounts of water. If eye irritation persists, consult your doctor.The hands should be washed after each application of Skinoren gel.It is advisable to avoid alcohol cleanser, tinctures and stringents, abrasives and peeling agents when using Skinoren gel for treatment of papulopustular rosacea.Benzoic acid is irritant to the skin, eyes and mucous membranes.Propylene glycol may cause skin irritation.Pregnancy and breastfeeding:If you are pregnant or breastfeeding your baby while using Skinoren gel, please consult your doctor, pharmacist or other healthcare professional for advice.Safety in pregnancy and breastfeeding has not been established.Using other medicines with Skinoren gel:If you are using other medicines on a regular basis, including complementary or traditional medicines, the use of Skinoren gel with these medicines may cause undesirable interactions.Please consult your doctor, pharmacist or other healthcare professional for advice.There are no interactions so far known for Skinoren gel.If you use more Skinoren gel than you should or if Skinoren gel is taken by mouth:In the event of an overdosage, consult your doctor or pharmacist.If neither is available, rush the patient to the nearest hospital or Poison Control Centre.Possible side effects:Skinoren gel can have side effects.The spectrum of undesirable skin effects related to Skinoren gel was similar in acne and rosacea.Acne:Frequent:Application site pruritus (itchiness).Application site burning.Application site pain.Application site dryness.Application site rash.Application site paraesthesia (sensation of tingling, burning, pricking or numbness).Less frequent:Contact dermatitis (allergic reaction of the skin).Application site erythema (superficial reddening of the skin).Application site exfoliation (peeling off).Application site warmth.Application site discolouration.Rosacea:Frequent:Application site burning.Application site pain.Application site pruritus (itchiness).Application site paraesthesia (sensation of tingling, burning, pricking or numbness).Application site dryness.Application site rash.Application site oedema (swelling).Less frequent:Acne.Contact dermatitis (allergic reaction of the skin).Application site discomfort.Application site erythema (superficial reddening of the skin).Application site urticaria (hives).Worsening of asthma in patients treated with azelaic acid has been reported post-marketing.Not all side effects reported for Skinoren gel are included in this leaflet. Should your general health worsen while using Skinoren gel, please consult your doctor, pharmacist or other healthcare professional for advice.

Ingredients:
Azelaic Acid 15% Gel