One gram of Skinoren Cream contains 200 mg (20% w/w) of azelaic acid.
Excipients/Inactive Ingredients: The other ingredients are: Arlatone 983S (polyoxyethylene fatty acid ester), cutina CBS (mixture of mono-diglycerides, fatty alcohols, triglycerides and wax esters), cetearyl octanoate, propylene glycol, glycerol 85% (E422), benzoic acid (E210), purified water.
Skinoren attacks the bacterium called Propionibacterium acnes, which plays an essential part in causing acne. Skinoren also reduces growth of the harder outermost skin cells that block the pores of the skin to cause blackheads and whiteheads.
Skinoren is a skin cream used to treat common acne (acne vulgaris).
Skinoren cream should only be used to treat acne. Do not use this medicine for any other skin condition.
Always use this medicine exactly as the doctor or pharmacist has told to. Check with the doctor or pharmacist if unsure.
Adults and Adolescents (12-18 years of age): First, thoroughly wash with plain water the whole area to be treated. If the skin is greasy, use a mild skin cleanser. Dry the skin thoroughly before applying Skinoren.
Unless the doctor or pharmacist has told otherwise, start treatment with Skinoren twice a day.
If the skin is very sensitive, use Skinoren once a day in the evening during the first week of treatment. Then, change to twice a day.
The amount of Skinoren to be used will depend on the size of the area to be treated: As a guide, if the whole of the face is affected, use 2.5 cm (approx. 0.5 g) of cream each time Skinoren is applied. If there is acne on the chest and back, as well as the face, adjust the amount of cream accordingly.
Use the cream regularly. Rub it in gently.
Wash hands thoroughly after using Skinoren.
How long Skinoren has to be used varies from person to person. It depends upon how bad the acne is when treatment is started. A distinct improvement should be seen after about 4 weeks.
To get the best effect, Skinoren should be used regularly for several months. However, Skinoren should not be used for more than 12 months at any time.
If there are any further questions on the use of this product, ask the doctor or pharmacist.
Do not use Skinoren cream if allergic to azelaic acid or any of the other ingredients of the cream (listed in Description).
Talk to the doctor or pharmacist before using Skinoren cream.
Skinoren cream is for external use on the skin only. Do not allow Skinoren to come into contact with the eyes, mouth and other mucous membranes. If it does, wash the eyes, mouth and other mucous membranes immediately with large amounts of cool water.
Rarely, it has been reported that in some patients with asthma who were treated with azelaic acid worsening of asthma symptoms had occurred.
Skinoren contains benzoic acid: Benzoic acid is mildly irritating to the skin, eyes and mucous membranes. Skinoren contains a very small amount of this ingredient.
Skinoren contains propylene glycol: Propylene glycol may cause skin irritation.
Driving and using machines: Skinoren has no influence on the ability to drive and use machines.
Use in Children: Skinoren is not recommended for use in children below the age of 12 due to a lack of data on safety and efficacy.
There is limited experience with use of the active substance azelaic acid during pregnancy. If pregnant or breastfeeding, thinking may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reasons to stop using Skinoren: Stop using Skinoren and see the doctor as soon as possible if an allergic reaction (e.g. rash) to Skinoren is present.
Occasionally local skin irritation occurs with Skinoren, usually at the start of treatment. In most cases, the irritation is mild and usually gets better as treatment continues. If skin irritation remains troublesome: reduce the amount of Skinoren applied each time; or apply it only once a day; or stop treatment temporarily.
If skin irritation still remains troublesome, tell the doctor or pharmacist.
The reported side effects of Skinoren are listed as follows by frequency and starting with the most frequent ones: Very common (may affect more than 1 in 10 people): Burning, itching or abnormal redness of the skin (erythema) at the site of application.
Common (may affect up to 1 in 10 people): Scaling, pain, dryness, skin discolouration or irritation at the site of application.
Uncommon (may affect up to 1 in 100 people): Greasy skin, acne or loss of skin colour, tingling, dermatitis, discomfort or swelling at the site of application.
Rare (may affect up to 1 in 1,000 people): Cracking of the lips, vesicles (small blisters), eczema, ulceration, warmth at the site of application, allergic reaction, rash at the site of application, worsening of asthma symptoms.
Reporting of side effects: If any side effects are experienced, talk to the doctor or pharmacist. This includes any possible side effects not previously listed. By reporting side effects, more information on the safety of this medicine can be provided.
Tell the doctor or pharmacist if using, have recently used or might use any other medicines.
Store Skinoren below 30°C.
Shelf life: After first opening of the container, the in-use stability is 6 months.
D10AX03 - azelaic acid ; Belongs to the class of other topical preparations used in the treatment of acne.
Skinoren cream 20%
30 g x 1's
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