Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK
Topical treatment of acne vulgaris.
Cutaneous use.
Skinoren Cream should be applied to the affected areas of skin twice daily (mornings and evenings), and rubbed in gently. As a guide 2.5 cm (approx. 0.5 g) of cream is sufficient for the entire facial area. If other areas of acne, in addition to the face require treatment, for example the chest and back, the amount of cream should be adjusted accordingly.
Patients with sensitive skin should be advised to use Skinoren only once a day (in the evening) for the first week of treatment and then proceed to twice daily applications.
Before Skinoren Cream is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used.
The duration of use of Skinoren Cream can vary from patient to patient and also depends on the severity of the acne. In general, a distinct improvement becomes apparent after about 4 weeks. To obtain the best results, Skinoren Cream should be used continuously over a period of several months (see Section 5.1 Pharmacodynamic properties).
It is important to continue to use Skinoren Cream regularly over the entire period of treatment. However, in the event of intolerable skin irritation (see Section 4.8 Undesirable effects), the amount of cream per application should be reduced or the frequency of use of Skinoren Cream should be reduced to once a day until the irritation ceases. If required, treatment might have to be temporarily interrupted for a few days.
Use in adolescents (12-18 years of age): dose adjustment is not required when Skinoren Cream is administered to adolescents aged 12-18 years.
The safety and efficacy of Skinoren Cream in children below the age of 12 years have not been established.
No targeted studies have been performed in patients aged 65 and over.
No targeted studies have been performed in patients with hepatic impairment.
No targeted studies have been performed in patients with renal impairment.
No known cases of azelaic acid overdosage resulting from topical administration of Skinoren Cream have been reported. Results from acute toxicity studies do not indicate that any risk of acute intoxication is to be expected following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. Due to the very low local and systemic toxicity of azelaic acid intoxication is unlikely.
3 years.
After first opening of the container, the in-use shelf life is 6 months.
Do not store above 30°C.
Tubes containing 20, 30 or 50 g. Not all pack sizes are marketed.
Aluminium tube with internal epoxide coating and polyethylene screw cap.
No special requirements.
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