SKINOREN Cream Ref.[6345] Active ingredients: Azelaic acid

For external use only.

Care must be taken when using Skinoren Cream to avoid contact with the eyes, mouth and other mucous membranes, and patients should be instructed accordingly (see Section 5.3 Preclinical safety data). In the event of accidental contact, the eyes, mouth and/or affected mucous membranes should be washed with large amounts of water. If eye irritation persists, patients should consult a physician. The hands should be washed after each application of Skinoren Cream.

Worsening of asthma in patients treated with azelaic acid has been reported rarely during post-marketing surveillance.

Skinoren contains a small amount of benzoic acid, which is mildly irritating to the skin, eyes and mucous membranes.

Skinoren also contains propylene glycol, which may cause skin irritation.

No interaction studies have been performed.

Pregnancy

There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.

Animal studies do indicate the potential for effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development. However, the dose levels without observed adverse effects in animals ranged across studies from 3-32 times the maximum recommended human dose based on body surface area (see Section 5.3 Preclinical safety data).

Caution should be exercised when prescribing azelaic acid to pregnant women.

Lactation

Infants must not come into contact with treated skin/breast.

It is not known if azelaic acid is passed into breast milk in vivo. Due to low percutaneous absorption and since azelaic acid is not concentrated in milk, the amount of azelaic acid reaching the infant via mother’s milk is approximately 0.01%. This corresponds to less than 200 µg per day following administration of the maximum recommended dose of 5 g Skinoren 20% Cream twice daily. Caution should be exercised when Skinoren Cream is administered to a nursing mother.

Fertility

There are no data on the effect of Skinoren cream on human fertility. Results from animal studies showed no effect on fertility in male or female rats (see section 5.3 Preclinical safety data).

Skinoren Cream has no influence on the ability to drive and use machines.

From clinical studies and post-marketing surveillance, the most frequently observed side-effects included application site burning, application site pruritus and application site erythema.

Frequencies of side-effects observed in clinical studies and post-marketing surveillance and given in the table below are defined according to the MedDRA frequency convention:

Very common (≥1/10),
Common (≥1/100 to <1/10),
Uncommon (≥1/1,000 to <1/100),
Rare (≥1/10,000 to <1/1,000),
Very rare (<1/10,000),
Not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Uncommon: seborrhoea, acne, skin depigmentation

Rare: cheilitis

Not known¹: Urticaria, rash

General disorders and administration site conditions

Very common: application site burning, application site pruritus, application site erythema

Common: application site exfoliation, application site pain, application site dryness, application site discolouration, application site irritation

Uncommon: application site paraesthesia, application site dermatitis, application site discomfort, application site oedema

Rare: application site vesicles, application site eczema, application site warmth, application site ulcer

Immune system disorders

Rare: drug hypersensitivity, worsening of asthma (see section 4.4)

Not known¹: angioedema², dermatitis contact², eye swelling², swelling face²

¹ These additional adverse reactions have been reported during post-approval use of Skinoren cream (frequency unknown).
² may occur with hypersensitivity

Generally, local skin irritation regresses in the course of treatment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None known.