Staquis

Posology Adults A layer of ointment is to be applied twice daily to affected areas. The ointment should only be applied to affected skin areas up to a maximum of 40% BSA. The ointment can be used on all skin areas except on the scalp.

Use on the scalp has not been studied. The ointment can be used twice daily for up to 4 weeks per treatment course. 1). Medicinal product no longer authorised 3 Paediatric population For children and adolescents (2-17 years) the posology is the same as for adults.

The safety and efficacy of Staquis in children less than 2 years of age has not been established. No data are available. Special populations Hepatic impairment Clinical studies in subjects with hepatic impairment have not been conducted.

However, dosage adjustment is not expected to be necessary in subjects with mild to moderate hepatic impairment. Renal impairment Clinical studies in subjects with renal impairment have not been conducted. However, dosage adjustment is not expected to be necessary in this patient population.

Elderly Atopic dermatitis is uncommonly observed in patients aged 65 years and over. 1). However, dosage adjustment is not expected to be necessary in this patient population. Method of administration The ointment is for cutaneous use only.

4). Staquis has not been specifically studied under occlusion. , nappies or clothing) has not shown the necessity for any dosage adjustment. Patients should be instructed to wash their hands after applying the ointment, unless it is their hands that are being treated.

If someone else applies the ointment to the patient, they too should wash their hands after application.

4%). Generally, application site pain was noted early in the treatment period and was transient in nature, resolving spontaneously. Tabulated list of adverse reactions Adverse reactions are ranked under headings of frequency, with the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 toMedicinal product no longer authorised 5 < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

, application site pain1, application site pruritus, application site dermatitis, application site erythema, application site irritation, application site urticaria) 1 Refers to skin sensations such as burning or stinging. 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 national reporting system listed in Appendix V.

2). In cases of accidental exposure in the eyes or mucous membranes, the ointment should be thoroughly wiped off and/or rinsed with water. Available data indicate that local skin reactions, such as burning or stinging, may be more likely to occur on sensitive skin areas (such as the face and neck).

Hypersensitivity Hypersensitivity, including contact urticaria, has occurred in patients treated with Staquis. Hypersensitivity should be suspected in the event of severe pruritus, swelling and erythema at the application site or at a distant site.

Medicinal product no longer authorised 4 Excipients with known effect This medicine contains 90 mg propylene glycol in each gram of ointment.

1.