Altargo

Posology Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine months to 11 years) A thin layer of ointment should be applied to the affected area twice daily for five days. The area treated may be covered with sterile bandage or gauze dressing.

Safety and efficacy have not been established in the following: • Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area. Medicinal product no longer authorised 3 In patients aged less than 18 years the total surface area treated should be no more than 2% of the body surface area.

4). Special populations Elderly (aged 65 and older) No dosage adjustment is necessary. Renal impairment No dosage adjustment is necessary. 3. Hepatic impairment No dosage adjustment is necessary. 3. Paediatric population The safety and efficacy of retapamulin ointment in infants less than nine months of age has not been established.

2, but no recommendation on a posology can be made. Method of administration Retapamulin is for cutaneous use only.

Summary of the safety profile In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which affected approximately 1% of patients.

Tabulated list of adverse reactions The following convention has been used for the classification of frequency: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Organ systems Common Uncommon Not known Immune system disorders Hypersensitivity, including angioedema Skin and subcutaneous tissue disorders Contact dermatitisMedicinal product no longer authorised 6 General disorders and administration site conditions Application site reactions Irritation Application site reactions Pain Pruritus Erythema Application site irritation (including burning sensation) Paediatric population Frequency, type and severity of adverse reactions in the paediatric population are the same as in adults.

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.

Sensitisation or severe local irritation In the event of a sensitisation or severe local irritation from the use of retapamulin ointment, treatment should be discontinued, the ointment carefully wiped off, and appropriate alternative therapy for the infection instituted.

Eyes and mucous membranes Retapamulin ointment must be kept away from the eyes and mucous membranes. Epistaxis has been reported with use of Altargo on nasal mucosa. Ingestion Care must be taken to avoid ingestion. Medicinal product no longer authorised 4 Prolonged use and overgrowth of non-susceptible micro-organisms Prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including fungi.

If super-infection with a non-susceptible organism is suspected, treatment should be guided by clinical and microbiological assessments. Abscesses Retapamulin should not be used to treat abscesses. 1). In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by MRSA.

The reason for the reduced clinical efficacy observed in these patients is unknown. g. contact dermatitis), or irritation to the eyes and mucous membranes.

1.