ALACARE Medicated plaster Ref.[27706] Active ingredients: Aminolevulinic acid

Alacare is not recommended for the treatment of pregnant women unless clearly necessary (see 4.6).

Very thick, red, scaly indurated AK lesions should not be treated with Alacare.

There is no experience of treating AK lesions in patients with dark brown or black skin (skin sun sensitivity type V or VI according to Fitzpatrick).

No data regarding efficacy and safety are available for repeated treatment of AK lesions with Alacare.

Any UV-therapy should be discontinued before treatment. As a general precaution, sun exposure of the treated lesion sites and surrounding skin should be avoided for approximately 48 hours following treatment.

Direct eye contact with Alacare should be avoided.

Alacare should only be administered by a nurse or other healthcare professional trained with the use of photodynamic therapies under the supervision of a physician.

The success and assessment of treatment may be impaired if the treated area is affected by the presence of skin diseases (skin inflammation, located infection, psoriasis, eczema, and benign or malignant skin cancers) as well as tattoos. No experience exists with these situations.

Concomitant use of medicinal products with known phototoxic or photoallergic potential such as St. John’s wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines may enhance the phototoxic reaction to photodynamic therapy. Concomitant use with other topical medicinal products should be avoided.

As hypericin can increase phototoxic reactions induced by PDT, treatment with hypericin-containing products (St John’s Wort, Hypericum perforatum) should be discontinued two weeks before PDT with Alacare.

Pregnancy

There are no adequate data from the use of 5-aminolevulinic acid in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal and fetal development, parturition and postnatal development (see section 5.3). The potential risk for humans is unknown. Alacare should not be used during pregnancy unless clearly necessary.

Breastfeeding

It is unknown whether 5-aminolevulinic acid is excreted in human breast milk. The excretion of 5-aminolevulinic acid has not been studied in animals. Breast-feeding should be discontinued for 48h after application of Alacare.

None.

a) Almost all patients (99%) experience adverse reactions localised at the treatment site (local reactions) that are attributable to toxic effects of the photodynamic therapy (phototoxicity). During application of Alacare and prior to illumination of the treatment site, 33% of patients show local reactions, most frequently pruritus, burning and erythema. During illumination, erythema, burning and pain are the local reactions reported most often. The symptoms are usually of mild or moderate severity and require early termination of illumination in 1% of the patients. Cooling of the treated area may alleviate these symptoms. After therapy, pruritus, erythema, scabbing and exfoliation are the most frequent local reactions which are likewise mainly mild to moderate and persist for 1 to 2 weeks or occasionally longer.

A common (<10%) adverse reaction not involving the treatment site is headache.

b) The incidence of adverse reactions in patients receiving Alacare plus illumination, is shown in the table below.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.