Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Eye exposure
Contact with the eyes can cause chemical conjunctivitis and corneal burns. Patients should wash their hands thoroughly after applying the gel and following any contact with the treated area, to avoid inadvertent transfer of the gel to the eyes. If accidental exposure occurs, the eyes should be flushed immediately with large amounts of water, and the patient should seek medical care as soon as possible. Eye disorders such as eye pain, eyelid oedema and periorbital oedema should be expected to occur after accidental eye exposure of Picato (see section 4.8).

Ingestion
Picato must not be ingested. If accidental ingestion occurs the patient should drink plenty of water and seek medical care.

General
Administration of Picato is not recommended until the skin is healed from treatment with any previous medicinal product or surgical treatment and should not be applied to open wounds or damaged skin where the skin barrier is compromised.
Picato should not be used near the eyes, on the inside of the nostrils, on the inside of the ears or on the lips.

Local skin responses
Local skin responses such as erythema, flaking/scaling, and crusting should be expected to occur after cutaneous application of Picato (see section 4.8). Localised skin responses are transient and typically occur within 1 day of treatment initiation and peak in intensity up to 1 week following completion of treatment. Localised skin responses typically resolve within 2 weeks of treatment initiation when treating areas on the face and scalp and within 4 weeks of treatment initiation when treating areas on the trunk and extremities. Treatment effect may not be adequately assessed until resolution of local skin responses.

Sun exposure
Studies have been conducted to assess the effects of UV irradiation of the skin following single and multiple applications of ingenol mebutate gel, 100 mcg/g. Ingenol mebutate gel did not demonstrate any potential for photo irritation or photo allergic effects. However, due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised.

Keratoacanthoma
Reports of keratoacanthoma occurring within the treatment area with a time to onset ranging from weeks to months following use of ingenol mebutate gel have been received from a post- authorisation clinical trial (see section 5.1). Health care professionals should advise patients to be vigilant for any lesions developing within the treatment area and to seek medical advice immediately should any occur.

Management of actinic keratosis
Lesions clinically atypical for actinic keratosis or suspicious for malignancy should be biopsied to determine appropriate treatment.

Effects on Driving

4.7   Effects on ability to drive and use machines
Picato has no or negligible influence on the ability to drive and use machines.