Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
ingenol mebutate
LEO Pharma Pty Ltd
Ingenol mebutate
Registered
PICATO ® GEL, 0.015% 1 PICATO ® GEL, 0.015% Ingenol (_in' jen ol_) mebutate (_me bue' tate_) _ _ CONSUMER MEDICINE INFORMATION (CMI) PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START YOUR TREATMENT. Picato ® gel, 0.015% is the brand name. The generic name of the active ingredient is ingenol mebutate. KEEP THIS LEAFLET. You may want to read it again. WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about using the medicine Picato ® gel, 0.015%. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Picato ® gel against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING PICATO ® GEL TALK TO YOUR DOCTOR OR PHARMACIST. WHAT PICATO ® GEL, 0.015% IS USED FOR Picato ® gel, 0.015% is used as a topical treatment of solar keratoses (sun spots) on the face and scalp of adults. Solar keratoses are thickened, scaly patches of skin caused by too much sun exposure. Solar keratoses are also known as actinic keratoses. Picato ® gel contains the active ingredient ingenol mebutate. The ingenol mebutate in Picato ® gel treats the lesions in the area where the gel is applied. USE PICATO ® GEL 0.015% ON YOUR FACE AND SCALP IT IS NOT RECOMMENDED THAT PICATO ® GEL, 0.015% IS USED ON OTHER PARTS OF YOUR BODY Picato ® gel is only available with a doctor’s prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. This medicine is not addictive. BEFORE YOU USE PICATO ® GEL _WHEN YOU MUST NOT USE _ _PICATO_ _® _ _GEL_ _ _ DO NOT USE PICATO ® GEL, IF YOU are allergic to ingenol mebutate or any of the other ingredients listed at the end of this leaflet (see PRODUCT DESCRIPTION). Some of the symptoms of an allergic reaction include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or “hives” on the Read the complete document
1 AUSTRALIAN PI – PICATO ® (INGENOL MEBUTATE) GEL 1 NAME OF THE MEDICINE Ingenol mebutate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Picato® gel 0.015% - each gram of gel contains 150 micrograms of ingenol mebutate. Each tube contains 70 micrograms of ingenol mebutate in 0.47 g of gel. Picato® gel 0.05% - each gram of gel contains 500 micrograms of ingenol mebutate. Each tube contains 235 micrograms of ingenol mebutate in 0.47 g of gel. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Gel. Picato® gel is a clear colourless gel intended for topical administration. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Picato® gel is indicated for the topical treatment of solar (actinic) keratoses in adults. 4.2 D OSE AND METHOD OF ADMINISTRATION Picato® gel is indicated for TOPICAL USE ONLY. Picato® gel is NOT for oral, ophthalmic, intravaginal or anal use. DOSE ADULTS FOR THE TREATMENT OF SOLAR (ACTINIC) KERATOSES ON THE FACE AND SCALP Picato® gel, 0.015% should be applied to the affected area once daily for 3 consecutive days. FOR THE TREATMENT OF SOLAR (ACTINIC) KERATOSES ON THE BODY Picato® gel, 0.05% should be applied to the affected area once daily for 2 consecutive days. CHILDREN There is no relevant use of Picato® gel in the paediatric population. eDoc-000756024 - Version 2. 0 2 APPLICATION INSTRUCTIONS FOR THE FACE AND SCALP AND BODY Picato® gel should be applied to the treatment area as defined by the treating physician. Each tube contains enough gel to cover an area of approximately 25 cm 2 (e.g. 5 cm x 5 cm). Tubes should not be re-used once opened. Patients should be instructed to squeeze the gel from the single use tube onto the fingertip and then spread it evenly over the area to be treated, avoiding touching the treatment area and allowing it to dry for 15 minutes. Picato® gel should not be applied immediately before or after taking a shower or less than 2 hours before bedtime. Patients should be instructed to wash their hands with so Read the complete document