Picato
ingenol mebutate
ingenol mebutate
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Picato is and what it is used for
What you need to know before you use Picato
How to use Picato
Possible side effects
How to store Picato
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Contents of the pack and other information
Picato contains the active substance ingenol mebutate.
This medicine is used for topical (on the skin) treatment of actinic keratosis, also called solar keratosis, in adults. Actinic keratoses are rough areas of skin found in people who have been exposed to too
much sunshine over the course of their lifetime. Picato 150 micrograms/gram gel is used for actinic keratosis on the face and scalp.
If you are allergic to ingenol mebutate or any of the other ingredients of this medicine (listed in section 6).
Talk to your doctor or pharmacist before using Picato.
Do not get Picato in your eyes. Wash your hands thoroughly after you have applied the gel.
Wash your hands again if you happen to touch the area where you applied the gel. Take care not to transfer gel from the treatment area into your eyes. In the event of accidental contact, remove
the gel by rinsing with plenty of water and seek medical assistance as soon as possible.
Do not swallow this medicine. Drink plenty of water if you accidentally swallow this medicine and seek medical assistance.
Make sure that your skin has healed from any other treatments or surgery before using this
medicine. Do not apply Picato on open-wounds or damaged skin.
Do not apply this medicine internally, to the area near the eyes, to the inside of the nostrils, the inside of the ear or on the lips.
Avoid sunlight as much as possible (including sunlamps and tanning beds).
Be vigilant for any new scaly red patches, open sores, elevated or warty growths within the treatment area. Should any occur, talk to your doctor immediately.
This medicine is intended to treat one area of 25 cm2 for three days.
Do not apply more gel than your doctor has advised.
You should expect to get local skin reactions, such as reddening and swelling, after treatment with this medicine (see section 4). Contact your doctor if these local skin reactions get severe.
Actinic keratosis does not occur in children, and this medicine must not be used in children and adolescents under 18 years of age.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
If you have previously used Picato or other similar medicines tell your doctor before starting the treatment.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. You should avoid the use of Picato if you are pregnant.
If you are breast-feeding, avoid physical contact between the baby and the treated area for 6 hours after application of this medicine.
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This medicine does not have any effect on your ability to drive or to use machines.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If you have been prescribed two different strengths for treatment of two different areas you should make sure that you use the prescribed strength on the correct area. Do not apply the 500 mcg/g gel on the face or scalp as this could lead to intense local skin responses.
Treatment of actinic keratosis on the face and scalp is one tube of Picato 150 micrograms/g gel (containing 70 micrograms of ingenol mebutate) once a day for 3 days in a row.
Instructions for use:
Open a new tube each time you use this medicine. Remove the cap from the tube just before use.
Squeeze the gel from one tube onto a fingertip.
Apply the content of one tube to one area of 25 cm2 (e.g. 5 cm x 5 cm).
Gently rub the gel onto the treatment area.
Allow the area to dry for 15 minutes. Avoid touching the treatment area for 6 hours after applying your medicine.
Wash your hands with soap and water immediately after applying the gel, and also in between
administrations if prescribed two different strengths for two different areas.
Do not apply this medicine immediately after taking a shower or less than 2 hours before bedtime.
Do not wash the areas where you applied the gel for at least 6 hours after you apply it.
Do not touch the treatment area yourself or allow anyone or any pets to touch the treatment area for a period of 6 hours after applying the gel.
Do not cover the treated area with air- or water-tight bandages after you have applied this
medicine.
The full effect of Picato can be evaluated approximately 8 weeks after treatment.
If more than half of the treatment area is located in the upper part of the neck:
Use Picato 150 mcg/g gel (face and scalp)
If more than half of the treatment area is located in the lower part of the neck:
Use Picato 500 mcg/g gel (trunk and extremities)
Wash the area with soap and water. Please contact your doctor or pharmacist if you experience severe skin reactions.
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Please contact your doctor or pharmacist if you forget to use Picato.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical attention right away if you experience an allergic reaction that may include swelling of the mouth, tongue or throat when using this medicine. This side effect is uncommon.
After using this medicine the skin where you apply it is likely to get red, peel and have scabs. These side effects most often occur within one day after applying this medicine. The side effects may get worse for up to 1 week after you have stopped using this medicine. They will usually get better within 2 weeks from when you started the treatment.
Infection of the skin in the treatment area can occur (has been reported as a common side effect, which may affect up to 1 in 10 people, when treating the face and scalp).
Swelling of the application site is very common (has been reported in more than 1 in 10 people). Application site swelling on the face or scalp may gravitate to the eye area.
Should the symptoms described above intensify beyond the first week after you have stopped using this medicine, or if there is discharge of pus, you might have an infection and should contact your doctor or pharmacist.
The most frequently occurring side effects when treating the face and scalp:
On the treatment area:
Some of the outer layer of your skin may wear away (erosion)
Blisters (vesicles, pustules)
Peeling (exfoliation)
Scabs
Redness due to widening of the small blood vessels (erythema)
Pain (including application site burning)
The most frequently occurring side effects when treating the trunk and extremities:
On the treatment area:
Some of the outer layer of your skin may wear away (erosion)
Blisters (vesicles, pustules)
Peeling (exfoliation)
Scabs
Redness due to widening of the small blood vessels (erythema)
Other possible side effects when treating the face and scalp:
On the treatment area:
Itching (pruritus)
Irritation
Other side effects:
Swelling of the area around the eye (periorbital oedema)
Swelling (oedema) of your eye lid
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Headache
On the treatment area:
Tingling or numbness (paraesthesia)
Open sores (ulcer)
Discharge (secretion) of fluid
Change in skin colour (pigmentation change)
Other side effects:
Eye pain
Injury or irritation to the surface of the eye (cornea, conjunctiva) following accidental exposure
On the treatment area:
Scarring
Other possible side effects when treating the trunk and extremities:
On the treatment area:
Itching (pruritus)
Irritation
Pain (including application site burning)
On the treatment area:
Tingling or numbness (paraesthesia)
Open sores (ulcer)
Change in skin colour (pigmentation change)
Warmth
Other side effects:
Injury or irritation to the surface of the eye (cornea, conjunctiva) following accidental exposure
On the treatment area:
Scarring
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C).
For single use only. Do not re-use the tubes once opened.
Medicinal product no longer authorised
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is ingenol mebutate. Each gram of gel contains 150 micrograms of ingenol mebutate. Each tube contains 70 micrograms of ingenol mebutate in 0.47 g of gel.
The other ingredients are isopropyl alcohol, hydroxyethylcellulose, citric acid monohydrate, sodium citrate, benzyl alcohol, purified water.
Picato 150 micrograms/g gel is clear and colourless and each carton contains 3 tubes with 0.47 g of gel each.
LEO Laboratories Ltd. 285 Cashel Road
Crumlin, Dublin 12
Ireland
LEO Laboratories Ltd.
285 Cashel Road, Crumlin, Dublin 12 Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
LEO Pharma A/S Tel: +45 44 94 58 88
Borola Ltd
Teл.: +359 2 9156 136
LEO Pharma s.r.o. Tel: +420 225 992 272
LEO Pharma
Tel: +36 1 888 0525
LEO Pharma AB Tlf: +45 70 22 49 11
PHARMA-COS LTD Tel: +356 2144 1870
LEO Pharma GmbH Tel: +49 6102 2010
LEO Pharma B.V. Tel: +31 205104141
LEO Pharma A/S Tel: +45 44 94 58 88
LEO Pharma AS Tlf: +47 22514900
LEO Pharmaceutical Hellas S.A.
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Τηλ: +30 210 68 34322
LEO Pharma GmbH Tel: +43 1 503 6979
Laboratorios LEO Pharma, S.A. Tel: +34 93 221 3366
LEO Pharma Sp. z o.o. Tel.: +48 22 244 18 40
LEO Pharma
Tél: +33 1 3014 4000
Remedia d.o.o
Tel: +385 1 3778 770
LEO Farmacêuticos Lda. Tel: +351 21 711 0760
LEO Pharma Romania Tel: +40 213121963
LEO Laboratories Ltd Tel: +353 (0) 1 490 8924
Vistor hf.
Sími: +354 535 7000
LEO Pharma S.p.A Tel: +39 06 52625500
LEO Pharma Oy
Puh/Tel: +358 20 721 8440
The Star Medicines Importers Co. Ltd.
Τηλ: +357 2537 1056
LEO Pharma AB Tel: +46 40 3522 00
LEO Pharma A/S Tel: +45 44 94 58 88
LEO Laboratories Ltd Tel: +44 (0) 1844 347333
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