Picato Gel: 0.015%

Picato Gel: 0.015% is a brand of medicine containing the active ingredient ingenol mebutate.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

Picato® gel, 0.015%

Ingenol (in' jen ol) mebutate (me bue' tate)


Consumer Medicine Information

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.

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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.

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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 skin.

Do not use Picato® gel, on broken skin.

Do not use Picato® gel:

  • after the expiry date printed on the pack OR
  • if the packaging is torn, doesn’t look quite right or shows signs of tampering.

If any of these apply, return the medicine to your pharmacist for disposal.

If you are not sure whether you should start using Picato® gel, talk to your doctor.

Before you start to use Picato® gel

Tell your doctor if you have a known allergy to Picato® gel ingenol mebutate or any of the ingredients listed at the end of this leaflet.

Tell your doctor if you:

  • are pregnant or intend to become pregnant
  • are taking any other medicines
  • currently have, or in the past have had, any other medical conditions.

Do not use Picato® gel on children. Solar keratoses is not a condition that normally affects children. Safety and effectiveness of Picato® gel in those below 18 years of age has not been established.

If you have not told your doctor about any of the above, tell him/her before you start using this medicine.

Other medicines

Tell your doctor or pharmacist if you are using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Your doctor and pharmacist have more information on medicines you should be careful with or avoid whilst using Picato® gel.

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How to use Picato® gel, 0.015%

Follow carefully all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much Picato® gel, 0.015% to use

Each carton of Picato® gel, 0.015% contains 3 small tubes.

Each tube of Picato® gel, 0.015% contains a single dose. You should apply the contents of 1 tube to the area on your face or scalp containing the sun spot (s) / lesion(s).

Each tube of Picato® gel, 0.015% contains enough gel to cover an area of approximately 25cm2 (e.g. 5cm x 5cm). However, avoid getting Picato® gel close to the eyes, nostrils and mouth. If the lesion is near the eyes, nostrils or mouth you may need to apply Picato® gel to a smaller treatment area.

How to use Picato® gel, 0.015%

Apply Picato® gel, 0.015% only to treatment areas on the face or scalp.

Use Picato® gel, 0.015% as follows:

  • Squeeze the gel from the single use tube onto the fingertip and then spread it evenly over the treatment area.
  • Allow treatment area to dry for 15 minutes. Do not touch during this time.
  • Wash your hands with soap and water immediately after application.
  • Do not wash the area of the body where Picato® gel, 0.015% was applied for at least 6 hours after application.
  • After this period the treatment area may be washed using mild soap and water.
  • Picato® gel, 0.015% should not be applied immediately before or after taking a shower as the skin needs to be very dry before application.
  • Picato® gel, 0.015% should not be applied less than 2 hours before bedtime.
  • The area treated with Picato® gel, 0.015% should not be covered with occlusive bandages.

The full effects of Picato® gel, 0.015% are best assessed approximately 8 weeks after treatment.

How long to use Picato® gel

A treatment course lasts for 3 days.

Apply Picato® gel, 0.015% once a day for 3 days in a row.

If you forget to use Picato® gel

If you forget to apply the second or third tube of Picato® gel within 3 days of the last application, apply the second or third tube when you remember. If it has been more than 3 days since the last application, do not apply the remaining tube(s). If this happens you should contact your doctor.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much or use it other than directed (Overdose) immediately telephone your doctor or the Poisons Information Centre (Telephone 13 11 26 in Australia or 0800 764 766 in New Zealand) for advice, or go to the Emergency Department at the nearest hospital, if you think that you or anyone else may have used too much or swallowed some of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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While you are using Picato® gel

Things you must do

While you are using Picato® gel you should protect the treated skin areas from sunlight and ultraviolet (UV) rays. This can be done by covering the treated area with clothing before going outside. Sunscreen can be applied to the treatment site once treatment is completed and the treatment area has healed.

Non-medicated, non-irritant products can also be applied to the treatment area once treatment is completed and the treatment area has healed.

If you are going to start any new medicine, tell your doctor and pharmacist that you are using Picato® gel.

If you become pregnant while using Picato® gel tell your doctor immediately.

Keep all appointments with your doctor so that your progress can be checked.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not use more than the recommended daily dose (see How to use Picato® gel, 0.015%).

DO NOT APPLY PICATO® GEL TO OR NEAR YOUR EYES. If it gets into your eyes, flush with plenty of water then consult your doctor immediately.

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Side effects

As with all medicines, Picato® gel can cause some side effects.

The most common effects are expected and show that the treatment is working.

The expected effects at the application site include:

  • Skin reddening
  • Skin flaking or scaling
  • Mild swelling
  • Crusting or Scabbing
  • Blistering

Side effects not listed above may also occur in some people. These less common side effects include:

  • Pain
  • Itching
  • Irritation
  • Ulceration

of the treatment site.

All these effects usually clear within 2 weeks. If the effects continue for longer you should talk to your doctor.

Tell your doctor or pharmacist if you notice the following side effects:

  • Ulcers forming
  • Skin weeping
  • Swelling of the eyelids
  • You think the application site has become infected.

You should also tell your doctor or pharmacist if you have any additional unpleasant effects while you are using Picato® gel.

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After using Picato® gel

Keep Picato® gel in the box in the refrigerator until required.

Storage

STORE PICATO® GEL IN THE REFRIGERATOR.

Picato® gel can spend a short time outside of the refrigerator if the temperature is below 30ºC. This will allow you time to get Picato® gel home from the pharmacy and into the refrigerator.

Periods of storage outside of the refrigerator may reduce the effectiveness of Picato® gel.

Store Picato® gel where children cannot reach it.

Disposal

Ask your pharmacist what to do with Picato® gel that is left over if:

  • your doctor tells you to stop using Picato® gel
    or
  • the expiry date has passed

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Product description

What it looks like

Picato® gel is a clear, colourless gel.

Ingredients

Picato® gel contains the active ingredient ingenol mebutate.

It also contains:

  • isopropyl alcohol,
  • hydroxyethylcellulose,
  • citric acid monohydrate,
  • sodium citrate,
  • benzyl alcohol

The Australian Registration Number is AUST R 190122.

This is not all the information available on Picato® gel, 0.015%. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

Supplier

Picato® gel is supplied in Australia by:
LEO Pharma Pty Ltd,
Level 3, Tower 1, 25 Montpelier Road,
Bowen Hills, QLD 4006, AUSTRALIA

Picato® gel is supplied in New Zealand by:
LEO Pharma Ltd,
Level 31, Vero Centre, 48 Shortland St, Auckland,
NEW ZEALAND

Contact details:

  • Web: www.leo-pharma.com.au
  • Australia Toll free no: 1800 991 778
    New Zealand Toll free no: 0800 497 456
    Email: medical-info.au@leo-pharma.com
  • Picato, LEO and LEO/lion device are registered trademarks of LEO Pharma A/S.

This leaflet was prepared in November 2012 and last revised in September 2014.

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CMI provided by MIMS Australia, June 2015  

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