Picato 150 micrograms/gram gel ingenol mebutate – patient leaflet, side effects, dosage

1. What Picato is and what it is used for

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 500 micrograms/gram gel is used for actinic keratosis on the body, arms, hands and legs.

2. What you need to know before you use Picato

Do not use Picato

• If you are allergic to ingenol mebutate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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 two 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.

Children and adolescents

Actinic keratosis does not occur in children, and this medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Picato

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

aby, ask you are

If you have previously used Picato or other similar medicines tell your doctor before startin treatment.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to your doctor for advice before using this medicine. You should avoid the use of Pi pregnant.

If you are breast-feeding, avoid physical contact between the baby and the treated area for 6 hours after application of this medicine.

Driving and using machines

e machines.

This medicine does not have any effect on your ability to drive

3. How to use Picato

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 body, arms, hands and legs is one tube of Picato 500 micrograms/g gel (containing 235 micrograms of ingenol mebutate) once a day for 2 days in a row.

Instructions for

e each time you use this medicine. Remove the cap from the tube just before he gel from one tube onto a fingertip.

the content of one tube to one area of 25 cm² (e.g. 5 cm x 5 cm).

tly rub the gel onto the treatment area.

llow 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. If you are treating your hands you should only wash the fingertip which you used for applying the gel.

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.

experience severe

If you use Picato for treatment of the neck

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)

If you use more Picato than you should

Wash the area with soap and water. Please contact your doctor or p skin reactions.

If you forget to use Picato

Please contact your doctor or pharmacist if you forget

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine ca

side effects, although not everybody gets them.

Seek medical attention right a the mouth, tongue or throat w

After using this medic

ou experience an allergic reaction that may include swelling of g this medicine. This side effect is uncommon.

side effects most o worse for up to 1 w 4 weeks from whe skin where you apply it is likely to get red, peel and have scabs. These r within one day after applying this medicine. The side effects may get after you have stopped using this medicine. They will usually get better within 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:

Very common side effects on the treatment area, may affect more than 1 in 10 people: 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:

Very common side effects on the treatment area, may affect more than 1 in 10 people: 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:

Common side effects, may affect up to 1 in 10 people:

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
• Headache

Uncommon side effects, may affect up to 1 in 100 people:

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 irr the surface of the eye (cornea, conjunctiva) following accidental exposure

Rare side effects, may affect up to 1 in 1000 people:

On the treatment area:

• Scarring sible side effects when treating the trunk and extremities:

Common side effects, may affect up to 1 in 10 people:

On the treatment area:

Itching (pruritus) Irritation

Pain (including application site burning)

Uncommon side effects, may affect up to 1 in 100 people:

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.

Rare side effects, may affect up to 1 in 1000 people:

On the treatment area:

• Scarring

Reporting of side effects

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.

5. How to store Picato

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.

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.

6. Contents of the pack and other information

What Picato contains

• The active substance is ingenol mebutate. Each gram of gel contains 500 micrograms of ingenol mebutate. Each tube contains 235 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.

What Picato looks like and contents of the pack

Picato 500 micrograms/g gel is clear and colourless and each carton contains 2 tubes with 0.47 g of gel each.

Marketing Authorisation Holder

LEO Laboratories Ltd.

285 Cashel Road Crumlin, Dublin 12 Ireland

Manufacturer

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:

Belgie/Belgique/Belgien

LEO Pharma N.V./S.A

Tél/Tel: +32 3 740 7868

Lietuva

LEO Pharma A/S

Tel: +45 44 94 58 88

Latvija

LEO Pharma A/S

Tel: +45 44 94 58 88

United Kingdom

LEO Laboratories Ltd Tel: +44 (0) 1844 347333

This leaflet was last revised in.

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/

SCIENTIFIC CONCLUSIONS AND GROUNDS

ANNEX IV

THE VARIATION TO THE TERMS

OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for ingenol mebutate, the scientific conclusions of CHMP are as follows:

Taking into account the treatment purpose for actinic keratosis, which is prevention of skin malignancy, and considering the number of skin tumour cases reported to ingenol mebutate in clinical trials and post-marketing, the PRAC has serious concerns about the impact of the risk of skin tumours on the benefit risk balance of Picato. The PRAC is of the opinion that a thorough review is needed of the impact of all available data related to skin malignancies, including the results of study LP0041-63, on the benefit risk balance of Picato. Additionally, the product information should be varied concerning ingenol mebutate use and the risk of skin malignancy. The PRAC also agreed that a DHPC is needed in order to mitigate this risk.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for ingenol mebutate the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ingenol mebutate is unchanged subject to the proposed changes to the product information

on(s) should be varied.

The CHMP recommends that the terms of the marketing au

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