A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release LEO Laboratories Ltd.

285 Cashel Road

Crumlin, Dublin 12

Ireland

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of th opean Medicines Agency;

Whenever the risk agement system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

o conduct post-authorisation measures

complete, within the stated timeframe, the below measures:

Description	Due date
Post-Authorisation safety study: In order to further investigate the incidence of treatment area skin malignancy, particularly squamous cell carcinoma, the MAH should conduct and submit the results of a randomised, double-blind, trial in patients treated with ingenol mebutate compared with vehicle control, over at least 18 months of follow-up. The study should be based on an agreed protocol. The final study report shall be submitted:	31 December 2024
Non-interventional Post-Authorisation safety study: In order to investigate the rate of skin malignancies (squamous cell carcinoma,

Bowen’s disease, basal cell carcinoma, keratoacanthoma, malignant melanoma) in patients with actinic keratosis treated with ingenol mebutate, the MAH should conduct and submit the results of a cohort study comparing patients treated with ingenol mebutate with patients exposed to other actinic keratosis treatments. The final study report shall be submitted:

31 December 2020

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE )

EXP

• 9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

Picato 150 mcg/g

• 17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included.

• 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number} SN: {number} NN: {number}

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF 500 mcg/g GEL

• 1. NAME OF THE MEDICINAL PRODUCT

Picato 500 micrograms/g gel ingenol mebutate

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

  
  

Each gram of gel contains 500 micrograms of ingenol mebutate. Each tube contains 235 micrograms of ingenol mebutate in 0.47 g of gel.

Isopropyl alcohol Hydroxyethylce­llulose Citric acid monohydrate Sodium citrate

Benzyl alcohol Purified water

4. PHARMACEUTICAL FORM AND C

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE )

EXP

• 9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

Picato 500 mcg/g

• 17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included.

• 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number} SN: {number} NN: {number}

TUBE 150 mcg/g GEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Picato 150 mcg/g gel ingenol mebutate Cutaneous use

TUBE 500 mcg/g GEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Picato 500 mcg/g gel ingenol mebutate Cutaneous use

Package leaflet: Information for the patient

Picato 150 micrograms/gram gel 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.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – 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 is in this leaflet

• 1. What Picato is and what it is used for

• 2. What you need to know before you use Picato

• 3. How to use Picato

• 4. Possible side effects

• 5. How to store Picato

• 6. Contents of the pack and other information

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 150 micrograms/gram gel is used for actinic keratosis on the face and scalp.

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 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.

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 me

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

Pregnancy and breast-feeding

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

This medicine does not have any effect on your

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 coul d to intense local skin responses.

Treatment of actinic k sis 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.

ube 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 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 effectsLike all medicines, this medicine caside effects, although not everybody gets them.Seek medical attention right a the mouth, tongue or throat wAfter using this medic side effects most oou experience an allergic reaction that may include swelling of g this medicine. This side effect is uncommon.2 weeks froworse for up toskin where you apply it is likely to get red, peel and have scabs. These ccur within one day after applying this medicine. The side effects may get after you have stopped using this medicine. They will usually get better withinyou 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 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 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.

What Picato looks like and contents of the pack

Picato 150 micrograms/g gel is clear and colourless and each carton contains 3 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:

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:

Package leaflet: Information for the patient

Picato 500 micrograms/gram gel 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.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – 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 is in this leaflet

• 1. What Picato is and what it is used for

• 2. What you need to know before you use Picato

• 3. How to use Picato

• 4. Possible side effects

• 5. How to store Picato

• 6. Contents of the pack and other information

............ \OX

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.

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

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.

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.

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 effectsLike all medicines, this medicine caside effects, although not everybody gets them.Seek medical attention right a the mouth, tongue or throat wAfter using this medic

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

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:

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 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,

What Picato looks like and contents of the pack

Picato 150 micrograms/g gel is clear and colourless and each carton contains 3 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:

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:

Package leaflet: Information for the patient

Picato 500 micrograms/gram gel 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.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – 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 is in this leaflet

• 1. What Picato is and what it is used for

• 2. What you need to know before you use Picato

• 3. How to use Picato

• 4. Possible side effects

• 5. How to store Picato

• 6. Contents of the pack and other information

............ \OX

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.

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

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.

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.

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 effectsLike all medicines, this medicine caside effects, although not everybody gets them.Seek medical attention right a the mouth, tongue or throat wAfter using this medic

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

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 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 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,