PROTOPIC 0.03% Ointment

Зміст інструкції

1. Protopic 0.03% ointment
   1. What is Protopic and what is it used for
   2. What you need to know before using Protopic
   3. How to use Protopic
   4. Possible side effects
   5. How to store Protopic
   6. Contents of the pack and other information
2. Protopic 0,1% ointment
   1. What is Protopic and what is it used for
   2. What you need to know before using Protopic
   3. How to use Protopic
   4. Possible side effects
   5. How to store Protopic
   6. Package Contents and Other Information

Protopic 0.03% ointment

tacrolimus monohydrate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Protopic is and what it is used for
• 2. What you need to know before you use Protopic
• 3. How to use Protopic
• 4. Possible side effects
• 5. How to store Protopic
• 6. Contents of the pack and other information

1. What is Protopic and what is it used for

The active ingredient of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Protopic 0.03% ointment is indicated for the treatment of moderate to severe atopic dermatitis
(eczema) in adults who do not respond adequately or who are intolerant to conventional therapies
such as topical corticosteroids and in children (from 2 years of age) who have not responded
adequately to conventional therapies such as topical corticosteroids.
If moderate to severe atopic dermatitis has disappeared or almost disappeared after treatment of
exacerbations for up to 6 weeks, and if frequent relapses occur (4 or more
per year), they can be prevented or the time in which they do not occur can be prolonged with the use of
Protopic 0.03% ointment twice a week.
In atopic dermatitis, there is a hyperreaction of the skin's immune system that causes
skin inflammation (itching, redness, dryness). Protopic modifies the abnormal immune response
and relieves skin inflammation and itching.

2. What you need to know before using Protopic

Do not use Protopic

• if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6) or to macrolide antibiotics (i.e. azithromycin, clarithromycin, erythromycin).

Warnings and precautions
Talk to your doctor before using Protopic:

• If you have hepatic impairment.
• If you have any malignant tumor(neoplasia) of the skinor if you have a weakened immune system(immunocompromised), whatever the cause.
• If you have a congenital skin diseasesuch as Netherton syndrome, lamellar ichthyosis (widespread scaling of the skin caused by thickening of the outer skin layer), or if

you have an inflammatory skin disease such as pyoderma gangrenosum, or if you suffer from

generalized erythroderma(redness from inflammation and scaling of the entire skin).

• If you develop Graft Versus Host Disease (cutaneous) (a skin immune reaction that is a common complication in patients undergoing bone marrow transplantation).
• If you have swollen lymph nodesat the start of treatment. If your lymph nodes swell during treatment with Protopic, consult your doctor.
• If you have infected lesions.Do not apply the ointment to infected lesions.
• If you notice any change in the appearance of the skin, tell your doctor.
• Based on the results of long-term studies and experience, a correlation between treatment with Protopic ointment and the development of malignant neoplasms has not been confirmed, but definitive conclusions cannot be drawn.
• Avoid prolonged exposure of the skin to sunlight or artificial light such as tanning beds. If you spend time outdoors after applying Protopic, use a sunscreen and wear comfortable clothing that protects the skin from the sun. Also, consult your doctor for other appropriate sun protection methods. If you have been prescribed heliotherapy, tell your doctor that you are using Protopic and that the use of Protopic and sun therapy is not recommended at the same time.
• If your doctor prescribes Protopic twice a week to prevent a new flare-up of your atopic dermatitis, your condition should be re-evaluated by your doctor at least every 12 months even if the disease is under control. In children, maintenance treatment should be discontinued after 12 months to verify if there is still a need for continuous treatment.
• It is recommended to use Protopic ointment with the lowest possible dose, with the lowest frequency and for the shortest possible time necessary. This decision should be based on the doctor's assessment of how your eczema responds to Protopic ointment.

Children

• Protopic ointment is not approved for use in children under 2 years of age. It should therefore not be used in this age group. Please consult your doctor.
• The effect of treatment with Protopic on the development of the immune system in children, especially young children, has not been established.

Other medicines, cosmetics and Protopic
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
You can use moisturizers and lotions during treatment with Protopic, however they can only be
applied to the same treated area two hours before or two hours after applying Protopic.
The effect of the simultaneous use of Protopic with other preparations to be applied to the
skin or with the assumption of oral corticosteroids (e.g. cortisone) or medicines that act
on the immune system has not been studied.

Protopic with alcohol
During the use of Protopic, the consumption of alcoholic beverages may cause flushing on the face or skin
and sensations of heat.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Protopic contains butylhydroxytoluene (E321)
Protopic contains butylhydroxytoluene (E321), which may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to use Protopic

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

• Apply a thin layer of Protopic to the affected areas of the skin.
• Protopic can be applied to most of the body surface, including the face, neck and areas subject to flexion of the elbows and knees.
• Avoid using the ointment in the nose, mouth or eyes. If the ointment is accidentally applied to these areas, the area should be thoroughly cleaned and/or rinsed with water.
• Do not cover the affected area of skin with bandages or dressings.
• Wash your hands after applying Protopic, unless your hands are also part of the area to be treated.
• Before applying Protopic after a bath or shower, you must ensure that the skin is completely dry.

Use in children (aged 2 years and over)
Apply Protopic 0.03% ointment twice a day for three weeks, once in the morning and once in the
evening. Afterwards, the ointment should be used once a day on each area of the
affected skin until the eczema heals.

Adults (aged 16 years and over)
Two strengths of Protopic are available (Protopic 0.03% and Protopic 0.1% ointment) for adult
patients (aged 16 years and over). Your doctor will decide which strength is most suitable for
you.
Generally, treatment starts with Protopic 0.1% twice a day, once in the morning and once in the
evening, until the eczema has disappeared. Based on the eczema's response, your doctor will decide whether the
frequency of applications can be reduced or whether the lower strength can be used
(Protopic 0.03%).
Treat the affected areas of skin until the eczema heals. Improvements are generally observed
within one week. Consult your doctor about other types of treatment if you do not
see any visible improvements after two weeks.
Your doctor may prescribe the use of Protopic ointment twice a week after the atopic dermatitis has disappeared or almost disappeared (Protopic 0.03% for children and Protopic 0.1% for adults).
Protopic ointment should be applied once a day, twice a week (for example,
Monday and Thursday) to the areas of your body normally affected by atopic dermatitis. 2-3 days should pass between
applications without treatment with Protopic.
If symptoms reappear, return to using Protopic twice a day as described above and make an
appointment with your doctor for a therapy check.

If you accidentally swallow the ointment
If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible. Do
not try to induce vomiting.

If you forget to use Protopic
If you forget to apply the ointment at the scheduled time, apply it as soon as you remember, then
continue as prescribed.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):

• Burning and itching sensation. These symptoms are usually mild to moderate and generally disappear within a week of starting treatment with Protopic.

Common (may affect up to 1 in 10 people):

• Redness
• Feeling of warmth
• Pain
• Increased skin sensitivity (especially to heat and cold)
• Skin tingling
• Rash
• Local skin infection regardless of specific causes, including but not limited to: inflamed or infected hair follicles, cold sores, widespread herpes simplex infections
• Facial flushing or skin irritation after consuming alcoholic beverages are also common reactions

Uncommon (may affect less than 1 in 100 people):

• Acne

Following twice-weekly treatment, infections at the application site have been reported in children and adults. Impetigo, a superficial bacterial skin infection that usually causes blisters or sores on the skin, has been reported in children.
During the post-marketing phase, rosacea (facial redness), pseudo-rosacea dermatitis, lentigines (presence of dark, flat spots on the skin), edema at the application site and eye infections caused by herpes have been reported.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system indicated in Annex V. By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Protopic

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 tube and the packaging after EXP.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25ºC.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Protopic contains

• The active ingredient is tacrolimus monohydrate. One gram of Protopic 0.03% ointment contains 0.3 mg of tacrolimus (as tacrolimus monohydrate).
• The other ingredients are white petrolatum, liquid paraffin, propylene carbonate, white beeswax, solid paraffin, butylhydroxytoluene (E321) and all- rac-α-tocopherol.

Description of Protopic and contents of the pack
Protopic is a white ointment, slightly tending to yellow. It is available in tubes of 10, 30 or
60 grams of ointment. Not all pack sizes may be marketed. Protopic is
available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).

Marketing Authorisation Holder
LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

Manufacturer
Astellas Ireland Co. Ltd.
Killorglin
County Kerry
Ireland
LEO Laboratories Ltd.
285 Cashel Road
Crumlin, Dublin 12
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
LEO Pharma N.V./S.A
Tel/Tél: +32 3 740 7868

Lietuva
LEO Pharma A/S
Tel: +45 44 94 58 88

България
LEO Pharma A/S
Teл.: +45 44 94 58 88

Luxembourg/Luxemburg
LEO Pharma N.V./S.A
Tél/Tel: +32 3 740 7868

Česká republika
LEO Pharma s.r.o.
Tel: +420 734 575 982

Magyarország
LEO Pharma A/S
Tel: +45 44 94 58 88

Danmark
LEO Pharma AB
Tlf: +45 70 22 49 11

Malta
LEO Pharma A/S
Tel: +45 44 94 58 88

Deutschland
LEO Pharma GmbH
Tel: +49 6102 2010

Nederland
LEO Pharma B.V.
Tel: +31 205104141

Eesti
LEO Pharma A/S
Tel: +45 44 94 58 88

Norge
LEO Pharma AS
Tlf: +47 22514900

Ελλάδα
LEO Pharmaceutical Hellas S.A.
Τηλ: +30 210 68 34322

Österreich
LEO Pharma GmbH
Tel: +43 1 503 6979

España
Laboratorios LEO Pharma, S.A.
Tel: +34 93 221 3366

Polska
LEO Pharma Sp. z o.o.
Tel: +48 22 244 18 40

France
Laboratoires LEO
Tél: +33 1 3014 40 00

Portugal
LEO Farmacêuticos Lda.
Tel: +351 21 711 0760

Hrvatska
LEO Pharma A/S
Tel:+45 44 94 58 88

România
LEO Pharma A/S
Tel: +45 44 94 58 88

Ireland
LEO Laboratories Ltd
Tel: +353 (0) 1 490 8924

Slovenija
LEO Pharma A/S
Tel: +45 44 94 58 88

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
LEO Pharma s.r.o.
Tel: +420 734 575 982

Italia
LEO Pharma S.p.A.
Tel: +39 06 52625500

Suomi/Finland
LEO Pharma Oy
Puh./Tel: +358 20 721 8440

Κύπρος
The Star Medicines Importers Co. Ltd.
Τηλ: +357 2537 1056

Sverige
LEO Pharma AB
Tel: +46 40 3522 00

Latvija
LEO Pharma A/S
Tel: +45 44 94 58 88

United Kingdom (Northern Ireland)
LEO Laboratories Ltd
Tel: +44 (0) 1844 347333
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/ .

Protopic 0,1% ointment

tacrolimus monohydrate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Protopic is and what it is used for
• 2. What you need to know before you use Protopic
• 3. How to use Protopic
• 4. Possible side effects
• 5. How to store Protopic
• 6. Contents of the pack and other information

1. What is Protopic and what is it used for

The active ingredient of Protopic, tacrolimus monohydrate, is an immunomodulating agent.
Protopic 0.1% ointment is indicated for the treatment of moderate to severe atopic dermatitis
(eczema) in adults who do not respond adequately or who are intolerant to conventional therapies
such as topical corticosteroids.
If moderate to severe atopic dermatitis has disappeared or almost disappeared after treatment of
exacerbations for up to 6 weeks, and if frequent relapses occur (4 or more
per year), they can be prevented or the time in which they do not occur can be prolonged with the use of
Protopic 0.1% ointment twice a week.
In atopic dermatitis, there is a hyperreaction of the skin's immune system that causes
skin inflammation (itching, redness, dryness). Protopic modifies the abnormal immune response
and relieves skin inflammation and itching.

2. What you need to know before using Protopic

Do not use Protopic

• if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6) or to macrolide antibiotics (i.e. azithromycin, clarithromycin, erythromycin).

Warnings and precautions
Talk to your doctor or pharmacist before using Protopic:

• If you have liver failure.
• If you have any malignant tumor(neoplasia) of the skinor if you have a weakened immune system(immunocompromised), whatever the cause.
• If you have a congenital skin diseasesuch as Netherton syndrome, lamellar ichthyosis (widespread skin scaling caused by thickening of the outer skin layer), or if you have an inflammatory skin disease such as pyoderma gangrenosum, or if you suffer from generalized erythroderma(redness and scaling of the entire skin due to inflammation).
• If you develop Graft Versus Host Disease (cutaneous) (a skin immune reaction that is a common complication in patients undergoing bone marrow transplantation).
• If you have swollen lymph nodesat the beginning of treatment. If your lymph nodes swell during treatment with Protopic, consult your doctor.
• If you have infected lesions. Do not apply the ointment to infected lesions.
• If you notice any change in the appearance of the skin, tell your doctor.
• Based on the results of long-term studies and experience, a correlation between treatment with Protopic ointment and the development of malignant neoplasms has not been confirmed, but definitive conclusions cannot be drawn.
• Avoid prolonged exposure of the skin to sunlight or artificial light such as tanning beds. If you spend time outdoors after applying Protopic, use a sunscreen and wear comfortable clothing that protects the skin from the sun. Also, consult your doctor for other appropriate sun protection methods. If you have been prescribed heliotherapy, inform your doctor that you are using Protopic and that the use of Protopic and sun therapy in combination is not recommended.
• If your doctor prescribes Protopic twice a week to prevent a new manifestation of your atopic dermatitis, your condition should be re-evaluated by your doctor at least every 12 months even if the disease is under control. In children, maintenance treatment should be discontinued after 12 months to verify if there is still a need for continued treatment.
• It is recommended to use Protopic ointment with the lowest possible dosage, with the lowest frequency and for the shortest possible time necessary. This decision should be based on the doctor's assessment of how your eczema responds to Protopic ointment.

Children

• Protopic 0.1% ointment is not approved for use in children under 16 years of age. It should therefore not be used in this age group. Please consult your doctor.
• The effect of treatment with Protopic on the development of the immune system in children, especially young children, has not been established.

Other medicines, cosmetics and Protopic
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
You can use moisturizing creams and lotions during treatment with Protopic, however they can only be applied to the same treated area two hours before or two hours after applying Protopic.
The effect of the simultaneous use of Protopic with other preparations to be applied to the skin or with the intake of oral corticosteroids (e.g. cortisone) or medicines that act on the immune system has not been studied.

Protopic with alcohol
During the use of Protopic, the consumption of alcoholic beverages may cause flushing on the face or skin and sensations of heat.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Protopic contains butylhydroxytoluene (E321)
Protopic contains butylhydroxytoluene (E321) which may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to use Protopic

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.

• Apply a thin layer of Protopic to the affected areas of the skin.
• Protopic can be applied to most of the body surface, including the face, neck and areas subject to flexion of the elbows and knees.
• Avoid using the ointment in the nose, mouth or eyes. If the ointment is accidentally applied to these areas, the area should be thoroughly cleaned and/or rinsed with water.
• Do not cover the affected area of skin with bandages or dressings.
• Wash your hands after applying Protopic, unless your hands are also part of the area to be treated.
• Before applying Protopic after a bath or shower, you must ensure that the skin is completely dry.

Adults (aged 16 years and over)
Two strengths of Protopic are available (Protopic 0.03% and Protopic 0.1% ointment) for adult
patients (aged 16 years and over). Your doctor will decide which strength is most suitable for
you.
Generally, treatment starts with Protopic 0.1% twice a day, once in the morning and once in the
evening, until the eczema has disappeared. Based on the eczema’s response, your doctor will decide whether the
frequency of applications can be reduced or whether the lower strength can be used
(Protopic 0.03%).
Treat the affected skin areas until the eczema has healed. Improvements are generally observed
within a week. Consult your doctor about other types of treatment if you do not
notice any visible improvements after two weeks.
Your doctor may prescribe the use of Protopic 0.1% ointment twice a week after the
atopic dermatitis has disappeared or almost disappeared. Protopic 0.1% ointment should be applied once
a day, twice a week (for example, Monday and Thursday) to the areas of your body
normally affected by atopic dermatitis. There should be 2-3 days between applications
without Protopic treatment. If the symptoms reappear, return to using Protopic twice
a day as described above and make an appointment with your doctor for a review of
therapy.

If you accidentally ingest the ointment
If you accidentally ingest the ointment, consult your doctor or pharmacist as soon as possible. Do not
attempt to induce vomiting.

If you forget to use Protopic
If you forget to apply the ointment at the scheduled time, apply it as soon as you remember, then
continue as prescribed.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):

• Burning and itching sensation. These symptoms are usually mild to moderate and generally disappear within a week of starting treatment with Protopic.

Common (may affect up to 1 in 10 people):

• Redness
• Warmth sensation
• Pain
• Increased skin sensitivity (especially to heat and cold)
• Skin tingling
• Rash
• Local skin infection regardless of specific causes, including but not limited to: inflamed or infected hair follicles, cold sores, widespread herpes simplex infections
• Facial flushing or skin irritation after consuming alcoholic beverages are also common reactions

Uncommon (may affect less than 1 in 100 people):

• Acne

Following twice-weekly treatment, infections at the application site have been reported in adults.
During the post-marketing phase, rosacea (facial redness), pseudo-rosacea dermatitis, lentigines (presence of dark, flat spots on the skin), edema at the application site, and eye infections caused by herpes have been reported.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Protopic

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 tube and the carton after EXP.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25ºC.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Protopic Contains

• The active ingredient is tacrolimus monohydrate. One gram of Protopic 0.1% ointment contains 1.0 mg of tacrolimus (as tacrolimus monohydrate).
• The other ingredients are white petrolatum, liquid paraffin, propylene carbonate, white beeswax, solid paraffin, butylhydroxytoluene (E321) and all- rac-α-tocopherol.

Description of Protopic’s Appearance and Package Contents
Protopic is a white ointment, slightly tending towards yellow. It is available in tubes of 10, 30 or
60 grams of ointment. Not all pack sizes may be marketed. Protopic is
available in two strengths (Protopic 0.03% and Protopic 0.1% ointment).

Marketing Authorisation Holder
LEO Pharma A/S
Industriparken 55
2750 Ballerup
Denmark

Manufacturer
Astellas Ireland Co. Ltd.
Killorglin
County Kerry
Ireland
LEO Laboratories Ltd.
285 Cashel Road
Crumlin, Dublin 12
Ireland
For further information on this medicine, contact the local representative of the marketing authorisation holder:

België/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

България
LEO Pharma A/S
Teл.: +45 44 94 58 88

Luxembourg/Luxemburg
LEO Pharma N.V./S.A
Tél/Tel: +32 3 740 7868

Česká republika
LEO Pharma s.r.o.
Tel: +420 734 575 982

Magyarország
LEO Pharma A/S
Tel: +45 44 94 58 88

Danmark
LEO Pharma AB
Tlf: +45 70 22 49 11

Malta
LEO Pharma A/S
Tel: +45 44 94 58 88

Deutschland
LEO Pharma GmbH
Tel: +49 6102 2010

Nederland
LEO Pharma B.V.
Tel: +31 205104141

Eesti
LEO Pharma A/S
Tel: +45 44 94 58 88

Norge
LEO Pharma AS
Tlf: +47 22514900

Ελλάδα
LEO Pharmaceutical Hellas S.A.
Τηλ: +30 210 68 34322

Österreich
LEO Pharma GmbH
Tel: +43 1 503 6979

España
Laboratorios LEO Pharma, S.A.
Tel: +34 93 221 3366

Polska
LEO Pharma Sp. z o.o.
Tel: +48 22 244 18 40

France
Laboratoires LEO
Tél: +33 1 3014 40 00

Portugal
LEO Farmacêuticos Lda.
Tel: +351 21 711 0760

Hrvatska
LEO Pharma A/S
Tel:+45 44 94 58 88

România
LEO Pharma A/S
Tel: +45 44 94 58 88

Ireland
LEO Laboratories Ltd
Tel: +353 (0) 1 490 8924

Slovenija
LEO Pharma A/S
Tel: +45 44 94 58 88

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
LEO Pharma s.r.o.
Tel: +420 734 575 982

Italia
LEO Pharma S.p.A.
Tel: +39 06 52625500

Suomi/Finland
LEO Pharma Oy
Puh./Tel: +358 20 721 8440

Κύπρος
The Star Medicines Importers Co. Ltd.
Τηλ: +357 2537 1056

Sverige
LEO Pharma AB
Tel: +46 40 3522 00

Latvija
LEO Pharma A/S
Tel: +45 44 94 58 88

United Kingdom (Northern Ireland)
LEO Laboratories Ltd
Tel: +44 (0) 1844 347333
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .

Annex IV
Scientific conclusions and justification for the variation of the terms of the marketing authorisation(s)
Scientific conclusions
In light of the assessment of the Pharmacovigilance and Risk Assessment Committee (PRAC) of the Periodic Safety Update Report (PSUR) for tacrolimus (topical formulations), the scientific conclusions are as follows:
Based on the data available from cases described in the literature regarding the risk of significant systemic absorption when used outside of the approved therapeutic indications (off-label) for the treatment of pyoderma gangrenosum, the PRAC concluded that the product information relating to medicinal products containing tacrolimus for topical use should be amended to add pyoderma gangrenosum to the list of conditions for which tacrolimus ointment is not recommended.
Following review of the PRAC recommendation, the CHMP agrees with the PRAC’s overall conclusions and the rationale for the recommendation.

Justification for the variation of the terms of the marketing authorisation(s)
Based on the scientific conclusions relating to tacrolimus (topical formulations), the CHMP considers that the benefit-risk ratio of the medicinal product(s) containing tacrolimus (topical formulations) remains unchanged, subject to the proposed changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation(s).