What is it and how is it used?

The active substance of Protopic, tacrolimus monohydrate, is an immunomodulating agent.

Protopic 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who

are not adequately responsive to or are intolerant of conventional therapies such as topical

corticosteroids and in children (2 years of age and older) who failed to respond adequately to

conventional therapies such as topical corticosteroids.

Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment

of a flare, and if you are experiencing frequent flares (i.e. 4 or more per year), it may be possible to

prevent flares coming back or prolong the time you are free from flares by using Protopic 0.03%

ointment twice weekly.

In atopic dermatitis, an over-reaction of the skin?s immune system causes skin inflammation

(itchiness, redness, dryness). Protopic alters the abnormal immune response and relieves the skin

inflammation and the itch.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use Protopic

  • If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopic or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin).

Take special care with Protopic
Tell your doctor if you:

  • have liver failure.
  • have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
  • have an inherited skin barrier disease such as Netherton?s syndrome or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin).
  • have swollen lymph nodes at initiation of treatment. If your lymph nodes become swollen during treatment with Protopic, consult your doctor.
  • have infected lesions. Do not apply the ointment to infected lesions.
  • notice any change to the appearance of your skin, please inform your physician.

Please note

  • Protopic ointment is not approved for children younger than 2 years of age. Therefore it should not be used in this age group. Please consult your doctor.
  • The effect of treatment with Protopic on the developing immune system in children, especially the young, has not been established.
  • The safety of using Protopic for a long time is not known. A very small number of people who have used Protopic ointment have had malignancies (for example, skin or lymphoma). However, a link to Protopic ointment treatment has not been shown.
  • Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds. If you spend time outdoors after applying Protopic, use a sunscreen and wear loose fitting clothing that protects the skin from the sun. In addition, ask your doctor for advice on other appropriate sun protection methods. If you are prescribed light therapy, inform your doctor that you are using Protopic as it is not recommended to use Protopic and light therapy at the same time.
  • If your doctor tells you to use Protopic twice weekly to keep your atopic dermatitis cleared, your condition should be reviewed by your doctor at least every 12 months, even if it remains under control. In children, maintenance treatment should be suspended after 12 months, to assess whether the need for continued treatment still exists.

Taking or using other medicines and cosmetics
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You may use moisturising creams and lotions during treatment with Protopic but these products should not be used within two hours of applying Protopic.

The use of Protopic at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.

Using Protopic with food and drink
While using Protopic, drinking alcohol may cause the skin or face to become flushed or red and feel hot.

Pregnancy and breast-feeding
Don?t use Protopic if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

How is it used?

Always use Protopic exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

  • Apply Protopic as a thin layer to affected areas of your skin.
  • Protopic may be used on most parts of the body, including the face and neck and in the creases of your elbows and knees.
  • Avoid using the ointment inside your nose or mouth or in your eyes. If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water.
  • Do not cover the skin being treated with bandages or wraps.
  • Wash your hands after applying Protopic unless your hands are also being treated.
  • Before applying Protopic after a bath or shower, be sure your skin is completely dry.

Children (2 years of age and older)
Apply Protopic 0.03% ointment twice a day for up to three weeks, once in the morning and once in the evening. Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away.

Adults (16 years of age and older)
Two strengths of Protopic (Protopic 0.03% and Protopic 0.1% ointment) are available for adult patients (16 years of age and older). Your doctor will decide which strength is best for you.

Usually, treatment is started with Protopic 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared. Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopic 0.03% ointment, can be used.

Treat each affected region of your skin until the eczema has gone away. Improvement is usually seen within one week. If you do not see any improvement after two weeks, see your doctor about other possible treatments.

You may be told by your doctor to use Protopic ointment twice weekly once your atopic dermatitis has cleared or almost cleared (Protopic 0.03% for children and Protopic 0.1% for adults). Protopic ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis. There should be 2?3 days without Protopic treatment between applications.
If symptoms reappear you should use Protopic twice daily as outlined above and arrange to see your doctor to review your treatment.

If you accidentally swallow some 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, do it as soon as you remember and then continue as before.

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

What are possible side effects?

Like all medicines, Protopic can cause side effects, although not everybody gets them.

Very common (probably affecting more than 1 in 10):

  • burning sensation and itching These symptoms are usually mild to moderate and generally go away within one week of using Protopic.

Common (probably affecting up to 1 in 10):

  • redness
  • feeling of warmth
  • pain
  • increased skin sensitivity (especially to hot and cold)
  • skin tingling
  • rash
  • inflamed or infected hair follicles
  • herpes viral infections (e.g. cold sores, generalised herpes simplex infections)
  • facial flushing or skin irritation after drinking alcohol is also common

Uncommon (probably affecting fewer than 1 in 100):

  • acne

Following twice-weekly treatment application site infections have been reported in children and adults. Impetigo, a superficial bacterial skin infection that usually produces blisters or sores on skin, has been reported in children.

Rosacea (facial redness) and rosacea-like dermatitis have been reported during post-marketing experience.

Since commercial availability a very small number of people who have used Protopic ointment have had malignancies (for example, skin or lymphoma). However, a link to Protopic ointment treatment has not been confirmed or refuted on the available evidence so far.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Protopic after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25ºC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Protopic contains

  • The active substance is tacrolimus monohydrate. One gram of Protopic 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
  • The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax and hard paraffin.

What Protopic looks like and contents of the pack

Protopic is a white to slightly yellowish ointment. It is supplied in tubes containing 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: Astellas Pharma Europe B.V., Elisabethhof 19, 2353 EW Leiderdorp, Netherlands.

Manufacturer: Astellas Ireland Co. Ltd., Killorglin, County Kerry, Ireland.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Astellas Pharma B.V. Branch Erasmus ParkParc Erasme Square Marie Curie 50 B-1070 BrüsselBruxelles TélTel 32 02 5580710 LuxembourgLuxemburg Astellas Pharma B.V. Branch Erasmus ParkParc Erasme Square Marie Curie 50 B-1070 BrüsselBruxelles BelgiqueBelgien TélTel 32 02 5580710

. 6 1407 Te. 359 2 862 53 72 Magyarország Astellas Pharma Kft. Kelenhegyi út 43 H-1118 Budapest Tel. 36 061 3614673

eská republika Astellas Pharma s.r.o. Meteor Centre Office Park Sokolovskà 10094 CZ-18600 Praha 8 Tel 420 236 080300 Malta Astellas Pharma Europe B.V. Elisabethhof 19 NL-2353 EW Leiderdorp L-Olanda Tel 31 071 5455745

Danmark Astellas Pharma as Naverland 4 DK-2600 Glostrup Tlf 45 43 430355 Nederland Astellas Pharma B.V. Elisabethhof 19 NL-2353 EW Leiderdorp Tel 31 071 5455745

Deutschland Astellas Pharma GmbH Georg-Brauchle-Ring 64 66 D-80992 München Tel 49 089 454401 Norge Astellas Pharma Solbråveien 47 N-1383 Asker Tlf 47 6676 4600

Österreich Astellas Pharma Ges.m.b.H. Linzer Straße 221E02 A-1140 Wien Tel 43 01 8772668 Eesti Astellas Pharma Europe B.V. Elisabethhof 19 NL-2353 EW Leiderdorp Holland Tel 31 071 5455745

Astellas Pharmaceuticals AEBE 1 GR-14565, 30 210 8189900 Polska Astellas Pharma Sp.z o.o. ul. Poleczki 21 PL-02-822 Warszawa Tel. 48 0 225451 111

España Astellas Pharma S.A. Paseo del Club Deportivo n 1 Bloque 14-2aE-28223 Pozuelo de Alarcón, Madrid Tel 34 91 4952700 Portugal Astellas Farma, Lda. Edifício Cinema Rua José Fontana, n.1, 1Andar P-2770-101 Paço de Arcos Tel 351 21 4401320

France Astellas Pharma S.A.S. 114 rue Victor Hugo F-92300 Levallois Perret Tél 33 01 55917500 România S.C.Astellas Pharma SRL oseaua Bucureti-Ploieti 42-44, Cldire 1 Parter, RO-013696-Bucureti Tel 40 021 361 0495

Ireland Astellas Pharma Co. Ltd. 25, The Courtyard Kilcarbery Business Park, Clondalkin IRL-Dublin 22 Tel 353 01 4671555 Slovenija Astellas Pharma Europe B.V. Elisabethhof 19 NL-2353 EW Leiderdorp Nizozemska Tel 31 071 5455745

Ísland Vistor hf. Hörgatúni 2 IS-210 Garðabæ Sími 354 535 7000 Slovenská republika Astellas Pharma s.r.o., organizaná zloka Galvániho 15C SK-821 04 Bratislava Tel 421 2 4444 2157

Italia Astellas Pharma S.p.A. Via delle Industrie 1 I-20061 Carugate Milano Tel 39 02 921381 SuomiFinland Algol Pharma Oy PL 13 FIN-02611 EspooEsbo PuhTel 358 9 50991

Sverige Astellas Pharma AB Per Albin Hanssons väg 41 S-205 12 Malmö Tel 46 040-650 15 00 Astellas Pharmaceuticals AEBE 1 GR-14565, 30 210 8189900

Latvija Astellas Pharma Europe B.V. Elisabethhof 19 NL-2353 EW Leiderdorp Nderlande Tel 31 071 5455745 United Kingdom Astellas Pharma Ltd. Lovett House Lovett Road, Staines Middlesex, TW18 3AZ-UK Tel 44 0 1784 419615

Lietuva
Astellas Pharma Europe B.V.
Elisabethhof 19
NL-2353 EW Leiderdorp
Nyderlandai
Tel. +31 (0)71 5455745

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