PROTOPIC 0.1% OINTMENT

Introduction

Package Leaflet: Information for the User

Protopic 0.1% Ointment

tacrolimus monohydrate

Read the package leaflet carefully before you start using the medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of thepackage leaflet

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

1. What is Protopic and what is it used for

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

Protopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who do not respond adequately to or are intolerant of conventional therapies such as topical corticosteroids.

Once the moderate to severe atopic dermatitis has disappeared or almost disappeared after up to 6 weeks of treatment for a flare, and if you suffer from frequent flares (i.e. 4 or more per year), you can prevent flares from coming back or prolong the time you are free of flares by using Protopic 0.1% ointment twice a week.

In atopic dermatitis, the skin's immune system overreacts, causing skin inflammation (itching, redness, dryness). Protopic modifies the abnormal immune response and relieves skin inflammation and itching.

2. What you need to know before you start 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 (e.g. azithromycin, clarithromycin, erythromycin).

Warnings and precautions

Talk to your doctor before you start using Protopic:

• If you have liver problems.
• If you have any skin malignancies(tumors) or if you have a weakened immune system(immunocompromised) for any reason.
• If you have a hereditary skin barrier diseasesuch as Netherton's syndrome, lamellar ichthyosis (widespread scaling of the skin due to thickening of the outer layer of the skin), or if you suffer from generalized erythroderma(inflammatory redness and scaling of the entire skin).
• If you have a skin graft-versus-host disease (an immune reaction of the skin that is a common complication in patients who have undergone a bone marrow transplant).
• If you have inflamed lymph nodesat the start of treatment. If your lymph nodes become inflamed during treatment with Protopic, talk to your doctor.
• If you have infected lesions. Do not apply the ointment to infected lesions.
• If you notice any change in the appearance of your skin, please inform your doctor.
• After long-term studies and experience, no relationship has been confirmed between treatment with Protopic ointment and the occurrence of malignant tumors. However, no definitive conclusions can be drawn.

• Avoid exposing your skin to long periods of sunlight or artificial light such as sunlamps. If you stay outdoors after applying Protopic, use a sunscreen and wear loose clothing that protects your skin from the sun. Also, talk to your doctor about other suitable methods to protect yourself from the sun. 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 a week to keep your atopic dermatitis under control, 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 stopped after 12 months to assess whether continued treatment is still needed.
• It is recommended to use Protopic ointment with the lowest concentration and frequency necessary for the shortest possible time. This decision should be based on your doctor's assessment of how your eczema responds to Protopic ointment.

Children

• Protopic 0.1% ointment is not authorized for children under 16 years. Therefore, it should not be used in this age group. Please talk to your doctor.
• The effect of treatment with Protopic on the development of the child's immune system, especially in younger children, has not been established.

Other medicines, cosmetics, and Protopic

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

You can use moisturizing creams and lotions during treatment with Protopic, but not in the 2 hours before and after applying Protopic.

The use of Protopic at the same time as other skin preparations or simultaneously with oral corticosteroids (e.g. cortisone) or immunosuppressants has not been studied.

Using Protopic with alcohol

While using Protopic, drinking alcohol may cause flushing or redness of the skin or face and a feeling of warmth.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Protopic contains butylhydroxytoluene (E321)

Protopic contains butylhydroxytoluene (E321), which may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Protopic

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, talk to your doctor or pharmacist again.

• Apply Protopic as a thin layer to the affected areas of your skin.
• Protopic can be used on most areas of the body, including the face and neck, and in the folds of the elbows and knees.
• Avoid using the ointment inside your nose or mouth, or in your eyes. If ointment gets into any of these areas, it should be removed by gently rubbing and/or rinsing with water.
• Do not cover the treated skin with bandages or dressings.
• Wash your hands after applying Protopic if they are not being treated.
• Before using Protopic after a bath or shower, make sure your skin is completely dry.

Adults (16 years of age and older)

Two concentrations 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 concentration is most suitable for you.

Treatment is usually started with Protopic 0.1% ointment, applied twice daily, in the morning and at night, until the eczema has cleared. Your doctor will decide if the frequency of application can be reduced depending on the response of your eczema, or if the lower concentration ointment Protopic 0.03% can be applied.

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

Your doctor may tell you to use Protopic 0.1% ointment twice a week once your atopic dermatitis has cleared or almost cleared. Protopic 0.1% ointment should be applied once daily, twice a week (e.g. Monday and Thursday), to the areas of your body that are usually affected by atopic dermatitis. There should be 2-3 days without treatment with Protopic between applications.

If the symptoms come back, you should use Protopic twice daily, as described above, and go see your doctor to review your treatment.

If you accidentally swallow some ointment

If someone accidentally swallows the ointment, talk to 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 right time, do so as soon as you remember, and then continue as before.

If you have any further questions 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 sensation and itching

These symptoms are usually mild or moderate and generally disappear within one week of using Protopic.

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

• redness
• feeling of warmth
• pain
• increased sensitivity of the skin (especially to heat and cold)
• tingling
• rash
• local skin infections, regardless of their specific cause, including but not limited to: inflamed or infected hair follicles, cold sores, generalized herpes simplex infections
• facial redness or skin irritation after drinking alcohol is also common

Uncommon (may affect up to 1 in 100 people):

• acne

After twice-weekly treatment, infections at the application site have been reported in adults.

Rosacea (facial redness), rosacea-like dermatitis, lentigo (flat brown spots on the skin), edema at the application site, and herpes infections in the eyes have also been reported during post-marketing use.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package 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. Storage of 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 packaging and carton after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

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 protect the environment.

6. Contents of the pack and further information

Composition of Protopic

• The active substance is tacrolimus monohydrate.

One gram of Protopic 0.1% ointment contains 1.0 mg of tacrolimus (as tacrolimus monohydrate).

• The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin, butylhydroxytoluene (E321), and all-rac-α-tocopherol.

Appearance and packaging of the product

Protopic is a white or slightly yellowish ointment. It is available in tubes containing 10, 30, or 60 grams of ointment. Not all pack sizes may be marketed. Protopic is available in two concentrations (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

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this package leaflet:

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.