Protopic 0.1% ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Protopic 0.1% ointment

tacrolimus monohydrate

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

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Protopic is and what it is 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

1. What Protopic is and what it is used for

The active substance in Protopic, tacrolimus monohydrate, is an immunomodulatory agent.

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

Once moderate to severe atopic dermatitis has cleared or almost cleared after up to 6 weeks of treatment of a flare-up, and if you experience frequent flare-ups (i.e., 4 or more per year), the recurrence of flare-ups can be prevented or the time free from flare-ups can be prolonged by using Protopic 0.1% ointment twice a week.

In atopic dermatitis, the skin's excessive immune response 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 to any of the other ingredients of this medicine (listed in section 6), or to macrolide antibiotics (for example, azithromycin, clarithromycin, erythromycin).

Warnings and precautions

Talk to your doctor before starting to use Protopic:

• If you have hepatic impairment.
• If you have any malignant skin disease (tumors) or if you have a weakened immune system (immunocompromised), regardless of the cause.
• If you have a hereditary epidermal barrier disorder such as Netherton syndrome, lamellar ichthyosis (widespread skin scaling 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 graft-versus-host skin disease (an immune reaction of the skin that is a common complication in patients who have undergone bone marrow transplantation).
• If you have swollen lymph nodes at the start of treatment. If your lymph nodes become swollen during treatment with Protopic, consult your doctor.
• If you have infected lesions. Do not apply the ointment to infected areas.
• If you notice any changes in the appearance of your skin, please inform your doctor.
• Based on long-term study results and experience, a relationship between treatment with Protopic ointment and the development of malignant tumors has not been confirmed. However, definitive conclusions cannot be drawn.
• Avoid prolonged exposure of the skin to sunlight or artificial light sources such as sunbeds. If you need to be outdoors after applying Protopic, use a sunscreen and wear loose-fitting clothing that protects your skin from the sun. Additionally, consult your doctor for advice on other suitable methods of sun protection. If you are prescribed phototherapy, inform your doctor that you are using Protopic, as the concomitant use of Protopic and phototherapy is not recommended.
• If your doctor has instructed you to use Protopic twice a week to maintain remission of your atopic dermatitis, 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 discontinued after 12 months to assess whether continued treatment is still necessary.
• It is recommended to use Protopic ointment at the lowest concentration and frequency necessary, and for the shortest possible duration. 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 of age. Therefore, it should not be used in this age group. Please consult your doctor.
• The effect of Protopic treatment on the development of the immune system in children, especially in younger children, has not been established.

Other medicines, cosmetics, and Protopic

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

You may use moisturizing creams and lotions during treatment with Protopic, but not within the two hours before or the two hours after applying Protopic.

The use of Protopic together with other topical preparations or simultaneously with corticosteroids (e.g., cortisone) or immunosuppressive medicines taken orally has not been studied.

Use of Protopic with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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 exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Apply Protopic as a thin layer to the affected areas of your skin.
• Protopic can be used on most of the body, including the face and neck, and in the folds of the elbows and knees.
• Avoid using the ointment inside the nose or mouth, or in the eyes. If ointment gets into any of these areas, wipe it off carefully and/or wash it out with water.
• Do not cover treated skin with bandages or dressings.
• Wash your hands after applying Protopic if they do not require treatment.
• 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, once in the morning and once at night, until the eczema has cleared. Your doctor will decide whether the frequency of application can be reduced depending on your eczema's response, or whether the lower concentration ointment, Protopic 0.03%, can be used.

Treat each affected area of your skin until the eczema has disappeared. Improvement is usually seen within one week. If you do not notice any improvement after two weeks, consult your doctor regarding other possible treatments.

Your doctor may instruct 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 a 2–3 day gap without Protopic treatment between applications.

If symptoms reappear, use Protopic twice daily as described above and see your doctor to review your treatment.

If you accidentally swallow some ointment

If someone accidentally swallows 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 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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
• sensation of heat
• pain
• increased skin sensitivity (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, widespread herpes simplex infections
• facial flushing or skin irritation after drinking alcohol is also common

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

• acne

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

Rosacea (facial redness), rosacea-like dermatitis, lentigo (flat brown spots on the skin), application site oedema, and herpes infections of the eye have also been reported during the post-marketing period.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the container and carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Protopic

• The active substance is tacrolimus monohydrate.

One gram of Protopic 0.03% ointment contains 0.3 mg of tacrolimus (as tacrolimus monohydrate).

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

Appearance of the product and contents of the container

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 Authorization Holder

LEO Pharma A/S

Industriparken 55

2750 Ballerup

Denmark

Manufacturer

LEO Laboratories Ltd.

285 Cashel Road

Crumlin, Dublin 12

Ireland

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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