Label: information for the user

Protopic 0.03% ointment

tacrolimus monohydrate

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents ofthe label:

1. What Protopic is and for what it is used
2. What you need to know before starting to use Protopic
3. How to use Protopic
4. Possible adverse effects
5. Storage of Protopic
6. Contents of the package and additional information

The active ingredient of Protopic, tacrolimus monohydrate, is an immunomodulator agent.

Protopic 0.03% 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, and in children (2 years of age and older) who failed to obtain an adequate response to conventional therapies such as topical corticosteroids.

Once moderate to severe atopic dermatitis disappears or almost disappears after up to 6 weeks of treatment of a flare-up, and if you experience frequent flares (i.e., 4 or more per year), you can prevent them from recurring or prolong the time free of flares by using Protopic 0.03% ointment twice a week.

In atopic dermatitis, excessive skin reaction of the immune system causes skin inflammation (pruritus, redness, dryness). Protopic modifies the abnormal immune response and relieves skin inflammation and pruritus.

Do not use Protopic

• If you are allergic to tacrolimus or any of the other components of this medication (listed in section 6), or to macrolide antibiotics (for example, azithromycin, clarithromycin, erythromycin).

Warnings and precautions

Consult your doctor before starting to use Protopic:

• If you haveliver insufficiency.
• If you have anyskin malignancy (tumors) or if you have aweakened immune system(immunocompromised) for any reason.
• If you have ahereditary skin barrier disordersuch as Netherton syndrome, lamellar ichthyosis (broad skin peeling due to thickening of the outer layer of the skin), or if you suffer fromgeneralized erythroderma(inflammatory redness and peeling of the entire skin).
• If you have a skin graft-versus-host disease (a common immune reaction of the skin that is a complication in patients who have undergone a bone marrow transplant).
• If you haveinflamed lymph nodesat the beginning of treatment. If your lymph nodes become inflamed during treatment with Protopic, consult your doctor.
• If you haveinfected lesions. Do not apply the ointment to infected lesions.
• If you notice anychange in the appearance of your skin, please inform your doctor.
• After obtaining long-term study results and experience, no relationship has been confirmed between Protopic ointment treatment and the appearance of malignant tumors.However,no definitive conclusions can be drawn.
• Avoid exposure of the skin to long periods of sunlight or artificial light such as solariums. If you stay outside after applying Protopic, use a sunscreen filter and wear loose clothing that protects your skin from the sun. Also, consult your doctor for other suitable methods to protect yourself from the sun. If you are prescribed solar therapy, inform your doctor that you are using Protopic, as it is not recommended to use Protopic and solar therapy at the same time.
• If your doctor tells you to use Protopic twice a week to maintain the disappearance of your atopic dermatitis, your condition should be reviewed by your doctor at least every 12months, even if it remains controlled. In children, treatment should be discontinued after 12months to evaluate whether continued treatment is still necessary.
• 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 evaluation of how your eczema responds to Protopic ointment.

Children

• Protopic ointmentis not authorized for children under 2years. Therefore, it should not be used in this age group. Please consult your doctor.

• The effect of Protopic treatment on the development of a child's immune system, especially in the youngest children, has not been established.

Other medications, cosmetics, and Protopic

Inform your doctor or pharmacist if you areusing,haveusedrecentlyor may have to useany other medication.

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

The use of Protopic at the same time as other topical preparations or simultaneously with oral immunosuppressive medications or corticosteroids (for example, cortisone) has not been studied.

Use of Protopic with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Children (2 years of age and older)

Apply Protopic 0.03% ointment twice a day for a maximum of three weeks, once in the morning and once at night. Subsequently, the ointment should be used once a day on each affected skin area until the eczema disappears.

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.

Typically, treatment begins with Protopic 0.1% ointment twice a day, once in the morning and once at night, until the eczema is eliminated. Your doctor will decide whether the frequency of application can be reduced based on your eczema response or if the lower concentration Protopic 0.03% ointment can be used.

Treat each affected skin area until the eczema has disappeared. Improvement is usually seen within a week. If no improvement is seen after two weeks, consult your doctor for other possible treatments.

Your doctor may tell you to use Protopic ointment twice a week once your 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 two times a week (e.g., Monday and Thursday) on 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 symptoms reappear, use Protopic twice a day as indicated above, and visit your doctor to review your treatment.

If you accidentally ingest something of the ointment

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

If you forgot 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication mayproduceadverse effects, although not all people will experience them.

Very frequent (may affect more than 1 in 10 people):

• burning sensation and itching

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

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

• redness
• sensation of heat
• pain
• increased skin sensitivity (especially to heat and cold)
• tingling
• exanthema
• local skin infections, regardless of their specific cause, including but not limited to: inflamed or infected hair follicles, herpes labial, generalized herpes simplex infections
• facial flushing or skin irritation after drinking alcohol is also frequent

Rare (may affect fewer than 1 in 100 people):

• acne

After treatment twice a week, skin infections at the application site have been reported in children and adults. Impetigo, a superficial bacterial skin infection that usually produces blisters or sores, has been reported in children.

Also, rosacea (facial redness), rosacea-type dermatitis, lentigo (flat brown skin patches), edema at the application site, and herpes eye infections have been reported during post-marketing.

Reporting 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 prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do notusethis medicationafterthe expiration date that appears on the packaging and on the boxafter EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Protopic

• The active ingredient is tacrolimus monohydrate.

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

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

Appearance of the product and contents of the package

Protopic is a white or slightly yellowish ointment. It is presented in tubes with 10, 30 or60grams of ointment.Only some package sizes may be commercially available.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

Responsible for manufacturing

Astellas Ireland Co. Ltd.

Killorglin

County Kerry

Ireland

LEO Laboratories Ltd.

285 Cashel Road

Crumlin, Dublin 12

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

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