Dermitopic

Package Leaflet: Information for the User

Dermitopic, 0.03%, Ointment

Tacrolimus

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Dermitopic and what is it used for

The active substance of Dermitopic is tacrolimus, which is an immunomodulating agent.
Dermitopic, 0.03%, ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults and adolescents who have not responded to or did not tolerate conventional treatment, such as topical corticosteroids, and in children (aged 2 years and above) who have not responded to conventional treatment, such as topical corticosteroids.
If, after treating moderate to severe atopic dermatitis for up to 6 weeks, the lesions have completely or almost completely resolved and if the disease frequently exacerbates (i.e., 4 times a year or more), it is possible to prevent exacerbations of the disease or prolong the period without exacerbations by applying Dermitopic, 0.03%, ointment twice a week.
In atopic dermatitis, an overactive immune response of the skin causes its inflammatory state (itching, redness, dryness). Dermitopic changes the abnormal immune response, eliminating the inflammatory state and itching.

2. Important information before using Dermitopic

When not to use Dermitopic

Warnings and precautions

Before starting treatment with Dermitopic, inform your doctor if you have:

• liver failure,
• any skin tumors(cancer) or immune system weakness(immunodeficiency) for any reason.
• a genetic skin barrier defect, such as Netherton's syndrome, fish-scale disease (severe scaling due to thinning of the outer skin layer), or if you have an inflammatory skin disease such as impetiginous eczemaor generalized erythroderma(inflammatory redness and scaling of the entire skin).
• a skin graft-versus-host disease (an immune reaction of the skin that is a common complication in patients after bone marrow transplantation).
• lymph node swelling at the start of treatment. If lymph node swelling occurs during treatment with Dermitopic, consult your doctor.
• infected skin lesions. Do not apply the ointment to infected skin lesions.
• any changes in skin appearance, inform your doctor.
• Based on long-term studies and experience, no link has been established between the use of tacrolimus ointment and the development of malignant tumors, but no definitive conclusions can be drawn.
• Avoid prolonged exposure of the skin to sunlight or artificial sunlight, such as sunbeds. If you spend time outdoors after applying Dermitopic, use sunscreens and wear loose clothing that protects the skin from the sun. Additionally, ask your doctor about other methods of sun protection. If phototherapy is prescribed, inform the doctor treating you about the use of Dermitopic, as it is not recommended to use Dermitopic and phototherapy at the same time.
• If your doctor recommends using Dermitopic twice a week to prevent atopic dermatitis exacerbations, you should visit your doctor for a check-up at least every 12 months, even if there is no exacerbation of the disease. In children, maintenance treatment should be stopped after 12 months to assess whether there is still a need for continued treatment.
• It is recommended to use Dermitopic ointment at the lowest strength and with the lowest frequency for the shortest possible duration. The decision will be made by your doctor based on the assessment of the response of eczema to Dermitopic ointment.

Children

• Dermitopic is not intended for use in children under 2 years of age. Therefore, the ointment should not be used in this age group. Consult your doctor.
• The effect of Dermitopic treatment on the developing immune system in children, especially young ones, has not been established.

Dermitopic and other medicines and cosmetics

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take, including those obtained without a prescription.
You can use moisturizing creams and cosmetic lotions during treatment with Dermitopic, but do not use them within 2 hours after applying Dermitopic.
The effects of using tacrolimus at the same time as other medicines applied to the skin or oral corticosteroids (e.g., cortisone) or medicines that affect the immune system have not been studied.

Dermitopic and alcohol

During treatment with Dermitopic, 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 plan to have a child, consult your doctor or pharmacist before using this medicine.

3. How to use Dermitopic

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

• Apply a thin layer of Dermitopic to the affected skin area.
• Dermitopic can be used on most areas of the body, including the face and neck, as well as the folds of the knees and elbows.
• Avoid getting the ointment into the nose, mouth, or eyes. If the ointment gets into any of these areas, wipe it off and/or rinse with water.
• Do not cover the treated skin area with bandages, dressings, or other covering materials.
• Wash your hands after applying Dermitopic, unless they are being treated.
• Before applying Dermitopic after a bath or shower, make sure the skin is completely dry.
• Do not bathe, shower, or swim immediately after applying the ointment. Water may wash the medicine off the skin.

Children (aged 2 years and above)

Dermitopic, 0.03%, ointment should be applied twice a day, once in the morning and once in the evening, for up to three weeks. After this period, the ointment should be applied once a day to each affected skin area until the eczema has cleared.

Adults and adolescents (aged 16 years and above)

For adolescent and adult patients (aged 16 years and above), Dermitopic is available in two strengths (Dermitopic 0.03% and Dermitopic 0.1% ointment). The treating doctor will decide which one is suitable for the patient.
Typically, treatment starts with Dermitopic, 0.1%, ointment applied twice a day, once in the morning and once in the evening, until the eczema has cleared. Depending on the response to treatment, the doctor may decide to reduce the frequency of application or use a lower-strength ointment, 0.03% with tacrolimus.
Each affected skin area should be treated until the eczema has cleared. Improvement is usually seen within one week. If no improvement is seen within two weeks, you should consult your doctor for alternative treatment.
The doctor may recommend applying Dermitopic ointment twice a week if the atopic dermatitis lesions have completely or almost completely resolved (Dermitopic, 0.03% for children and Dermitopic 0.1% for adults). Dermitopic ointment should be applied once a day, twice a week (e.g., on Mondays and Thursdays) to the skin area usually affected by atopic dermatitis. A 2- or 3-day break in treatment should be maintained between applications.
In case of recurrence of symptoms, Dermitopic should be applied twice a day as described above, and a doctor's appointment should be scheduled to discuss this treatment.

In case of accidental ingestion of the ointment

In case of accidental ingestion of the ointment, contact your doctor or pharmacist immediately. Do not induce vomiting.

Missing a dose of Dermitopic

If you forget to apply the ointment at the scheduled time, apply it as soon as possible, and then return to the previous treatment schedule.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dermitopic 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 disappear within the first week of using Dermitopic.

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

• redness
• feeling of warmth
• pain
• increased skin sensitivity (especially to heat and cold)
• tingling and irritation of the skin
• rash
• local skin infection unrelated to a specific cause, including: folliculitis, cold sore, generalized Herpes simplexvirus infections
• flushing of the face or skin irritation after drinking alcohol also occur commonly
• hypersensitivity at the application site

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

• acne

After using the ointment twice a week in adults and children, skin infections at the application site have been reported. In children, eczema herpeticum (a viral infection of the skin) has also been reported, as well as superficial bacterial skin infections usually causing blisters or ulcers on the skin.
After marketing, rosacea (redness of the face), a skin condition similar to rosacea, lentigo (flat brown spots on the skin), swelling at the application site, and eye infections with the Herpesvirus have been reported.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dermitopic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton. The expiry date refers to the last day of the month.
Do not store above 25°C.
Shelf life after first opening the tube: 90 days. Do not leave the tube for future use. Write the date of first opening on the carton to remember when to discard the tube.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dermitopic contains

• The active substance is tacrolimus. One gram of Dermitopic, 0.03%, ointment contains 0.3 mg of tacrolimus (as tacrolimus monohydrate).
• The other ingredients are: white petrolatum, liquid paraffin, propylene carbonate, white wax, paraffin.

What Dermitopic looks like and contents of the pack

Dermitopic is a white or slightly yellowish ointment. The medicine is available in aluminum tubes with an inner LDPE coating, closed with a PP cap, containing 10 g, 30 g, or 60 g of ointment, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
tel.:+48 17 865 51 00
(logo of the marketing authorization holder)

Importer

Laboratori Fundació Dau
Pol. Ind. Consorci Zona Franca, c/ C, 12-14, 08040 Barcelona, Spain
Bausch Health Poland sp. z o. o.
ul. Kosztowska 21, Mysłowice, 41-409, Poland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Croatia Dermitopic 0.03% mast
Poland Dermitopic
Portugal Dermitopic
Date of last revision of the leaflet:January 2024