Dermitopic

Package Leaflet: Information for the User

Dermitopic, 0.1%, 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 those not listed in this package 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 monohydrate, which is an immunomodulating agent.
Dermitopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who have not responded to or did not tolerate 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 recurs (i.e., 4 times a year or more), it is possible to prevent recurrences or prolong the period without recurrences by applying Dermitopic 0.1% ointment twice a week.
In atopic dermatitis, the skin's immune system overreacts, causing inflammation (itching, redness, dryness). Dermitopic changes the abnormal immune response, eliminating inflammation 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 weakened immune system (immunodeficiency) for any reason.
• a genetic skin barrier defect, such as Netherton's syndrome, ichthyosis (excessive scaling of the skin due to thinning of the outer layer of the skin), or if you have an inflammatory skin disease such as impetiginized eczema or generalized erythroderma (inflammatory redness and scaling of the entire skin).
• a skin graft-versus-host disease (an immune reaction of the skin, which 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 confirmed between the use of tacrolimus ointment and the development of malignant tumors, but no final 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. Also, ask your doctor about other methods of sun protection. If your doctor recommends light therapy, inform the doctor treating you about the use of Dermitopic, as it is not recommended to use Dermitopic and light therapy at the same time.
• If your doctor recommends using Dermitopic twice a week to prevent recurrences of atopic dermatitis, you should visit your doctor for a check-up at least every 12 months, even if you do not have a recurrence of the disease. In children, maintenance treatment should be discontinued after 12 months to assess whether there is still a need for continued treatment.
• Tacrolimus should be used at the lowest potency and with the lowest frequency for the shortest possible duration. The decision will be made by your doctor based on the assessment of the eczema's response to tacrolimus.
• Do not bathe, shower, or swim immediately after applying the ointment, as water may wash the medicine off the skin.

Children

• Dermitopic 0.1% ointment is not intended for use in children under 16 years of age. Therefore, do not use the ointment in this age group. Consult your doctor.
• The effect of Dermitopic treatment on the developing immune system in children, especially young children, 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, as well as any medicines you plan to use.
Moisturizing creams and cosmetic lotions can be used during treatment with Dermitopic, but they should not be used 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.

Using Dermitopic with alcohol

During treatment with Dermitopic, drinking alcohol may cause redness or flushing 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, ask your doctor or pharmacist for advice before using this medicine.

3. How to use Dermitopic

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• Apply a thin layer of Dermitopic to the affected skin area.
• Dermitopic can be used on most skin areas, including the face and neck, as well as the folds of the elbows and knees.
• Avoid getting the ointment into your 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 dressing materials.
• Wash your hands after using Dermitopic, unless they are being treated.
• Before applying Dermitopic after a bath or shower, make sure your skin is completely dry.
• Do not bathe, shower, or swim immediately after applying the ointment. Water may wash the medicine off the skin.

Adults (16 years and older)

For adult patients (16 years and older), tacrolimus ointment is available in two strengths (tacrolimus 0.03% ointment and tacrolimus 0.1% ointment). Your doctor will decide which one is suitable for you.
Usually, 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, your doctor may decide to reduce the frequency of application or use a lower-strength ointment - 0.03% tacrolimus ointment.
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 visit your doctor for alternative treatment.
Your doctor may recommend using Dermitopic 0.1% ointment twice a week if the atopic dermatitis lesions have completely or almost completely resolved.
Dermitopic 0.1% ointment should be applied once a day, twice a week (e.g., Monday and Thursday) to the skin area usually affected by atopic dermatitis. Maintain 2- or 3-day breaks in treatment between applications of the medicine.
In case of recurrence of symptoms, use Dermitopic as described above and make an appointment with your doctor to discuss the 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 your 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, impetigo, or generalized herpes simplex virus infections
• flushing of the face or skin irritation after drinking alcohol are also common
• hypersensitivity at the application site

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

• acne

After using the ointment twice a week in adults, infections at the application site have been reported.
After marketing, rosacea (redness of the face), a condition similar to rosacea, solar lentigines (flat brown spots on the skin), swelling at the application site, and eye infections with the herpes virus have been reported.

Reporting side effects

If you experience any side effects, including those not listed in this package 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 after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Shelf life after first opening of the tube: 90 days
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 other information

What Dermitopic contains

• The active substance is tacrolimus monohydrate. One gram of Dermitopic 0.1% ointment contains 1 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. This medicine is available in aluminum tubes coated with LDPE from the inside, 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

Manufacturer/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

Date of last revision of the package leaflet: January 2024