Dermitopic

Package leaflet: Information for the user

Dermitopic, 0.1% ointment
Tacrolimus
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dermitopic is and what it is used for
2. What you need to know 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 Dermitopic is and what it is used for

The active substance in Dermitopic is tacrolimus monohydrate, an immunomodulatory agent.
Dermitopic 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who have not responded to or cannot tolerate conventional treatment such as topical corticosteroids.
If, after treatment of moderate to severe atopic dermatitis lasting up to 6 weeks, skin lesions have completely or almost completely cleared and if the disease frequently flares (i.e., 4 times per year or more), recurrence of flares may be prevented or the flare-free period prolonged by applying Dermitopic 0.1% ointment twice weekly.
In atopic dermatitis, an overactive immune response in the skin causes inflammation (itching, redness, dryness). Dermitopic modulates this abnormal immune response, thereby reducing inflammation and itching.

2. Important information before using Dermitopic

When not to use Dermitopic

• if the patient is 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
Before starting treatment with Dermitopic, inform your doctor if the patient:

• has liver impairment,
• has any skin tumours (skin cancers) or weakened immune system (immunosuppression) for any reason,
• has a genetic defect of the epidermal barrier, such as Netherton's syndrome, ichthyosis (excessive scaling of the skin due to thinning of the outer layer of the skin), or if there is an inflammatory skin disease such as pyoderma gangrenosum or generalized erythroderma (inflammatory redness and scaling of the entire skin),
• has graft-versus-host disease of the skin (an immune reaction of the skin, which is a common complication in patients after bone marrow transplantation),
• has swollen lymph nodes at the start of treatment. If swollen lymph nodes occur during treatment with Dermitopic, consult your doctor,
• has infected skin lesions. Do not apply the ointment to infected skin lesions,
• notices any changes in the appearance of the skin, inform your doctor,
• Long-term studies and clinical experience have not confirmed a link between the use of tacrolimus ointment and the development of malignant tumours, but definitive conclusions cannot be drawn,
• Avoid prolonged exposure of the skin to sunlight or artificial UV light, such as sunbeds. If spending time outdoors after applying Dermitopic, use sunscreen cosmetics and wear loose clothing that protects the skin from the sun. Additionally, consult your doctor about other sun protection methods. If phototherapy is recommended, inform the treating doctor about the use of Dermitopic, as concurrent use of Dermitopic and phototherapy is not recommended,
• If the doctor recommends using Dermitopic twice weekly to prevent flare-ups of atopic dermatitis, a follow-up visit with the doctor should occur at least every 12 months, even if there is no recurrence of the disease. In children, maintenance treatment should be interrupted after 12 months to assess whether continued treatment is still necessary,
• It is recommended to use tacrolimus at the lowest strength and with the lowest frequency for the shortest possible duration. The decision will be made by the doctor based on 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 with other medicines and cosmetics
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Moisturizing creams and cosmetic lotions may be used during treatment with Dermitopic, but should not be applied within two hours after applying Dermitopic.
The effects of using tacrolimus simultaneously with other topical medicines or with orally administered corticosteroids (e.g. cortisone), or with medicines affecting the immune system, have not been studied.

Use of Dermitopic with alcohol
During treatment with Dermitopic, drinking alcohol may cause flushing or redness of the skin or face and a sensation of warmth.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

3. How to use Dermitopic

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

• Apply a thin layer of Dermitopic ointment to the affected area of skin.
• Dermitopic may be used on most areas of the body, including the face and neck, as well as skin folds at the elbows and knees.
• Avoid getting the ointment into the nose, mouth, or eyes. If the ointment comes into contact with these areas, wipe it off thoroughly and (or) rinse with water.
• Do not cover the treated area of skin with bandages, dressings, or other occlusive materials.
• Wash your hands after applying Dermitopic, unless your hands are the area being treated.
• Before applying Dermitopic, ensure the skin is completely dry after bathing or showering.
• Do not bathe, shower, or swim immediately after applying the ointment, as water may wash the medicine off the skin.

Adults (aged 16 years and above)
For adult patients (aged 16 years and above), tacrolimus ointment is available in two strengths (tacrolimus 0.03% ointment and tacrolimus 0.1% ointment). Your doctor will decide which strength is appropriate for you.
Treatment usually begins with applying Dermitopic 0.1% ointment twice daily, once in the morning and once in the evening, until the eczema clears. Depending on the response to treatment, your doctor may decide to reduce the frequency of application or switch to a lower strength ointment – 0.03% tacrolimus ointment.
Each affected area of skin should be treated until the eczema resolves. Improvement is usually seen within one week. If no improvement is observed after two weeks, consult your doctor for consideration of alternative treatment.
Your doctor may recommend using Dermitopic 0.1% ointment twice a week if the symptoms of atopic dermatitis have completely or almost completely cleared.
Apply Dermitopic 0.1% ointment once daily, two days per week (e.g., Monday and Thursday), to the areas typically affected by atopic dermatitis. Ensure a 2- or 3-day treatment-free interval between applications.
If symptoms recur, resume using Dermitopic twice daily as described above and schedule an appointment with your doctor to discuss further treatment options.

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

Missed dose of Dermitopic
If you forget to apply the ointment at the scheduled time, apply it as soon as possible, then return to your previous treatment schedule.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

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

• burning sensation and itching. These symptoms are usually mild or moderate in intensity and subside within the first week of using Dermitopic.

Common (may affect less than 1 in 10 people):

• redness
• sensation of warmth
• pain
• increased skin sensitivity (especially to heat and cold)
• tingling and irritation of the skin
• rash
• local skin infections of non-specific cause, including folliculitis, cold sores, generalized infection with Herpes simplex virus
• facial flushing or skin irritation after alcohol consumption
• hypersensitivity at the application site

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

• acne

Infections at the application site have been reported when the ointment was used twice weekly in adults.
After marketing authorization, rosacea (facial redness), rosacea-like dermatitis, lentigines (flat, brown spots on the skin), local swelling, and herpes simplex virus eye infections have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dermitopic medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton.
Expiry date: The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Period of use after first opening of the tube: 90 days
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine 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 vaseline, liquid paraffin, propylene carbonate, white wax, and paraffin wax.

What Dermitopic looks like and contents of the pack
Dermitopic is a white or slightly yellowish ointment. The medicine is available in an aluminum tube internally coated with LDPE, 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 Authorisation 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