Dermitopic

Package leaflet: Information for the user

Dermitopic, 0.03% ointment
Tacrolimus
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to read again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Dermitopic is and what it is 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 Dermitopic is and what it is used for

The active substance in Dermitopic is tacrolimus, which is an immunomodulatory agent.
Dermitopic 0.03% ointment is used in the treatment of moderate to severe atopic dermatitis (eczema) in adults and adolescents who have not responded to or do not tolerate conventional treatment, such as topical corticosteroids, and in children (aged 2 years and older) who have not responded to conventional treatment, such as topical corticosteroids.
If, after treatment of moderate to severe atopic dermatitis lasting up to 6 weeks, lesions have completely or almost completely resolved and if the disease frequently flares (i.e., 4 times per year or more), recurrences of flares may be prevented or the flare-free period prolonged by applying Dermitopic 0.03% 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 (growths) or weakened immune system (immunosuppression) for any reason,
• has a genetic defect of the epidermal barrier, such as Netherton's syndrome, lamellar ichthyosis (severe scaling of the skin due to thinning of the outer layer of skin), or has 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 the doctor,
• Long-term studies and experience have not confirmed a link between the use of tacrolimus-containing ointment and the development of malignant tumours; however, definitive conclusions cannot be drawn,
• Avoid prolonged exposure of the skin to sunlight or artificial sunlight, 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 a week to prevent recurrences of atopic dermatitis, a follow-up visit to the doctor should be scheduled 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 Dermitopic ointment at the lowest potency and with the lowest frequency for the shortest possible duration. The decision will be made by the doctor based on an assessment of the rash's response to Dermitopic ointment.

Children

• Dermitopic is not intended for use in children under 2 years of age. Therefore, do not use the ointment in this age group. Consult your doctor.
• The effect of treatment with Dermitopic 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 the patient is currently using or has recently used, as well as any medicines the patient plans to use, including those available without a prescription.
Moisturizing creams and cosmetic lotions may be used during treatment with Dermitopic; however, they should not be used within two hours after applying Dermitopic.
The effects of concomitant use of tacrolimus with other topical medicines or with orally administered corticosteroids (e.g. cortisone), or with medicines affecting 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 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

Always use this medicine exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

• Apply a thin layer of Dermitopic ointment to the affected area of skin.
• Dermitopic can be used on most areas of the body, including the face and neck, as well as skin folds at the elbows and knees.
• Avoid contact of the ointment with the nose, mouth, or eyes. If the ointment gets into any of these areas, wipe it off thoroughly and (or) rinse with water immediately.
• Do not cover the treated skin area with bandages, dressings, or other occlusive materials.
• Wash your hands after applying Dermitopic, unless the hands are part of the treated area.
• 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.

Children (aged 2 years and above)
Dermitopic 0.03% ointment should be applied twice daily, once in the morning and once in the evening, for up to three weeks. After this period, apply the ointment once daily to each affected area of skin until the rash resolves.

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 physician will decide which strength is appropriate for the individual patient.

Treatment is usually initiated with Dermitopic 0.1% ointment applied twice daily, once in the morning and once in the evening, until the rash resolves. Depending on the response to treatment, the doctor may decide to reduce the frequency of application or switch to the lower strength formulation, 0.03% tacrolimus ointment.

Each affected area of skin should be treated until the rash resolves. Improvement is usually seen within one week. If no improvement is observed within two weeks, consult your doctor to consider alternative treatment options.

Your doctor may recommend applying Dermitopic ointment twice weekly if atopic dermatitis lesions have completely or almost completely resolved (Dermitopic 0.03% in children and Dermitopic 0.1% in adults). Apply the ointment once daily on two non-consecutive days per week (e.g. Monday and Thursday) to areas typically affected by atopic dermatitis. Ensure a 2- or 3-day treatment-free interval between applications.

In case of recurrence of symptoms, resume using Dermitopic twice daily as described above and schedule a visit to your doctor to review the treatment.

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

If you forget to apply Dermitopic
If you forget to apply the ointment at the scheduled time, apply it as soon as possible, then return to your previous dosing schedule.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

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

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

Common (may occur in fewer than 1 in 10 people):

• redness
• sensation of warmth
• pain
• increased skin sensitivity (especially to heat and cold)
• skin tingling and irritation
• rash
• local skin infection unrelated to a specific cause, including inflammation or infection of hair follicles, cold sores, generalized infection with Herpes simplex virus
• facial flushing or skin irritation after alcohol consumption also occur commonly
• hypersensitivity at the application site

Uncommon (may occur in fewer than 1 in 100 people):

• acne

When the ointment was used twice weekly in adults and children, infections at the application site were reported. In children, pityriasis and superficial bacterial skin infections, usually leading to formation of blisters or ulcers on the skin, were also reported.

After marketing authorization, rosacea (facial redness), rosacea-like skin inflammation, lentigines (flat, brown spots on the skin), local swelling at the application site, and herpes virus eye infections have been reported.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Adverse effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Dermitopic medicine

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 stated month.
Do not store above 25°C.
Period of use after first opening the tube: 90 days. Do not leave the tube for future use. Write the date of first opening the tube on the carton to remember when the tube should be discarded.
Medicines must 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 vaseline, liquid paraffin, propylene carbonate, white wax, and solid paraffin.

What Dermitopic looks like and contents of the pack
Dermitopic is a white or slightly yellowish ointment. The medicine is available in an aluminium tube lined internally 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
Tel.:+48 17 865 51 00
(logo of the marketing authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Croatia Dermitopic 0.03% mast
Poland Dermitopic
Portugal Dermitopic