Carelimus

Package leaflet: Information for the user

Carelimus 0.1% ointment

Tacrolimus
Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Carelimus is and what it is used for

The active substance of Carelimus, tacrolimus monohydrate, is an immunomodulatory agent.
Carelimus 0.1% ointment is indicated for the treatment of moderate to severe atopic dermatitis (eczema) in adults who do not respond adequately or are intolerant to conventional therapies such as topical corticosteroids.
If moderate to severe atopic dermatitis has cleared or almost cleared after treatment of flare-ups for up to a maximum of 6 weeks, and if frequent relapses occur (i.e. 4 or more per year), these relapses may be prevented or the time during which they do not occur may be prolonged by using Carelimus 0.1% ointment twice a week.
In atopic dermatitis, there is an excessive immune response in the skin which causes skin inflammation (itching, redness, dryness). Carelimus modifies the abnormal immune response and alleviates skin inflammation and itching.

2. What you need to know before using Carelimus

Do not use Carelimus

• If you are allergic (hypersensitive) to tacrolimus or to any of the excipients of Carelimus (listed in section 6), or to macrolide antibiotics (such as azithromycin, clarithromycin, erythromycin).

Warnings and precautions
Inform your doctor if:

• you have liver impairment.
• you have any malignant skin tumor (neoplasm), or if you have a weakened immune system (immunocompromised), for any reason.
• you have a congenital skin disease, such as Netherton syndrome, lamellar ichthyosis (widespread skin peeling caused by thickening of the outer skin layer), or if you suffer from generalized erythroderma (inflammatory redness and peeling of the entire skin).
• you have skin graft-versus-host disease (an immune reaction of the skin, a common complication in patients who have undergone bone marrow transplantation).
• you have swollen lymph nodes at the start of treatment. If your lymph nodes swell during treatment with Carelimus, consult your doctor.
• you have infected skin lesions. Do not apply the ointment to infected lesions.
• you notice any change in the appearance of your skin, inform your doctor.
• The long-term safety of using tacrolimus ointment is not known. A very small number of people who have used tacrolimus ointment have developed malignant tumors (e.g., skin cancer or lymphomas). However, a link to treatment with tacrolimus ointment has not been established.
• Avoid prolonged exposure of the skin to sunlight or artificial light, such as sunbeds. If you spend time outdoors after applying Carelimus, use a sunscreen and wear loose-fitting clothing that protects your skin from the sun. Additionally, consult your doctor for other appropriate sun protection methods. If you have been prescribed phototherapy, inform your doctor that you are using Carelimus, as concurrent use of Carelimus and phototherapy is not recommended.
• If your doctor prescribes Carelimus twice a week to prevent recurrence of your atopic dermatitis, your condition should be re-evaluated by your doctor at least every 12 months, even if the disease is under control. In children, maintenance treatment should be suspended after 12 months to assess whether continued treatment is still necessary.
• Patients should be advised not to bathe, shower, or swim immediately after applying the ointment; water may wash away the medication.

Children

• Carelimus 0.1% ointment is not approved for use in children under 16 years of age. It should therefore not be used in this age group. Please consult your doctor.
• The effect of treatment with Carelimus on the development of the immune system in children, especially in younger children, has not been established.

Other medicines, cosmetics, and Carelimus
Inform your doctor or pharmacist if you are using, have recently used, or might use any other
medicines, including those not requiring a prescription.
You may use moisturizing creams and lotions during treatment with Carelimus; however, they should be applied
to the same treated area only two hours before or two hours after applying Carelimus.
The effect of concomitant use of tacrolimus with other topical skin preparations or with oral corticosteroids (e.g., cortisone) or immunosuppressive medicines has not been studied.

Carelimus and alcoholic beverages
During use of Carelimus, consumption of alcoholic beverages may cause facial or skin flushing and sensations of warmth.

Pregnancy and breastfeeding
Do not use Carelimus during pregnancy or while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to use Carelimus

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

• Apply a thin layer of Carelimus to the affected areas of skin.
• Carelimus may be applied to most areas of the body, including the face, neck, and skin folds such as elbows and knees.
• Avoid using the ointment inside the nose, in the mouth, or in the eyes. If the ointment is accidentally applied to these areas, wash the area thoroughly and/or rinse with water.
• Do not cover the treated skin areas with bandages, dressings, or other wound coverings.
• Wash your hands after applying Carelimus, unless the hands are also areas to be treated.
• Before applying Carelimus after a bath or shower, make sure the skin is completely dry.
• Do not bathe, shower, or swim immediately after applying the ointment, as water may wash off the medicine.

Adults (aged 16 years and older)
Two strengths of tacrolimus ointment (tacrolimus 0.03% ointment and tacrolimus 0.1% ointment) are available for adult patients (aged 16 years and older). Your doctor will decide which strength is most appropriate for you.
Generally, treatment starts with Carelimus 0.1% ointment applied twice daily, once in the morning and once in the evening, until the eczema has cleared. Depending on your response, your doctor will decide whether the frequency of application can be reduced or whether the lower strength, tacrolimus 0.03% ointment, can be used.
Treat the affected skin areas until the eczema has healed. Improvement is usually seen within one week. If you do not notice visible improvement after two weeks, consult your doctor for alternative treatment options.
Your doctor may prescribe the use of Carelimus 0.1% ointment twice a week after atopic dermatitis has cleared or nearly cleared. Carelimus 0.1% ointment should be applied once daily, twice a week (for example, Monday and Thursday) to the areas of your body usually affected by atopic dermatitis. Between applications, there should be a 2- to 3-day break from treatment with Carelimus. If symptoms return, resume using Carelimus twice daily as described above and make an appointment with your doctor to review your treatment.

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

If you forget to use Carelimus
If you forget to apply the ointment at the scheduled time, apply it as soon as you remember, then continue as prescribed.
If you have any doubts about how to use Carelimus, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Carelimus 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 to moderate and generally disappear within one week of starting treatment with Carelimus.

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
• skin rash
• local skin infection unrelated to specific causes, including but not limited to: inflamed or infected hair follicles, cold sores, generalized herpes simplex infections
• facial flushing or skin irritation after consuming alcoholic beverages are also common reactions
• hypersensitivity at the application site.

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

• acne.

Following treatment twice weekly, application site infections have been reported in adults.
During the post-marketing phase, rosacea (facial redness), pseudo-rosacea dermatitis, lentigines (presence of flat, dark spots on the skin), application site edema, and eye infections caused by herpes have been reported.
Since its availability on the market, a very small number of people using tacrolimus ointment have developed malignant tumors (e.g. lymphoma, including cutaneous lymphoma, and other skin cancers). However, based on the data available so far, a link with tacrolimus ointment treatment has neither been proven nor ruled out.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Carelimus

Keep this medicine out of the sight and reach of children.
Do not use Carelimus after the expiry date stated on the tube and carton after "Exp". The expiry date refers to the last day of the month.
Do not store above 25°C.
Discard opened tubes after 90 days from first opening, even if they are not empty. They should not be kept for future use.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Carelimus contains

• The active substance is tacrolimus monohydrate. One gram of Carelimus 0.1% ointment contains 1.0 mg of tacrolimus (as tacrolimus monohydrate).
• The excipients are white vaseline; liquid paraffin; propylene carbonate; white wax; solid paraffin.

Description of the appearance of Carelimus and contents of the pack
Carelimus is a white ointment, slightly yellowish in tint. It is available in tubes of 10, 30 or 60 grams
of ointment. Not all pack sizes may be marketed.
Marketing Authorization Holder
Difa Cooper S.p.A. – Via Milano 160 – 21042 Caronno Pertusella (VA)
Manufacturer:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
Harrow, HA1 4HF,
United Kingdom
Wessling Hungary Kft.
Fòti út 56., Budapest 1047,
Hungary
Laboratori Fundació Dau
Pol. Ind. Consorci Zona Franca,
c/ C, 12-14 Barcelona, 08040,
Spain
This medicinal product is authorized in the European Economic Area countries under the following
names: