CARELIMUS 0.03% Ointment

Зміст інструкції

1. Carelimus 0,1% ointment
   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

Carelimus 0,1% ointment

Tacrolimus
Equivalent medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 immunomodulating agent.
Carelimus 0.1% ointment is indicated for the treatment of atopic dermatitis (eczema), from moderate to
severe, in adults who do not respond adequately or who are intolerant to conventional therapies such as
topical corticosteroids.
If moderate to severe atopic dermatitis has disappeared or almost disappeared after a treatment
of exacerbations for up to 6 weeks, and if frequent relapses occur (i.e. 4 or
more per year), they can be prevented or the time in which they do not manifest can be prolonged with the use
of Carelimus 0.1% ointment twice a week.
In atopic dermatitis, there is an excessive reaction of the skin's immune system that
causes skin inflammation (itching, redness, dryness). Carelimus modifies the response
abnormal immune response and relieves 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 any of the excipients of Carelimus (listed in section 6) or to macrolide antibiotics (such as azithromycin, clarithromycin, erythromycin).

Warnings and precautions
Tell your doctor if:

• you have hepatic insufficiency.
• you have any malignant tumor(neoplasia) of the skinor if you have a weakened immune system(immunocompromised), for any reason.
• you have a congenital skin diseasesuch as Netherton syndrome, lamellar ichthyosis (widespread skin scaling caused by thickening of the outer skin layer), or if you suffer from generalized erythroderma(redness and scaling of the entire skin due to inflammation).
• you develop skin disease from Graft-versus-Host Disease (an immune reaction of the skin, a common complication in patients undergoing bone marrow transplantation).
• your lymph nodes are swollenat the start of treatment. If your lymph nodes swell during treatment with Carelimus, consult your doctor.
• you have infected lesions.Do not apply the ointment to infected lesions.
• you notice any change in the appearance of the skin, tell your doctor.
• The safety of using tacrolimus ointment for a long period of time is unknown. A very limited number of people who have used tacrolimus ointment have had malignant tumors (e.g., of the skin or lymphomas). However, no link has been demonstrated with treatment with tacrolimus ointment.
• Avoid prolonged exposure of the skin to sunlight or artificial light, such as tanning beds. If you spend time outdoors after applying Carelimus, use a sunscreen and wear comfortable clothing that protects the skin from the sun. Also, consult your doctor for other appropriate sun protection methods. If you have been prescribed heliotherapy, inform your doctor that you are using Carelimus as the use of Carelimus and sun therapy at the same time is not recommended.
• If your doctor prescribes Carelimus twice a week to prevent a new outbreak 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 discontinued after 12 months to verify whether there is still a need for continued treatment.
• Patients should be advised not to bathe, shower or swim immediately after applying the ointment; water may wash away the medicine.

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 ones, has not been established.

Other medicines, cosmetics and Carelimus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine, including over-the-counter medicines.
You can use moisturizing creams and lotions during treatment with Carelimus, however they can only be applied
to the same treated area two hours before or two hours after applying Carelimus.
The effect of the simultaneous use of tacrolimus with other preparations to be applied to the skin
or with the assumption of oral corticosteroids (e.g. cortisone) or medicines that act on the immune system
has not been studied.

Carelimus with alcoholic beverages
During the use of Carelimus, the consumption of alcoholic beverages may cause flushing of the face or skin and
feelings of warmth.

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

3. How to use Carelimus

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.

• Apply a thin layer of Carelimus to the affected areas of the skin.
• Carelimus can be applied to most of the body surface, including the face, neck and areas subject to flexion of the elbows and knees.
• Avoid using the ointment in the nose, mouth or eyes. If the ointment is accidentally applied to these areas, the area should be cleaned thoroughly and/or rinsed with water.
• Do not cover the affected area of skin with bandages, dressings or other wound coverings.
• Wash your hands after applying Carelimus, unless your hands are also areas to be treated.
• Before applying Carelimus after a bath or shower, you must be sure that the skin is completely dry.
• Do not bathe, shower or swim immediately after applying the ointment. Water may wash away the medicine.

Adults (aged 16 years and over)
Two strengths of tacrolimus ointment (tacrolimus 0.03% ointment and tacrolimus 0.1%
ointment) are available for adult patients (aged 16 years and over). Your doctor will decide which strength is most
suitable for you.
Generally, treatment starts with Carelimus 0.1% ointment twice a day, once in the morning and
once in the evening, until the eczema has disappeared. Based on the eczema's response, your doctor will decide whether the
frequency of applications can be reduced or whether the lower strength, tacrolimus
0.03% ointment can be used.
Treat the affected areas of skin until the eczema has healed. Improvements are generally observed
within one week. If you do not see any visible improvements after two weeks, consult your doctor
for other possible treatments.
Your doctor may prescribe the use of Carelimus 0.1% ointment twice a week after the atopic dermatitis has disappeared or almost disappeared. Carelimus 0.1% ointment should be applied once a day,
twice a week (for example, Monday and Thursday) to the areas of your body normally affected
by atopic dermatitis. 2-3 days should pass between applications with a suspension of treatment with
Carelimus. If symptoms reappear, return to using Carelimus twice a day as described above and
make an appointment with your doctor for a review of the therapy.

If you accidentally ingest the ointment
If you accidentally ingest the ointment, consult your doctor or pharmacist as soon as possible. Do not attempt
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 the use of 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 and itching sensation. These symptoms are usually mild to moderate and generally disappear within a 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)
• skin tingling and irritation
• rash
• local skin infection independent of specific causes, including but not limited to: inflamed or infected hair follicles, cold sores, widespread herpes simplex infections
• 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 twice-weekly treatment, infections at the application site have been reported in adults.
During the post-marketing phase, rosacea (facial redness), pseudo-rosacea dermatitis, lentigines (presence of dark, flat spots on the skin), edema at the application site and
herpes-related eye infections have been reported.
Since its availability on the market, a very small number of people who have used
tacrolimus ointment have had malignant tumors (e.g., lymphoma, including cutaneous lymphoma and other skin tumors). However, based on the data available so far, a correlation
with treatment with tacrolimus ointment has not been demonstrated or excluded.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the tube and the carton after Scad. The expiry
date refers to the last day of the month.
Do not store at a temperature above 25ºC.
Dispose of 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Carelimus contains

• The active ingredient is tacrolimus monohydrate. One gram of Carelimus 0.1% ointment contains 1.0 mg of tacrolimus (as tacrolimus monohydrate).
• The excipients are white petrolatum; 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 tending to yellow. It is available in tubes of 10, 30 or 60 grams of ointment. Not all pack sizes may be marketed.

Marketing Authorisation 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.
Fòtiùt 56., Budapest 1047,
Hungary
Laboratori FundacióDau
Pol. Ind. Consorci Zona Franca,
c/ C, 12-14 Barcellona, 08040,
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the following
names: