CELLMUNE 0.3 mg/g OINTMENT

Introduction

Patient Information Leaflet

Cellmune 0.3 mg/g ointment

tacrolimus

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as 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, as it may harm them, even if they have the same symptoms as you.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Cellmune and what is it used for
2. What you need to know before using Cellmune
3. How to use Cellmune
4. Possible side effects
5. Storage of Cellmune
6. Package contents and additional information

1. What is Cellmune and what is it used for

The active ingredient of Cellmune, tacrolimus, is an immunomodulating agent.

Cellmune 0.3 mg/g ointment is used for the treatment of moderate to severe atopic dermatitis (eczema) in adults and adolescents who do not respond adequately or are intolerant to conventional therapies such as topical corticosteroids, and in children (from 2 years of age) who have not responded adequately to conventional therapies such as topical corticosteroids.

Once the moderate to severe atopic dermatitis has disappeared or almost disappeared after a treatment period of up to 6 weeks, and if you are experiencing frequent flare-ups (i.e., 4 or more per year), it may be possible to prevent the recurrence of flare-ups or prolong the time you are flare-up free using Cellmune 0.3 mg/g ointment twice a week.

In atopic dermatitis, the excessive reaction of the skin's immune system causes skin inflammation (itching, redness, dryness). Cellmune modifies the abnormal immune response and relieves skin inflammation and itching.

2. What you need to know before using Cellmune

Do not useCellmune

If you are allergic (hypersensitive) 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

Consult your doctor or pharmacist before starting to use this medicine:

• If you have liver failure.
• If you have any skin malignancy(tumor) or if you have a weakened immune system(immunocompromised), regardless of the cause.
• If you have a hereditary skin barrier disease, such as Netherton syndrome, lamellar ichthyosis (extensive skin scaling due to thickening of the outer skin layer), if you have an inflammatory skin disease such as pyoderma gangrenosum, or if you have generalized erythroderma(inflammatory redness and scaling of the entire skin).
• If you have a skin graft-versus-host disease (an immune reaction of the skin that is a common complication in patients who have undergone a bone marrow transplant).
• If you have inflamed lymph nodesat the start of treatment. If your lymph nodes become inflamed during treatment with tacrolimus, consult your doctor.
• If you have infected lesions.Do not apply the ointment to infected lesions.
• If you notice any change in the appearance of your skin, inform your doctor.
• According to the results of long-term studies and experience, no definitive relationship has been confirmed between treatment with tacrolimus ointment and the development of malignant tumors, but no definitive conclusions can be drawn.
• Avoid prolonged exposure to sunlight or artificial sunlight, such as tanning beds. If you spend time outdoors after applying tacrolimus, use a sunscreen and wear loose clothing that protects your skin from the sun. Also, ask your doctor for advice on other suitable sun protection methods. If you have been prescribed light therapy, inform your doctor that you are using tacrolimus, as it is not recommended to use tacrolimus and light therapy at the same time.
• If your doctor tells you to use tacrolimus twice a week to maintain the disappearance of your atopic dermatitis, your condition should be reviewed by your doctor at least every 12 months, even if you remain under control. In children, maintenance treatment should be discontinued after 12 months to assess whether there is still a need for continued treatment.
• Tacrolimus ointment should be used at the lowest possible concentration, with the lowest frequency, and for the shortest duration necessary. This decision should be based on your doctor's assessment of how your eczema responds to tacrolimus ointment.

Children

• Cellmune 0.3 mg/g ointment is not approved for children under 2 years of age. Therefore, it should not be used in this age group. Please consult your doctor.
• The effect of treatment with this medicine on the development of the immune system in children, especially the youngest, has not been established.

Other medicines, cosmetics, and Cellmune

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

You can use moisturizing creams and lotions during treatment with tacrolimus, but these products should not be used in the 2 hours following application of this medicine.

The use of tacrolimus at the same time as other preparations for use on the skin or while taking oral corticosteroids (e.g., cortisone) or medicines that affect the immune system has not been studied.

Use of Cellmune with alcohol

While using tacrolimus, alcohol consumption may cause your skin or face to become red or feel hot.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

3. How to use Cellmune

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Apply this medicine as a thin layer to the affected areas of your skin.
• Tacrolimus can be used on most parts of the body, including the face and neck, and in the folds of the elbows and knees.
• Avoid using the ointment inside the nose or mouth, or in the eyes. If the ointment comes into contact with any of these areas, it should be thoroughly cleaned and/or rinsed with water.
• Do not cover the skin being treated with bandages, dressings, or other wound dressings.
• Wash your hands after applying tacrolimus, unless your hands are also being treated.
• Before applying tacrolimus 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 remove the medicine.

Children (from 2 years of age)

Apply Cellmune 0.3 mg/g ointment twice a day for a maximum of three weeks, once in the morning and once at night. After that, the ointment should be used once a day on each affected area of the skin until the eczema has disappeared.

Adults and adolescents (from 16 years of age)

There are two concentrations of tacrolimus available (Cellmune 0.3 mg/g ointment and Cellmune 1 mg/g ointment) for adults and adolescents (over 16 years). Your doctor will decide which concentration is best for you.

Usually, treatment is started with tacrolimus 1 mg/g ointment twice a day, once in the morning and once at night, until the eczema has disappeared. Depending on the response of your eczema, your doctor will decide if the application frequency can be reduced or if the lower-strength ointment, tacrolimus 0.3 mg/g, can be used.

Treat each affected area of your skin until the eczema has disappeared. Improvement is usually seen within a week. If you do not see any improvement after two weeks, consult your doctor about other possible treatments.

It is possible that your doctor will tell you to use tacrolimus ointment twice a week once your atopic dermatitis has disappeared or almost disappeared (tacrolimus 0.3 mg/g for children and tacrolimus 1 mg/g for adults). Tacrolimus ointment should be applied once a day, twice a week (e.g., Monday and Thursday) to the areas of your body commonly affected by atopic dermatitis. There should be 2-3 days without treatment with tacrolimus ointment between applications.

If symptoms recur, you should use tacrolimus ointment twice a day as previously indicated and make an appointment with your doctor to review your treatment.

If you accidentally ingest Cellmune ointment

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Cellmune

If you forget to apply the ointment at the scheduled time, do so as soon as you remember, and then continue as before.

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

4. Possible side effects

Like all medicines, this medicine 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 a week of using this medicine.

Common (may affect up to 1 in 10 people):

• Redness.
• Feeling of warmth.
• Pain.
• Increased sensitivity of the skin (especially to cold and heat).
• Tingling and skin irritation.
• Rash.
• Local skin infection, regardless of the specific cause, including, but not limited to, the following: inflamed or infected hair follicles, cold sores, generalized herpes simplex infections.
• Facial redness or skin irritation after alcohol consumption is also common.
• Hypersensitivity at the application site.

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

• Acne.

After twice-weekly treatment, infections at the application site have been reported in children and adults. Cases of impetigo, a superficial bacterial skin infection that usually produces blisters or sores on the skin, have been reported in children.

During post-marketing, cases of rosacea (facial redness), rosacea-like dermatitis, lentigo (presence of flat brown spots on the skin), edema at the application site, and eye infections due to herpes have been reported.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cellmune

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Discard opened tubes 90 days after opening, even if they are not empty. They should not be kept for future use. Note the date of first opening of the tube on the outer carton to remember when to discard it.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Cellmune

• The active ingredient is tacrolimus.

One gram of Cellmune 0.3 mg/g ointment contains 0.3 mg of tacrolimus (as tacrolimus monohydrate).

• The other ingredients (excipients) are white petrolatum, liquid paraffin, propylene carbonate, white beeswax, and hard paraffin.

Appearance and packaging of the product

Cellmune is a white to slightly yellowish ointment.

It is available in tubes containing 10, 30, or 60 grams of ointment. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Manufacturer

Laboratori Fundació Dau

Pol. Ind. Consorci Zone Franca, c/C, 12-14

08040 Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Cellmune 0.3 mg/g ointment

Portugal: Tacrolimus Cantabria 0.3 mg/g ointment

Italy: Carelimus 0.03% ointment

Date of the last revision of this leaflet:June 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es