Cellmune 1 mg/g ointment

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cellmune 1 mg/g ointment

Tacrolimus

Read the entire leaflet carefully before you start using this medicine, because 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Cellmune is and what it is used for

The active substance in Cellmune, tacrolimus monohydrate, is an immunomodulatory agent.

Cellmune is used to treat moderate to severe atopic dermatitis (eczema) in adults who do not respond adequately or who are intolerant to conventional treatments, such as topical corticosteroids.

Once moderate to severe atopic dermatitis has cleared or almost cleared after up to 6 weeks of treatment for a flare-up, and if you experience frequent flare-ups (i.e., 4 or more per year), using Cellmune twice a week can help prevent flare-ups from returning or prolong the time without flare-ups.

In atopic dermatitis, an overreaction 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 starting to use Cellmune

Do not use Cellmune

• If you are allergic (hypersensitive) to tacrolimus or to any of the other components of Cellmune (listed in section 6), or to macrolide antibiotics (for example, azithromycin, clarithromycin, erythromycin).

Warnings and precautions

Consult your doctor if:

• you have hepatic insufficiency.

• you have any malignant skin disease (tumors) or if you have a weakened immune system (immunocompromised), regardless of the cause.

• you have a hereditary skin barrier disorder, such as Netherton syndrome, lamellar ichthyosis (extensive skin peeling due to thickening of the outer layer of the skin), if you have an inflammatory skin disease such as pyoderma gangrenosum, 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, which is 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 become swollen during treatment with Cellmune, consult your doctor.

• you have infected lesions. Do not apply the ointment to infected lesions.

• you notice any changes in the appearance of your skin; please inform your doctor.

• The long-term safety of tacrolimus use is unknown. A very small number of people who have used tacrolimus ointment have developed malignant diseases (e.g., skin cancer or lymphoma). However, a causal relationship with tacrolimus treatment has not been established.

• Avoid exposing the skin to prolonged periods of sunlight or artificial light, such as tanning beds. If you go outdoors after applying Cellmune, use sunscreen and wear loose clothing that protects your skin from the sun. Additionally, consult your doctor for advice on other appropriate methods of sun protection. If you are prescribed phototherapy, inform your doctor that you are using Cellmune, as the concomitant use of Cellmune and phototherapy is not recommended.

• If your doctor instructs you to use Cellmune twice a week to maintain remission of your atopic dermatitis, your condition should be reviewed by your doctor at least every 12 months, even if it remains controlled. In children, maintenance treatment should be discontinued 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

• Cellmune 1 mg/g ointment is not authorized for children under 16 years of age. Therefore, it should not be used in this age group. Please consult your doctor.
• The effect of Cellmune treatment on the development of the immune system in children, especially in younger children, has not been established.

Use of Cellmune with other medicines and cosmetics

Inform your doctor or pharmacist if you are taking or using, or have recently taken or used, any other medicines, including those obtained without a prescription.

You may use moisturizing creams and lotions during treatment with Cellmune, but you should not use them within two hours before or two hours after applying Cellmune.

The use of Cellmune together with other topical preparations or while taking oral corticosteroids (e.g., cortisone) or oral immunosuppressive medications has not been studied.

Use of Cellmune with alcohol

While using Cellmune, alcohol consumption may cause flushing or redness of the skin or face and a sensation of warmth.

Pregnancy and breastfeeding

Do not use Cellmune if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using any medicine.

3. How to use Cellmune

Follow exactly the administration instructions for Cellmune given by your doctor. If in doubt, consult your doctor or pharmacist.

• Apply Cellmune as a thin layer to the affected areas of your skin.
• Cellmune may 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 your nose or mouth, or in your eyes. If ointment gets into any of these areas, wipe it off thoroughly and/or rinse with water.
• Do not cover treated skin with bandages or other wound dressings.
• Wash your hands after applying Cellmune, unless your hands are also being treated.
• Before applying Cellmune 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 wash off the medication.

Adults (16 years of age and older)

For adult patients (16 years of age and older), two strengths of tacrolimus ointment are available (tacrolimus 0.3 mg/g ointment and tacrolimus 1 mg/g ointment). Your doctor will decide which strength is most suitable for you.

Usually, treatment is started with Cellmune 1 mg/g ointment twice daily, once in the morning and once in the evening, until the eczema has cleared. Depending on how your eczema responds, your doctor will decide whether the frequency of application can be reduced or whether the lower strength, tacrolimus 0.3 mg/g ointment, can be used.

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

Your doctor may instruct you to use Cellmune 1 mg/g ointment twice a week once your atopic dermatitis has cleared or almost cleared. Cellmune 1 mg/g ointment should be applied once daily on two days per week (e.g., Monday and Thursday) to areas of your body that are usually affected by atopic dermatitis. There should be 2–3 days without treatment with Cellmune between applications. If symptoms reappear, you should use Cellmune twice daily as described above and see your doctor to review your treatment.

If you accidentally swallow some 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 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Cellmune may cause adverse effects, although not everyone experiences 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 tacrolimus.

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

• redness
• sensation of warmth
• pain
• increased skin sensitivity (especially to heat and cold)
• tingling and skin irritation
• rash
• local skin infections regardless of their specific cause, including but not limited to: inflamed or infected hair follicles, cold sores, widespread herpes simplex infections
• facial redness or skin irritation after drinking alcohol is also common
• hypersensitivity at the application site

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

• acne

In adults, infections at the application site have been reported following twice-weekly treatment.

In post-marketing experience, rosacea (facial redness), rosacea-like dermatitis, lentigo (flat brown spots on the skin), application site edema, and herpes infections of the eye have also been reported.

Since its marketing, a very small number of people using tacrolimus ointment have developed malignant diseases (e.g., lymphoma, including skin lymphoma, and other skin tumors). However, based on currently available evidence, a link with treatment with tacrolimus ointment has neither been confirmed nor ruled out.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cellmune

Keep this medicine out of sight and reach of children.

Do not use Cellmune after the expiry date stated on the tube and carton, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Discard opened tubes 90 days after first opening, even if they are not empty. They should not be kept for later use.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cellmune

• The active substance is tacrolimus monohydrate.

One gram of Cellmune contains 1 mg of tacrolimus (as tacrolimus monohydrate).

• The other components are soft white paraffin, liquid paraffin, propylene carbonate, white beeswax, and hard paraffin.

Appearance of the product and contents of the container

Cellmune is a cream that is white to slightly yellowish in colour.

It is available in tubes containing 10, 30 or 60 grams of cream.

Only certain pack sizes may be marketed.

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Cellmune 1 mg/g cream
Portugal: Tacrolímus Cantabria 1 mg/g cream
Italy: Carelimus 0.1% ointment

Date of latest review of this leaflet: March 2024

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