PROSPECTUS: INFORMATION FOR THE USER

Cellmune 1 mg/g ointment

Tacrolimus

Read this prospectus carefully before starting to use the medication, as it contains important information for you

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

The active ingredient of Cellmune, tacrolimus monohydrate, is an immunomodulator agent.

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

Once moderate to severe atopic dermatitis disappears or almost disappears 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), you may prevent them from recurring or prolong the time without flare-ups by using Cellmune twice a week.

In atopic dermatitis, excessive skin 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.

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:

• The long-term safety of using tacrolimus is unknown. A very small number of people who have used tacrolimus ointment have had malignant diseases (for example, skin or lymphoma). However, no relationship has been demonstrated with tacrolimus treatment.
• Avoid exposure of the skin to long periods of sunlight or artificial light, such as tanning beds. If you stay outdoors after applying Cellmune, use a sunscreen and wear loose clothing that protects your skin from the sun. Also, consult your doctor for other suitable methods to protect yourself from the sun. If you are prescribed sun therapy, inform your doctor that you are using Cellmune, as it is not recommended to use Cellmune and sun therapy at the same time.
• If your doctor tells you to use Cellmune 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 it remains controlled. In children, treatment should be discontinued after 12 months to evaluate if continued treatment is still necessary.
• Patients should be informed not to bathe, shower, or swim immediately after applying the ointment; water may remove the medication.

Children

• Cellmune 1 mg/g ointmentis not authorized for children under 16 years. 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 the youngest, has not been established.

Use of Cellmune with other medications and cosmetics

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

You can use moisturizing creams and lotions during treatment with Cellmune, but do not use them during the two hours before and after applying Cellmune.

The use of Cellmune at the same time as other topical preparations or while taking oral corticosteroids (e.g., cortisone) or oral immunomodulating medications has not been studied.

Use of Cellmune with alcohol

While using Cellmune, consuming alcohol may cause redness or inflammation of the skin or face and a sensation of heat.

Pregnancy and breastfeeding

Do not use Cellmune if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using any medication

Follow exactly the administration instructions for Cellmune indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Adults (16 years of age and older)

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

Usually, treatment begins with Cellmune 1 mg/g ointment twice a day, once in the morning and once at night, until the eczema disappears. Depending on your eczema response, your doctor will decide if the application frequency can be reduced or if the lower dose, tacrolimus 0.3 mg/g ointment, 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 notice any improvement after two weeks, consult your doctor about other possible treatments.

Your doctor may tell you to use Cellmune 1 mg/g ointment twice a week once your atopic dermatitis has disappeared or almost disappeared. Cellmune 1 mg/g ointment should be applied once a day twice a week (e.g., Monday and Thursday) on the 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 a day, as previously indicated, and visit your doctor to review your treatment.

If you accidentally ingest something of the ointment

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

If you forgot to use Cellmune

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

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

Like all medications, Cellmune can produce adverse effects, although not all people may experience them.

Very frequent (may affect more than 1 in 10 people):

Usually, these symptoms are mild to moderate and generally disappear within a week of using tacrolimus.

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

Rare (may affect fewer than 1 in 100 people):

In adults, skin infections at the application site have been reported twice a week after treatment.

During post-marketing experience, rosacea (facial redness), rosacea-type dermatitis, lentigo (presence of flat brown skin patches), edema at the application site, and herpes eye infections have also been reported.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Cellmune after the expiration date that appears on the tube and carton, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Dispose of opened tubes within 90 days of their first opening, even if they are not empty. They should not be stored for future use.

Medicines should not be thrown down the drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Cellmune

• The active ingredient is tacrolimus monohydrate.

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

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

Appearance of the product and contents of the packaging

Cellmune is a white to slightly yellowish ointment.

It is presented in tubes containing 10, 30 or 60 grams of ointment.

Only some sizes of packaging may be marketed.

Holder of the Marketing Authorization

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Responsible for manufacturing

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 with the following names:

Spain: Cellmune 1 mg/g ointment

Portugal: Tacrolímus Cantabria 1 mg/g ointment

Italy:Carelimus 0.1% ointment

Revision date of thisleaflet:March 2024

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