Tacgalen 1 mg/ml cutaneous emulsion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET

Package leaflet: Information for the patient

Tacgalen 1 mg/ml cutaneous emulsion

tacrolimus

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult 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 could harm them.

  • If you experience adverse effects, consult your doctor or pharmacist. This includes even those adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Tacgalen is and what it is used for

The active substance in Tacgalen, tacrolimus, is an immunomodulatory agent.

Tacgalen is used for the short-term treatment of mild to moderate scalp psoriasis in adults.

In scalp psoriasis, red, scaly, and itchy patches appear on the skin. This skin is extremely dry and often cracks and bleeds at the surface. Within the affected areas, the function of the skin's immune cells is altered, causing new skin cells to be produced faster than normal, while old, dead cells are shed at a normal rate. As living skin cells accumulate, the skin thickens and becomes inflamed. Tacgalen modifies the abnormal immune function and relieves skin inflammation and itching.

2. What you need to know before using Tacgalen

Do not use Tacgalen

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

Warnings and precautions

Talk to your doctor before starting to use this medicine:

• If you have hepatic insufficiency.
• If you have any malignant skin neoplasm (tumors).
• If you have a weakened immune system (immunocompromised), regardless of the cause.
• If 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 have generalized erythroderma (inflammatory redness and peeling of the entire skin surface).
• If you have swollen lymph nodes at the start of treatment. If your lymph nodes become swollen during treatment with this medicine, consult your doctor.
• If you have infected lesions. Do not apply the cutaneous emulsion to infected lesions.
• If you notice any changes in the appearance of your skin, inform your doctor.
• Based on study results and long-term experience, a causal relationship between treatment with this medicine and the development of malignant neoplasms has not been confirmed, but definitive conclusions cannot be drawn.
• Avoid exposing the skin to prolonged periods of sunlight or artificial sunlight, such as sunbeds. If you spend time outdoors after applying tacrolimus, use sunscreen and wear loose clothing that protects the skin from the sun. In addition, ask your doctor for advice on other suitable sun protection methods. If you are prescribed phototherapy, inform your doctor that you are using tacrolimus, as concomitant use of this medicine and phototherapy is not recommended.

Children and adolescents

The effect of treatment with this medicine in children and adolescents up to 18 years of age with scalp psoriasis has not been established. Therefore, it should not be used in this age group. Consult your doctor.

Other medicines, cosmetics, and Tacgalen

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

You may use moisturizing creams and lotions during treatment with tacrolimus, but you should wait two hours after applying this medicine before using them.

The use of this medicine together with other topical skin preparations or while taking oral corticosteroids (e.g., cortisone) or medicines that affect the immune system has not been studied.

Tacgalen and alcohol

During the use of tacrolimus, alcohol consumption may cause flushing or redness of the skin or face and a sensation of warmth.

Pregnancy and breastfeeding

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

Driving and using machines

No effect on the ability to drive or operate machinery is expected.

Tacgalen contains 1,2-Pentanediol

1,2-Pentanediol may cause eye irritation if this medicine comes into accidental contact with your eyes.

3. How to use Tacgalen

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

Method of administration

• Shake the bottle before use.
• Apply Tacgalen as a thin layer to the affected areas of the scalp. Apply it directly to the scalp using the dropper and spread it with the fingertip, or apply it onto the fingertip and spread it over the affected area.
• Avoid contact with the face.
• If the cutaneous emulsion comes into contact with the nose, mouth, or eyes, clean thoroughly and rinse completely with water.
• Do not cover the treated scalp area with bandages or dressings.
• Wash your hands after applying Tacgalen. Wipe your hands with a paper towel before washing them. The paper towel should be disposed of with the remaining waste.
• When applying Tacgalen after bathing or showering, ensure that your skin and hair are completely dry.

Duration of treatment

Generally, treatment with Tacgalen is performed twice daily, once in the morning and once at night, for 8 weeks.

It is recommended to use this medicine for the shortest duration necessary. This decision should be based on the physician's assessment of how the scalp psoriasis responds to tacrolimus.

If you accidentally ingest any cutaneous emulsion

If you accidentally ingest the cutaneous emulsion, consult your doctor or pharmacist as soon as possible.

If you forget to use Tacgalen

If you forget to apply the cutaneous emulsion 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, this medicine can cause adverse effects, although not everyone experiences 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 one or two weeks after using Tacgalen.

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

• Redness
• Feeling of warmth
• Pain
• Generalized hair loss
• Increased skin sensitivity (especially to cold and heat)
• Skin tingling
• Pricking, chills, burning, or numbness of the skin not caused by another condition
• Rash
• Local skin infections regardless of specific cause, including: inflamed or infected hair follicles, cold sores, and generalized herpes simplex infections
• Facial redness or skin irritation after drinking alcohol

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

• Acne

Cases of rosacea (facial redness), rosacea-like dermatitis, lentigo (flat brown spots on the skin), swelling at the application site, and ocular herpes infections have been reported with other formulations of tacrolimus.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist. This includes any possible adverse effect not listed in this leaflet.

You can also report side effects directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tacgalen

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

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

• Store in a refrigerator (between 2°C and 8°C).

• After first opening: Do not store above 25°C and use within 5 weeks.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the Sigre Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tacgalen

The active substance is tacrolimus. 1 ml of cutaneous emulsion contains 1 mg of tacrolimus (as tacrolimus monohydrate).

• The other components are: polysorbate 80, macrogol lauryl ether, isopropyl myristate, 1,2-pentanediol, purified water, tartaric acid.

Appearance of Tacgalen and contents of the pack

Tacgalen 1 mg/ml cutaneous emulsion is a yellowish transparent liquid. It is supplied in high-density polyethylene (HDPE) bottles equipped with a low-density polyethylene (LDPE) dropper and closed with an HDPE screw cap.

Pack sizes:

30 ml and 60 ml of cutaneous emulsion.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Galenicum Derma, S.L.U.

Crta. N-1, km 3628750 San Agustín del Guadalix (Madrid)

Spain

Manufacturer

Nuvisan GmbH

Wegenerstraße 13

89231 Neu-Ulm

Germany

Date of latest revision of this leaflet: 07/2025

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/)