TACGALEN 1 mg/ml CUTANEOUS EMULSION

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the Patient

Tacgalen 1 mg/ml Cutaneous Emulsion

tacrolimus

Read all of this 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Tacgalen and what is it used for

The active substance of Tacgalen, tacrolimus, is an immunomodulating 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 on its surface. Within the affected areas, the function of the skin's immune cells is altered, and new cells are produced more quickly than normal, while old dead cells are eliminated at a normal rate. As the living skin cells accumulate, the skin thickens and becomes inflamed. Tacgalen alters the abnormal immune function and relieves the inflammation and itching of the skin.

2. What you need to know before you start using Tacgalen

Do not use Tacgalen

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

Warnings and precautions

Talk to your doctor before you start using this medicine:

• If you have liver failure.
• If you have any malignant skin neoplasia (tumors).
• If you have a weakened immune system (immunocompromised), whatever the cause.
• If you suffer from 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 suffer from generalized erythroderma (inflammatory redness and scaling of the entire skin surface).
• If you suffer from a skin graft-versus-host disease (an immune reaction of the skin that is a frequent complication in patients who have undergone a bone marrow transplant).
• If you have inflamed lymph nodes at the start of treatment. If your lymph nodes become inflamed during treatment with this medicine, talk to your doctor.
• If you have infected lesions. Do not apply the cutaneous emulsion to infected lesions.
• If you notice any change in the appearance of your skin, inform your doctor.
• According to the results of studies and long-term experience, no relationship has been confirmed between treatment with this medicine and the development of malignant neoplasias, but no definitive conclusions can be drawn.
• Avoid exposing your skin to prolonged periods of 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 methods of sun protection. If you are prescribed phototherapy, inform your doctor that you are using tacrolimus, as the simultaneous use of this medicine and phototherapy is not recommended.

Children and adolescents

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

Other medicines, cosmetics, and Tacgalen

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

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

The use of this medicine 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.

Tacgalen and alcohol

During the use of tacrolimus, alcohol consumption may cause the skin or face to flush or redden and feel hot.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

No effect on the ability to drive and use machines is expected.

Tacgalen contains1,2-Pentanediol

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

3. How to use Tacgalen

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of 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 with the dropper and spread it with your fingertip, or apply it to your 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, it must be cleaned thoroughly and rinsed 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 your hands. The paper towel must be disposed of with the remaining waste.
• When applying Tacgalen after bathing or showering, make sure your skin and hair are completely dry.

Duration of treatment

Treatment with Tacgalen is usually carried out twice a day, once in the morning and once at night, for 8 weeks.

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

If you accidentally swallow some of the cutaneous emulsion

If you accidentally swallow the cutaneous emulsion, talk to your doctor or pharmacist as soon as possible.

If you forget to use Tacgalen

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

If you have any further questions on 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 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 sensitivity of the skin (especially to cold and heat)
• Tingling of the skin
• Pins and needles, chills, burning, or numbness of the skin not caused by another condition
• Rash
• Local skin infections regardless of the specific cause, including, among others: 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 (presence of 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 side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side 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 which is stated on the carton and the bottle after ‘EXP’. The expiry date is the last day of the month stated.

• 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. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tacgalen

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

• The other ingredients are: polysorbate 80, lauryl macrogol 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 clear yellowish liquid. It is supplied in low-density polyethylene (LDPE) bottles equipped with an LDPE dropper and closed with a high-density polyethylene (HDPE) screw cap.

Package sizes:

30 ml and 60 ml of cutaneous emulsion.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Galenicum Derma, S.L.

Crta. N-1, Km 36, 28750 San Agustín del Guadalix (Madrid)

Spain

Manufacturer

Orion Oyj, Kuopio plant

Volttikatu 8

70700 Kuopio

Finland

Date of 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/)