Alacare

Package Leaflet: Information for the User

Alacare, 8 mg, medicinal patch

5-Aminolevulinic Acid

Read the package leaflet carefully before using the medicinal product, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What Alacare medicinal patch is and what it is used for
• 2. Important information before using Alacare medicinal patch
• 3. How to use Alacare medicinal patch
• 4. Possible side effects
• 5. How to store Alacare medicinal patch
• 6. Contents of the pack and other information

1. What Alacare medicinal patch is and what it is used for

Alacare medicinal patch is used to treat mild skin changes on the scalp or face called solar keratosis. These are small, rough patches that appear on the skin. The cause of their formation is prolonged exposure of the skin to sunlight. These changes are also called senile keratosis. Treatment with Alacare patches is a two-stage process called "photodynamic therapy". It involves applying the Alacare patch to the skin patches and leaving it on for 4 hours. Then, the treated area is exposed to red light for a few minutes. The red light exposure initiates a chemical reaction in the diseased skin cells, leading to their destruction. The reaction is called "phototoxic reaction".

2. Important information before using Alacare medicinal patch

The Alacare patch is applied by a doctor, nurse, or other healthcare professional during a single treatment session.

When not to use Alacare medicinal patch

• if you are allergic to 5-aminolevulinic acid or any of the other ingredients of this medicinal product (listed in section 6).
• if you have a blood metabolism disorder called porphyria.
• if you have been treated with 5-aminolevulinic acid-containing preparations and the treatment was unsuccessful.
• if you have other light-induced diseases or conditions that may worsen under its influence.

The efficacy of the treatment and the assessment of its effectiveness may be reduced if the treated skin area:

• has inflammation, infection, psoriasis, eczema, or cancer
• has tattoos

Warnings and precautions

Before starting treatment with Alacare medicinal patch, discuss it with your doctor.

• if you have dark brown or black skin or the skin changes are very visible, as there are no clinical data on the use of Alacare patch in such cases.
• if you are pregnant or breastfeeding, as the use of Alacare patch is not recommended during pregnancy or breastfeeding.
• if you are being treated with ultraviolet (UV) radiation, this treatment should be discontinued before using Alacare patch.

The doctor or nurse must ensure that the Alacare patch does not come into contact with the patient's eyes. As a general safety precaution, the treated skin and surrounding area should not be exposed to sunlight for 48 hours after treatment.

Alacare medicinal patch and other medicinal products

Tell your doctor about any medicinal products that may enhance allergic reactions or other side effects that may occur under the influence of light therapy:

• St. John's Wort and its preparations: medicinal products used to treat depression
• Griseofulvin: medicinal products used to treat fungal infections
• Diuretics, whose active substance names usually end in "thiazide" or "tizide".
• Certain medicinal products used to treat diabetes, such as glibenclamide, glimepiride
• Medicinal products used to treat mental disorders, nausea, or vomiting, whose active substance names usually end in "azine".
• Medicinal products used to treat bacterial infections, whose active substance names start with "sulfa" or end in "oxacine" or "cycline".

Tell your doctor about all medicinal products you are currently taking or have recently taken, as well as any medicinal products you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicinal product. The risk of harm to the pregnancy and the unborn child cannot be entirely excluded. Alacare patch should not be used during pregnancy unless absolutely necessary. Breastfeeding should be discontinued for 48 hours after using Alacare patch. Always ask your doctor for advice before using any medicinal product.

Driving and using machines

Using Alacare patch does not affect the ability to drive or operate machines.

3. How to use Alacare medicinal patch

This medicinal product is administered exclusively by medical personnel.

Remember not to apply any cream to the scalp or face on the day of treatment before visiting the doctor.

Adults (including elderly patients)

Alacare patches will be applied to the skin affected by solar keratosis for 4 hours during a single treatment session. Then, these areas will be exposed to red light for a few minutes (photodynamic therapy). To protect the eyes from intense light, the patient will receive protective eyewear, which should be worn during light exposure. After applying the patch and light exposure, the skin should be protected from sunlight for 48 hours. The doctor should check the changes after three months.

Use in children and adolescents

The use of Alacare patch is not recommended, as there are no clinical data on its use in children and adolescents under 18 years of age.

Discontinuation of Alacare medicinal patch

The efficacy of the treatment may be reduced if:

• the patch is removed from the skin prematurely or
• light exposure is interrupted too early.

4. Possible side effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.

Local side effects (at the site of application)

Almost all patients (99%) experienced side effects at the site of treatment (local side effects). They may occur during the application of the Alacare patch, light exposure, and/or after the procedure. The symptoms are usually mild or moderate in severity. Rarely, they require early termination of light exposure. To alleviate symptoms during light exposure, cooling of the treated area can be used, e.g., with a fan. After the treatment, local side effects persist for 1 or 2 weeks, and sometimes longer.

Very common (in more than 1 in 10 patients):

• skin peeling
• irritation
• itching
• pain
• redness
• crust

Common (in more than 1 in 100 patients, but less than 1 in 10 patients)

• areas of lighter or darker skin discoloration
• bleeding
• blister on the skin
• discomfort
• erosion
• swelling (fluid accumulation in tissue)
• skin peeling
• pustules
• skin reaction
• discharge
• swelling (edema)

Uncommon (in more than 1 in 1000 patients, but less than 1 in 100 patients)

• burn
• discoloration
• infection
• inflammation
• ulcer
• superficial skin damage

Side effects not related to the site of application:

Common

• headache

Uncommon

• anxiety
• increased activity of the enzyme alanine aminotransferase
• nosebleed
• pustular rash
• skin discoloration

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Alacare medicinal patch

Keep this medicinal product out of the sight and reach of children. Do not use this medicinal product after the expiry date stated on the carton and sachet after "Expiry date". The expiry date refers to the last day of the month stated. The medicinal product is suitable for use within 3 months of first opening. After opening, store in the sachet to protect from light. After removing the used patches, fold them in half with the adhesive side inward, and then dispose of them safely. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Alacare medicinal patch contains

• The active substance is 5-aminolevulinic acid hydrochloride. One medicinal patch with a surface area of 4 cm² contains 8 mg of 5-aminolevulinic acid, 2 mg/cm².
• The other ingredients are:
• Adhesive layer:Acrylate-vinyl acetate copolymer (Duro-Tak 387-2353/87-2353)
• Outer protective layer:Polyethylene/Polyester/Aluminum (3M ScotchPak 1109)
• Protective layer (removable):Polyethylene terephthalate, siliconized

What Alacare medicinal patch looks like and contents of the pack

One medicinal patch with a surface area of 4 cm² is square in shape with rounded corners and consists of a skin-colored backing foil and an adhesive matrix covered with a removable protective layer. The protective sachet contains 4 patches. Alacare patch is available in packs containing 4 or 8 patches (1 or 2 protective sachets) in a cardboard box.

Marketing authorization holder and manufacturer

photonamic GmbH & Co. KG, Eggerstedter Weg 12, 25421 Pinneberg, Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Denmark, Finland, Ireland, Germany, Norway, Poland, Portugal, Sweden, United Kingdom (Northern Ireland), Italy - ALACARE, France - EFFALA

Date of last revision of the leaflet: 01/2025