AMELUZ 78 mg/g GEL

Introduction

Package Leaflet: Information for the User

Ameluz 78mg/g gel

5‑aminolevulinic acid

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 get 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 Ameluz and what is it used for
2. What you need to know before you use Ameluz
3. How to use Ameluz
4. Possible side effects
   1. Storage of Ameluz

1. Contents of the pack and further information

1. What is Ameluz and what is it used for

Ameluz contains the active substance 5‑aminolevulinic acid. It is used for the treatment:

• of actinic keratosisthat is slightly palpable or moderately thick or of entire fields affected by actinic keratoses in adults. Actinic keratoses are caused by a series of changes in the outer layer of the skin that can lead to skin cancer.
• of basal cell carcinomathat is superficial and/or nodular and cannot be treated with surgery due to possible morbidity related to treatment and/or poor aesthetic outcome in adults. Basal cell carcinoma is a type of skin cancer that can cause the appearance of reddish, scaly patches or one or more small bumps that bleed easily and do not heal.

After application, the active substance in Ameluz is converted into a photoactive substance that accumulates in the affected cells. Illumination with suitable light produces reactive oxygen molecules that attack the target cells. This treatment is called photodynamic therapy (PDT).

2. What you need to know before you use Ameluz

Do not use Ameluz

• if you are allergicto

• 5‑aminolevulinic acid or any of the other ingredients of this medicine (listed in section 6)
• photoactive substances called porphyrins
• soy or peanuts

• if you have a disorder of the formation of the red pigments of the blood called porphyria
• if you have otherskin conditionscaused or worsenedby lightexposure

Warnings and precautions

Consult your doctor before you start using Ameluz.

• In very rare cases, photodynamic therapy may increase the risk of development of

temporary memory loss.

• Ameluz is not recommended if you are using immunosuppressants.
• Do not apply Ameluz:
• • to bleeding lesions.
  • to the eyes or mucous membranes.
  • to areas of skin that are affected by other diseases or with tattoos, as this could make the treatment less successful and more difficult to evaluate.

• Intensive preparation of the lesions (e.g. chemical exfoliation followed by ablative laser) may increase pain during photodynamic therapy.

• Suspend any UV therapy before treatment.
• Avoid sun exposure of the treated lesions and surrounding skin for up to 48 hours

after treatment.

Children and adolescents

Actinic keratosis and basal cell carcinoma do not affect children or adolescents, except in extremely rare cases.

Using Ameluz with other medicines

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

Tell your doctor if you are using medicines that increase allergic reactions or other adverse reactions after light exposure, such as

• St. John's Wort or its preparations: medicines for the treatment of depression

• griseofulvin: medicine for the treatment of fungal infections
• medicines to increase water excretionthrough the kidneys, with active ingredients whose names usually end in «thiazide» or «thiazide» (or «tiacide», «ticide»), such as hydrochlorothiazide
• certain medicines for the treatment of diabetes, such as glibenclamide or glimepiride
• medicines for the treatment of mental disorders, nausea or vomitingwith active ingredients whose names usually end in «azine» (or «acine»), such as phenothiazine
• medicines for the treatment of bacterial infectionswith active ingredients whose names start with «sulfa» or end in «oxacin» or «cycline», such as tetracycline

Pregnancy and breastfeeding

Ameluz is not recommended during pregnancy, as there is not enough information available.

Breastfeeding should be interrupted for 12 hours after application of Ameluz.

Driving and using machines

Ameluz has no or negligible influence on the ability to drive and use machines.

Ameluz contains

• 2.4 mg of sodium benzoate (E211) per gram of gel. Sodium benzoate may cause local irritation.
• soy phosphatidylcholine: if you are allergic to peanuts or soy, do not use this medicine.

3. How to use Ameluz

Ameluz is only applied to the skin. The treatment consists of the application of Ameluz and exposure to light. One treatment session can be administered to treat single or multiple lesions, or entire treatment fields. The light source for the treatment of actinic keratosis lesions can be daylight (natural or artificial) or a special red light lamp. Your doctor will decide which therapeutic option to use, depending on your lesions.

The light source for photodynamic therapy should always be a red light lamp for the treatment of actinic keratosis on the trunk, neck, and limbs and for basal cell carcinoma.

Treatment of actinic keratosis and basal cell carcinoma lesions with a red light lamp

The use of Ameluz with a red light lamp requires specific equipment and knowledge of photodynamic therapy. Therefore, this treatment is performed in the doctor's office.

Preparation of the lesions

The application area is cleaned with a cotton swab soaked in alcohol to degrease the skin. Scales and crusts are carefully removed and the surface of all lesions is gently scraped. Bleeding of the lesions should be avoided.

Application of the gel

Ameluz is applied to form a film of about 1 mm thickness that covers all lesions or fields and approximately 5 mm of the surrounding area, with the fingertips protected with a glove or with a spatula.

A minimum distance of 1 cm should be maintained from the eyes and mucous membranes. In case of accidental contact, wash with water.

The gel should be allowed to dry for about 10 minutes before applying an opaque dressing to the treated area. Remove the dressing after 3 hours. Wash to remove any remaining gel.

Illumination with a red light lamp

After cleaning the remaining gel, the entire treated area is exposed to a red light source. The efficacy and adverse effects, such as temporary pain, depend on the light source used.

Both patients and healthcare professionals should follow the safety instructions that come with the lamp used during treatment. Suitable protective glasses should be worn during illumination. There is no need to protect untreated healthy skin.

Treatment of actinic keratosis lesions on the face and scalp with natural daylight

Considerations before treatment

Use natural daylight treatment only if the weather is suitable for staying outside comfortably for 2 hours (with temperatures > 10 °C). If the weather is rainy, or is likely to be, you should not use natural daylight treatment.

Preparation of the lesions

Apply a sunscreen to the exposed skin 15 minutes before treating the lesions. Use only sunscreens with chemical filters and a sun protection factor of 30 or higher. Do not use sunscreens with physical filters such as titanium dioxide or zinc oxide, as these inhibit light absorption and may affect the efficacy of the treatment. Then, clean the application area with a cotton swab soaked in alcohol to degrease the skin. Scales and crusts are carefully removed and the surface of all lesions is gently scraped. Be careful to avoid bleeding.

Application of the gel

A thin layer of Ameluz is applied to the lesions or entire fields and approximately 5 mm of the surrounding area with the fingertips protected with a glove or with a spatula.

Avoid direct contact with the eyes and mucous membranes, maintaining a distance of at least 1 cm. In case of contact, wash the affected area with water.

No opaque dressing is required. Do not clean the gel during the entire natural daylight treatment session.

Illumination with natural daylight for the treatment of actinic keratosis

If the conditions are suitable (see previous Considerations before treatment), you should go outside within 30 minutes of applying the gel and stay in full daylight for 2 hours consecutively. It is acceptable to take shelter in the shade if it is hot. If you interrupt your time outside, you should make up for it by increasing the illumination time. Remove any remaining gel after 2 hours of light exposure.

Treatment of actinic keratosis lesions on the face and scalp with artificial daylight

The use of Ameluz with an artificial daylight lamp requires specific equipment and knowledge of photodynamic therapy. Therefore, this treatment is performed in the doctor's office.

Preparation of the lesions

The application area is cleaned with a cotton swab soaked in alcohol to degrease the skin. Scales and crusts are carefully removed and the surface of all lesions is gently scraped. Bleeding of the lesions should be avoided.

Application of the gel

A thin layer of Ameluz is applied to cover all lesions or fields and approximately 5 mm of the surrounding area with the fingertips protected with a glove or with a spatula. A minimum distance of 1 cm should be maintained from the eyes and mucous membranes. In case of contact, wash with water.

Incubation and illumination with an artificial daylight lamp

After application, the total treatment time (including incubation and illumination) should be 2 hours and not exceed 2.5 hours. However, illumination should start between 0.5 and 1 hour after gel application. There is no need to apply an occlusive dressing during incubation; it can be used optionally, but should be removed at the latest before illumination. Both patients and healthcare professionals should follow the safety instructions that come with the light source used during treatment. There is no need to protect untreated healthy skin. After light exposure, remove any remaining gel.

Number of treatments

• Actinic keratosis lesions and fields are treated with one session.
• Basal cell carcinoma is treated with two sessions, with a one-week interval between sessions.

The treated lesions are evaluated 3 months after treatment. Your doctor will determine how each skin lesion has responded to treatment and may need to repeat the treatment at that time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Approximately 9 out of 10 patients experience side effects at the application site, indicating that the affected cells are responding to treatment.

Side effects are usually mild or moderate and appear during light exposure or up to 4 days afterwards. However, in some cases they may persist for 1 or 2 weeks or even longer. In rare cases, due to adverse reactions such as pain, it may be necessary to interrupt or stop illumination. After longer periods of time, treatment with Ameluz often results in continued improvement of skin-related parameters.

The following side effects have been reported with the use of Ameluz with a red light lamp. The study of Ameluz with natural or artificial daylight showed similar types of side effects, although, especially for pain, of lesser intensity. Some reactions at the application site have been observed before using the light.

Very common: may affect more than 1 in 10 people

• reactions at the application site

• redness of the skin
• pain (including burning sensation)

-irritation

• itching
• inflammation of tissues caused by excess fluid
• crusts
• skin peeling
• hardening
• abnormal sensations, such as pinching, tingling or numbness

Common: may affect up to 1 in 10 people

• reactions at the application site

• blisters
• discharge
• abrasion
• other reaction
• discomfort
• increased sensitivity to pain
• bleeding
• heat
• headache

Uncommon: may affect up to 1 in 100 people

• reactions at the application site

• change in skin color
• pustules
• ulcer
• swelling
• inflammation
• eczema with pustules
• allergic reaction
• blisters
• dry skin
• inflammation of the eyelids caused by excess fluid, blurred vision, visual impairment
• unpleasant and abnormal sense of touch
• chills
• sense of heat, fever, hot flashes
• temporary memory loss
• pain
• nervousness
• wound suppuration
• fatigue
• rash, red or purple spots on the body
• ulcer
• swelling
• skin tightness

1Data from the post-marketing period

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 to the Spanish Medicines Agency at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ameluz

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 packaging after «EXP». The expiry date refers to the last day of the month shown.

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

Keep the tube tightly closed after first opening. Discard opened tubes 4 months after opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Container contents and additional information

Ameluz composition

• The active ingredient is 5-aminolevulinic acid.

Each gram of Ameluz contains 78 mg of 5-aminolevulinic acid (as hydrochloride).

• The other components are:

disodium phosphate dihydrate, isopropyl alcohol, polysorbate 80, purified water, sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, soy phosphatidylcholine, medium-chain triglycerides, xanthan gum. See section 2.

Product appearance and container contents

Ameluz is a white or yellowish gel.

Each box contains an aluminum tube with 2 g of gel closed with a polyethylene screw cap.

Marketing authorization holder

Biofrontera Bioscience GmbH

Hemmelrather Weg 201

51377 Leverkusen, Germany

Tel.: +49 214 87632 66, Fax: +49 214 87632 90

Email: [email protected]

Manufacturer

Biofrontera Pharma GmbH

Hemmelrather Weg 201

51377 Leverkusen, Germany

Tel.: +49 214 87632 66, Fax: +49 214 87632 90

Email: [email protected]

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Belgium/Belgique/Belgien Czech Republic

Biofrontera Pharma GmbH Biofrontera Pharma GmbH

Germany/Germany/Germany Czech Republic

Tel: +49 214 87632 66 Tel: +49 214 87632 66

[email protected] [email protected]

Denmark

Biofrontera Pharma GmbH Galenica AB

Sweden

Tel: +49 214 87632 66 Tel: +46 40 32 10 95

[email protected] [email protected]

Germany Estonia

Biofrontera Pharma GmbH Biofrontera Pharma GmbH

Tel: +49 214 87632 66 Tel: +49 214 87632 66

[email protected] [email protected]

Greece Croatia

Biofrontera Pharma GmbH Biofrontera Pharma GmbH

Germany

Tel: +49 214 87632 66 Tel: +49 214 87632 66

[email protected] [email protected]

Spain Ireland

Biofrontera Pharma GmbH, Spanish branch Biofrontera Pharma GmbH

Tel: 900 974943 Germany

[email protected] Tel: +49 214 87632 66

[email protected]

France Iceland

Biofrontera Pharma GmbH Galenica AB

Germany Iceland

Tel: 0800 904642 Tel: +46 40 32 10 95

[email protected] [email protected]

ItalyCyprus

Biofrontera Pharma GmbH Biofrontera Pharma GmbH

Germany Germany

Tel: +49 214 87632 66 Tel: +49 214 87632 66

[email protected] [email protected]

Latvia Lithuania

Biofrontera Pharma GmbH Biofrontera Pharma GmbH

Germany Germany

Tel: +49 214 87632 66 Tel: +49 214 87632 66

[email protected] [email protected]

Luxembourg/Luxemburg Hungary

Biofrontera Pharma GmbH Biofrontera Pharma GmbH

Germany/Germany Hungary

Tel: +49 214 87632 66 Tel: +49 214 87632 66

[email protected] [email protected]

Malta Norway

Biofrontera Pharma GmbH Galenica AB

Germany Sweden

Tel: +49 214 87632 66 Tel: +46 40 32 10 95

[email protected] [email protected]

Netherlands Austria

Biofrontera Pharma GmbH Pelpharma Handels GmbH

Germany Tel: +43 2273 70 080

Tel: +49 214 87632 66 [email protected]

[email protected]

Poland Romania

medac GmbH Sp. z o.o. Biofrontera Pharma GmbH

Polish branch Germany

Tel.: +48 (0)22 430 00 30 Tel: +49 214 87632 66

[email protected] [email protected]

Portugal Slovenia

Biofrontera Pharma GmbH Biofrontera Pharma GmbH

Germany Germany

Tel: +49 214 87632 66 Tel: +49 214 87632 66

[email protected] [email protected]

Slovak Republic Finland

Biofrontera Pharma GmbH Galenica AB

Germany Sweden

Tel: +49 214 87632 66 Tel: +46 40 32 10 95

[email protected] [email protected]

Sweden United Kingdom (Northern Ireland)

Galenica AB Biofrontera Pharma GmbH

Tel: +46 40 32 10 95 Germany

[email protected] Tel: +49 214 87632 66

[email protected]

Date of last revision of this leaflet: 07/2024

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.