Ameluz 78 mg/g gel

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• 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. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to
  • 5-aminolaevulinic acid or any of the other ingredients of this medicine (listed in section 6)
  • photoactive substances known as porphyrins
  • soya or peanuts
• if you have impaired formation of red blood pigment called porphyria
• if you have other skin conditions caused by, or made worse by, exposure to light

Talk to your doctor before using Ameluz.

• In very rare cases photodynamic therapy may increase the risk of developing temporary memory loss.
• The use of Ameluz is not recommended if you use immunosuppressants.
• Avoid applying Ameluz
  • to bleeding lesions
  • into eyes or to mucous membranes
  • on skin areas affected by other diseases or tattoos, because this may hinder the success and assessment of the treatment.
• Intensive lesion preparation (e.g. chemical peel followed by ablative laser) might lead to increased pain during PDT.
• Discontinue any UV-therapy before treatment.
• Avoid sun exposure on the treated lesion sites and surrounding skin for approximately 48 hours following treatment.

Actinic keratoses and basal cell carcinomas do not occur in children and adolescents, except in extremely rare cases.

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

Inform your doctor if you use medicines that increase allergic or other harmful reactions after light exposure, such as

• St. John’s wort or its preparations: medicines to treat depression
• griseofulvin: a medicine to treat fungal infections
• medicines to increase water output through your kidneys with active substance names mostly ending in “thiazide” or “tizide”, such as hydrochlorothiazide
• certain medicines to treat diabetes, such as glibenclamide, glimepiride
• medicines to treat mental disorders, nausea or vomiting with active substance names mostly ending in “azine”, such as phenothiazine
• medicines to treat bacterial infection with active substance names beginning with “sulfa” or ending in “oxacin” or “cycline”, such as tetracycline

Ameluz is not recommended during pregnancy, due to insufficient knowledge.

Breast-feeding should be interrupted for 12 hours after application of Ameluz.

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

• 2.4 mg sodium benzoate (E211) in each gram of gel. Sodium benzoate may cause local irritation.
• soybean phosphatidylcholine: If you are allergic to peanut or soya, do not use this medicine.

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

Preparation of the lesions

The application area is wiped with an alcohol-soaked cotton pad to degrease the skin. Scales and crusts are carefully removed, and all lesion surfaces are gently roughened. Care is taken to avoid bleeding.

Application of the gel

Ameluz is applied to form a film of about 1 mm thickness to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula. A distance of at least 1 cm to eyes and mucous membranes is to be maintained. Rinse with water if such contact occurs. The gel is allowed to dry for approximately 10 minutes before placing a light-tight dressing over the treatment site. The dressing is removed after 3 hours. The remaining gel is wiped off.

Illumination using a red-light lamp

After cleaning, the entire treated area is illuminated using a red-light source. Efficacy and side effects such as temporary pain are dependent on the light source used. Both patients and healthcare professionals should adhere to any safety instructions provided with the light source used during therapy. All should wear suitable protective goggles during illumination. There is no need to protect healthy untreated skin.

Considerations before treatment

Only use natural daylight treatment if the weather is suitable to stay comfortably outdoors for two hours (with temperatures > 10 °C). If the weather is rainy, or is likely to become so, you should not use natural daylight treatment.

Preparation of the lesions

Apply sunscreen to sun exposed skin for sun protection 15 min before lesion treatment. Only use sunscreen with chemical filters and sun protection factor 30 or higher. Do not use sunscreen with physical filters such as titanium dioxide, zinc oxide, as these inhibit light absorption and may therefore impact efficacy.

Then wipe the application area with an alcohol-soaked cotton pad to degrease the skin. Carefully removed scales and crusts and gently roughen all lesion surfaces. Take care to avoid bleeding.

Application of the gel

Apply Ameluz to form a thin layer to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula.

Avoid any contact with the eyes and mucous membranes, keeping a distance of at least 1 cm. Rinse with water if such contact occurs.

A light-tight dressing is not necessary. Do not wipe off the gel during the entire natural daylight treatment session.

Illumination using natural daylight for actinic keratosis treatment

If weather conditions are suitable (please see above; Considerations before treatment), you should go outside within 30 minutes after application of the gel and stay for 2 continuous hours in full daylight. Taking shelter in the shade in hot weather is acceptable. If the time outdoors is interrupted, you should compensate this with a longer illumination time. After the two hour light exposure, wash off the remaining gel.

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

Preparation of the lesions

The application area is wiped with an alcohol-soaked cotton pad to degrease the skin. Scales and crusts are carefully removed, and all lesion surfaces are gently roughened. Care is taken to avoid bleeding.

Application of the gel

A thin layer of Ameluz is applied to the entire lesions or fields and approximately 5 mm of the surrounding area using glove-protected fingertips or a spatula. A distance of at least 1 cm to eyes and mucous membranes is to be maintained. Rinse with water if such contact occurs.

Incubation and illumination using an artificial daylight lamp

After application, total treatment (covering incubation and illumination) should be 2 hours and should not exceed 2.5 hours. However, illumination should start within 0.5 to 1 hour after gel application.

During incubation, no occlusive dressing is necessary. It can be used optionally but should be removed before illumination at the latest. Both patients and healthcare professionals should adhere to any safety instructions provided with the light source used during therapy. There is no need to protect healthy untreated skin. After light exposure, the remaining gel is wiped off.

• Lesions and fields of actinic keratoses are treated with one session.
• Basal cell carcinoma is treated with two sessions, with an interval of one week between sessions.

The treated lesions should be evaluated 3 months after treatment. Your doctor will decide how well each skin lesion has responded, and treatment may have to be repeated at this time.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is 5-aminolaevulinic acid.
  1 g Ameluz contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
• The other ingredients are:
  disodium phosphate dihydrate, isopropyl alcohol, polysorbate 80, purified water, sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, soybean phosphatidylcholine, triglycerides medium-chain, xanthan gum. See section 2.

Ameluz is a white to yellowish gel.

Each carton contains one aluminium tube with 2 g gel closed with a polyethylene screw cap.