Package leaflet: Information for the user

Alacare 8 mg medicated patch

5-aminolevulinic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Alacare is and what it is used for
What you need to know before using Alacare
How to use Alacare
Possible side effects
How to store Alacare
Contents of the pack and other information

1. What Alacare is and what it is used for

Alacare is used for the treatment of mild skin lesions of the scalp or face called
actinic keratosis. These are small, rough patches that develop on the skin. They are the result
of long-term sun exposure over many years. They are also known as actinic keratoses.
Treatment with Alacare is a two-step procedure called "photodynamic therapy". It involves
applying Alacare patches to the affected areas for 4 hours, followed by illumination with red light
for a few minutes. The red light illumination triggers a chemical reaction in the abnormal skin cells,
which are eventually destroyed. This reaction is called a "phototoxic reaction".

2. What you need to know before using Alacare

Alacare must be applied by a doctor, nurse, or other healthcare professional in a single treatment session.
Do not use Alacare

if you are allergic to 5-aminolevulinic acid or to any of the other components of this medicinal product (listed in section 6);
if you suffer from a specific blood metabolism disorder called porphyria;
if you have previously undergone a similar treatment with 5-aminolevulinic acid-based preparations without success;
if you suffer from other skin diseases caused or worsened by exposure to light.

The success and evaluation of treatment may be compromised if the treated skin area is also affected by:

inflammation, infection, psoriasis, eczema, or cancer;
or if it is covered by tattoos.

Warnings and precautions

Consult your doctor or pharmacist before using Alacare: if you have dark or black skin, or if the lesions are very thick, as there is no experience with Alacare treatment in these cases;
if there is any possibility that you may be pregnant, because Alacare treatment is not recommended in such cases;
if you are undergoing UV light therapy, this must be discontinued before Alacare treatment.

Your doctor or nurse will ensure that the Alacare patch does not come into contact with your eyes.
As a general precaution, you must avoid exposing the treated and surrounding skin to sunlight for approximately 48 hours after treatment.
Other medicines and Alacare
Inform your doctor if you are taking medicines that increase allergic reactions or other harmful reactions after exposure to light, such as for example:

St. John’s wort or its preparations: medicines used to treat depression.
griseofulvin: a medicine used to treat fungal infections;
medicines that increase water excretion through the kidneys and contain active substances with names mostly ending in “thiazide” or “tizide”;
certain medicines used to treat diabetes, such as glibenclamide and glimepiride;
medicines used to treat mental disorders, nausea, or vomiting, containing active substances with names mostly ending in “azine”;
medicines used to treat bacterial infections containing active substances with names beginning with “sulfa” or ending in “oxacin” or “cycline”. Inform your doctor if you are taking, have recently taken, or might take any other medicine.

Pregnancy and breastfeeding
Based on the available data, it cannot be completely ruled out that harmful effects and risks to pregnancy and the fetus may occur.
Alacare should not be used during pregnancy unless clearly necessary.
Breastfeeding must be interrupted for 48 hours after application of Alacare.
Always ask your doctor for advice before taking any medicine.
Driving and using machines
No effects of Alacare on the ability to drive and use machines are known.

3. How to use Alacare

It is important that on the day of treatment you do not apply any cream to the scalp or face before going to the doctor for therapy.
Adults (including elderly patients)
You will be treated with Alacare patches applied to the actinic keratosis lesions (altered skin) for 4 hours in a single treatment session. Afterwards, these areas will be exposed to red light for a few minutes (photodynamic therapy). For protection of the eyes from intense light, protective glasses will be provided for you to wear during light exposure.
After treatment with the patch and illumination, you must protect your skin from sunlight for 48 hours.
The lesions should be checked by your doctor after three months.
Use in children and adolescents
The use of Alacare is not recommended, as there is no experience with treatment in children and adolescents under 18 years of age.
If you interrupt treatment with Alacare
The effectiveness of treatment may be reduced

by removing the patches prematurely, or
by stopping the light therapy too early.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects affecting the treatment site (local side effects)
Almost all patients (99%) experience side effects localized at the treatment site (local side effects), which may occur during application of the Alacare patch, during illumination of the treatment site, and/or afterwards. Usually, symptoms are mild to moderate in intensity. They rarely require premature termination of illumination. To relieve symptoms during illumination, the treated area may be cooled using a fan or similar device.
After treatment, local side effects may persist for 1 or 2 weeks, sometimes longer.

Very common (in more than 1 patient out of 10):

exfoliation
irritation
pruritus (itching)
pain
redness
crusting

Common (in more than 1 patient out of 100, but less than 1 patient out of 10):

areas of skin lightening or darkening
bleeding
blisters
discomfort
erosion
edema (fluid accumulation in the tissue)
desquamation
pustules (pimples)
skin reaction
secretion
swelling

Uncommon (in more than 1 patient out of 1,000, but less than 1 patient out of 100):

burning
spots
infection
inflammation
ulcer
superficial skin imperfections

Side effects not affecting the treatment site:
Common

Headache

Uncommon

anxiety
elevated levels of the enzyme alanine aminotransferase
nosebleed
skin rash with pustules (similar to pimples)
skin spots

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco):
Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alacare

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 box and on the sachet after "Exp.". The expiry date refers to the last day of that month.
Use within 3 months of first opening.
After opening, store in the original sachet to protect the medicine from light.
After removal, fold the used patch in half with the adhesive surface facing inwards, so that it is no longer exposed, and dispose of it safely.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Alacare contains

The active substance is 5-aminolevulinic acid hydrochloride. Each medicated patch has a surface area of 4 cm² and contains 8 mg of 5-aminolevulinic acid (as hydrochloride), equivalent to 2 mg per cm².
The other components are a pressure-sensitive acrylic adhesive, a backing layer made of pigmented polyethylene and vapour-deposited aluminium-coated polyester, and a removable liner made of polyethylene terephthalate (to be removed before application).

Description of the appearance of Alacare and contents of the pack
Each medicated patch, sized 4 cm², is square with rounded corners and consists of a thin skin-coloured backing layer and an adhesive matrix covered by a removable liner, which must be removed prior to use.
Four patches are enclosed in a protective pouch.
Alacare is available in packs of 4 or 8 patches (1 or 2 protective pouches) in a cardboard box.

Marketing Authorisation Holder and Manufacturer
photonamic GmbH & Co. KG
Eggerstedter Weg 12
25421 Pinneberg
Germany

Selling Agent:
Altais Pharma s.r.l.
Viale Parioli 160
00197 Rome
Italy

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany, Austria, Ireland, Portugal, Denmark, Norway, Sweden, Finland, Poland, United Kingdom (Northern Ireland), Italy: Alacare
France: Effala