ALACARE 8 mg Transdermal Patch

Зміст інструкції

1. Alacare 8 mg medicated patch
   1. What is Alacare and what is it used for
   2. What you need to know before using Alacare
   3. How to use Alacare
   4. Possible side effects
   5. How to store Alacare
   6. Contents of the pack and other information

Alacare 8 mg medicated patch

5-aminolevulinic acid

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Alacare is and what it is used for
• 2. What you need to know before you use Alacare
• 3. How to use Alacare
• 4. Possible side effects
• 5. How to store Alacare
• 6. Contents of the pack and other information

1. What is Alacare and what is it used for

Alacare is used for the treatment of mild skin changes on the scalp or face called
solar keratoses. These are small rough patches that develop on the skin. They are the consequence
of prolonged sun exposure over many years. They are also called actinic keratoses.
Treatment with Alacare is a two-step procedure called "photodynamic therapy". It consists
of applying Alacare patches to the spots for 4 hours, followed by illumination with red light
for a couple of minutes. Illumination with red light induces a chemical reaction in the
altered 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 any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a particular blood metabolism disorder called porphyria;
• if you have undergone unsuccessful similar therapy with preparations based on 5-

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aminolevulinic acid;

• if you suffer from other skin diseases caused or worsened by exposure to light.

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

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

Warnings and precautions

• Talk to your doctor or pharmacist before using Alacare: if you have dark or black skin or if the lesions are very thick, because there is no experience with the treatment with Alacare in these cases;
• if there is a possibility that you are pregnant, because in this case treatment with Alacare is not recommended;
• if you are undergoing UV radiation therapy, it must be stopped before treatment with Alacare.

The doctor or nurse will verify that the Alacare patch does not come into contact with the eyes.
As a general precaution, do not expose the treated skin and the surrounding area to sunlight
for about 48 hours after treatment.

Other medicines and Alacare
Tell your doctor if you are using 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 for the treatment of depression.
• griseofulvin: a medicine for the treatment of fungal infections;
• medicines that increase water excretion through the kidneys and that contain active substances with names that mostly end with “thiazide” or “tizide”;
• some medicines for the treatment of diabetes, such as glibenclamide and glimepiride;
• medicines for the treatment of mental disorders, nausea or vomiting, containing active substances with names that mostly end with “azine”:
• medicines for the treatment of bacterial infections containing active substances with names that begin with “sulfa” or end with “oxacin” or “cycline”. Tell your doctor if you are taking, have recently taken or may take any other medicine.

Pregnancy and breastfeeding
Based on available data, the possibility of harmful effects and risks to pregnancy and the fetus cannot be completely excluded.
Alacare should not be used during pregnancy unless absolutely necessary.
Breastfeeding must be stopped for 48 hours after applying Alacare.
Always ask your doctor for advice before taking any medicine.
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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 the elderly)
Alacare patches will be applied to the actinic keratosis lesions (altered skin) for 4 hours in
a single treatment session. Subsequently, these areas will be exposed to red light
for a few minutes (photodynamic therapy). To protect your eyes from the intense light, you
will be provided with protective glasses 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 the doctor after three months.

Use in children and adolescents
The use of Alacare is not recommended, because there is no experience in the treatment of children and
adolescents under the age of 18 years.

If you stop treatment with Alacare
The effectiveness of the treatment may be reduced

• by prematurely stopping the application of the patches or
• by stopping the light therapy too soon.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects affecting the treatment site (local side effects)
Almost all patients (99%) experience localised side effects at the treatment site
(local side effects), which can occur during the application of the Alacare patch, during
illumination of the treatment site and/or afterwards. Symptoms are usually mild
to moderate in intensity. They rarely require premature termination of illumination. To relieve symptoms
during illumination, you can cool the treated area with a fan or similar device.
After therapy, local side effects persist for 1 or 2 weeks, sometimes longer.
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Very common (in more than 1 in 10 patients):

• exfoliation
• irritation
• itching
• pain
• redness
• crusting

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

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

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

• burning sensation
• spots
• infection
• inflammation
• ulcer
• superficial skin imperfections

Side effects not affecting the treatment site:
Common

• Headache

Uncommon

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

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Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor. You can also report side effects directly through the national
reporting system at www.agenziafarmaco.gov.it/it/responsabili 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the sachet
after "Exp.". The expiry date refers to the last day of the month.
Use within 3 months of first opening.
After opening, store the patches in the original sachet to protect them from light.
After removal, fold the used patch in half, with the adhesive surface inwards so that
it is not exposed, and dispose of it safely.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Alacare contains

• The active substance is 5-aminolevulinic acid hydrochloride. Each medicated patch has a surface area of 4 cm and contains 8 mg of 5-aminolevulinic acid (as hydrochloride), 2 mg per cm .
• The other components are a pressure-sensitive acrylic adhesive, coating film consisting of pigmented polyethylene and aluminum-vaporized coated polyester, the peelable film in polyethylene terephthalate (to be removed before application).

Description of the appearance of Alacare and contents of the pack
Each medicated patch, measuring 4 cm, is square in shape with rounded corners and consists of a thin flesh-colored coating and a self-adhesive matrix covered with a peelable film, to be removed before use.
4 patches are enclosed in a protective sachet.
Alacare is available in packs of 4 or 8 patches (1 or 2 protective sachets) in a cardboard box.

Marketing authorisation holder and manufacturer
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Marketing authorisation holder:
PHOTONAMIC GMBH & CO. KG
Theaterstrasse 6
22880 Wedel
Germany
Manufacturer:
Medac Gesellschaft
für klinische Spezialpraeparate mbH
Theaterstrasse 6
D-22880 Wedel
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany, Austria, Great Britain, Ireland, Portugal, Denmark, Norway, Sweden, Finland,
Poland, Italy: Alacare
Spain, France: Effala
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