Patient leaflet - Alacare 8 mg medicated plaster
1. WHAT ALACARE IS AND WHAT IT
IS USED FOR
Alacare is used for the treatment of mild skin abnormalities on the head or face
called solar keratosis. These are small,
rough, spots which develop on the skin. They are caused by a lot of exposure to the sun over many years. They are also called actinic keratosis.
Treatment with Alacare is a two-step
procedure and is called ‚photodynamic
therapy’. It consists of Alacare plaster
application to the spots for 4 hours. This is followed by illumination with red light
for a couple of minutes. Illumination with red light induces a chemical reaction in
the cells of the changed skin, which leads to their destruction. The reaction is called ‚phototoxic reaction’.
- 2. WHAT YOU NEED TO KNOW
BEFORE YOU USE ALACARE
Alacare should be applied by a physician, a nurse or other health care professionals in one single 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 certain disease of
blood metabolism known as porphyria. • if you were undergoing similar therapy
with 5-aminolevulinic acid-containing
preparations and it was unsuccessful. • if you have other skin conditions
caused by or made worse by exposure to light.
The success and assessment of
treatment may be impaired if the treated area of the skin is further affected by:
inflammation, infection, psoriasis,
eczema or cancer
- tattoos
Warnings and precautions
Talk to your doctor before using Alacare: • if you have dark brown or black skin or
if you have very thick lesions since
there is no experience with Alacare
treatments in those cases.
if you might be pregnant since
treatment with Alacare is not
recommended then.
if you are receiving UV-therapy, it
should be stopped before treatment
with Alacare.
Your doctor or nurse will make sure
that the Alacare plaster does not get
into contact with your eyes. As a general precaution, treated and surrounding skin should not be exposed to sunlight for
about 48 hours following treatment.
Other medicines and Alacare
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”.
- 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”. • medicines to treat bacterial infection with active substance names beginning with “sulfa” or ending in “oxacin” or “cycline”.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
Possible harmful effects and risks for a pregnancy and for the unborn child cannot be completely excluded at this time. Alacare should not be used during pregnancy unless clearly necessary. Breast-feeding should be stopped for 48 hours after application of Alacare. Always ask your doctor for advice before taking any medicines.
Driving and using machines
Alacare has no known effect on the ability to drive and use machines.
3. HOW TO USE ALACARE
It is important that you do not apply any cream to your scalp or face on the day of treatment before arriving for therapy at your doctor.
Adults (including the elderly)
Alacare plasters will be applied to your actinic keratoses (changed skin) for 4 hours in one single session. Afterwards 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 given goggles to wear during light exposure.
After treatment with plaster and illumination you should protect the skin from sunlight for 48 hours.
Use in children and adolescents
Use of Alacare is not recommended, as there is no experience in treatment of children and adolescents below 18 years of age.
If you stop using Alacare
The effectiveness of the treatment might be reduced, if
- plaster application is stopped prematurely or
- light therapy is stopped too early.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects involving the treatment site (local side effects)
Almost all patients (99%) experience side effects localised to the treatment site (local side effects). These can occur during application of the Alacare plaster, during illumination of the treatment site and/or thereafter. Symptoms are usually of mild or moderate intensity. They rarely require early termination of illumination. For relief, the treated area can be cooled by a fan or similar during illumination. After therapy, local side effects persist for 1 to 2 weeks or occasionally longer.
Very common (more than 1 out of 10 patients):
- flaking
- irritation
- itching
- pain
- redness
- scab
Common (more than 1 out of 100 patients, but less than 1 out of 10 patients):
- areas of paleness or darkening of the skin
- bleeding
- blister
- discomfort
- erosion
- oedema (fluid accumulated in the tissue)
- peeling
- pustules (pimples)
- skin reaction
- secretion
- swelling
Uncommon (more than 1 out of 1000 patients, but less than 1 out of 100 patients):
- burn
- staining
- infection
- inflammation
- ulcer
- superficial skin defects
Side effects not involving the treatment site:
Common:
- headache
Uncommon:
- anxiety
- increased levels of the enzyme alanine aminotransferase
- nosebleed
- pustule (pimple like) rash
- staining of the skin
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 carton and sachet after ‘EXP’. The expiry date refers to the last day of that month.
Use within 3 months after first opening. After opening store plaster in the sachet in order to protect from light. After removal, the used plaster should be folded in half, adhesive side inwards so that the adhesive is not exposed, and then discarded safely. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 plaster of 4 cm2 contains 8 mg 5-aminolevulinic acid (as hydrochloride), 2 mg per cm2.
- The other ingredients are acrylic pressure sensitive adhesive, backing film, consisting of pigmented polyethylene and aluminium vapour coated polyester, release liner consisting of polyethylene terephthalate film (to be removed before application).
What Alacare looks like and contents of the pack
Each medicated plaster has a size of 4 cm2, is square with rounded corners and consists of a skin tone backing foil and a self-adhesive matrix, covered by a release liner which is removed prior to use. 4 plasters are sealed in a protective sachet. Alacare is available in pack sizes of 4 or 8 plasters (1 or 2 protective sachet(s)) in a cardboard box.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Marketing Authorisation Holder and Manufacturer:
photonamic GmbH & Co. KG
Eggerstedter Weg 12
25421 Pinneberg
Germany
This leaflet was last revised in January 2025.
XXXXXXX AC 81770VBGBPHNEXT This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Alacare: Austria, Denmark, Finland, Germany, Ireland, Italy, Norway, Poland, Portugal, Sweden, United Kingdom (Northern Ireland)
Effala: France
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: 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.