Alacare 8mg Medicated Plaster
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Alacare 8 mg medicated plaster
5-aminolevulinic acid
Read all of this leaflet carefully before you start using this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Alacare is and what it is used for
2. Before you use Alacare
3. How to use Alacare
4. Possible side effects
5. How to store Alacare
6. Further information
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. 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 (hypersensitive) to 5-aminolevulinic acid, acrylic pressure sensitive adhesive or any of the other ingredients of Alacare.
- suffer from a certain disease of blood metabolism known as porphyria.
- were undergoing similar therapy with 5-aminolevulinic acid-containing preparations and it was unsuccessful.
Please ask your doctor if you are not sure.
Take special care with 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.
- might be pregnant since treatment with Alacare is not recommended then.
- are receiving UV-therapy, it should be stopped before treatment with Alacare.
Please ask your doctor if you are not sure.
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.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any medicines, even those which were obtained without prescription.
It is important to inform your doctor if you are taking or have taken products containing St John's Wort (Hypericum perforatum) or used products containing Hypericum on your skin in the last two weeks. This could increase the phototoxic reaction when it is given together with Alacare.
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.
Lesions should be checked by your doctor after three months.
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 want to 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, Alacare 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
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
5. HOW TO STORE ALACARE
Keep out of the reach and sight of children.
Do not use Alacare 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. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER 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 polyethyleneterephthalate 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: Spirig Pharma Europe GmbH
TeichstraBe 66 D-79539 Lorrach Germany
Manufacturer: LTS Lohmann Therapie-Systeme AG
LohmannstraBe 2 D-56626 Andernach Germany
medac Gesellschaft fuer klinische Spezialpraeparate mbH Fehlandtstrasse 3 D-20354 Hamburg Germany
Production site:
Theaterstrasse 6 D-22880 Wedel Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Austria Denmark Finland France Germany Ireland Italy Norway Poland Portugal Spain Sweden UK |
Alacare Alacare Alacare Effala Alacare Alacare Alacare Alacare Alacare Alacare Effala Alacare Alacare |
This leaflet was last approved in
02/2012