Skip to Content

ALACARE 8MG MEDICATED PLASTER

Active substance(s): 5-AMINOLEVULINIC ACID HYDROCHLORIDE / 5-AMINOLEVULINIC ACID HYDROCHLORIDE / 5-AMINOLEVULINIC ACID HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
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
Teichstraße 66
D-79539 Lörrach
Germany
Manufacturer:

LTS Lohmann Therapie-Systeme AG
Lohmannstraße 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
Alacare
Denmark
Alacare
Finland
Alacare
France
Effala
Germany
Alacare
Ireland
Alacare
Italy
Alacare
Norway
Alacare
Poland
Alacare
Portugal
Alacare
Spain
Effala
Sweden
Alacare
UK
Alacare
This leaflet was last approved in

02/2012
-------------------------------------------------------------------------------------------------------------------

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide