Skip to Content

ALACARE 8MG MEDICATED PLASTER

Active substance(s): 5-AMINOLEVULINIC ACID HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Alacare 8 mg medicated plaster
5-aminolevulinic a cid
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
-

Keep this leaflet. You may need to read it again.

-

If you ha ve any further questions, ask your doctor.

-

This medicine ha s be en pr escribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.

-

If you get an y s ide ef fects, talk to your doc tor. T his i ncludes a ny pos sible s ide e ffects not
listed in this leaflet. See section 4.

What is in this leaflet
1.

What Alacare is and what it is used for

2.

What you ne ed 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 Alacare is and 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 a re s mall, r ough, s pots w hich de velop on t he s kin. T hey a re c aused by a lot of e xposure to the
sun over many years. They are also called actinic keratosis.
Treatment w ith A lacare is a t wo-step procedure a nd is c alled ‚ photodynamic t herapy’. I t c onsists of
Alacare plaster application t o the spots f or 4 hour s. T his is f ollowed by i llumination w ith r ed light f or
a c ouple of minutes. I llumination w ith r ed light induces a c hemical r eaction in t he 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 s hould be a pplied by a phys ician, a nur se or ot her health care professionals in one single
session.

Do not use Alacare:
-

if you are al lergic t o 5 -aminolevulinic a cid or a ny of the other i ngredients of t his m edicine
(listed in s ection 6) .

-

if you suffer from a certain disease of blood metabolism known as porphyria.

-

if you were unde rgoing s imilar t herapy w ith 5 -aminolevulinic a cid-containing pr eparations
and it was unsuccessful.

-

if you ha ve other skin conditions caused by or made worse by e xposure to light.

The s uccess and as sessment of t reatment may be impaired if t he t reated area of the skin is further
affected by:
- inflammation, infection, ps oriasis, eczema or cancer
- tattoos
Warnings and precautionsTalk to your doctor before using Alacare:
-

if you have da rk br own or bl ack s kin or i f you ha ve ve ry t hick l esions s ince t here i s 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 doc tor or nur se w ill make s ure t hat t he A lacare plaster does not get into contact with your eyes.
As a g eneral precaution, t reated and surrounding s kin s hould not be e xposed t o s unlight f or a bout 48
hours following treatment.
Other medicines and Alacare
Inform your doc tor i f you us e m edicines t hat i ncrease a llergic or ot her ha rmful r eactions a fter l ight
exposure, such as:
St. John’s wort or its preparations: medicines to treat depression.
-

griseofulvin: a medicine to treat fungal infections.

-

medicines to increase w ater out put t hrough your kidneys w ith a ctive s ubstance na mes mostly
ending i n “thiazide” or “tizide”.

-

certain medicines to treat diabetes, such as glibenclamide, glimepiride.

-

medicines t o t reat m ental di sorders, na usea or vom iting w ith a ctive s ubstance na mes mostly
ending in “azine”.

-

medicines to t reat bacterial infection w ith act ive s ubstance names beginning w ith “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 ha rmful e ffects a nd r isks f or a pr egnancy a nd f or the unborn child cannot be completely
excluded at this time.

Alacare should not be used during pr egnancy unl ess c learly ne cessary. B reast-feeding s hould 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 know n 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 pl asters w ill be a pplied t o your a ctinic ke ratoses ( 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 t reatment w ith pl aster a nd i llumination you s hould pr otect t he s kin f rom s unlight f or 48 hours.
Lesions should be checked by your doctor after three months.
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 a ll m edicines, this m edicine can cause side effects, although not everybody gets them.
Side effects involving the treatment site (local side effects)
Almost a ll pa tients ( 99%) e xperience s ide ef fects localised t o t he t reatment site (local side effects).
These can occur during application of the Alacare pl aster, dur ing i llumination of t he t reatment s ite
and/or t hereafter. S ymptoms a re us ually of m ild or moderate intensity. They rarely require ear ly

termination of i llumination. F or r elief, t he t reated a rea c an be c ooled by a fan or similar during
illumination. After therapy, local side effects persist for 1 to 2 w eeks or occasionally longer.
Very common (more than 1 out of 10 pa tients):


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 r eaction



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 l ike) r ash



staining of the skin

Reporting of side effects
If you ge t a ny s ide e ffects, t alk t o your doc tor. T his includes any possible side effects not listed in this
leaflet. Y ou c an a lso r eport s ide effects directly (see details below). By reporting side effects, you c an
help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
FREEPOST: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
5.

How to store Alacare

Keep this medicine out of the sight and reach of children.
Do not us e this m edicine 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 ope ning s tore plaster in t he s achet in or der t o pr otect f rom light. After removal, the used plaster
should be f olded in ha lf, a dhesive s ide inwards s o t hat t he a dhesive is not exposed, and then discarded
safely. Do not t hrow a way 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 a cid hydr ochloride. E ach medicated plaster of 4 c m2
contains 8 mg 5-aminolevulinic acid (as hydrochloride), 2 mg per cm2 .

-

The other ingredients a re a crylic pr essure s ensitive a dhesive, ba cking f ilm, c onsisting
of pi gmented pol yethylene a nd a luminium va pour c oated 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 f oil a nd a s elf-adhesive m atrix, covered by a r elease l iner w hich i s r emoved 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 A uthorisation Holder:

UK

Galdema (UK) Ltd
Meridien H ouse
69-71 C larendon R oad
Watford
Herts
WD17 1DS

Manufacturer:
medac Gesellschaft
für klinische Spezialpraeparate mbH
Theaterstrasse 6
D-22880 W edel
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

SwedenAlacare
UK

Alacare

This leaflet was last approved in September 2015

Expand view ⇕

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