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Alacare 8mg Medicated Plaster

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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

called solar keratosis. lot of expos ure to the

Alacare is used for the treat ment of mild skin abnormalities on the head or f ace These are small, rough, spots which develop on the skin. They are caused by a sun over many years. They are also called actinic keratosis.

Treatment with Alacare is a two-step procedure and is called ,photodynam ic therapy’. It consists of Alacare plaster application to the spots for 4 hours. This is followed by illum ination 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 phy sician, a nurse or other health care professionals in one singl e session.

Do not use Alacare if you

- are allergic ( hypersensitive) to 5-am inolevulinic acid, acry lic pressure sensitiv e adhesive or any of the other ingredients of Alacare.

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

- were undergoing sim ilar therapy with 5-am inolevulinic acid-containing prep arations and it was unsuccessful.

Please ask your doctor if you are not sure.

Take special care with Alacare if you

- have dark br own or black skin or if you have very thick lesions s ince there is no experienc e 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 rece ntly taken any medicines, even those which were obtained without prescription.

It is im portant to inform your doctor if y ou are taking or have taken produc ts containing St John' s Wort (Hypericum perforatum) or used products cont aining Hypericum on you r 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 pregnanc y and for the unborn child cannot be com pletely excluded at this time.

Alacare should not be used during pr egnancy unless cl early 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 importa nt that you do not apply any cream to your scalp or face on the day of tr eatment before arriving for therapy at your doctor.

Adults (including the elderly)

Alacare plast ers 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 illu mination you shou ld protect the skin fro m 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 a pplication of the Alacare plaster, during illum ination of the treatment site and/or thereafter. Sy mptoms are usually of m ild or m oderate i ntensity. The y rarely require early termination of illum ination. For relief, the treat ed area can be cooled by a fan or si milar 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 eff ects gets se rious, or if you notice any side effe cts not listed in thi s 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 sache t 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 y our 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 rem oved 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.