8 mg medicated patch
5-aminolevulinic acid
1. WHAT ALACARE IS AND WHAT IT IS USED FOR
Alacare is used to treat mild skin changes on the head or face called sun keratosis. These are small, uneven spots that appear on the skin. They are caused by abundant sun exposure for many years. They are also called actinic keratosis.
Treatment with Alacare is a two-step procedure and is called “photodynamic therapy”. It consists of applying Alacare‑ patches to the stains for 4 hours. This is followed by lighting with red light for a few minutes. Lighting with red light causes a chemical reaction in the cells of the altered skin, which leads to the destruction of these cells. The reaction is called a “phototoxic reaction”.
2. What you need to know before using Alacare
Do not use Alacare
Alacare should be applied by a physician, nurse or other healthcare professional on a single occasion.
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 metabolic disease in the blood, which is called porphyria.
- if you have undergone similar treatment with 5-aminolevulinic acid-containing preparations that failed.
- if you have other skin problems caused by or aggravated by exposure to light.
The treatment result may be worse if the treated skin area is also affected by:
- inflammation, infection, psoriasis, eczema, or cancer
- tattoos
If you are not sure, talk to your doctor.
Take special care with Alacare
- if you have dark brown or black skin or if you have very thick skin changes, as there is no experience of treatment with Alacare in these cases.
- if you may be pregnant, as treatment with Alacare is not recommended during pregnancy.
- if you are receiving UV treatment, it should be discontinued before treatment with Alacare.
Your doctor or nurse will make sure that the Alacare patch does not come into contact with your eyes.
As a general precaution, treated and surrounding skin should not be exposed to sunlight for approximately 48 hours after treatment.
Taking other medicines
Tell your doctor if you are taking medicines that increase the risk of allergic or other harmful reactions when exposed to light such as:
- St. John’s wort products: for depression.
- griseofulvin: medicine for fungal infections.
- diuretic drugs called diuretics with an active substance whose name usually ends with “thiazide”.
- some medicines for diabetes , such as glibenclamide, glimepiride.
- drugs for mental illness, nausea or vomiting with active substance whose name usually ends with “in”.
- drugs for bacterial infections with active substance whose name begins with “sulfa” or ends with “oxacin” or “cyclin”.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breastfeeding
Any harmful effects and risks to the pregnancy and the unborn child can not currently be completely ruled out.
Alacare should not be used during pregnancy unless clearly necessary.
You should not breast-feed within 48 hours after applying Alacare.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Alacare has no known effect on the ability to drive or use machines.
3. HOW TO USE ALACARE
It is important that you do not apply any cream to the scalp or face on the day of treatment before you come for treatment by your doctor.
Adults (including the elderly)
Alacare patches are applied to your actinic keratosis (skin change) for 4 hours at a single visit. These areas are then exposed to red light for a few minutes (photodynamic therapy). To protect your eyes from the strong light, you get glasses that you should wear during the light exposure.
After the treatment with patches and lighting, protect the skin from sunlight for 48 hours.
The skin changes should be checked by your doctor after three months.
Use for children and adolescents
The use of Alacare is not recommended as there is no experience in the treatment of children and adolescents under 18 years of age.
If you stop using Alacare
The effect of the treatment may decrease if
- the application of patches is stopped too soon or
- the light treatment is stopped too soon.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Alacare can cause side effects, although not everybody gets them.
Side effects at the treatment site (local side effects )
Almost all patients (99%) experience side effects at the treatment site (local side effects ). These may occur when applying the Alacare patch, when illuminating the treatment site and / or thereafter. The symptoms are usually mild or moderate. They rarely demand that the lighting be stopped too soon. As a relief, the treated area can be cooled with a fan or the like under lighting. After treatment, local side effects may persist for 1 to 2 weeks or sometimes longer.
Very common (affects more than 1 patient in 10):
- peeling
- skin irritation
- itching
- pain
- redness
- scabs
Common (affects more than 1 in 100 patients, but less than 1 in 10 patients):
- pale or dark skin areas
- bleeding
- blisters
- discomfort
- superficial wounds
- edema (accumulation of fluid in tissue one)
- flaking
- blisters (pimples)
- skin reaction
- secretion
- swelling
Uncommon (affects more than 1 in 1,000 patients, but less than 1 in 100 patients):
- Aveda
- discoloration
- infection
- inflammation
- wound
- superficial skin defects
Other side effects (not local at the treatment site):
Usual
- headache
Less common
- concern
- elevated levels of enzyme et alalanine aminotransferase
- nosebleeds
- blister-like (fin-like) rash
- discoloration 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 or pharmacist.
Reporting of side effects ar
If you get any side effects, talk to your doctor. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
The Medical Products Agency
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 expiration date is the last day of the specified month.
Used within 3 months after opening.
Store the patch in the protective bag after opening. Sensitive to light. After removal, fold the applied patch in half with the adhesive side inwards so that the adhesive does not expose. Thereafter, the patch should be disposed of 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. Contents of the packaging and other information
Content declaration
- The active substance is 5-aminolevulinic acid hydrochloride. Each 4 cm² medical patch contains 8 mg of 5 ‑ aminolevulinic acid (as hydrochloride), 2 mg per cm².
- The other ingredients are acrylic-based pressure-sensitive adhesive, backing film consisting of pigmented polyethylene and polyester coated with aluminum by means of steam, protective film consisting of polyethylene terephthalate film (which must be removed before application).
What the medicine looks like and the contents of the pack
Each medical patch has a size of 4 cm², is square with rounded corners and consists of a skin-colored support film and a self-adhesive mass, which is covered with a protective film that must be removed before use. 4 patches are enclosed in a protective bag.
Alacare is available in pack sizes of 4 or 8 patches (1 or 2 protective bags) in a cardboard outer carton.
Marketing Authorization Holder and Manufacturer
| Marketing Authorisation Holder: | photonamic GmbH & Co. KGEggerstedter Weg 1225421 PinnebergGermany |
| Manufacturer: | medac societyfuer klinische Spezialpraeparate mbHTheaterstrasse 6D-22880 WedelGermany |
This medicinal product is authorized under the European Economic Area under the names:
- Denmark, Finland, Ireland, Italy, Norway, Poland, Portugal, United Kingdom, Germany, Austria: Alacare
- France, Spain: Offaly