RESINA P-TER-BUTILFENOLO FORMALDEIDICA ALLERGEAZE

PACKAGE LEAFLET
Package leaflet: Information for the Patient
p-tert-butylphenol formaldehyde resin allergEAZE 1%, ointment
p-tert-butylphenol formaldehyde resin

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 have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. See Section 4. What is in this leaflet
• 1. What p-tert-butylphenol formaldehyde resin allergEAZE 1% is and what it is used for
• 2. What you need to know before you use p-tert-butylphenol formaldehyde resin allergEAZE 1%
• 3. How to use p-tert-butylphenol formaldehyde resin allergEAZE 1%
• 4. Possible side effects
• 5. How to store p-tert-butylphenol formaldehyde resin allergEAZE 1%
• 6. Contents of the pack and other information

1. What p-tert-butylphenol formaldehyde resin allergEAZE 1% is and what it is used for

p-tert-butylphenol formaldehyde resin allergEAZE 1% is a medicinal product only for diagnostic use.
p-tert-butylphenol formaldehyde resin allergEAZE 1% patch test is indicated in adult patients with
suspected allergic contact dermatitis to p-tert-butylphenol formaldehyde resin. It contains p-tert-
butylphenol formaldehyde resin that can trigger contact allergies on the skin.
Allergic contact dermatitis is an inflammatory response of the skin caused by repeated exposure to
foreign substances to which you are allergic.
The test is performed at the doctor's office.

2. What you need to know before you use p-tert-butylphenol formaldehyde resin allergEAZE

1%
Do not use p-tert-butylphenol formaldehyde resin allergEAZE 1%

• If your general well-being is significantly impaired (e.g., you have an infection).
• If you are allergic (sensitive) to any of the ingredients of this medicine (listed in Section 6).
• If you, at the time of testing, have severe or generalised dermatitis. The patch testing should be done after resolution of the acute phase.
• Existing dermatological pathology at the application site of the patch test.
• If your skin has been exposed to UV (sun) light intensively in the test area in the past 4 weeks. Warnings and precautions
• Before applying the patch test, your doctor will make sure the patch test application area is free of any ongoing skin conditions that may interfere with the test results.
• During the application period, you should avoid wetting the patch test application area (e.g., excessive exercise and sweating, bathing or showering).
• Your doctor should suspend, if possible, your medicines such as corticosteroids that suppress the immune system as these may cause false-negative test results.
• Anaphylactic reactions have been reported very rarely with some substances; however, no anaphylactic reactions with p-tert-butylphenol formaldehyde resin are known in the literature.
• If you have earlier had anaphylactoid reactions the use of p-tert-butylphenol formaldehyde resin should be considered carefully.
• Active sensitisation is in general rare for patch tests but possible, and it is probable if a positive reaction occurs approximately 10-21 days after the application of the patch test. However, rare cases have been described with p-tert-butylphenol formaldehyde resin. A subsequent patch test with a positive reaction within 72-96 hours can be considered a case of active sensitisation of the previous patch test.
• Sensitisers in p-tert-butylphenol formaldehyde resin can cross-react with similar substances (p-tert- butylphenol and 4-tert-butylcatechol), so that in the event of unclear reactions in the patch test, these substances should also be considered as triggering allergens.
• Sensitisers in p-tert-butylphenol formaldehyde resin are reported to cause temporary depigmentation at the application site, which can be expected to reverse within a few weeks.

Children and adolescents
Data on the use of the p-tert-butylphenol formaldehyde resin allergEAZE 1% patch test in the paediatric
population are available in the scientific literature. The medicinal product should only be tested in
children in case of suspected allergic contact dermatitis to p-tert-butylphenol formaldehyde resin on the
basis of a careful anamnestic evaluation. Interpretation of patch test results in the paediatric population
requires experience and particular caution.

Other medicines and p-tert-butylphenol formaldehyde resin allergEAZE 1%
Tell your doctor or healthcare professional if you are taking, have recently taken, or might plan to take
any other medicines, including medicines obtained without prescription, before p-tert-butylphenol
formaldehyde resin allergEAZE 1% is applied. Remember that your doctor may not be aware of what
you are taking.

• Corticosteroids and medicines that weaken immune system (immunosuppressive medicines) can cause false-negative test results. Your doctor will decide if you must stop corticosteroid treatment prior to testing. If you are not sure if any of your medicines contain corticosteroids, talk to your doctor.
• If you are undergoing treatment with medicines against cancer (cytostatic medicines) or immunosuppressive therapy, patch testing should be postponed. Pregnancy, breastfeeding and fertilityNo experimental data are available on the use of the p-tert-butylphenol formaldehyde resin allergEAZE 1% patch test in pregnant women. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before using this medicine. Patch testing for allergy should not be carried out during pregnancy or while breastfeeding, unless it is considered absolutely necessary. Your doctor will decide if you should use a patch test or not. Driving and using machinesp-tert-butylphenol formaldehyde resin allergEAZE 1% is unlikely to affect your ability to drive and use machines. Talk to your doctor about this if you have any concerns.