PARABENS MIX ALLERGEAZE

PACKAGE LEAFLET
Package leaflet: Information for the Patient
paraben mix allergEAZE 16%, ointment
methyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate and ethyl
parahydroxybenzoate
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 paraben mix allergEAZE 16% is and what it is used for
2. What you need to know before you use paraben mix allergEAZE 16%
3. How to use paraben mix allergEAZE 16%
4. Possible side effects
5. How to store paraben mix allergEAZE 16%
6. Contents of the pack and other information

1. What paraben mix allergEAZE 16% is and what it is used for

Paraben mix allergEAZE 16% is a medicinal product intended solely for diagnostic use. The paraben mix allergEAZE 16% patch test is indicated in adult patients with suspected allergic contact dermatitis to methyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate and ethyl parahydroxybenzoate (also known as methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate and/or ethyl p-hydroxybenzoate, or collectively as parabens). It contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate and ethyl p-hydroxybenzoate, which may provoke contact allergic reactions on the skin.

Allergic contact dermatitis is an inflammatory reaction of the skin caused by repeated exposure to substances to which you are allergic.

This test is administered in a medical setting by a healthcare professional.

2. What you need to know before you use paraben mix allergEAZE 16%

Do not use paraben mix allergEAZE 16%

• 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 Paraben mix allergEAZE 16% are known in the literature.
• If you have earlier had anaphylactoid reactions, the use of Paraben Mix allergEAZE 16% should be considered carefully.
• Irritant effects have been reported for parabens. 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. A subsequent patch test with a positive reaction within 72–96 hours can be considered a case of active sensitisation from the previous patch test.

Children and adolescents
Data on the use of the Paraben Mix allergEAZE 16% 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 parabens 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 paraben mix allergEAZE 16%
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 paraben mix allergEAZE 16% is applied. Remember that your doctor may not be aware of what you are taking.

• Corticosteroids and medicines that weaken the 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 fertility
No experimental data are available on the use of the paraben mix allergEAZE 16% 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 machines
Paraben mix allergEAZE 16% is unlikely to affect your ability to drive or use machines. Talk to your doctor about this if you have any concerns.

3. How to use paraben mix allergEAZE 16%

Method of administration
The following steps are performed by qualified healthcare personnel:

• 5 mm of ointment (20–25 mg) is applied into the application chamber of the test device (patch test) using the syringe containing the medicinal product.
• The patch test panel is then applied to healthy, dry skin (usually on the patient’s upper back, or, if not possible, on the skin of the upper arm).

Duration of treatment

• The patch test must be removed by qualified healthcare personnel 48 hours after application. Your doctor will read the test result at least 30 minutes after removal and again 1 day (72-hour reading) or 2 days (96-hour reading) afterwards, when any allergic reactions are fully developed and possible mild irritant reactions have subsided.
• Assessment of skin reactions is performed by the doctor according to an established protocol. Instructions for this assessment can be found in the information for healthcare professionals (see section “ Interpretation ” at the end of this document).

If you use more paraben mix allergEAZE 16% than you should
When used properly, overdosing is not possible.
If you have any further questions about the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, paraben mix allergEAZE 16% may cause side effects, although not everybody gets them.
The following adverse reactions have been reported from published scientific literature for patch testing (frequency cannot be estimated from the available data):

• Sensitisation to the substance you are being tested with,
• Skin reactions at the patch test application site. The reactions include itching, reddening of the skin and possibly blistering. These reactions are expected and may indicate a contact allergy,
• Localised transient pale (hypopigmentation) or darker area (hyperpigmentation) of the skin,
• Scar,
• Irritant reactions,
• Infection of the skin at the application site,
• Flare-up of a pre-existing reddening of the skin,
• Anaphylactic reaction (systemic reaction, possibly with a life-threatening drop of blood pressure); however, no anaphylactic reactions with parabens are known in the literature.

If you experience severe discomfort at the patch test application site, it is necessary to contact a doctor.
Your doctor may decide to remove the patch test.
In rare cases, patch testing can lead to serious allergic reactions, including systemic reactions (allergic shock). Warning signs of an allergic shock reaction may include itching of the palms and soles of the feet, feeling generally unwell, difficulty breathing, rapid heartbeat, feeling of warmth, change in tone of voice, feeling lightheaded, tightness in the throat, and agitation/anxiety.
Inform your doctor or healthcare professional immediately if you experience any of these reactions.

Reporting of side effects
If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store paraben mix allergEAZE 16%

Do not store above 25 °C.
After opening, the product is stable for 3 months.
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 labels after EXP (or Scad.). The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your doctor or healthcare professional how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What paraben mix allergEAZE 16% contains

• The active substances are methyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate and ethyl parahydroxybenzoate.
• The excipient is paraffin, white soft (petrolatum).

What paraben mix allergEAZE 16% looks like and contents of the pack
White to off-white ointment in a syringe.
Pack size: Polyethylene pouch with 1 pre-filled syringe (barrel: polypropylene; plunger: polyethylene)
closed by a cap (polyethylene) containing 5 mL (4.7 g) of ointment.
Marketing Authorisation Holder and Manufacturer
SmartPractice Europe GmbH
Bövemannstr. 8
48268 Greven
Germany
This leaflet was last revised in
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The following information is intended for healthcare professionals only:
Interpretation
Interpretation of the patch test reaction should be done in accordance with the interpretation method
recommended by the International Contact Dermatitis Research Group (ICDRG) and based on the S3
Guideline “Conducting patch tests with contact allergens and drugs (J Dtsch Dermatol Ges. 2019
Oct.;17(19):1075-1093)” (see table for diagram).