P-toluylenediamine SmartPractice 10 mg/g (1%) ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

p-toluendiamine SmartPractice 10 mg/g (1%) ointment

2,5-diaminotoluene

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What p-toluendiamine SmartPractice is and what it is used for
2. What you need to know before using p-toluendiamine SmartPractice
3. How to use p-toluendiamine SmartPractice
4. Possible adverse effects
5. Storage of p-toluendiamine SmartPractice
6. Contents of the pack and other information

1. What p-toluendiamine SmartPractice is and what it is used for

p-toluendiamine SmartPractice is a diagnostic agent. It contains p-toluendiamine, which may trigger allergic contact reactions on the skin.

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

The test is performed in the doctor's office.

2. What you need to know before using p-toluenediamine SmartPractice

Do not use p-toluenediamine SmartPractice

• If your general health is significantly affected (e.g., you have an infection).
• If you are allergic to any of the components of this medicinal product (listed in section 6).
• If, at the time of testing, you have severe or generalized dermatitis. The test area must be free from any skin condition for 14 days prior to patch testing.
• If your skin has been exposed to UV radiation (sunlight) on the test area within the past 4 weeks.

Warnings and precautions

Consult your doctor or nurse before starting to use p-toluenediamine SmartPractice.

• Before applying the patch test, your doctor will ensure that the test area is free from any ongoing skin condition that might interfere with the results.
• Avoid strenuous physical activity and excessive sweating while wearing the patch test.
• Avoid showers and baths, as moisture may cause the patch test panel to detach.
• Refrain from taking medications such as steroids, which suppress the immune system, as they may lead to false-negative reactions.
• If you have previously experienced anaphylactoid reactions, the use of p-toluenediamine SmartPractice should be carefully considered.
• If you are allergic to p-toluenediamine, you may also be allergic to other chemicals with a similar structure, such as those found in certain hair dyes. Your doctor may decide to perform additional tests to identify these chemicals.

Other medicines and p-toluenediamine SmartPractice

Inform your doctor or nurse if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription, before applying p-toluenediamine SmartPractice. Remember that your doctor may not be aware of all the medicines you are taking.

• Steroids may cause false-negative results in the test. Your doctor will decide whether you should discontinue steroid treatment before testing. If you are unsure whether any of your medicines contain steroids, speak with your doctor.
• If you are undergoing treatment with cytotoxic drugs or immunosuppressive therapy, patch testing should be postponed.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or nurse before using this medicinal product.

Allergy patch testing should not be performed during pregnancy or breastfeeding unless considered absolutely necessary. Your doctor will decide whether you should undergo patch testing.

Driving and use of machines

It is unlikely that this medicinal product will affect your ability to drive or operate machinery. Speak with your doctor if you have any concerns about this.

3. How to use p-toluenediamine SmartPractice

Method of administration

During the patch test, the healthcare professional will perform the following steps:

• For allergy testing, a 5 mm strip of ointment is applied directly onto the designated area of the patch test panel.
• The patch test panel is then applied to healthy, dry skin (usually on the back or upper arm).

Duration of treatment

• The patch test will be removed 48 hours after application.
• Your doctor will read the test result 30 minutes after removal, and again after 1 and 2 days, when allergic reactions have fully developed and any possible irritant reactions have subsided.
• Evaluation of skin reactions will be performed by your doctor according to an established protocol. Instructions for this evaluation are provided in the information for healthcare professionals (see section "Interpretation").
• If you experience severe discomfort at the test site, you should contact your doctor. Your doctor may decide to remove the test.

Use in children and adolescents

Clinical study data in children are limited.

Children under 12 years of age should only undergo the p-toluenediamine SmartPractice test when there is a strong suspicion of contact allergy to p-toluenediamine. Your doctor will decide whether the test should be performed.

The patch test may be removed after 24 hours to reduce irritant reactions.

If you use more p-toluenediamine SmartPractice than you should

If the test is used correctly, overdose is not possible. If used incorrectly, it may cause a stronger allergic reaction, including blisters on the skin. In such cases, the doctor will take appropriate measures.

If you have any further questions about the use of this medicinal product, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Class effects for epicutaneous patch tests (frequency cannot be estimated from the available data):

• Anaphylactic reaction (systemic reaction, possibly with a drop in blood pressure that may be life-threatening). If you experience sweating, dizziness, or other discomfort immediately after application of the test panel, inform your doctor or nurse immediately.
• Sensitization to the substance used in the test.
• Skin reactions at the test site. Reactions include itching, redness of the skin, and possibly blisters. These reactions are expected and may indicate contact allergy.
• Type I allergic reactions (mild to moderate allergic reactions).

Emergency measures in case of adverse effects

Rarely, patch tests may cause severe allergic reactions, including systemic reactions (allergic shock). Warning signs of an allergic shock reaction include burning, itching, and a sensation of heat in and under the tongue, throat, palms of the hands, and soles of the feet. Inform your doctor or nurse immediately if you experience any of these reactions.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of p-toluenediamine SmartPractice

Store in a refrigerator (between 2 °C and 8 °C).

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its container. This will help protect the environment.

6. Contents of the pack and other information

Composition of p-toluenediamine SmartPractice

• The active substance is p-toluenediamine.
• The excipient is white soft paraffin.

Appearance of the product and contents of the container

• Ointment ranging in colour from reddish-brown to violet, contained in a syringe.
• Pack size: one 5 ml syringe containing 5 ml (4.7 g) of ointment.

Marketing Authorization Holder and Manufacturer

SmartPractice Europe GmbH

Bövemannstr. 8

48268 Greven

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: p-Toluylendiamin 1%, Testsalbe

France: p-toluènediamine SmartPractice 1%, pommade

Spain: p-toluendiamina SmartPractice 10 mg/g (1%), pomada

Sweden: p-toluendiamin SmartPractice 1%, salva

Date of the most recent review of this leaflet: 02/2022

Detailed information on this medicinal product is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)

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This information is intended for healthcare professionals only:

Interpretation

The interpretation of the patch test reaction should be performed according to the method recommended by the International Contact Dermatitis Research Group (ICDRG).