P-TOLUENDIAMINE SMARTPRACTICE 10 mg/g (1%) OINTMENT

Introduction

Leaflet: information for the patient

p-toluendiamina SmartPractice10mg/g (1%) ointment

2,5-diaminotoluene

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

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

Contents of the leaflet

1. What is p-toluendiamina SmartPractice and what is it used for
2. What you need to know before starting to use p-toluendiamina SmartPractice
3. How to use p-toluendiamina SmartPractice
4. Possible side effects

5 Conservation of p-toluendiamina SmartPractice

1. Package contents and additional information

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

p-toluendiamina SmartPractice is a diagnostic agent. It contains p-toluendiamina, which can trigger contact allergies on the skin.

Contact allergic dermatitis is an inflammatory skin response 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 starting to use p-toluendiamina SmartPractice

Do not use p-toluendiamina SmartPractice

• If your general state of health is significantly affected (e.g., you have an infection).
• If you are allergic to any of the components of this medication (listed in section 6).
• If, at the time of the test, you have severe or widespread dermatitis. The test area must be free of any skin condition for 14 days before performing the patch test.
• If your skin has been exposed to UV radiation (sun) in the test area in the last 4 weeks.

Warnings and precautions

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

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

Other medications and p-toluendiamina SmartPractice

Tell your doctor or nurse if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription, before applying p-toluendiamina SmartPractice. Remember that your doctor may not know what medications you are taking.

• Steroids can cause false-negative results in the test. Your doctor will decide whether to interrupt steroid treatment before the test. If you are unsure whether any of your medications contain steroids, talk to your doctor.
• If you are undergoing treatment with cytotoxic medications or immunosuppressive therapy, the patch test should be postponed.

Pregnancy and breastfeeding

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

The patch test for allergies should not be performed during pregnancy or breastfeeding, unless it is considered absolutely necessary. Your doctor will decide whether you should perform the patch test or not.

Driving and using machines

It is unlikely that this medication will affect your ability to drive or use machines. Talk to your doctor if you have any concerns about this.

3. How to use p-toluendiamina SmartPractice

Method of administration

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

• For the allergy test, a 5 mm strip of ointment is applied directly to the designated area of the test panel.
• Then, the test panel is 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 possible irritant reactions have disappeared.
• The evaluation of skin reactions will be performed by the doctor following an established protocol. The instructions for this evaluation are found in the information for healthcare professionals (see section "Interpretation").
• If you experience severe discomfort in the test area, contact your doctor. Your doctor may decide to remove the test.

Use in children and adolescents

Clinical trial data in children are limited.

Children under 12 years old should only undergo the test with p-toluendiamina SmartPractice when there is a strong suspicion of contact allergy to p-toluendiamina. Your doctor will decide whether to perform the test.

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

If you use more p-toluendiamina SmartPractice than you should

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

Emergency measures in case of side effects

Rarely, patch tests can cause severe allergic reactions, including systemic reactions (anaphylactic shock). Warning signs of an anaphylactic shock reaction are burning, itching, and a feeling 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 side effects

If you experience any side effects, consult your doctor or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of p-toluendiamina SmartPractice

Keep in the refrigerator (between 2 °C and 8 °C).

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

Do not use this medication after the expiration date shown on the label after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of p-toluendiamina SmartPractice

• The active ingredient is p-toluendiamina.
• The excipient is white petrolatum.

Appearance of the product and package contents

• Brown-red to purple ointment in a syringe.
• Package size: a 5ml syringe with 5 ml (4.7 g) of ointment.

Marketing authorization holder and manufacturer

SmartPractice Europe GmbH

Bövemannstr. 8

48268 Greven

Germany

This medication is authorized in the Member States of the European Economic Area with the following names:

Germany: p-Toluylendiamin 1%, Testsalbe

France: p-toluènediamine SmartPractice 1%, pommade

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

Sweden: p-toluendiamin SmartPractice 1%, salva

Date of the last revision of this leaflet:02//2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Interpretation

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