Label: information for the user

TRUTEST 36adhesive patch for allergen provocation test

TRUTEST 36 consists of 3 strips of surgical tape with 12 patches each. 35 patches are covered with a film containing a specific allergen or a mixture of allergens. One of the patches (patch No. 9) is empty.

1. Five parts of benzocaine, one part of cinchocaine hydrochloride, and tetracaine hydrochloride.
2. Five parts of geraniol and oak moss, four parts of hydroxycitronella and cinnamyl alcohol, two parts of cinnamaldehyde and eugenol, and one part of isoeugenol and α-aminocinnamaldehyde.
3. Equal weights of methylparaben, ethylparaben, propylparaben, butylparaben, and benzylparaben.
4. Equal weights of diphenylguanidine, zinc diethyldithiocarbamate, and zinc dibutyl dithiocarbamate.
5. Two parts of N-isopropyl-N'-phenyl paraphenylenediamine, five parts of N-cyclohexyl-N'-phenyl paraphenylenediamine, and five parts of N,N'-diphenyl paraphenylenediamine.
6. Contains N-hydroxymethyl succinimide.
7. Equal parts of morpholinyl mercaptobenzothiazole, N-cyclohexylbenzothiazylsulfenamide, and dibenzothiazyl disulfide.
8. Equal parts of disulfiram, dipentamethylenethiuram disulfide, tetramethylthiuram disulfide, and tetramethylthiuram monosulfide.
9. Equal weights of clioquinol and chloroquinaldol

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What is TRUTEST 36 and what is it used for

2.What you need to knowbeforestarting touse TRUTEST 36

3.How to use TRUTEST 36

4.Possible adverse effects

5.Storage of TRUTEST 36

6.Contents of the package and additional information

TRUTEST 36 is used to diagnose contact allergic dermatitis. Contact dermatitis is a skin reaction caused by exposure to foreign substances that trigger an allergic reaction.

TRUTEST 36 is a pre-coated adhesive patch for provocation testing ready for use to determine the cause of contact allergic dermatitis.

TRUTEST 36 is indicated for adults.

The test consists of 3 strips of surgical adhesive tape. The strips contain 12 patches each. Each patch is covered with a film containing a substance that can cause a reaction on the skin of sensitive individuals. These substances are called allergens. Each patch contains a different allergen and one of the patches is empty. TRUTEST 36 contains 35 of the most common allergens/allergen mixtures and one empty patch.

TRUTEST 36 demonstrates whether you are allergic to any of the test substances (allergens) on the patches.

If a substance you are allergic to comes into contact with your skin, it causes an inflammatory reaction called contact dermatitis.

These substances could be an ingredient in your perfume or shaving cream, ointment or cream, rubber gloves, industrial chemicals, etc.The substances in TRUTEST 36 are known allergens. If you are allergic to the substance on a particular patch of TRUTEST 36, then the skin under the patch will react to that substance, becoming red and inflamed.If you are not allergic to a particular patch, the skin under the patch will not react. You may be allergic to more than one patch.

No use TRUTEST 36:

• If you have severe or generalized dermatitis.The test must be postponed until the acute phase of the dermatitis has ended.
• If you are allergic to any of the excipients of TRUTEST 36 (listed in section6).

Warnings and precautions

• Avoid exposure to the sun on the test area. Sunburn can mask positive reactions to allergens to which you are actually allergic.
• Avoid excessive sweating while wearing the adhesive strips with patches.
• If you are taking immunosuppressive medications such as steroids (e.g., prednisolone) or topical steroid creams (e.g., hydrocortisone). These medications should not be used for at least two weeks before the test.
• If you have a skin irritation syndrome. This is a state of over-sensitivity of the skin caused by a reaction in other parts of the body. If you react to all the patches, the doctor may need to repeat the test another day.
• If you have had previous anaphylactoid reactions. The use of TRUTEST 36 should be carefully considered.

Consult your doctor before using TRUTEST 36 if any of these factors apply to you. Your doctor will decide what to do.

Sensitization: In rare cases, you may develop sensitivity to a substance in the patches while using TRUTEST 36. A reaction test that appears more than 10 days after application may be a sign of contact sensitization.

TRUTEST 36 should only be applied to the skin:

• without acne
• without scars
• without dermatitis
• in a state that will not interfere with the test results. Consult your doctor if you have doubts.

Moisture should be avoided around the test. Therefore, when bathing or showering, be careful not to get the test panel or its surroundings wet. If the test panel gets wet, it may come off, allowing the water to carry the test substances.

Avoid any activities such as sunbathing or exercising that may cause the patches to come off.

BHA (E320) and BHT (E312) are present in patch allergen No. 7 Colofonia (panel 1) for stability reasons. BHA and BHT may cause local skin reactions (e.g., contact dermatitis), which may result in a false positive reaction for Colofonia.

Children

TRUTEST 36 is not recommended for use in children, as its safety and efficacy have not been established in these patients.

Other medications and TRUTEST 36

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication, including those purchased without a prescription, before applying TRUTEST 36. Remember that your specialist doctor needs to know if you are taking other medications.

Since steroids can suppress a positive test reaction, the use of topical steroids in the application area or oral steroids equivalent to 20 mg of prednisolone or more daily should be discontinued for at least two weeks before the test.

Pregnancy,breastfeedingand fertility

Pregnant women should not use TRUTEST 36. It is essential to inform your doctor if you are pregnant or think you may be pregnant.

You should not breastfeed your baby during the use of TRUTEST 36.

Driving and operating machinery

It is unlikely that TRUTEST 36 will affect your ability to drive or operate machinery.Consult your doctor if you have any doubts.

TRUTEST 36 must be applied by your doctor.

1.Open the packaging and removethe TRUTEST 36 panel.

2.Remove the plastic protective cover from the surface of the panel. Be careful not to touch the test substances. A desiccant is included in the panel packaging for stability reasons.

3.Place the patch on the upper back of the patient. However,it can also be placed on the outer surface of the upper arm. Gently smooth out the panel from the center to the edges, ensuring that each allergen comes into contact with the skin properly. The two panels are best placed on either side of the spine at a distance of a few centimeters.

4. Mark the two grooves of the panels (upper left and lower edge) with a medical marker.

You must wear the test strips for 48 hours without removing them. Be careful not to get the test area wet (water, sweat).

If the patch is removed or peels off too soon, it is possible that positive reactions to the allergens that actually cause you an allergy will not occur. Inform your doctor if the patch is removed or peels off before 48 hours.

After 48 hours, you or your doctor can remove the panels.

When should the results be read?

Your doctor will read the test result 30 minutes after removing the test and again 1 or 2 days after removing the test, when any allergic reaction is fully developed and any possible irritating reactions have disappeared. Some allergens sometimes cause reactions that do not appear until 4-5 days after removing the test. Please inform your doctor if this happens.

What should the doctor look for?

The doctor will carefully examine the test area in search of signs of an allergic reaction. This reaction usually consists of a rash with swelling, redness, and small blisters. However, redness alone does not necessarily mean it is an allergic reaction. If you are allergic, your doctor will give you the following information:

• Where in your daily environment it is likely that you will come into contact with the harmful substances.
• The best way to avoid these substances. Your doctor may suggest alternatives to the elements you should avoid.

If you have doubts, consult your doctor or pharmacist.

Contact your doctor if you experience severe discomfort in the area where the test was applied. Your doctor will decide whether to remove the patches.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them..

Very common adverse effects (may affect more than 1 in 10 people):

• Irritation caused by the surgical adhesive tape may occur, but it usually disappears quickly.
• Burning sensation.
• Long-term reactions. A positive test reaction usually disappears in 1-2 weeks, while a long-term reaction may persist for weeks or months.

Common adverse effects (may affect up to 1 in 10 people):

• The test reactions may leave a temporarily lighter or darker area on the skin.
• Redness of the skin caused by irritation or inflammation (erythema)

Uncommon adverse effects (may affect up to 1 in 100 people):

Rare adverse effects (may affect up to 1 in 1,000 people):

Frequency not known (cannot be estimated from available data):

• Anaphylactic reaction (systemic reaction, possibly with a drop in blood pressure that may be life-threatening).
• Hypersensitivity (allergic reaction).

In extremely rare cases and only in relation to certain substances, anaphylactic reactions (systemic reaction, possibly with a drop in blood pressure that puts life at risk) have occurred. Allergy departments are prepared to treat these incidents for other reasons. Anaphylactic reactions related to the application of TRUTEST 36 are not documented.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packagingafter “EXP:”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications that you no longer need.This will help protect the environment.

Composition of TRUTEST 36

• In addition to the active substances indicated on the first page, the test contains the following excipients: Polyester fiber tape with adhesive (copolymer of ethylene-acetate of vinyl) with acrylic adhesive, polyester patches, povidone 90, hydroxypropylcellulose, methylcellulose, β-cyclodextrin, sodium carbonate, sodium bicarbonate, butylhydroxyanisole, and butylhydroxytoluene.

Appearance of the product and contents of the packaging

Each panel is covered with a protective layer of polyethylene coated with silicone and packaged in laminated hermetic bags.

The laminated bag of Panel 2 also contains a desiccant to preserve the allergens properly during storage.

Contents of the packaging: 10 tests (1 test = 1 Panel 1, 1 Panel 2, and 1 Panel 3)

Holder of the marketing authorization and responsible manufacturer

SmartPractice Denmark ApS

Herredsvejen 2

3400 Hillerød

Denmark

[email protected]

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

MARTI TOR ALERGIA, S.L.

C/Ull de Llebre, 16

08758 Cervelló (Barcelona)

Spain

Last review date of this prospectus:February 2021

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

This information is intended solely for healthcare professionals:

With each package of TRUTEST 36, a template for identification is provided for a quick identification of any allergen that causes a reaction. To ensure correct positioning, the marks on the skin must correspond to the grooves on the template. Note the difference between page 1 and 2 of the template, which correspond to Panel 1 and Panel 2, respectively.

The recommended interpretation method by the International Contact Dermatitis Research Group is:

Note

• Patients who show a negative reaction may still be sensitive to another substance not included in this test panel. On the other hand, false negative results may occur. It may be necessary to repeat the test or perform it with complementary substances.

• A positive reaction must meet the criteria for an allergic reaction (erythematous papular or vesicular and infiltration).

• Pustules, as well as homogeneous or irregular follicular erythema without infiltration, are usually signs of irritation and do not indicate allergy.

What is important in the evaluation of a positive response is not the number of positives assigned to the test response, but the determination of whether the response is a truly positive reaction (caused by allergy) or a non-specific irritative reaction.

Some of the allergens (neomycin sulfate, p-phenylenediamine, wool alcohols, mixture of caines, gold sodium thiosulfate, parachlorophenol, dispersed blue 106, bacitracin, imidazolidinyl urea, diazolidinyl urea, budesonide, hydrocortisone-17-butylate, and tixocortol-21-pivalate) may sometimes cause reactions that may not appear until 4-5 days after application. Patients should be advised to inform their doctor if this reaction occurs. A medical review between the 5th and 7th day will verify a late reaction if necessary.

All positive reactions should be carefully evaluated, considering the patient's individual clinical history and symptoms, especially in the case of positive reactions to specific allergens with lower sensitization rates (e.g., gold sodium thiosulfate).

Contraindications

Severe or generalized dermatitis. The test should be postponed until the acute phase has ended.

Known hypersensitivity to any of the excipients included in the test, in addition to the active principles.

Warnings and special precautions for use

The substances in the test panel rarely cause sensitization. A reaction that appears on day 10 or later may be a sign of contact sensitization.

The skin irritation syndrome is a state of hyperreactivity induced by dermatitis in other parts of the body or by a strong positive reaction to the test. Therefore, results should be carefully evaluated in patients with multiple, concurrent positive test results. It may be necessary to repeat the test at a later date to determine which reactions are false positives.

Before application, the use of TRUTEST 36 should be evaluated with caution in patients with a history of anaphylactoid reactions.

Excessive sweating and exposure to sunlight in the test area should be avoided. Sunburn can reduce the reactivity of the patches and cause false negatives.

Avoid applying the test to skin with acne, scars, dermatitis, or any other condition that may interfere with the results.

If a severe reaction occurs due to the test, the patient may be treated with a topical corticosteroid or, in rare cases, a systemic corticosteroid.

Butilhydroxyanisole (BHA) (E320) and butylhydroxytoluene (BHT) (E312) are present as antioxidants in patch allergen No. 7 Colophony (Panel 1). BHA and BHT may cause local skin reactions (e.g., contact dermatitis), which may result in a false positive reaction for Colophony.