a)    Five parts of benzocaine, one part of cinchocaine hydrochloride and tetracaine hydrochloride.

b)    Five parts of geraniol and oak moss, four parts of hydroxycitronellal and cinnamylalcohol, two parts of cinnamaldehyde and eugenol and one part of isoeugenol and •-amylcinnamaldehyde.

c)    Equal weights of clioquinol and chlorquinaldol.

d)    Equal weights of methyl parahydroxybenzoate, ethyl parahydroxybenzoate propyl parahydroxybenzoate, butyl parahydroxybenzoate and benzyl parahydroxybenzoate.

e)    Equal weights of diphenylguanidine, zincdiethyldithio-carbamate and zincdibutyldithiocarbamate.

f)    Two parts of N-isopropyl-N'-phenyl paraphenylenedi-amine, five parts of N-cyclohexyl-N'-phenyl para-phenylenediamine and five parts of N,N'-diphenyl para-phenylenediamine.

g)    Actually contains N-hydroxymethyl succinimide.

h)    Equal weights of morpholinylmercaptobenzothiazole, N-cyclohexylbenzothiazylsulphenamide and dibenzoth-iazyl disulphide.

i)    Equal weights of disulfiram, dipentamethylenethiuram disulphide, tetramethylthiuram disulphide and tetram-ethylthiuram monosulphide.

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.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet:

1.    What TRUE Test is and what it is used for

2.    Before you use TRUE Test

3.    How to use TRUE Test

4.    Possible side effects

5.    How to store TRUE Test

6.    Further information

1. WHAT TRUE TEST IS AND WHAT IT IS USED FOR

TRUE Test is used to test for allergic contact dermatitis. Contact dermatitis is a skin reaction caused by exposure to foreign substances resulting in an allergic reaction.

TRUE Test is a ready-to-use patch test for finding out the cause of allergic contact dermatitis.

The test consists of two strips of surgical tape. Each strip contains 12 polyester patches. Each patch is coated with a film containing a substance which might cause a skin reaction in sensitive people. Such substances are called allergens. Each patch contains a different allergen. TRUE Test contains 24 of the most common allergens/allergens mixes.

TRUE Test works by showing if you are allergic to any of the test substances (allergens) on the patches. If a substance to which you are allergic comes into contact with your skin it causes an inflammatory reaction called contact dermatitis. These substances could be an ingredient in your perfume or aftershave, an ointment or cream, rubber gloves, industrial chemicals, etc. The substances in TRUE Test are well-known allergens. If you are allergic to the substance in a particular TRUE Test patch, then the skin under that patch will react to it, becoming red and inflamed. If you are not allergic to a particular patch, the skin under it will not react. You may be allergic to more than one patch.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRUE TEST

Do not use TRUE Test

•    If you suffer from acute contact dermatitis. The testing should be delayed until acute course of contact dermatitis is over.

•    if you are pregnant

•    if the patient is a child due to limited clinical investigation of patch testing on children.

Take special care with TRUE Test

•    if you go out in the sun regularly, as you should avoid exposing the test area to the sun. This is particularly important during the summer.

•    avoid sweating profusely while wearing the patch test strips. This is especially important during the summer and if you do any hard exercise.

•    if you are taking steroid medicines (e.g. prednisolone) or using steroid ointments/creams (e.g. hydrocortisone). These should not be used for at least two weeks before the test.

•    if you have excited skin syndrome (angry back). This is a state of skin over-irritability caused by a reaction on other parts of the body. If you react to all of the patches, the doctor may need to repeat the test another day.

•    If you have earlier had anaphylactioid reactions. The use of TRUE Test should be considered carefully.

•    Have strong contact allergy. TRUE Test should be used with caution since it may lead to transient flare-up of previous dermatitis sites.

•    If you are extremely sensitive you may experience strong positive reactions to one or more of the allergens in TRUE Test

You should talk to your doctor before using TRUE Test if any of these factors apply to you. Your doctor will be able to decide what to do.

Children: TRUE Test is not recommended for use in children.

Sensitisation: In rare instances you may become sensitive to a substance on the patches while using TRUE Test. A test reaction that appears later than 10 days after application may be a sign of contact sensitisation.

Late reactions: When testing with TRUE Test you may experience late positive reactions occuring at day 10 or later. You should talk to your doctor if this applies to you.

Some of of the test patches (nickel sulphate, potassium dichromate, cobalt chloride, epoxy resin and thiuram mix)are known to have the potential to cause cancer. However, due to the low content of allergen and the brief contact period, there is no risk of cancer.

TRUE Test should be applied only to skin that is

•    free of acne

•    free of scars

•    free of dermatitis

•    in a condition, which can not interfere with the test results. Please ask your doctor if you are in doubt.

Moisture around the test must be avoided. Therefore, when bathing or showering, you must be careful not to get the test panel or surrounding area wet. If the test panel does become wet it may loosen, allowing the test substances to be washed away.

Avoid any activity such as sunbathing or exercising, which may cause the patches to loosen.

Use adhesive tape, if for any reason an area of the patches does become loose.

Other medicines and TRUE Test

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription, before TRUE Test is applied. Remember that the skin specialist may not be aware of your other medicines.

4

Since steroids may suppress a positive test reaction, use of topical steroids on the test site or oral steroids equivalent to 10 mg prednisolone or more daily should be discontinued for at least two weeks prior to testing.

TRUE Test with food and drink

You should ask your doctor about what you can eat and drink while you are using TRUE Test.

Pregnancy and breast feeding

Pregnant women should not use TRUE Test. It is important to tell your doctor if you are pregnant or think you might be pregnant.

You should not breastfeed your baby while using TRUE Test.

Driving and using machines

TRUE Test 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 TRUE Test

Always use TRUE Test exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

TRUE Test will usually be given to you by a health professional.

The self-adhesive surgical tapes will be applied to your upper back. The amount of allergen contained in each patch has been specially chosen. The amount is high enough to cause a reaction and low enough to minimise the risk of skin irritation. The doctor will probably mark the location of the plasters on your back with a pen. The locations are marked in order to know exactly where a possible reaction from the plasters will appear. You should wear the test strips for at least 48 hours without removing them.

You should be careful not to get the test area wet. After 48 hours you or your doctor may remove the plasters. The doctor will examine your back 72-96 hours after application to see any signs of an allergic reaction. This

reaction usually consists of a rash with swelling, redness and tiny blisters. Redness alone does not necessarily mean that you have had an allergic reaction.

A few of the allergens sometimes cause reactions until 4-5 days after application of the test strips. Please tell your doctor if this happens.

If you are allergic, your doctor will provide you with the following information:

•    Where in your everyday surroundings, you are likely to come into contact with the offending substances.

•    How to best avoid these substances. Your doctor may suggest alternatives to the items you should avoid.

If you use more TRUE Test than you should

This is not possible, as your doctor or skin specialist will use TRUE Test only as directed. However, if a severe patch test reaction develops, your doctor may treat you with a steroid preparation.

Please consult your doctor immediately, if you have a severe patch test reaction.

If you forget to use TRUE Test

This does not apply as your doctor or skin specialist will use TRUE Test as directed above.

If you stop using TRUE Test

Do not stop using TRUE Test without talking to your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, TRUE Test can cause side effects, although not everybody gets them.

The side effects could include:

Very common side effects (affects more than 1 in 10 people):

• Irritation caused by the surgical tape adhesive may occur, but usually disappears rapidly. Itching of the skin under the tape may occur. Try not to scratch the affected area. If you do, the skin may become irritated and itch even more. Skin that has become red and irritated by scratching will make it difficult to interpret the results.

•    Long-lasting test teactions. A positive test reaction usually disappears within 1-2 weeks, whereas a long-lasting test reaction may persist for weeks or months.

Common side effect (affects more than 1 in 100 people but less than 10 people):

•    Test reactions may leave a temporary area of either pale of darker coloured skin.

Uncommon side effect (affects more than 1 in 1,000 people but less than 1 in 100 people):

•    A flare-up of your dermatitis.

Rare side effect (affects more than 1 in 10,000 people but less than 1 in 1000 people):

•    sensitisation to a substance on the test panel. A test reaction that appears later than 10 days after application may be a sign of contact sensitisation. Contact sensitisation occurs in case a patient develops an allergy to a substance due to the use of TRUE Test. This may in rare instances occur with patch testing.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5. HOW TO STORE TRUE Test

Store in a refrigerator (2-8 °C).

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

Do not use TRUE Test after the expiry date which is stated on the foil pouches. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. At the end of the test period, return any leftover TRUE Test to your hospital or pharmacist. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What TRUE Test contains

In addition to the active substances indicated on the first page, the test contains the following excipients: Tape of cellulose acetate with acrylic adhesive, polyester patches, povidone 90, hydroxypropylcellu-lose, methylcellulose, b-cyclodextrin, sodium carbonate and sodium bicarbonate.

What TRUE Test looks like and contents of the pack

Each panel is coated with a protective foil consisting of silicone-coated polyethylene and packed in sealed pouches of laminated foil.

The Panel 2 foil pouch also contains a special type of paper (desiccant) to keep the allergens fresh during storage.

Contents of the pack: 10 test units (1 test unit = one Panel 1 and one Panel 2).

Marketing Authorisation Holder and Manufacturer

SMARTPRACTICE DENMARK ApS DK-3400 Hillerod • Denmark.

Distributed by:

Diagenics Ltd

South House 3, Bond Avenue, Bletchley Milton Keynes MK1 1SW, United Kingdom

PACKAGE LEAFLET: INFORMATION FOR THE USER

TRUE TEST™

PLASTER FOR PROVOCATION TEST

TRUE Test consists of 2 strips of surgical tape, each strip contains 12 patches. Each patch is coated with a film containing a specific allergen or a mix of allergens.

Panel 1

Micrograms/ Micrograms/

		crrr	patch
□	Nickel sulphate	200	160
□	Wool alcohols	1000	810
El	Neomycin sulphate	230	190
□	Potassium dichromate	23	19
□	Caine mixa)	630	510
□	Fragrance mixb)	430	350
H	Colophony	850	690
□	Epoxy resin	50	41
□	Quinoline mixc)	190	154
EE	Balsam of Peru	800	650
ED	Ethylenediamine dihydrochloride	50	41
EE	Cobalt Chloride	20	16

This leaflet was last revised in July 2012 Your appointments 1st day

Date:	Time:
2nd day
Date:	Time:
3rd day
Date:	Time:

52-0154-SPCupdate

	Panel 2
EE	p-tert Butylphenol formaldehyde resin	50	41
ED	Paraben mixd) 1000		800
EE	Carba mix*1	250	200
EE	Black rubber mix0	75	60
EB	C!+ Me-isothiazoiinone (Kathon CG)	4	3.2
EE	Quaternium-15	100	81
EE	Mercaptobenzothiazole	75	61
S3	p-Phenyienediamine	90	73
51	Formaldehyde g)	180	150
	Mercapto mixh)	75	60
S3	Thiomersal	8	6.5
m	Thiuram mix0	25	20