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COLOURSTART TEST 65 MCG CUTANEOUS PATCH

Active substance(s): PARAPHENYLENEDIAMINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Colourstart® Test 65 mcg Cutaneous Patch
p-Phenylenediamine: 80 mcg/cm2 65 mcg/patch
Read all of this leaflet carefully before you start using this medicine.
 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.

1.
2.
3.
4.
5.
6.

What Colourstart is and what it is used for
Before you use Colourstart
How to use Colourstart
Possible side effects
How to store Colourstart
Further information

1. What Colourstart is and what it is used for
Colourstart 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.
Colourstart is a ready-to-use patch test for finding if your
allergic contact dermatitis is due to p-Phenylenediamine
(PPD).

Colourstart works by showing if you are allergic to the PPD
(allergen) on the patch. If a substance to which you are
allergic comes into contact with your skin it causes an inflammatory reaction called contact dermatitis. This substance
could be an ingredient in your hair dye. PPD is a well-known
allergen. If you are allergic to PPD, then the skin under that
patch will react to it, becoming red and inflamed. If you are
not allergic to PPD, the skin under it will not react.

The test consists of surgical tape with two patches. One of
the patches contains PPD and the other is a control.

2. Before you use Colourstart
Do not use Colourstart
 if you know you are allergic (hypersensitive) to any of the
ingredients of Colourstart
 if you have large areas of active contact dermatitis on your
skin
 if you are pregnant
 if the patient is a child due to limited clinical investigation
of patch testing on children.
Take special care with Colourstart
 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.
 to avoid sweating profusely while wearing the patch test. 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 and may give rise to false positives. If in
doubt, your doctor may decide to repeat the test another
day.
You should talk to your doctor before using Colourstart if any
of these factors apply to you. Your doctor will be able to decide
what to do.
Children: Colourstart is not recommended for use in children.

In rare instances you may become sensitive to the substance
on the patch while using Colourstart. A test reaction that
appears later than 10 days after application may be a sign of
contact sensitisation.
Colourstart should be applied only to skin that is
 free of acne
 free of scars

 free of dermatitis
 in a condition, which cannot 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 plaster to loosen.
Use adhesive tape, if for any reason an area of the plaster
does become loose.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription, before Colourstart is applied.
Remember that the skin specialist may not be aware of your
other medicines.
Using Colourstart with food and drink
You should ask your doctor about what you can eat and drink
while you are using Colourstart.
Pregnancy and breast feeding
Pregnant women should not use Colourstart. 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 Colourstart.

Driving and using machines
Colourstart 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 Colourstart
Always use Colourstart exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.

the plaster at the edge with
finger tips place it on the
upper arm (above the
elbow but below the
shoulder) where you will be
able to see the test results.
The plaster should be
smoothed from the centre
to the outer edges (see
figure 2).

Colourstart will usually be given to you by a health professional. The instructions and diagrams below relate to use of
the test on the upper arm but the test can also be applied to
the back, about 5cm above the midline.
Peel open the package and remove the plaster. Remove the
tabs marked "1" from the surface of the plaster whilst taking
care not to touch the plasters (see figure 1). Whilst holding

figure 1
Continued overleaf

3. How to use Colourstart (continued from overleaf)
2” should then be remove
The second tabs, marked with a “2”
removed
o
(see figure 3). Whilst wearing the plaster, avoid exposure of
g and exposure to the sun.
sun
the test site to excessive sweating

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 PPD.
 How to best avoid this substance. Your doctor may
suggest alternatives to the items you should avoid.
If you use more Colourstart than you should
This is not possible, as your doctor will use Colourstart only
as directed. However, if a severe patch test reaction develops, your doctor may treat you with a steroid preparation.

figure 2

figure 3

Once the plaster is in place you will see one clear patch
measuring 0.81 cm2 marked “A+”, which is the active patch
containing PPD and one clear patch measuring 0.81 cm 2
marked “A-”, which is the control patch with no allergen
materials.
You should wear the test strip for at least 48 hours without
removing it. You should be careful not to get the test area
wet. After 48 hours you or your doctor may remove the
plaster.

Please consult your doctor immediately, if you have a severe
patch test reaction.
If you forget to use Colourstart
This does not apply as your doctor will use Colourstart as
directed above.
If you stop using Colourstart
Do not stop using Colourstart without talking to your doctor
first.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

The doctor will examine your arm 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.
PPD sometimes causes reactions until 4–5 days after application of the test strips. Please tell your doctor if this
happens.

4. Possible side effects
Like all medicines, Colourstart can cause side effects,
although not everybody gets them.
The side effects could include:
 a flare-up of your dermatitis, if the test is used during an
active phase of your skin disease.
 sensitisation to the 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 Colourstart. This may in rare instances
occur with patch testing.
 on rare occasions, test reactions may last for a month.

Such reactions will leave a temporary area of pale skin.
However, a positive test reaction usually disappears within
1-2 weeks.
 irritation caused by the surgical tape adhesive may occur,
but usually disappears rapidly.
 itching of the skin under the test panel 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.
If any of the side effects gets serious, or if you notice any side
effects not listed in the leaflet, please tell your doctor.

5. How to store Colourstart
Keep this medicine out of the sight and reach of children.

Medicines should not be disposed of via wastewater or
household waste.

Colourstart should be stored below 25°C.
Do not use Colourstart after the expiry date which is stated on
the foil pouch. The expiry date refers to the last day of that
month.

6. Further information
What Colourstart contains
 The active substance in the test patch is:
p-Phenylenediamine

This leaflet was last revised in February 2015
Your appointments
1st appointment

 Other ingredients in the patch are:
ethanol 99.5%
polyvidone 90

Date/Time:
2nd appointment

What Colourstart looks like and contents of the pack:
Colourstart is available as one self-adhesive plaster inside a
foil pouch.
The foil pouch also contains a special type of paper
(desiccant) to keep the allergen fresh during storage.

Date/Time:
3rd appointment
Date/Time:

Marketing Authorisation Holder
Trichocare Diagnostics Ltd
Berry End Farm House
Berry End
Eversholt
Bedfordshire MK17 9EB
United Kingdom.
Manufacturer
Smartpractice Denmark ApS
DK-3400 Hillerod
Denmark

© 2015 Trichocare Diagnostics Ltd. ‘Colourstart’ and the
hexagon logo are registered trademarks belonging to
Trichocare Diagnostics Ltd.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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