Colourstart Test 65 Mcg Cutaneous Patch
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.
In this leaflet:
1. What Colourstart is and what it is used for
2. Before you use Colourstart
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3. How to use Colourstart
4. Possible side effects
5. How to store Colourstart
6. Further information
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).
The test consists of surgical tape with two patches. One of the patches contains PPD and the other is a control.
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.
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.
Always use Colourstart exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
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 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).
figure 1
Continued overleaf
3. How to use Colourstart (continued from overleaf)
The second tabs, marked with a “2” should then be removed (see figure 3). Whilst wearing the plaster, avoid exposure of the test site to excessive sweating and exposure to the sun.
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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 cm2 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.
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.
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.
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.
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.
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.
Medicines should not be disposed of via wastewater or household waste.
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6. Further information | |
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What Colourstart contains |
This leaflet was last revised in February 2015 |
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* The active substance in the test patch is: |
Your appointments |
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p-Phenylenediamine |
1st appointment |
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* Other ingredients in the patch are: ethanol 99.5% |
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polyvidone 90 |
2nd appointment |
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What Colourstart looks like and contents of the pack: Colourstart is available as one self-adhesive plaster inside a foil pouch. |
Date/Time: |
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The foil pouch also contains a special type of paper |
3rd appointment |
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(desiccant) to keep the allergen fresh during storage. |
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Marketing Authorisation Holder Trichocare Diagnostics Ltd Berry End Farm House Berry End Eversholt Bedfordshire MK17 9EB United Kingdom. | |
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Manufacturer Smartpractice Denmark ApS DK-3400 Hillerod Denmark | |
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© 2015 Trichocare Diagnostics Ltd. ‘Colourstart’ and the hexagon logo are registered trademarks belonging to Trichocare Diagnostics Ltd. |
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