PHLEUM PRATENSE POLLEN SOLUPRICK 10 HEP ALLERGEN PRICK TEST SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pollen of Phleum pratenseSoluprick 10 HEP solution for allergy testing by prick

prick

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

Contents of the pack:

1. What is Pollen of Phleum pratense Soluprick and what is it used for
2. Before using Pollen of Phleum pratense Soluprick
3. How to use Pollen of Phleum pratense Soluprick
4. Possible side effects
5. Storage of Pollen of Phleum pratense Soluprick
6. Further information

1. What is Pollen of Phleum pratense Soluprick and what is it used for

Pollen of Phleum pratenseSoluprick is used to check if you are allergic. This medicine is for diagnostic use only. It is a solution (2 ml) for allergy testing by prick, containing an extract of timothy grass (Phleum pratense) pollen. An allergen is a substance that causes an allergic disease.

2. Before using Pollen of Phleum pratense Soluprick

Do not use Pollen ofPhleum pratenseSoluprick

• If you are allergic (hypersensitive) to any of the components of Pollen of Phleum pratense Soluprick, apart from the active ingredient (see section 6. Further information).
• If you are taking any medication that contains beta blockers to control your blood pressure.
• If you have skin problems in the area where the product is to be applied for the allergy test by prick.

Tell your doctor if any of these conditions apply to you.

Use of other medications:

Tell your doctor or pharmacist if you are using or have recently used any other medications, including those bought without a prescription.

Some medications may alter the results of the allergy test by prick, therefore:Inform your doctor or healthcare professional before carrying out the allergy test by prick, if you are taking any of the following medications, or meet any of the following conditions:

Medications:

• Short-acting antihistamines in the last two to three days;
• Long-acting antihistamines in the last eight weeks;
• Medications containing hydroxyzine in the last two weeks;
• Medications containing ketotifen in the last two weeks;
• Corticosteroids at doses greater than 10 mg of prednisolone per day;
• Potent corticosteroid preparations applied to the skin in the last two to three

weeks.

Application to the skin of corticosteroids at doses less than 30 mg of prednisone/prednisolone per day, for a period of up to one week, does not reduce the response to the allergy test by prick.

Treatment with tablets of less than 10 mg of prednisolone per day will not suppress the reaction to the allergy test by prick.

Antidepressants may interfere with the result of the allergy test by prick. You should consult your doctor about the risk of stopping treatment with an antidepressant compared to the benefits of carrying out the allergy test by prick.

Pregnancy and breastfeeding

There is not enough experience with the use of Pollen of Phleum pratense Soluprick during pregnancy.

This product should not be used in pregnant women unless the doctor considers that the benefit outweighs the risks.

The allergy test by prick can be performed during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

The influence of Pollen of Phleum pratense Soluprick on the ability to drive and use machines is nil.

3. How to use Pollen of Phleum pratense Soluprick

The allergy test by prick is possible from the first year of life, depending on the child's constitution, but it should not be carried out before the age of 4 years.

This medication will be applied exclusively by qualified healthcare professionals, who will give you the instructions to follow. The procedure is as follows:

• The allergy test by prick is usually carried out on the inner side of the forearm. Alternatively, the test can be performed on the back.

The skin must be dry and clean, and must be disinfected with alcohol by the nurse or doctor.

• The preparations for the test and the controls are applied in small drops on the skin at a suitable distance from each other (a numbered tape can be used).

The doctor/nurse pricks the superficial layer of the skin with an ALK lancet through the drops.

• The reaction is read after 15 minutes. A positive reaction is a small, pale, raised swelling, or a papule with a red border.

If you use more Pollen ofPhleum pratenseSoluprick than you should

Overdose cases are not known

4. Possible side effects

Like all medicines, Pollen of Phleum pratense Soluprick can cause side effects, although not everybody gets them.

Very frequently (in more than 1 in 10 patients) a papule may form that gradually extends in the area, during the first 10-20 minutes after application of the allergen.

Very frequently (in more than 1 in 10 patients) extensive local swelling and redness may appear 6-24 hours after application of the allergen.

In very rare cases (less than 1 in 10,000 patients) an anaphylactic reaction (a severe whole-body reaction recognized by the appearance of papules, itching, difficulty breathing, or fainting) may occur after carrying out the allergy test by prick with active allergens. If this happens, your doctor or healthcare professional will have an emergency kit available with an adrenaline syringe "ready for use".

If you experience any of these changes, inform your doctor or nurse immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

You can also report side effects directly through the Spanish Medicines Agency's website www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Pollen of Phleum pratense Soluprick

• Keep out of the reach and sight of children.
• Store in a refrigerator (between 2°C-8°C). Once opened: the product must be stored for a maximum of 6 months at 2°C-8°C (after which it must be discarded).

Do not use Pollen of Phleum pratense Soluprick after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Further information

Composition of Pollen ofPhleum pratenseSoluprick

• The active ingredient is a standardized allergenic extract. The activity is related to the biological activity (SQ). The active ingredient is the standardized allergenic extract of timothy grass (Phleum pratense) pollen 10 HEP.
• The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, glycerol, phenol, sodium hydroxide or hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and packaging contents

Pollen of Phleum pratenseSoluprick is supplied as a solution for allergy testing by prick.

One pack contains 1 vial of 2 ml.

Marketing authorisation holder:

ALK-Abelló A/S

Bøge Allé 6-8

DK-2970 Hørsholm

Denmark

Manufacturer:

ALK-Abelló, S.A.

Miguel Fleta, 19

E-28037 Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names

This leaflet was approved in April 2014

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es