PATIENT INFORMATION LEAFLET

Phleum pratensepollenSoluprick 10 HEP solution for prick testing with allergens

by puncture

Read this leaflet carefully before you start using this medicine.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor or pharmacist.

- If you think you have suffered a side effect, report it to your doctor or pharmacist.

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

2. Before using Phleum pratense pollen Soluprick

3. How to use Phleum pratense pollen Soluprick

4. Possible side effects

5. Storage of Phleum pratense pollen Soluprick

6. Additional information

Pollen ofPhleum pratenseSoluprick is used to check if you are allergic. This medication is solely for diagnostic use. It is a solution (2 ml) for prick testing with allergens, which contains timothy grass pollen extract (Phleum pratense). An allergen is a substance that causes an allergic disease.

No use Pollen ofPhleum pratenseSoluprick

• If you are allergic (hypersensitive) to any of the components of Pollen ofPhleum pratenseSoluprick, apart from the active ingredient (see section 6.Additional information).

• If you are taking any medication that contains beta-blockers (“beta-blockers”) to control your blood pressure.

• If you have skin problems in the area where the product will be applied to perform the allergen prick test.

Inform your doctor if any of these conditions affect you.

Use of other medications:

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

Some medications may affect the results of the allergen prick test, therefore:Inform your doctor or healthcare professional before undergoing the allergen prick test if you are taking any of the following medications, or if you meet any of the following conditions:

Medications:

• Antihistamines of short duration during the last two to three days;

• Antihistamines of long duration during the last eight weeks;

• Medications containing hydroxyzine during the last two weeks;

• Medications containing ketotifen during the last two weeks;

• Steroids at doses greater than 10 mg of prednisolone per day;

• Steroid preparations applied to the skin during the last two to three weeks.

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

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

Antidepressants may interfere with the result of the allergen prick test. You should consult with your doctor about the risk of discontinuing treatment with an antidepressant compared to the benefits of undergoing the allergen prick test.

Pregnancy and breastfeeding

There is not enough experience in the use of Pollen ofPhleum pratenseSoluprick during pregnancy.

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

The allergen prick test can be performed during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

The influence of Pollen ofPhleum pratenseSoluprick on the ability to drive and use machines is negligible.

Allergen prick testing is possible as early as the first year of life

depending on the child's constitution, but in general, it should not be performed 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 allergen prick test is usually performed on the inner aspect of the forearm. Alternatively,

the test can be done 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 controls are applied in small drops on the skin at an

adequate distance from each other (a numbered tape can be used).

• The doctor/nurse pierces 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, elevated swelling

or a papule with a red border.

If you use more Phleum pratense Soluprick than you should

No cases of overdose have been reported

Like all medications, Pollen fromPhleum pratenseSoluprick may

produce adverse effects, although not all people will experience them.

Very frequently (in more than 1 in 10 patients) a papule may form that gradually spreads in the area

over 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 rare cases (less than 1 in 10,000 patients) anaphylactic reaction (a severe body-wide reaction recognized by the appearance of papules, itching, difficulty breathing, or fainting) may occur after performing the test with active allergens by puncture.

If this happens, your doctor or healthcare professional will have an emergency team available with an adrenaline pen ready for use.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,

even if it is a possible adverse effect not listed in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

• Keep out of the reach and sight of children.

• Store in the 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 Phleum pratenseSoluprickpollen after the expiration date that appears on

the packaging. The expiration date is the last day of the month indicated.

The medicines should not be thrown away through the drains or in the trash. Dispose of the packaging and the

medicines that you do not need at the SIGRE collection pointof the pharmacy. In case of

doubt, ask your pharmacist how to dispose of the packaging and the medicines that you do not need. In this way, you will help to protect the environment.

Composition of Pollen fromPhleum pratenseSoluprick

• The active principle is a standardized allergenic extract. The activity is related to the

biological activity (SQ). The active principle is the standardized allergenic extract of

timothy grass pollen (Phleum pratense) 10 HEP.

• The other components are: Disodium phosphate dihydrate, sodium phosphate dihydrate, sodium chloride, glycerol, phenol, sodium hydroxide or hydrochloric acid (for pH adjustment) and water for

injectable preparations.

Appearance of the product and contents of the package

Pollen fromPhleum pratenseSoluprick is supplied as a solution for allergen testing by

puncture.

One package contains 1 vial of 2 ml.

Marketing Authorization Holder:

ALK-Abelló A/S

Bøge Allé 6-8

DK-2970 Hørsholm

Denmark

Responsible for Manufacturing:

ALK-Abelló, S.A.

Miguel Fleta, 19

E-28037 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names

This leaflet was approved in April 2014

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es