Pollen of Phleum pratense Soluprick 10 HEP allergen solution for skin prick test

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Phleum pratense pollen Soluprick 10 HEP allergen solution for skin prick testing

Read the entire leaflet carefully before you start using this medicine , because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• Consult your doctor or pharmacist if you experience any adverse reactions, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Phleum pratense pollen Soluprick is and what it is used for
2. What you need to know before using Phleum pratense pollen Soluprick
3. How to use Phleum pratense pollen Soluprick
4. Possible adverse effects
5. How to store Phleum pratense pollen Soluprick
6. Contents of the pack and other information

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

Polen de Phleum pratense Soluprick is used to check whether you are allergic. This medicine is for diagnostic use only. It is a solution (2 ml) for skin prick testing with allergens, containing an extract of timothy grass pollen (Phleum pratense). An allergen is a substance that causes an allergic disease.

2. What you need to know before using Phleum pratense Pollen Soluprick

Do not use Phleum pratense Pollen Soluprick

• If you are allergic (hypersensitive) to any of the components of Phleum pratense Pollen Soluprick, other than the active substance (see section 6.).

Inform your doctor if this condition applies to you.

Warnings and precautions

Talk to your doctor before using Phleum pratense Pollen Soluprick

• If you are being treated with beta-blockers

• If you have heart disease

• If you have asthma

• If you have skin problems in the area where the allergen skin prick test is to be applied (e.g., eczema, skin infections, or sunburn)

• If you have a disease affecting your general state of health

• If you have severe allergic symptoms on the day the allergen skin prick test is to be performed

Other medicines and Phleum pratense Pollen Soluprick:

Tell your doctor or healthcare professional if you are using or have recently used any other medicines, including those obtained without a prescription.

Some medicines may alter the results of the allergen skin prick test; therefore: Inform your doctor or healthcare professional before undergoing the allergen skin prick test if you are taking any of the following medicines:

• Antihistamines with short duration of action within the last three days;

• Antihistamines with long duration of action within the last week;

• Steroids at doses exceeding 10 mg of prednisolone per day during the last three weeks;

• Potent steroid preparations applied to the skin during the last three weeks;

• Tricyclic antidepressants;

• Omalizumab (a medicine used for allergic asthma and/or inflammation of the nose and paranasal sinuses) within the last four to six weeks;

• Beta-blockers;

• Allergen immunotherapy (previous or current treatment);

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

Other medicines may interfere with the results of the allergen skin prick test. You should consult your doctor about the risk of stopping treatment compared to the benefits of performing the allergen skin prick test.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

There are insufficient data on the use of Phleum pratense Pollen Soluprick during pregnancy.

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

The allergen skin prick test may be performed during breastfeeding, as the amount of medicine transferred into breast milk is negligible and no effect on the infant is expected.

Driving and using machines

The influence of Phleum pratense Pollen Soluprick on the ability to drive and use machines is none or negligible.

3. How to use Phleum pratense pollen Soluprick

This medicine will be administered exclusively by qualified healthcare professionals, who will
provide you with the instructions to follow. The procedure is as follows:

• The allergen prick test is usually performed on the inner surface of the
  forearm. Alternatively, the test may be carried out on the back.

• The skin must be dry and clean, and it will be disinfected with alcohol by the nurse or
  physician.

• The test preparations and controls are applied as small drops onto the skin,
  spaced adequately apart (a numbered tape may be used).

• The physician/nurse punctures the superficial layer of the skin with a lancet through the
  drops.

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

The allergen prick test may be performed in children after the first year of life, depending on the child's constitution; however, in general, it should not be performed before the age of 4 years.

If you use more Phleum pratense pollen Soluprick than you should

The allergen prick test with Phleum pratense pollen Soluprick is administered by a healthcare professional. In case of overdose, you will remain under observation and will be treated by a healthcare professional.

4. Possible adverse effects

Like all medicines, Phleum pratense Pollen Soluprick may

cause adverse effects, although not everyone will experience them.

Very rare cases (frequency not known): an anaphylactic reaction (a severe, whole-body reaction characterized by the appearance of hives, itching, sudden swelling of the face, mouth or throat, difficulty breathing or fainting) may occur minutes after performing the allergen skin prick test with active allergens. If this happens, your doctor or healthcare professional will have emergency equipment containing adrenaline available. Inform your doctor or nurse immediately if you experience any of these symptoms.

Frequent (may affect up to 1 in 10 people): In patients undergoing the Soluprick allergen skin prick test, local allergic reactions at the application site may occur, such as skin itching, swelling at the site, skin rash and redness, pain, or inflammation with induration. A wheal may develop gradually at the site within the first 20 minutes after allergen application. In some cases, a delayed reaction in the form of diffuse swelling may appear within the following 24 hours after allergen administration.

Some people may experience adverse effects in other parts of the body apart from the application site, such as:

Uncommon adverse effects (may affect up to 1 in 100 people): Nasal swelling and runny nose, eye inflammation, and urticaria may occur.

Rare cases (may affect up to 1 in 1,000 people): Asthma symptoms may worsen.

Reporting of 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 leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse

effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Phleum pratense Pollen Soluprick

• Keep out of the reach and sight of children.
• Store in the refrigerator (between 2°C-8°C). After first opening: 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 pratense Pollen Soluprick after the expiry date stated on

the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in

doubt, ask your pharmacist how to properly dispose of unused containers and medicines.

This will help protect the environment.

6. Contents of the pack and other information

Composition of Polen de Phleum pratense Soluprick

• The active substance is a standardized allergen extract. The activity is related to the biological activity (SQ). The active substance is standardized allergen 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 injections.

Nature of the product and pack contents

Polen de Phleum pratense Soluprick is supplied as a solution for allergen skin prick testing.

One pack contains 1 vial of 2 ml.

Marketing Authorization Holder:

ALK-Abelló A/S
Bøge Allé 6-8
2970 Hørsholm
Denmark

Manufacturer:

ALK-Abelló, S.A.
Miguel Fleta, 19
E-28037 Madrid
Spain

This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

This leaflet was approved in December 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).