Pollinex Tree

Package Leaflet: Information for the User

POLLINEX Tree

600 SU/ml, 1600 SU/ml, 4000 SU/ml – basic treatment
4000 SU/ml – maintenance treatment
suspension for injection
Mixture of allergoids from 3 tree pollens

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is POLLINEX Tree and what is it used for
• 2. Important information before using POLLINEX Tree
• 3. How to use POLLINEX Tree
• 4. Possible side effects
• 5. How to store POLLINEX Tree
• 6. Contents of the pack and other information

1. What is POLLINEX Tree and what is it used for

POLLINEX Tree is a medicine that contains a mixture of modified extracts (allergoids)
from the pollen of 3 commonly encountered trees.
POLLINEX Tree is used to treat allergic rhinitis, allergic conjunctivitis
and mild or moderate allergic asthma, caused by tree pollen, in adults,
adolescents and children over 6 years old.
In the case of allergic rhinitis, the presence of pollen causes sneezing, runny nose, nasal congestion and
eye burning and tearing. The modified pollen extracts (allergoids) contained in POLLINEX Tree are released gradually, which reduces the risk of side effects.

2. Important information before using POLLINEX Tree

When not to use POLLINEX Tree:

• if the patient has a lung disease, such as chronic obstructive pulmonary disease (COPD), bronchiectasis,
• if the patient has severe asthma,
• if the patient has a chronic or acute infection or inflammation (fever),
• if the patient has been diagnosed with an autoimmune disease, such as:
• rheumatoid arthritis,
• type 1 diabetes,
• multiple sclerosis,
• if the patient has an immune deficiency. Immune deficiency may occur in the case of certain diseases (e.g. HIV) or after transplantation or when taking immunosuppressive drugs,
• if the patient has been diagnosed with cancer,
• if the patient is taking beta-blocker medicines, such as atenolol,used to treat conditions such as high blood pressure and heart rhythm disorders,
• if the patient has a contraindication to the use of adrenaline (epinephrine),
• if the patient has a disorder of tyrosine metabolism, including tyrosinemia (elevated tyrosine levels in the blood) and alkaptonuria (causing skin and eye pigmentation, joint degeneration and dark urine),
• if the patient has a hypersensitivity to phenol, glycerol or any of the other ingredients of the medicine, listed in section 6.

Warnings and precautions

Tell your doctor if you have any heart or lung disease. This does not exclude the use of POLLINEX Tree, but the doctor will decide whether to use the medicine.
Whenever possible, avoid exposure to tree pollen.

Other medicines and POLLINEX Tree

• Do not take POLLINEX Tree at the same time as beta-blocker medicines.
• Do not take POLLINEX Tree at the same time as medicines that weaken the immune system.

Tell your doctor or pharmacist about the use of the following medicines before using POLLINEX Tree:

• antihistamine medicines, used to treat allergic conditions such as allergic rhinitis, rash and facial and throat swelling,
• corticosteroids ,used to treat conditions such as asthma, cold and nasal congestion,
• mast cell stabilizers ,used to treat conditions such as cold, nasal congestion, asthma and eye itching or burning.

Tell your doctor about all the medicines you are taking now or have taken recently, and about the medicines you plan to take.

POLLINEX Tree with food, drink and alcohol

Do not eat a heavy meal or drink alcohol immediately before the planned injection of the medicine.

Pregnancy and breastfeeding

Pregnant women should not start using POLLINEX Tree. If a woman becomes pregnant during treatment, therapy can be continued after a thorough assessment of her overall health and reaction to previous doses of the medicine.
There is no data on the passage of POLLINEX Tree into breast milk.

Driving and using machines

This medicine may occasionally cause mild drowsiness. If this occurs, do not drive or operate machinery.

POLLINEX Tree contains sodium

POLLINEX Tree contains less than 1 mmol (23 mg) of sodium per dose, which means it is "sodium-free".

3. How to use POLLINEX Tree

This medicine should not be used during the tree pollen season.
Therapy with POLLINEX Tree should be carried out by a specialist allergist in a clinic equipped with an emergency kit.
POLLINEX Tree should be injected subcutaneously with constant pressure on the syringe plunger.
POLLINEX Tree should not be used in children under 6 years old.

Dosing schedule

*SU stands for standard units
Tell your doctor if the interval between injections of POLLINEX Tree is longer than 14 days in the case of basic treatment or longer than 6 weeksin the case of maintenance treatment, as it may be necessary to reduce the dose or restart treatment.
It is recommended that POLLINEX + Tree treatment be continued for three to five years.
The patient should remain under medical supervision for at least 30 minutesafter each injection,
as they may require treatment if an allergic reaction occurs or until the symptoms of the reaction subside.
Do not rub the injection site.
Do not engage in intense physical activity within 12 hours before and after the injection.

Other vaccinations

If the patient has scheduled other preventive vaccinations against bacteria or viruses (e.g. flu vaccination), it is necessary to allow an interval of at least one week between the injection of POLLINEX Tree and another vaccine.
The next doseof POLLINEX Tree can be injected after two weeks from another vaccination,
provided that all symptoms associated with any side effects caused by the previous vaccination have completely subsided.

Using a higher dose of POLLINEX Tree than recommended

The medicine will be injected by a doctor or nurse, so it is unlikely that an incorrect dose will be administered. Tell your doctor about any doubts regarding the dose of the medicine being administered.

Missing a dose of POLLINEX Tree

Follow the schedule for injecting POLLINEX Tree. If the interval between doses exceeds 14 days in the case of basic treatment or 6 weeks in the case of maintenance treatment, tell your doctor or nurse, as it may be necessary to reduce the dose.

Stopping the use of POLLINEX Tree

If the use of POLLINEX Tree is stopped without consulting a doctor, the symptoms of the disease may worsen.
If you have any further doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical attention immediately if you experience any of the following symptoms:

• itching or a feeling of heat - especially on the skin of the head, in the mouth, throat, on the palms or soles of the feet,
• anxiety,
• dizziness,
• low blood pressure,
• rapid heartbeat,
• loud wheezing or difficulty breathing,
• swelling in the mouth or throat that makes breathing difficult,
• nausea and vomiting,
• pale or bluish skin color,
• loss of consciousness or fainting.

Anaphylactic shock may occur within a few minutes after injecting this medicine, often before the onset of a reaction at the injection site .

Other side effects that may occur:

• swelling or redness at the injection site,
• transient thickening or a lump caused by inflammation of the tissue at the injection site,
• eye burning,
• sneezing,
• coughing,
• recurrence or worsening of eczema,
• fever,
• feeling of weakness or numbness,
• joint pain,
• hives,
• swelling, especially of the mouth, face, tongue, or hands and feet,
• difficulty breathing or wheezing.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store POLLINEX Tree

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Before use, warm the vial to room temperature.
• Discard the vials after 10 weeks from the first opening.
• Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What does POLLINEX Tree contain:

• The active substance of the medicine is a mixture of allergoids from 3 tree pollens:
• alder ( Alnus spp.)
• birch ( Betula spp.)
• hazel ( Corylus spp.)
• The other ingredients are: L-tyrosine, phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, glycerol, water for injections

What POLLINEX Tree looks like and what the pack contains

POLLINEX Tree is a white, turbid suspension for injection.
The medicine is available in two kits:

Basic treatment

3 vials of 1.0 ml suspension:
Vial No. 1 (green) 600 SU/ml
Vial No. 2 (yellow) 1600 SU/ml
Vial No. 3 (red) 4000 SU/ml
5 single-use syringes and 5 single-use needles

Maintenance treatment

1 vial of 1.5 ml suspension:
Vial No. 3 (red) 4000 SU/ml
3 single-use syringes and 3 single-use needles

Marketing authorization holder and manufacturer

Manufacturer

Allergy Therapeutics (UK) Limited
Dominion Way
Worthing
West Sussex
BN14 8SA
United Kingdom

Marketing authorization holder

Allergy Therapeutics Ibérica, S.L.U.;
Avenida de Barcelona 115, Edificio Brasol, 2 planta

• 08970 - Sant Joan Despí Barcelona Spain

Date of last revision of the package leaflet

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Information intended for healthcare professionals only:

Dosing schedule

Ref. No.:
Patient:
Date of birth:
Basic treatment:doses should be injected at intervals of 7 to a maximum of 14 days.

*alternative dose applies to highly allergic patients
Maintenance treatment:doses should be injected at intervals of 1-4 weeks (may be extended to 6 weeks).

Exceeding the recommended interval between injections:

If the recommended interval between injections is exceeded, the dose should be modified as follows:
Basic treatment

Interval of 1-2 weeks between injections

Maintenance treatment

Interval of 1-4 weeks between injections (may be extended to 6 weeks)

Dose modification in case of strong reaction after injection