Pollinex + Rie

Package Leaflet: Information for the User

POLLINEX + Rye

600 SU/ml, 1600 SU/ml, 4000 SU/ml – basic treatment
4000 SU/ml – maintenance treatment
suspension for injection
Mixture of allergoids from 13 grass pollen

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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is POLLINEX+Rye and what is it used for

POLLINEX + Rye is a medicine that contains a mixture of modified extracts (allergoids)
from the pollen of 13 commonly encountered grasses.
POLLINEX + Rye is used to treat allergic rhinitis, allergic conjunctivitis
and mild or moderate allergic asthma, caused by grass pollen, in adults,
adolescents and children over 6 years old.
In the case of allergic rhinitis, the presence of pollen causes sneezing, a stuffy nose, runny nose and
burning and tearing of the eyes. The modified grass pollen extracts (allergoids) in POLLINEX + Rye are released gradually, which reduces the risk of side effects.

2. Important information before using POLLINEX+Rye

When not to use POLLINEX + Rye:

• 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 a transplant, or when taking medications that weaken the immune system,
• if the patient has been diagnosed with cancer,
• if the patient is taking beta-blockers, e.g. atenolol, used to treat conditions such as high blood pressure and heart rhythm disorders,
• if the patient has contraindications to the use of epinephrine (adrenaline),
• 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 black urine),
• if the patient has intolerance to phenol, glycerol or any other component of this 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 + Rye, but the decision to use the medicine will be made by your doctor.
As far as possible, avoid exposure to grass pollen.

Other medicines and POLLINEX + Rye

• Do not take POLLINEX + Rye at the same time as beta-blockers.
• Do not take POLLINEX + Rye 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 + Rye:

• antihistamines used to treat allergic conditions such as allergic rhinitis, rash and facial and throat swelling,
• corticosteroids used to treat conditions such as asthma, runny nose and nasal swelling,
• mast cell stabilizers used to treat conditions such as runny nose, nasal swelling, 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 + Rye 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 + Rye. 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 penetration of POLLINEX + Rye into breast milk.

Driving and using machines

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

POLLINEX + Rye contains sodium

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

3. How to use POLLINEX + Rye

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

Dosing schedule

*SU - standardized units
Tell your doctor if the interval between injections of POLLINEX + Rye 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 + Rye 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 + Rye and another vaccine.
The next doseof POLLINEX + Rye can be injected after two weeks from another vaccination, provided that all symptoms related to any side effects caused by the previous vaccination have completely subsided.

Use of a higher than recommended dose of POLLINEX + Rye

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 related to the dose of the medicine.

Missing a dose of POLLINEX + Rye

Follow the schedule for injecting POLLINEX + Rye. 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 + Rye

If the use of POLLINEX + Rye 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 hands 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 injection of 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al.Jerozolimskie181C, 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 + Rye

• 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 stated.
• 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 + Rye contain

• The active substance of the medicine is a mixture of allergoids from the pollen of 13 grasses:
• meadow foxtail (Alopecurus pratensis)
• crested dog's-tail (Cynosurus cristatus)
• cocksfoot (Dactylis glomerata)
• perennial ryegrass (Lolium perenne)
• smooth meadow-grass (Poa pratensis)
• sweet vernal grass (Anthoxanthum odoratum)
• meadow fescue (Festuca pratensis)
• red fescue (Festuca rubra)
• timothy grass (Phleum pratense)
• brome grass (Bromus spp.)
• tall oat-grass (Arrhenatherum elatius)
• Yorkshire fog (Holcus lanatus)
• rye (Secale cereale)
• -The other ingredients are: L-tyrosine, phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, glycerol, water for injections

What does POLLINEX + Rye look like and what does the pack contain:

POLLINEX + Rye 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 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 for highly sensitized patients
Maintenance treatment:doses should be injected at intervals of 1-4 weeks (up 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