Staloral

Leaflet attached to the packaging: patient information

STALORALPlant-based allergen extracts
STALORALAnimal-based allergen extracts
STALORALHouse dust mite allergen extracts
STALORALFungal allergen extracts (mold fungi, dermatophytes, yeast)
STALORALMixtures of allergen extracts (plant-based, animal-based, mite, fungal)
Solution for oral and sublingual use
10; 100 IR/ml or 10; 100 IC/ml

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their disease symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is STALORAL and what is it used for

STALORAL is a medicine for specific immunotherapy, which is used in patients allergic to plant-based allergens (plant pollen), animal-based allergens, house dust mites, or fungi. A complete list of allergens is attached to this leaflet as Appendix 1.

Indications for use

Allergic diseases of a seasonal or year-round nature, manifested by rhinitis (sneezing, runny nose, or itchy nose, stuffy nose), conjunctivitis (itchy and watery eyes), or asthma (mild or moderate) in adults and children (over 5 years old). The goal of treatment with STALORAL is to increase immunological tolerance to allergens and thus alleviate allergic reactions.

2. Important information before using STALORAL

When not to use STALORAL

• if the patient has been found to be allergic (hypersensitive) to any of the other ingredients of this medicine (listed in section 6);
• if the patient has been found to have immune system disorders or diseases;
• if the patient has been found to have cancer;
• if the patient has been found to have severe or uncontrolled asthma;
• if the patient has been found to have oral thrush.

Only a doctor can determine if there are contraindications to using the medicine.

Warnings and precautions

Before starting treatment, symptoms of allergy should be stabilized with appropriate symptomatic treatment, if necessary. Before starting treatment with STALORAL, the patient should inform their doctor or pharmacist:

• if the patient has severe clinical symptoms of allergy at the start of treatment - in this case, treatment should be postponed,
• if the patient has had other diseases recently or if the allergy has worsened recently,
• if the patient is to undergo oral surgery or have a tooth extracted. Treatment with STALORAL should be discontinued until the oral cavity has fully healed,
• if the patient has had eosinophilic esophagitis in the past,
• if the patient experiences severe or persistent abdominal pain, difficulty swallowing, or chest pain during treatment,
• if the patient is on a low-sodium diet, as the medicine contains sodium (see "STALORAL contains sodium chloride"),
• if the patient is taking beta-adrenergic blockers (including eye drops or ointments).

STALORAL and other medicines

The patient should tell their doctor about all medicines they have taken recently, including those that are available without a prescription. Before starting treatment, the patient should inform their doctor:

• if the patient is taking certain antidepressants (tricyclic antidepressants or monoamine oxidase inhibitors - MAOIs), as there is a greater risk of side effects if epinephrine (prescribed in case of severe allergic reactions) is needed, even with a fatal outcome,
• if the patient is scheduled for preventive vaccination against infectious diseases. Vaccination can be performed without interrupting treatment, but only after assessing the patient's overall health.

Symptomatic treatment (e.g., with antihistamines and/or nasal corticosteroids) may be used concurrently with STALORAL.

Pregnancy and breastfeeding

Pregnant or breastfeeding women, or those planning to become pregnant, should consult their doctor or pharmacist before using this medicine. There is no experience with the use of STALORAL in pregnant or breastfeeding women, so immunotherapy should not be initiated in pregnant or breastfeeding women unless the doctor considers it necessary. Women who become pregnant or start breastfeeding during treatment with this medicine should consult their doctor about continuing treatment.

Driving and using machines

There are no contraindications to driving or using machines during treatment with STALORAL.

STALORAL contains sodium

In the case of patients on a low-sodium diet, the presence of sodium chloride in the medicine should be taken into account (one vial, i.e., 10 ml of solution, contains 590 mg of sodium chloride). See "Warnings and precautions".

3. How to use STALORAL

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. Specific immunotherapy is most effective when started in the early stages of the disease. The dose does not depend on age but on the patient's individual reactivity. In the case of seasonal allergy, it is recommended to start treatment before the pollen season and continue until the end of the pollen season. In the case of year-round allergy, it is recommended to continue treatment throughout the year. Treatment is divided into two stages:

• basic treatment - with gradual dose increase
• maintenance treatment - with a constant dose.

Before each administration of the medicine, the patient should carefully check the information on the packaging and ensure that it matches the doctor's prescription (recipe): the patient's name, the composition and concentration of the medicine, as well as the expiration date of the medicine.

Basic treatment with dose increase

The medicine is used daily, with the dose increased every day until the maintenance dose is reached, according to the following scheme: The above dosing scheme should be considered as a guideline and example of treatment. Treatment may be modified depending on the patient's condition and their reaction to treatment.

Maintenance treatment - constant dose

The maximum well-tolerated dose should be taken daily or 3 times a week.

Duration of treatment

Treatment usually lasts 3 to 5 years. The doctor will reassess treatment in case of no significant improvement in symptoms after 1 year (year-round allergy) or after the first pollen season (seasonal allergy).

Method of administration

To ensure safe use of the medicine, the patient should strictly follow the doctor's recommendations. STALORAL is administered sublingually. The medicine should be taken during the day, to empty mouth, without food and drink. Before each use of the medicine, the patient should check the expiration date and ensure that the used vial matches the doctor's prescription (recipe). The patient should use the dosing pump mechanism to administer the appropriate amount of solution directly into the mouth under the tongue. The patient should wait 2 minutes before swallowing the solution. The doctor may prescribe a different dosing schedule depending on the patient's condition and their reaction to treatment. STALORAL should be administered to children by adults. Information about the first use of the medicine: For safety reasons and to ensure that the vial remains intact, the vials are hermetically sealed with plastic and aluminum caps. The patient should always check if the medicine matches the one prescribed by the doctor. In case of doubts, the patient should consult their doctor. It is extremely important to read the instructions for using the dosing pump carefully. If necessary, the patient should ask their doctor for detailed explanations.

When using the medicine for the first time, the patient should follow the steps below:

• 1. Remove the plastic, colored part of the cap.
• 2. Pull the metal tab and completely remove the aluminum cap.
• 3. Remove the gray cork.

• 4. Remove the dosing pump from the plastic cover. Place the vial on a flat surface and then, holding it firmly with one hand, press the pump firmly onto the vial.
• 5. Remove the purple protective ring.
• 6.

Activate the pump by pressing the plunger 5 times.

The released solution should be discarded. The dosing pump measures 1 full dose of the medicine only after 5 presses.

• 7. Place the tip of the dosing pump in the mouth, directly under the tongue.
• 8. Press the plunger with a smooth motion until it stops. Use the finger that can press the hardest.
• 9. Release the pressure on the plunger completely. The patient should ensure that there is at least a 2-second interval between presses.
• 10. The patient should repeat the above procedure until they reach the number of presses prescribed by their doctor. They should keep the solution under their tongue for 2 minutes and then swallow.
• 11. After use, the patient should clean the tip of the dosing pump and put on the protective ring.

During subsequent uses, the patient should remove the protective ring and repeat the steps starting from point 7.

Use in children

Allergen immunotherapy is not recommended for children under 5 years old.

Using a higher dose of STALORAL than recommended

The patient should immediately tell their doctor or pharmacist. If a higher dose than recommended is used, the risk of side effects increases, including systemic reactions or severe local reactions.

Missing a dose of STALORAL

The patient should take the medicine in the usual dose the next day. The patient should not take a double dose to make up for a missed dose. If the patient forgets to take several consecutive doses, they should contact their doctor to determine a new treatment schedule.

Stopping treatment with STALORAL

If the patient stops using STALORAL for less than a week, they can continue treatment using the last dose. If treatment is interrupted for more than a week, the patient should consult their doctor. In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, STALORAL can cause side effects, although not everybody gets them. During treatment with STALORAL, the patient will be exposed to substances that can cause allergic reactions at the injection site and/or symptoms that can affect the whole body. Such reactions can occur at the beginning of treatment or later, during treatment.

The patient should stop using STALORAL and seek medical help immediately if they experience or notice the following symptoms:

Severe allergic reaction with rapid onset of symptoms, which affects the whole body, e.g., intense itching or rash, difficulty breathing, abdominal pain, or symptoms related to low blood pressure, such as dizziness, malaise. Tolerance to a given dose may change over time, depending on the patient's health and environment. If the patient experiences a side effect, they should consult their doctor, who may change the treatment schedule. The doctor may prescribe pre-treatment with antiallergic medicines to reduce the frequency and severity of side effects.

The following additional side effects have been observed:

Frequent (affecting less than 1 in 10 patients)
Oral disorders (e.g., swelling, discomfort, tingling, itching, numbness, blisters, ulcers), tongue swelling, throat discomfort or pain or swelling or irritation, rhinitis (stuffy nose, runny nose, sneezing, itchy nose, discomfort in the nose), cough, salivary gland disorders, itchy eyes, itchy ears, nausea, vomiting, abdominal pain, diarrhea, skin redness or itching.
Uncommon (affecting less than 1 in 100 patients)
Eye disorders (redness, irritation, tearing), herpes, hoarseness, breathing difficulties, asthma, urticaria, atypical skin allergy symptoms (burning, tingling, pricking), gastritis, esophageal spasm.
Rare (affecting less than 1 in 1000 patients)
Headache, eczema, joint pain, muscle pain, weakness, enlarged lymph nodes, fever. Additionally, the following side effects have been reported: Taste disorders, dry mouth, dizziness, facial swelling, severe allergic reactions, esophagitis.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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. 22 49 21 301, fax 22 49 21 309, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store STALORAL

Before opening: Store in a refrigerator (2°C - 8°C). After first opening: Store in a refrigerator (2°C - 8°C) for up to 30 days. During transport, vials should always be carried in an upright position. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiration date stated on the carton after the "EXP" and no longer than 30 days after first opening. The expiration date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What STALORAL contains

The active substance of STALORAL is allergen extracts or their mixtures in combination with mannitol. The amount of mannitol does not exceed 40 mg/ml. 1 vial (10 ml) of solution contains allergen extracts (according to Appendix 1) at a concentration of: 10; 100 IR*/ml (standardized allergen extract) or 10; 100 IC**/ml (non-standardized allergen extract). The qualitative composition of the active substance can be individually selected for the patient within the range of allergens listed in Appendix 1. */**) The activity of the relevant allergen expressed in IR/ml or IC/ml is given on the label.

• Other ingredients are: sodium chloride, glycerol, purified water.

What STALORAL looks like and what the pack contains

STALORAL is a clear, colorless or yellow-brown solution, depending on the type of allergen and its concentration. The basic treatment kit contains: 2 vials of 10 ml (concentration 10 IR/ml or 10 IC/ml; concentration 100 IR/ml or 100 IC/ml) and 2 dosing pumps. Blue cap - concentration: 10 IR/ml or 10 IC/ml Red cap - concentration: 100 IR/ml or 100 IC/ml The maintenance treatment kit contains: 2 vials of 10 ml (concentration 100 IR/ml or 100 IC/ml) - red caps. 2 dosing pumps.

Marketing authorization holder and manufacturer

STALLERGENES 6, rue Alexis de Tocqueville 92160 Antony, France For more information, please contact the representative of the marketing authorization holder in Poland: STALLERGENES Sp. z o.o. tel. 22 620 29 98

Date of last update of the leaflet:

STALORAL APPENDIX 1

I. Plant-based allergen extracts

Weeds

641 Alfalfa (Medicago sativa) IC/ml 664 Dandelion (Taraxacum vulgare) IC/ml 623 Fat hen (Chenopodium album) IC/ml 673 Goldenrod (Solidago canadensis) IC/ml 636 Hop (Humulus lupulus) IC/ml 605 Mugwort (Artemisia vulgaris) IR/ml 646 Black mustard (Brassica nigra) IC/ml 654 Nettle (Urtica dioica) IC/ml 643 Ox-eye daisy (Chrysanthemum leucanthemum) IC/ml 665 Plantain (Plantago) IC/ml 604 Ragweed (Ambrosia elatior) IR/ml 625 Oilseed rape (Brassica oleifera) IC/ml 710 Russian thistle (Salsola kali) IC/ml 655 Sorrel (Rumex acetosa) IC/ml 678 Sunflower (Helianthus annus) IC/ml 657 Parietaria (Parietaria officinalis) IR/ml

Grasses

601 Red fescue (Agrostis vulgaris) IC/ml 705 Bermuda grass (Cynodon dactylon) IR/ml 627 Orchard grass (Dactylis glomerata) IR/ml 624 Quackgrass (Agropyron repens) IC/ml 630 Meadow fescue (Festuca elatior) IC/ml 658 Kentucky bluegrass (Poa pratensis) IR/ml 638 Perennial ryegrass (Lolium perenne) IR/ml 631 Sweet vernal grass (Anthoxantum odoratum) IR/ml 661 Timothy grass (Phleum pratense) IR/ml 637 Velvet grass (Holcus lanatus) IC/ml

Cereals

652 Barley (Hordeum vulgare) IC/ml 642 Corn (Zea mays) IC/ml 610 Oat (Avena sativa) IC/ml 671 Rye (Secale cereale) IR/ml 614 Wheat (Triticum vulgare) IC/ml 106 Wheat flour IC/ml

Trees

609 Alder (Alnus glutinosa) IR/ml 632 Ash (Fraxinus excelsior) IC/ml 635 Beech (Fagus sylvatica) IC/ml 615 Birch (Betula alba) IR/ml 620 Chestnut (Castanea vulgaris) IC/ml 626 Cypress (Cupressus sempervirens) IC/ml 675 Elder (Sambucus nigra) IC/ml 653 Elm (Ulmus campestris) IC/ml 667 Black locust (Robinia pseudoacacia) IC/ml 649 Hazel (Corylus avellana) IR/ml 619 Hornbeam (Carpinus betulus) IR/ml 644 Horse chestnut (Aesculus hippocastanum) IC/ml 634 Juniper (Juniperus communis) IC/ml 677 Lime (Tilia platyphyllos) IC/ml 629 Sycamore (Acer pseudoplatanus) IC/ml 645 Silver fir (Abies alba) IC/ml 647 White mulberry (Morus alba) IC/ml 621 English oak (Quercus robur) IC/ml 651 Olive (Olea europea) IR/ml 662 Scots pine (Pinus sylvestris) IC/ml 666 Plane tree (Platanus vulgaris) IC/ml 659 White poplar (Populus alba) IC/ml 680 Privet (Ligustrum vulgare) IC/ml 650 Walnut (Juglans regia) IC/ml 669 Goat willow (Salix caprea) IC/ml

Tobacco

904 Tobacco (leaves) IC/ml II. Animal-based allergen extracts(dander, epithelia, insects)

Animals

507 Cat IR/ml 509 Dog IC/ml 508 Goat IC/ml 510 Guinea pig IC/ml 511 Hamster IC/ml 516 Horse IC/ml 512 Rabbit IC/ml 505 Wool IC/ml

Insects

301 Cockroach IC/ml 303 Grain weevil IC/ml 310 Horsefly IC/ml 307 Mosquito IC/ml

III. House dust mite allergen extracts

325 Acarus siro IC/ml 314 Dermatophagoides farinae IR/ml 315 Dermatophagoides pteronyssinus IR/ml 326 Euroglyphus maynei IC/ml 324 Glyciphagus domesticus IC/ml 317 Lepidoglyphus destructor IC/ml 318 Tyrophagus putrescentiae IC/ml IV. Fungal allergen extracts(mold fungi, yeast, dermatophytes)

402 Botrytis cinerea IC/ml 403 Candida albicans IC/ml 407 Chaetomium globosum IC/ml 409 Epicoccum IC/ml 410 Epidermophyton IC/ml 411 Fusarium IC/ml 413 Helminthosporium IC/ml 447 Merulius lacrymans IC/ml 417 Mucor racemosus IC/ml 425 Pullularia pullulans IC/ml 426 Rhizopus nigricans IC/ml 432 Stemphylium botryosum IC/ml 435 Trichophyton IC/ml 405 Trichothecium roseum (Cephalothecium) IC/ml

V. Mixtures of allergen extracts * of animal origin

506 Feather mixture (duck, goose, chicken) IC/ml * of plant origina) weeds719 Mixture I - Compositae (Goldenrod, Dandelion, Lampourde, Ox-eye-daisy) IC/ml 714 Mixture II - Chenopodiaceae (Fat hen, Rough pigweed) IC/ml 706 Mixture III - Weed mixtures (Alfalfa, Red clover, Mustard, Nettle, Sorrel) IC/ml b) grasses701 3 grasses- (Orchard grass, Perennial ryegrass, Timothy grass) IR/ml 688 5 grasses- (Orchard grass, Kentucky bluegrass, Perennial ryegrass, Sweet vernal grass, Timothy grass) IR/ml 689 12 grasses- (Red fescue, Bermuda grass, Bromus, Orchard grass, Meadow fescue, Kentucky bluegrass, Oat grass, Perennial ryegrass, Sweet vernal grass, Timothy grass, Wild oat, Velvet grass) IR/ml 690 5 grasses/4 cereals- (Orchard grass, Kentucky bluegrass, Perennial ryegrass, Sweet vernal grass, Timothy grass / Barley, Corn, Oat, Wheat) IR/ml 687 4 cereals- (Barley, Corn, Oat, Wheat) IR/ml c) trees702 Betulaceae (Alder, Birch, Hazel, Hornbeam) IR/ml 696 Fagaceae (Beech, Chestnut, Oak) IC/ml 716 Cupressaceae (Cypress, Juniper) IC/ml 715 Oleaceae (Ash, Olive, Privet) IC/ml 717 Salicaceae (Poplar, Willow) IC/ml 718 Tree mixture (Sycamore, Horse chestnut, Plane tree, Black locust, Lime) IC/ml 917 Wood dust (Oak, Beech, Cherry, Pine) IC/ml * of house dust mites350 D. pteronyssinus + D. farinae IR/ml 330 Storage mite (Acarus siro, Glyciphagus domesticus, Lepidoglyphus destructor, Tyrophagus putrescentiae) IC/ml * of fungi400 Alternaria (Alternatalongipes) IC/ml 414 Cladosporium (Cladosporoides, herbarum) IC/ml 401 Aspergillus (fumigatus, nidulans, niger) IC/ml 422 Penicillium (digitatum, expansum, notatum) IC/ml 445 Yeast mixture (Saccharomyces cerevisiae, minor) IC/ml 446 Smut mixture (Ustilago avenae, tritici, holci, zeae) IC/ml