Oralair 300 ir

Package leaflet: Information for the user

ORALAIR 300 IR, 300 IR sublingual tablets
For use in adults, adolescents and children aged above 5 years.
Allergen extract from pollens of the following grasses:
Orchard grass ( Dactylis glomerata L.), Sweet vernal grass ( Anthoxanthum odoratum L.), Perennial
ryegrass ( Lolium perenne L.), Meadow fescue ( Poa pratensis L.) and Timothy grass ( Phleum
pratense L.)
Please read all of this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• Please contact your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any of the side effects worsen or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What ORALAIR is and what it is used for
2. What you need to know before taking ORALAIR
3. How to take ORALAIR
4. Possible side effects
5. How to store ORALAIR
6. Contents of the pack and other information

1. What ORALAIR is and what it is used for

ORALAIR contains an allergen extract. Treatment with ORALAIR aims to increase immunological tolerance to grass pollens and thereby reduce allergic symptoms.
ORALAIR is used to treat allergy (sensitisation) to grass pollens, which is characterised by rhinitis (sneezing, runny or itchy nose, nasal congestion) with or without conjunctivitis (itchy, watery eyes) in adults, adolescents and children aged 5 years and older.
Before starting treatment, a suitably trained and experienced physician in the management of allergic diseases will diagnose the allergy (sensitisation) using an appropriate skin test and/or blood test.

2. Important information before using ORALAIR

When not to use ORALAIR

• if the patient has a known allergy to any of the other components of this medicine (listed in section 6);
• if the patient suffers from severe and/or unstable asthma, or if there has been a severe asthma exacerbation within the last 3 months;
• if the patient's forced expiratory volume in one second (FEV1), as assessed by the physician, is below 80%;
• in patients with disorders affecting the immune system, patients taking medications that suppress immunity, or patients with malignant disease;
• in patients with oral ulcers or infections of the oral cavity. The physician may recommend delaying the start of treatment or interrupting treatment until oral lesions have healed completely. Women who are pregnant should not initiate treatment with ORALAIR.

Warnings and precautions
Before starting treatment with ORALAIR, discuss with your doctor if:

• you experience severe allergic symptoms such as difficulty swallowing or breathing, voice changes, hypotension (low blood pressure), or a sensation of throat lump. Treatment must be discontinued and you should contact your doctor immediately.
• you previously had a severe allergic reaction to a medicine containing allergen extracts.
• you experience a significant worsening of asthma symptoms. Treatment must be discontinued and you should contact your doctor immediately.
• you have coexisting cardiovascular diseases.
• you are taking beta-blockers (a class of medicines commonly prescribed for heart conditions and high blood pressure, but also present in certain eye drops and ointments).
• you are being treated for depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), or for Parkinson’s disease with catechol-O-methyltransferase (COMT) inhibitors.
• you are scheduled for dental procedures or tooth extraction. You should interrupt treatment with ORALAIR until complete healing has occurred.
• you suffer from persistent heartburn or difficulty swallowing, you should consult your doctor.
• you have remitted autoimmune diseases. Patients should talk to their doctor about:
  • any recent illnesses;
  • presence of any immune system disorders in themselves or their family;
  • if allergic symptoms have recently worsened.
    If you are using medications to control asthma and/or relieve symptoms, do not discontinue them without consulting your doctor, as this may lead to worsening asthma symptoms.
    If you have asthma and a respiratory tract infection, initiation of treatment with ORALAIR should be postponed until the infection has resolved.
    During treatment, mild or moderate local allergic reactions may occur. In case of allergic reactions of significant intensity, consult your doctor to determine whether anti-allergic medications such as antihistamines should be used.

Children and adolescents
ORALAIR is indicated for the treatment of grass pollen allergy, characterized by rhinitis with or without conjunctivitis, in adults, adolescents, and children aged 5 years and older.
ORALAIR is not recommended for use in children under 5 years of age.

Other medicines and ORALAIR
Inform your doctor or pharmacist about all medicines you are currently using or have recently used, as well as any medicines you plan to use, including those available without a prescription.
Specifically inform your doctor if you are taking certain antidepressants (tricyclic antidepressants and monoamine oxiduppose inhibitors (MAOIs)).
Patients using other anti-allergic medications, such as antihistamines, asthma medications, steroids, or drugs blocking a substance called immunoglobulin E (IgE), e.g. omalizumab, should discuss continued use with their doctor. Discontinuation of these anti-allergic medications may lead to further adverse reactions during ORALAIR treatment.
Symptomatic treatment (e.g. antihistamines and/or intranasal corticosteroids) may be used during ORALAIR therapy.
Inform your doctor or pharmacist before using ORALAIR if you are taking beta-adrenergic receptor blockers (a group of medicines commonly prescribed for heart conditions and hypertension, also present in certain eye drops or ointments), as they may reduce the effectiveness of adrenaline used in treating severe systemic reactions.

ORALAIR with food and drink
Do not eat or drink for 5 minutes after taking this medicine.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are already pregnant, consult your doctor or pharmacist before using this medicine.
There is no experience with the use of ORALAIR during pregnancy. Therefore, immunotherapy should not be initiated if the patient is pregnant. If a patient becomes pregnant during treatment with this medicine, she should discuss with her doctor whether treatment should be continued.

Breastfeeding
During breastfeeding, consult your doctor or pharmacist before using this medicine.
Immunotherapy should not be initiated during breastfeeding.
There is no experience with the use of ORALAIR during breastfeeding. No effect on breastfed infants is expected during treatment. If a patient intends to breastfeed during treatment, she should consult her doctor on whether continuing treatment is appropriate.

Driving and using machines
No influence of ORALAIR on the ability to drive or operate machinery has been observed.

ORALAIR contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, they should consult their doctor before using this medicine.

ORALAIR contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use ORALAIR

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
ORALAIR is prescribed by doctors who are appropriately trained and experienced in the treatment of allergies. If this medicine is prescribed for children, it must be prescribed by a doctor experienced in paediatric treatment.
It is recommended that the first tablet be taken under the supervision of a doctor. This allows the patient to discuss possible adverse reactions (side effects) with the doctor.

Dosing
Treatment consists of an initial treatment phase (including dose escalation over 3 days) and a maintenance treatment phase.
The recommended dose is 1 tablet of ORALAIR 300 IR once daily. ORALAIR 300 IR is intended for use in maintenance treatment.

Method of administration
It is recommended that the first dose of ORALAIR be taken under medical supervision. Medical supervision should be maintained for at least 30 minutes after the first dose. This precaution allows monitoring of any reaction to the medicine and enables discussion with the doctor regarding possible adverse effects.
Place the tablet under the tongue and allow it to dissolve completely (at least 1 minute), then swallow. It is recommended to take the tablet during the day on an empty stomach. For the next 5 minutes, the patient should not eat or drink anything.

Duration of treatment
These tablets should be taken according to the doctor's instructions for the entire treatment period. Treatment should begin approximately 4 months before the expected pollen season and should continue until the end of the pollen season.
There is no experience with the use of ORALAIR in patients over 65 years of age.

Use in children and adolescents
There is no experience with the use of ORALAIR in children under 5 years of age.
There is no experience with use in children for longer than one pollen season.
Dosing in children and adolescents aged 5 years and older is the same as in adults.

Taking more ORALAIR than prescribed
If a dose of ORALAIR larger than recommended is taken, allergic symptoms may occur, including local reactions in the mouth and throat. If severe symptoms occur, contact your doctor immediately.

Missing a dose of ORALAIR
Do not take a double dose to make up for a missed dose.
If treatment with ORALAIR is interrupted for less than one week, treatment may be resumed with the same dose as the last dose taken.
If treatment is interrupted for more than 7 days, consult your doctor regarding how to continue therapy.

Stopping ORALAIR treatment
If the treatment cycle with ORALAIR is interrupted, the continued benefits of treatment may be lost.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Patients receiving ORALAIR are exposed to substances that may cause reactions at the site of administration and/or symptoms affecting the whole body. Reactions at the site of administration (such as oral itching and throat irritation) are expected. These reactions usually occur at the beginning of therapy, are temporary, and generally decrease over time.

Treatment with ORALAIR must be discontinued and immediate contact with a doctor sought or hospitalization initiated if any of the following symptoms occur:

• Sudden swelling of the face, lips, throat or skin
• Difficulty swallowing
• Difficulty breathing
• Voice changes
• Hypotension (low blood pressure)
• Sensation of throat fullness (resembling swelling)
• Urticaria and skin itching

Treatment should only be resumed on the advice of a physician.

Other possible adverse reactions include:

Very common (affects more than 1 in 10 patients):

• Itching of the mouth
• Throat irritation
• Headache

Common (affects less than 1 in 10 patients):

• Conjunctivitis, eye itching or tearing
• Ear itching
• Rhinitis (stuffy nose, runny nose, nasal itching, sneezing, nasal discomfort), sinus congestion
• Swelling or itching of the lips or tongue, tongue pain
• Oral cavity disorders (such as dryness, tingling, numbness, inflammation, pain, blisters or swelling)
• Throat disorders (such as dryness, discomfort, pain, blisters or swelling), hoarseness, difficulty swallowing
• Stomatitis, nasopharyngitis
• Asthma, breathing difficulties
• Cough
• Chest discomfort
• Heartburn, upset stomach, abdominal pain, diarrhea, vomiting, nausea
• Persistent skin condition characterized by dryness, redness and itching, urticaria, pruritus

Uncommon (affects less than 1 in 100 patients):

• Eye swelling, eye redness, dry eyes
• Otitis, dizziness, ear discomfort
• Ulceration of the mouth or tongue, swelling of the palate, gingivitis or inflammation of lips or tongue
• Enlargement of salivary glands, excessive salivation
• Taste disturbances, burping
• Throat tightness, throat numbness, sensation of a foreign body in the throat
• Wheezing
• Allergic reaction with facial and throat swelling, hypersensitivity
• Lymph node enlargement
• Rash, acne, eczema, skin damage due to scratching
• Depression, fatigue, drowsiness
• Influenza-like symptoms

Rare (affects less than 1 in 1000 patients):

• Facial swelling, redness
• Restlessness
• Increase in eosinophil count

Frequency not known (cannot be estimated from available data):
Esophagitis has additionally been reported.
The number of adverse reactions reported by adults who used ORALAIR during three consecutive grass pollen seasons in a clinical trial decreased in the second and third year of treatment.

Adverse reactions in children and adolescents
In children and adolescents receiving ORALAIR, the following adverse reactions occurred more frequently than in adults: cough, nasopharyngitis, lip swelling (very common), oral allergy syndrome, cheilitis, sensation of lumps in the throat, glossitis, ear disorders (common).
Additionally, in children and adolescents, the following adverse reactions were reported: bronchitis, tonsillitis (common), chest pain (uncommon).

Other adverse reactions observed during use of the medicine in adults, adolescents and children (post-marketing experience, frequency not known):
Worsening of asthma, systemic allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to:
Department of Monitoring Adverse Reactions of Medicinal Products
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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ORALAIR

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after "Expiry date (EXP)" and on the blister after "EXP". The expiry date refers to the last day of the specified month.
No special precautions regarding storage temperature are required for this medicinal product.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ORALAIR contains
The active substance in this medicine is an allergen extract from the pollen of the following grasses:
Cock's-foot ( Dactylis glomerata L.), Sweet vernal-grass ( Anthoxanthum odoratum L.), Perennial rye-grass ( Lolium perenne L.), Meadow blue-grass ( Poa pratensis L.) and Timothy-grass ( Phleum pratense L.).
Each sublingual tablet contains 300 IR.
IR (index of reactivity) is a measure of biological activity and is determined in sensitized patients based on skin testing.

The other ingredients are: mannitol (E421), microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate and lactose monohydrate.

What ORALAIR looks like and contents of the pack
The tablets are slightly mottled, white to beige in colour, with the imprint "300" on both sides.
One blister contains 30 sublingual tablets 300 IR.
The tablets are supplied in blisters (Alu/Alu) made of foil (polyamide/aluminium/PCW). The blister cavities are numbered.
Pack sizes: 30 and 90 sublingual tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
STALLERGENES
6 rue Alexis de Tocqueville
92160 ANTONY
France
Tel. +33 (0) 1 55 59 20 00
Fax +33 (0) 1 55 59 21 68

This medicinal product is authorised in the European Economic Area under the following names:
Austria Oralair 300 IR Sublingualtabletten
Belgium, Estonia, Germany, Ireland, Italy, Latvia, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia Oralair 300 IR
Bulgaria, Czech Republic ORALAIR 300 IR
Croatia Oralair 300 IR sublingvalne tablete
Denmark, Finland, Sweden, Norway Aitgrys
France Oralair 300 IR, comprimé sublingual
Hungary Oralair 300 IR nyelvatti tabletta
Lithuania ORALAIR 300 IR poliežuvinés tabletés
Slovenia Oralair 300 IR podjezične tablete
Spain ORALAIR 300 IR comprimidos sublinguales