Oralair

Package Leaflet: Information for the User

ORALAIR 100 IR & 300 IR sublingual tablets

For adults, adolescents and children from the age of 5 years
Allergen extract from grass pollens of
orchard grass (Dactylis glomerata L.), sweet vernal grass (Anthoxanthum odoratum L.), perennial ryegrass (Lolium perenne L.), meadow grass (Poa pratensis L.) and timothy grass (Phleum pratense L.)
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See Section 4.

Contents of this 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 is intended to increase immunological tolerance to grass pollen, thereby reducing allergic symptoms.
ORALAIR is used for the treatment of allergy to grass pollen, characterized by rhinitis (sneezing, runny, itchy or blocked nose) with or without conjunctivitis (itchy, watery eyes), in adults, adolescents and children from the age of 5 years.
Before starting treatment, your allergy will be diagnosed by a doctor properly trained and experienced in the field of allergic diseases, who will perform appropriate skin tests and/or blood tests.

2. What you should know before taking ORALAIR

Do not take ORALAIR if:

• You are allergic to any of the other ingredients of this medicine (listed in Section 6);
• You have severe and/or unstable asthma or have experienced a severe asthma exacerbation in the past 3 months;
• Your forced expiratory volume in one second (FEV1) is less than 80%, as assessed by your doctor;
• You have a disease affecting the immune system, are taking medicines that suppress the immune system, or have cancer;
• You have mouth ulcers or mouth infections. Your doctor may advise you to delay starting treatment or to stop treatment until your mouth has healed;
• You are pregnant. Do not start taking ORALAIR if you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking ORALAIR if:

• You experience severe allergic symptoms such as difficulty swallowing or breathing, voice changes, hypotension (low blood pressure), or a sensation of throat tightness. Stop treatment immediately and contact your doctor without delay.
• You have previously had a severe allergic reaction to a medicine containing allergen extracts.
• Your asthma symptoms worsen significantly beyond their usual pattern. Stop treatment and contact your doctor immediately.
• You have a cardiovascular disease.
• You are taking a beta-blocker (a class of medicines often 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 need to undergo oral surgery or a tooth extraction; you must temporarily stop treatment with ORALAIR until complete healing has occurred.
• You experience persistent stomach burning or difficulty swallowing. You should contact your doctor.
• You have an autoimmune disease in remission.

Inform your doctor about:

• Any recent illnesses you have had.
• Personal or family history of any disease that may affect the immune system.
• If your allergic condition has recently worsened.

If you are taking medicines to control asthma and/or to relieve symptoms, do not stop your asthma treatment without consulting your doctor, as this could worsen asthma symptoms.
If you have asthma and a respiratory infection, delay starting treatment with ORALAIR until the infection has resolved.
Mild or moderate localized allergic reactions may occur during treatment. If such reactions are severe, consult your doctor to determine whether anti-allergic medicines such as antihistamines should be used.

Children and adolescents
ORALAIR is used for the treatment of grass pollen allergic rhinitis with or without conjunctivitis in adolescents and children from the age of 5 years. ORALAIR is not indicated for use in children under 5 years of age.

Other medicines and ORALAIR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor if you are taking certain medicines for depression (tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs)).
If you are taking other anti-allergy medicines such as antihistamines, asthma symptom medications, or steroids, or a medicine that blocks a substance called immunoglobulin E (IgE), e.g. omalizumab, ask your doctor whether you should continue taking them. If you stop taking these anti-allergy medicines, you may experience more adverse effects during treatment with ORALAIR. Symptomatic treatment (e.g. antihistamines and/or nasal corticosteroids) may be used alongside ORALAIR.
Inform your doctor or pharmacist before taking ORALAIR if you are taking beta-blockers (i.e. a class of medicines often prescribed for heart conditions and high blood pressure, but also present in certain eye drops and ointments), as this medicine may reduce the effectiveness of adrenaline used to treat 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
There is no experience regarding the use of ORALAIR during pregnancy. Therefore, you should not start immunotherapy if you are pregnant. If you become pregnant while taking this medicine, consult your doctor to determine whether treatment should be continued.

Breastfeeding
If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not start immunotherapy while breastfeeding.
There is no experience regarding the use of ORALAIR during breastfeeding. Effects on breastfed infants are not expected during treatment. If you wish to breastfeed while on treatment, ask your doctor whether treatment should be continued.

Driving and using machines
No effects of ORALAIR on the ability to drive or use machines have been observed.

ORALAIR contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

ORALAIR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take ORALAIR

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
ORALAIR is prescribed by doctors who are appropriately trained and experienced in the treatment of allergies. If prescribed for a child, the doctor has the necessary experience in treating children.
It is recommended that the first tablet be taken under medical supervision. This will allow you to discuss any possible side effects with the doctor.
Dosing
Treatment consists of an initial treatment phase (including 3 days of dose escalation) and a maintenance phase.
Initial treatment
ORALAIR treatment must be started as follows:

The IR (Reactivity Index) expresses activity.
ORALAIR 100 IR is indicated only for the dose escalation period and not for maintenance.
Maintenance treatment
The dose is 300 IR (one tablet) daily until the end of the pollen season.
Method of administration
The first tablet of ORALAIR must be taken under medical supervision. You must remain under medical supervision for at least 30 minutes after taking the first dose. This is a precaution to monitor your sensitivity to the medicine. You will also have the opportunity to discuss possible side effects with your doctor.
The tablet must be placed under the tongue and left until it dissolves completely (at least 1 minute), then swallowed. On the second day of treatment, two 100 IR tablets must be placed simultaneously under the tongue and swallowed after approximately 1 minute. It is recommended to take the tablet during the day, on an empty stomach. Do not consume food or drink for at least 5 minutes.
Duration of treatment
Begin treatment approximately 4 months before the start of the pollen season and continue until the end of the pollen season.
There is no experience with ORALAIR in patients over 65 years of age.
Use in children and adolescents
There is no experience with ORALAIR in children under 5 years of age.
There is no experience of use for more than one pollen season in children.
The dosage for adolescents and children from 5 years of age is the same as for adults.
If you take more ORALAIR than you should
If you take more ORALAIR than you should, allergic symptoms may occur, including local symptoms affecting the mouth and throat. If symptoms are severe, consult your doctor immediately.
If you forget to take ORALAIR
Do not take a double dose to make up for the forgotten dose.
If you have interrupted treatment with ORALAIR for less than one week, you may resume treatment at the point where it was interrupted.
If you have interrupted treatment for more than 7 days, ask your doctor how to resume treatment.
If you stop treatment with ORALAIR
If you do not complete the treatment cycle with ORALAIR, you may not achieve a lasting treatment effect.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with ORALAIR, you will be exposed to substances that may cause reactions and/or symptoms at the site of administration, which may also affect the whole body. Reactions at the site of administration (such as mouth itching or throat irritation) are expected. These reactions usually occur at the beginning of treatment, are transient, and generally decrease over time.
Stop taking ORALAIR and contact your doctor or go to hospital immediately if you experience any of the following symptoms:

• Rapid swelling of the face, mouth, throat, or skin
• Difficulty swallowing
• Breathing difficulties
• Voice changes
• Hypotension (low blood pressure)
• Sensation of tightness in the throat (such as swelling)
• Skin hives and itching

Treatment should only be resumed on the advice of your doctor.
Other possible side effects include the following
Very common (affects more than 1 in 10 people):

• Mouth itching
• Throat irritation
• Headache

Common (affects less than 1 in 10 people):

• Eye inflammation, 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
• Mouth disorders (such as dryness, tingling, numbness, inflammation, pain, blistering, or swelling)
• Throat disorders (such as dryness, discomfort, pain, blistering, or swelling), hoarseness, difficulty swallowing
• Mouth inflammation, inflammation of the nose and throat
• Asthma, breathing difficulties
• Cough
• Chest discomfort
• Heartburn, stomach discomfort, stomach pain, diarrhoea, vomiting, nausea
• Persistent skin condition characterized by dryness, redness, and itching, urticaria

Uncommon (affects less than 1 in 100 people):

• Eye swelling, red eyes, dry eyes
• Ear infection, dizziness, ear discomfort
• Mouth or tongue ulceration, swollen palate, inflammation of gums, lips, or tongue
• Enlargement of the salivary glands, excessive saliva production
• Taste alteration, burping
• Throat tightness, throat numbness, sensation of a foreign body in the throat
• Wheezing
• Allergic reaction with swelling of the face and throat, hypersensitivity
• Swollen lymph nodes
• Rash, acne, cold sores, skin excoriation due to scratching
• Depression, fatigue, drowsiness
• Influenza-like symptoms

Rare (affects less than 1 in 1,000 people):

• Facial swelling, hot flushes
• Anxiety
• Increase in eosinophil count

Frequency not known (cannot be estimated from available data)
Oesophagitis has also been reported.
The number of side effects reported by adults treated with ORALAIR in a clinical study over three consecutive grass pollen seasons decreased in the second and third years.
Side effects in children and adolescents
The following adverse reactions were more frequent in children and adolescents receiving ORALAIR compared to adults: cough, inflammation of the nose and throat, mouth oedema (very common), oral allergy syndrome, lip inflammation, sensation of a lump in the throat, tongue inflammation, ear disorders (common).
In addition, the following adverse reactions have been reported in children and adolescents: bronchitis, tonsillitis (common), chest pain (uncommon).
Additional experiences of side effects in current use in adults, adolescents, and children (post-marketing experience, frequency not known):
Worsening of asthma, systemic allergic reaction.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ORALAIR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp." and on the
blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ORALAIR contains

• The active substance is an allergenic extract of grass pollens from orchard grass (Dactylis glomerata L.), sweet vernal grass (Anthoxanthum odoratum L.), perennial rye grass (Lolium perenne L.), meadow grass (Poa pratensis L.) and timothy grass (Phleum pratense L.). One sublingual tablet contains 100 IR or 300 IR.

IR (Index of Reactivity) expresses the biological activity and is determined in sensitized patients by means of a skin test.

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

Description of the appearance of ORALAIR and contents of the pack
The 100 IR tablets are slightly mottled, white to beige in colour, with the imprint “100” on both sides.
The 300 IR tablets are slightly mottled, white to beige in colour, with the imprint “300” on both sides.
One small blister with 3 sublingual tablets of 100 IR and one blister with 28 sublingual tablets of 300 IR.
The tablets are supplied in blisters (alu/alu) made of a polyamide/aluminium/polyvinyl chloride film. The blister cells are numbered.
Pack: 31 sublingual tablets.

Marketing Authorisation Holder and Manufacturer
STALLERGENES
6 rue Alexis de Tocqueville
92160 ANTONY
France
Tel. 0033 (0) 1 55 59 20 00
Fax 0033 (0) 1 55 59 21 68

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Oralair 100 IR + 300 IR Sublingualtabletten
Belgium, Estonia, Germany, Ireland, Italy, Latvia, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia, Oralair 100 IR & 300 IR
Bulgaria, Czech Republic ORALAIR 100 IR & 300 IR
Croatia Oralair 100 IR i 300 IR sublingvalne tablete
Denmark, Finland, Norway, Sweden Aitgrys
France Oralair 100 IR & 300 IR, comprimé sublingual
Hungary Oralair 100 IR és 300 IR nyelvalatti tabletta
Lithuania ORALAIR 100 IR & 300 IR poliežuvinės tabletė
Slovenia Oralair 100 IR in 300 IR podjezične tablete
Spain ORALAIR INICIO 100 IR & 300 IR comprimidos sublinguales

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

ORALAIR 300 IR sublingual tablets

For adults, adolescents and children from the age of 5 years
Allergen extract from grass pollens of
orchard grass (Dactylis glomerata L.), sweet vernal grass (Anthoxanthum odoratum L.), perennial ryegrass (Lolium perenne L.), meadow grass (Poa pratensis L.) and timothy grass (Phleum pratense L.)
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See Section 4.

Contents of this 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 is intended to increase immunological tolerance to grass pollen, thereby reducing allergic symptoms.
ORALAIR is used for the treatment of allergy to grass pollen, characterized by rhinitis (sneezing, runny or itchy nose, nasal congestion) with or without conjunctivitis (itchy, watery eyes) in adults, adolescents, and children from the age of 5 years.
Before starting treatment, your allergy will be diagnosed by a suitably trained and experienced doctor in the field of allergic diseases, who will perform appropriate skin tests and/or blood tests.

2. What you should know before taking ORALAIR

Do not take ORALAIR if:

• You are allergic to any of the other ingredients of this medicine (listed in Section 6);
• You have severe and/or unstable asthma or have had a severe asthma exacerbation in the last 3 months;
• Your forced expiratory volume in one second (FEV1) is less than 80%, as assessed by your doctor;
• You have an illness affecting the immune system, are taking medicines that suppress the immune system, or have cancer;
• You have mouth ulcers or mouth infections. Your doctor may advise you to delay starting treatment or to stop treatment temporarily until your mouth has healed;
• You are pregnant. Do not start taking ORALAIR if you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking ORALAIR if:

• You experience severe allergic symptoms such as difficulty swallowing or breathing, changes in your voice, hypotension (low blood pressure), or a sensation of throat tightness. Stop treatment and contact your doctor immediately;
• You have previously had a severe allergic reaction to a medicine containing allergen extracts;
• Your asthma symptoms worsen significantly compared to normal. Stop treatment and contact your doctor immediately;
• You have a cardiovascular disease;
• You are taking a beta-blocker (a class of medicines often prescribed for heart conditions and high blood pressure, but also present in some 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 need to undergo oral surgery or tooth extraction; you must temporarily stop treatment with ORALAIR until you have fully healed;
• You experience persistent stomach burning or difficulty swallowing. You should contact your doctor;
• You have an autoimmune disease in remission.

Inform your doctor about:

• Any recent illnesses;
• Personal or family history of any condition that may affect the immune system;
• If your allergic condition has recently worsened.

If you are taking medicines to control asthma and/or relieve symptoms, do not stop your asthma treatment without consulting your doctor, as this could worsen asthma symptoms.
If you have asthma and a respiratory infection, delay starting treatment with ORALAIR until the infection has resolved.
Mild or moderate localized allergic reactions may occur during treatment. If such reactions are severe, consult your doctor to determine whether anti-allergic medicines such as antihistamines are needed.

Children and adolescents
ORALAIR is used for the treatment of grass pollen allergic rhinitis with or without conjunctivitis in adolescents and children aged 5 years and older. ORALAIR is not indicated for use in children under 5 years of age.

Other medicines and ORALAIR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor if you are taking certain medicines for depression (tricyclic antidepressants and monoamine oxidase inhibitors (MAO inhibitors)).
If you are taking other anti-allergy medicines such as antihistamines, asthma symptom relievers, or steroids, or a medicine that blocks a substance called immunoglobulin E (IgE), e.g. omalizumab, ask your doctor whether you should continue taking them. If you stop taking these anti-allergy medicines, you may experience more side effects during treatment with ORALAIR.
Symptomatic treatment (e.g. antihistamines and/or nasal corticosteroids) may be used together with ORALAIR.
Inform your doctor or pharmacist before taking ORALAIR if you are taking beta-blockers (a class of medicines often prescribed for heart conditions and high blood pressure, but also present in some eye drops and ointments), as this medicine may reduce the effectiveness of adrenaline used to treat severe systemic reactions.

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

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
There is no experience with the use of ORALAIR during pregnancy. Therefore, you should not start immunotherapy if you are pregnant. If you become pregnant while taking this medicine, ask your doctor whether you should continue treatment.

Breastfeeding
If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not start immunotherapy while breastfeeding.
There is no experience with the use of ORALAIR during breastfeeding. Effects on breastfed infants are not expected during treatment. If you wish to breastfeed while on treatment, ask your doctor whether you should continue treatment.

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

ORALAIR contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

ORALAIR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take ORALAIR

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
ORALAIR is prescribed by doctors who are appropriately trained and experienced in the treatment of allergies. If prescribed to a child, the doctor will have the necessary experience in treating children.
It is recommended that the first tablet be taken under medical supervision. This will allow you to discuss possible side effects with your doctor.

Dosage
Treatment consists of an initial treatment phase (including a 3-day dose escalation) and a maintenance phase. ORALAIR 300 IR is to be used only during the maintenance phase.
Take 1 tablet of 300 IR once daily.

Method of administration
The first tablet of ORALAIR must be taken under medical supervision. You must remain under medical supervision for at least half an hour after taking the first dose. This is a precaution to monitor your sensitivity to the medicine. You will also have the opportunity to discuss possible side effects with your doctor.
The tablet must be placed under the tongue and left until it dissolves completely (at least 1 minute), after which it may be swallowed. It is recommended to take the tablet during the day, on an empty stomach. Do not eat or drink for at least 5 minutes after administration.

Duration of treatment
Take these tablets as prescribed by your doctor until the end of the treatment course. Begin treatment approximately 4 months before the start of the pollen season and continue until the end of the pollen season.
There is no experience with ORALAIR in patients over 65 years of age.

Use in children and adolescents
There is no experience with ORALAIR in children under 5 years of age.
There is no experience beyond one pollen season in children.
The dosage for adolescents and children aged 5 years and older is the same as for adults.

If you take more ORALAIR than you should
If you take more ORALAIR than you should, allergic symptoms may occur, including local symptoms affecting the mouth and throat. If symptoms are severe, consult your doctor immediately.

If you forget to take ORALAIR
Do not take a double dose to make up for the missed dose.
If you have interrupted treatment with ORALAIR for less than one week, you may resume treatment at the point where it was interrupted.
If you have interrupted treatment for more than 7 days, consult your doctor on how to resume treatment.

If you stop taking ORALAIR
If you do not complete the full course of treatment with ORALAIR, the treatment may not have a lasting effect.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During treatment with ORALAIR, you will be 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 mouth itching or throat irritation) are expected. These reactions occur at the beginning of treatment, are transient, and usually diminish over time.
Stop taking ORALAIR and contact your doctor or hospital immediately if you experience any of the following symptoms:

• Rapid swelling of the face, mouth, throat, or skin
• Difficulty swallowing
• Breathing difficulties
• Voice changes
• Hypotension (low blood pressure)
• Sensation of tightness in the throat (as if swelling)
• Skin hives and itching

Treatment should only be resumed upon the advice of your doctor.
Other possible side effects include the following
Very common (affects more than 1 in 10 people):

• Mouth itching
• Throat irritation
• Headache

Common (affects less than 1 in 10 people):

• Eye inflammation, eye itching, or tearing
• Ear itching
• Rhinitis (stuffy nose, runny nose, sneezing, nasal itching, nasal discomfort), paranasal sinus congestion
• Swelling or itching of the lips or tongue, tongue pain
• Mouth disorders (such as dryness, tingling, numbness, inflammation, pain, blistering, or swelling)
• Throat disorders (such as dryness, discomfort, pain, blistering, or swelling), hoarseness, difficulty swallowing
• Mouth inflammation, inflammation of the nose and throat
• Asthma, breathing difficulties
• Cough
• Chest discomfort
• Heartburn, stomach discomfort, stomach pain, diarrhea, vomiting, nausea
• Persistent skin condition characterized by dryness, redness, and itching, hives

Uncommon (affects less than 1 in 100 people):

• Eye swelling, red eyes, dry eyes
• Ear infection, dizziness, ear discomfort
• Mouth or tongue ulceration, swollen palate, inflammation of the gums, lips, or tongue
• Enlargement of the salivary glands, excessive salivation
• Taste alteration, belching
• Throat tightness, throat numbness, sensation of a foreign body in the throat
• Wheezing
• Allergic reaction with swelling of the face and throat, hypersensitivity
• Swollen lymph nodes
• Rash, acne, cold sores, excoriated skin lesions
• Depression, fatigue, drowsiness
• Influenza-like symptoms

Rare (affects less than 1 in 1,000 people):

• Facial swelling, hot flushes
• Anxiety
• Increase in eosinophil count

Frequency not known (cannot be estimated from available data)
Oesophageal inflammation has also been reported.
The number of adverse reactions reported by adults treated with ORALAIR in a clinical trial over three consecutive grass pollen seasons decreased in the second and third years.

Adverse reactions in children and adolescents
The following adverse reactions were more frequent in children and adolescents receiving ORALAIR compared to adults: cough, inflammation of the nose and throat, mouth oedema (very common), oral allergy syndrome, lip inflammation, sensation of throat tightness, tongue inflammation, ear disorders (common).
Additionally, the following adverse reactions have been reported in children and adolescents: bronchitis, tonsillitis (common), chest pain (uncommon).

Additional experience of adverse reactions in current use in adults, adolescents, and children (post-marketing experience, frequency not known):
Worsening of asthma, systemic allergic reaction.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store ORALAIR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.” and on the
blister after “EXP”. The expiry date refers to the last day of the month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ORALAIR contains

• The active substance is an allergenic extract from grass pollen: timothy grass (Phleum pratense L.), orchard grass (Dactylis glomerata L.), sweet vernal grass (Anthoxanthum odoratum L.), perennial rye grass (Lolium perenne L.) and meadow fescue (Poa pratensis L.). One sublingual tablet contains 300 IR.

IR (Reactivity Index) expresses the biological activity and is determined in sensitized patients by means of a skin test.

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

Description of the appearance of ORALAIR and the contents of the pack
The 300 IR tablets are slightly mottled, white to beige in colour, with the imprint "300" on both sides.
One blister contains 30 sublingual tablets of 300 IR.
The tablets are supplied in blisters (alu/alu) made of a film (polyamide/aluminum/polyvinyl chloride).
Pack sizes: 30 and 90 sublingual tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
STALLERGENES
6 rue Alexis de Tocqueville
92160 ANTONY
France
Tel. 0033 (0) 1 55 59 20 00
Fax 0033 (0) 1 55 59 21 68

This medicinal product is authorised in the European Economic Area Member States 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, Norway, Sweden Aitgrys
France Oralair 300 IR, comprimé sublingual
Hungary Oralair 300 IR nyelvalatti tabletta
Lithuania ORALAIR 300 IR poliežuvinės tabletės
Slovenia Oralair 300 IR podjezične tablete
Spain ORALAIR 300 IR comprimidos sublinguales