ORALAIR 100IR/300IR Tabletki podjęzykowe

Treść ulotki

1. ORALAIR 100 IR & 300 IR sublingual tablets
   1. What is ORALAIR and what is it used for
   2. What you need to know before you take ORALAIR
   3. How to take ORALAIR
   4. Possible side effects
   5. How to store ORALAIR
   6. Package contents and other information
2. ORALAIR 300 IR sublingual tablets
   1. What is ORALAIR and what is it used for
   2. What you need to know before you take ORALAIR
   3. How to take ORALAIR
   4. Possible side effects
   5. How to store ORALAIR
   6. Package contents and other information

ORALAIR 100 IR & 300 IR sublingual tablets

For adults, adolescents and children starting from 5 years of age
Allergen extract of grass pollen from
orchard grass ( Dactylis glomerataL.), sweet vernal grass ( Anthoxanthum odoratumL.), Italian ryegrass ( Lolium

perenneL.), Kentucky bluegrass ( Poa pratensisL.) and timothy grass ( Phleum pratenseL.)

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is ORALAIR and what is it used for

ORALAIR contains an allergenic extract. Treatment with ORALAIR serves to increase
immunological tolerance to grass pollen and therefore reduce 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 and
watery eyes) in adults, adolescents and children from the age of 5 years.
Before starting treatment, your allergy will be diagnosed by a doctor appropriately
trained and experienced in the field of allergic diseases, who will perform skin tests and/or blood tests
appropriately.

2. What you need to know before you take ORALAIR

Do not take ORALAIR if:

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

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

• Severe allergic symptoms occur, such as difficulty swallowing or breathing, changes in your voice, hypotension (low blood pressure) or a feeling of a lump in your throat. 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 condition.
• You are taking a beta-blocker (a class of drugs often prescribed for heart conditions and hypertension 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 a tooth extraction; you should temporarily interrupt treatment with ORALAIR until complete healing.
• You experience persistent heartburn or difficulty swallowing. You should contact your doctor.
• You have an autoimmune disease in remission.

Tell your doctor about:

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

If you are taking medicines to control asthma and/or to relieve symptoms, do not stop your asthma treatment without your doctor's advice, as this may worsen your asthma symptoms.
If you have asthma and a respiratory infection, postpone the start of treatment with ORALAIR until your infection has resolved.
Mild or moderate localized allergic reactions may occur during treatment. If these reactions are severe, consult your doctor to assess whether the use of anti-allergic drugs such as antihistamines is necessary.

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 treatment in children under 5 years of age.

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

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

Pregnancy and breastfeeding
Pregnancy
If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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, ask your doctor whether it is appropriate to continue treatment.

Breastfeeding
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should not start immunotherapy if you are breastfeeding.
There is no experience regarding the use of ORALAIR during breastfeeding. No effects on breastfed infants are expected during treatment. If you wish to breastfeed while taking treatment, ask your doctor whether it is appropriate to continue treatment.

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

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

ORALAIR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’

3. How to take ORALAIR

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
ORALAIR is prescribed by doctors 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 to take the first tablet under the supervision of a doctor. This will allow you to
discuss possible side effects with your doctor.

Dosage
The treatment consists of an initial phase of treatment (including 3 days of dose increase) and a
maintenance phase.

Initial treatment
Treatment with ORALAIR must be started as follows:
The IR (Reactivity Index) expresses the activity.
ORALAIR 100 IR is indicated only for the dose increase period and not for maintenance.

Maintenance treatment
The dose is 300 IR (one tablet) per day until the end of the pollen season.

Method of administration
The first tablet of ORALAIR must be taken under the supervision of a doctor. 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 should be left under the tongue until it dissolves completely (at least
1 minute), then swallow. On the second day of treatment, two 100 IR tablets should be
placed simultaneously under the tongue, then swallowed after about 1 minute. It is recommended to
take the tablet during the day, on an empty stomach. Do not consume food or beverages for at least 5 minutes.

Duration of treatment
Start 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 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 appear, including local symptoms
in the mouth and throat. If the symptoms are severe, consult your doctor immediately.

If you forget to take ORALAIR
Do not take a double dose to make up for a missed dose.
If you have stopped treatment with ORALAIR for less than a week, you can resume treatment
where you left off.
If you have stopped treatment for more than 7 days, ask your doctor how to resume treatment.

If you stop taking ORALAIR

If you do not complete the treatment cycle with ORALAIR, it may not have a lasting effect of the
treatment.
If you have any questions about the use of this medicine, ask 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 affect the whole body. Reactions at the site of administration (such as itching in the mouth or irritation of the throat) are predictable.
These reactions usually occur at the beginning of treatment, are transient and generally decrease 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
• Difficulty breathing
• Changes in voice
• Hypotension (low blood pressure)
• Feeling of fullness in the throat (as if swollen)
• Hives and skin itching

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

Other possible side effects include the following

Very common (may affect more than 1 in 10 people):

• Itching of the mouth
• Irritation of the throat
• Headache.

Common (may affect up to 1 in 10 people):

• Inflammation of the eyes, itchy eyes or watering eyes
• Itching of the ears
• Rhinitis (blocked nose, runny nose or itchy nose, sneezing, nasal discomfort), congestion of the sinuses
• 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
• Inflammation of the mouth, inflammation of the nose and throat
• Asthma, difficulty breathing
• Cough
• Chest discomfort
• Heartburn, stomach discomfort, stomach pain, diarrhea, vomiting, nausea
• Persistent skin condition characterized by dryness, redness and itching, hives

Uncommon (may affect up to 1 in 100 people):

• Swelling of the eyes, red eyes, dry eyes
• Ear infection, dizziness, ear discomfort
• Ulcers in the mouth or on the tongue, swollen palate, inflammation of the gums or lips or tongue
• Enlargement of the salivary glands, excessive saliva production
• Altered taste, belching
• Constriction of the throat, numbness of the throat, 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 lesion from scratching
• Depression, fatigue, drowsiness
• Flu-like symptoms

Rare (may affect up to 1 in 1,000 people):

• Facial swelling, hot flushes
• Anxiety
• Increased eosinophil count.

Frequency not known (cannot be estimated from the available data)
Esophageal inflammation has also been reported.
The number of side effects reported by adults who were being treated with ORALAIR in a
clinical study during three consecutive grass pollen seasons decreased in the second and third
year.

Side effects in children and adolescents
The following adverse reactions were more frequent in children and adolescents who received
ORALAIR compared to adults: cough, inflammation of the nose and throat, edema of the mouth (very
common), oral allergy syndrome, inflammation of the lips, sensation of a lump in the throat,
inflammation of the tongue, ear disorders (common).
In addition, the following adverse reactions have been reported in children and adolescents: bronchitis, tonsillitis
(common), chest pain (uncommon).

Further 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 which is stated on the carton after “Scad.” and on the
blister after “EXP”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 ingredient is an allergenic extract of sweet vernal grass ( DactylisglomerataL.), timothy grass ( Anthoxanthum odoratumL.), perennial ryegrass ( Lolium perenneL.), meadow fescue ( Poa pratensisL.) and orchard grass ( Phleum pratenseL.) pollen. One sublingual tablet contains 100 IR or 300 IR. The IR (reactivity index) expresses the activity and is determined in sensitized patients via a skin test.
• The excipients are mannitol (E421), microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate and lactose monohydrate.

Description of ORALAIR and package contents
The 100 IR tablets are slightly mottled, from white to beige in colour, with the inscription “100”
embossed on both sides.
The 300 IR tablets are slightly mottled, from white to beige in colour, with the inscription "300"
embossed on both sides.
A small blister with 3 sublingual tablets of 100 IR and a blister with 28 sublingual tablets of
300 IR.
.
The tablets are supplied in (alu/alu) blisters consisting of a polyamide/aluminium/polyvinyl
chloride film. The blister cells are numbered.
Package: 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 Member States of the European Economic Area with the
following denominations:
Austria ORALAIR 100 IR + 300 IR Sublingualtabletten
Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Ireland, Italy, Latvia, Luxembourg,
Netherlands, Poland, Portugal, Romania, Slovakia, Hungary
ORALAIR 100 IR & 300 IR
Croatia Oralair 100 IR i 300 IR sublingvalne tablete
Denmark, Finland and Sweden Aitgrys
Lithuania ORALAIR 100 IR & 300 IR poliežuvines tabletes
Norway Oralair
Slovenia ORALAIR 100 IR in 300 IR podjezične tablete
Spain ORALAIR INICIO 100 IR & 300 IR

ORALAIR 300 IR sublingual tablets

For adults, adolescents and children from 5 years of age
Allergen extract of grass pollen from
orchard grass ( Dactylis glomerataL.), sweet vernal grass ( Anthoxanthum odoratumL.), Italian ryegrass ( Lolium

perenneL.), meadow fescue ( Poa pratensisL.) and timothy grass ( Phleum pratenseL.)

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is ORALAIR and what is it used for

ORALAIR contains an allergenic extract. Treatment with ORALAIR serves to increase
immunological tolerance to grass pollen and therefore to reduce 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 and
watery eyes) in adults, adolescents and children from 5 years of age.
Before starting treatment, your allergy will be diagnosed by a doctor appropriately
trained and experienced in the field of allergic diseases, who will perform skin tests and/or blood tests
appropriately.

2. What you need to know before you take ORALAIR

Do not take ORALAIR if:

• You are allergic to any of the other ingredients of this medicine (listed in Section 6);
• You suffer from severe and/or unstable asthma or have had a severe asthma exacerbation in the last 3 months.
• Your forced expiratory volume in the first second (FEV1) is less than 80% as assessed by your doctor.
• You suffer from a condition affecting the immune system, are taking medicines that suppress the immune system, or have cancer.
• You have ulcers or infections of the mouth. Your doctor may recommend delaying the start of treatment or interrupting it until your mouth has healed.

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 feeling of a lump in your throat. 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 cardiovascular disease.
• You are taking a beta-blocker (a class of drugs 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 a tooth extraction, you should temporarily interrupt treatment with ORALAIR until complete healing.
• You experience persistent heartburn or difficulty swallowing. You should contact your doctor.
• You have an autoimmune disease in remission.

Tell your doctor about:

• Any recent illness you have had.
• Personal or family history of any condition that may affect the immune system.
• If your allergic disease has recently worsened. If you are taking medicines to control asthma and/or to relieve symptoms, do not stop asthma treatment without your doctor's advice as this may worsen asthma symptoms. If you have asthma and a respiratory infection, postpone the start of treatment with ORALAIR until your infection has resolved.

It is possible that mild or moderate localised allergic reactions may occur during treatment. If such reactions are severe, see your doctor to assess whether the use of anti-allergic medicines such as antihistamines is necessary.

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 treatment in children under 5 years of age.

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

ORALAIR with food and drink
You should not eat food and drink for 5 minutes after taking this medicine.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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, ask your doctor whether it is appropriate to continue treatment.

Breastfeeding
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should not start immunotherapy if you are breastfeeding.
There is no experience regarding the use of ORALAIR during breastfeeding. No effects on breastfed infants are expected during treatment. If you wish to breastfeed while taking treatment, ask your doctor whether it is appropriate to continue treatment.

Driving and operating machinery
No effects on the ability to drive and operate machinery have been observed with ORALAIR.

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

ORALAIR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’

3. How to take ORALAIR

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
ORALAIR is prescribed by doctors appropriately trained and experienced in the treatment of
allergies. If prescribed to a child, the doctor has the necessary experience in treating
children.
It is recommended to take the first tablet under the supervision of a doctor. This will allow you to
discuss possible side effects with your doctor.

Dosage
The treatment consists of an initial phase of treatment (including 3 days of dose increase) and a
maintenance phase. ORALAIR 300 IR is to be used only for the maintenance phase.
Take 1 tablet of 300 IR once a day.

Method of administration
The first tablet of ORALAIR must be taken under the supervision of a doctor. 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 drug. You will also have the opportunity to discuss
possible side effects with your doctor.
The tablet should be left under the tongue until it dissolves completely (at least
1 minute), then swallow. It is recommended to take the tablet during the day, on an empty stomach. Do not
consume food or beverages for at least 5 minutes.

Duration of treatment
Take these tablets as prescribed by your doctor until the end of the treatment cycle. Start the
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 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 appear, including local symptoms
in the mouth and throat. If the symptoms are severe, consult your doctor immediately.

If you forget to take ORALAIR
Do not take a double dose to make up for a missed dose.
If you have stopped treatment with ORALAIR for less than a week, you can resume treatment
where you left off.
If you have stopped treatment for more than 7 days, ask your doctor how to resume treatment.

If you stop taking ORALAIR
If you do not complete the treatment cycle with ORALAIR, you may not have a lasting effect of the
treatment.
If you have any questions about the use of this medicine, ask 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 can cause reactions and/or symptoms at the site of
administration that may affect the whole body. Reactions at the site of administration (such as itching in the mouth or irritation of the throat) are predictable.
These reactions occur at the beginning of treatment, are transient and generally decrease 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
• Difficulty breathing
• Changes in voice
• Hypotension (low blood pressure)
• Feeling of fullness in the throat (as if swollen)
• Hives and itching of the skin

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

Other possible side effects include the following

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

• Itching in the mouth
• Irritation of the throat
• Headache.

Common (affects less than 1 in 10 people):

• Eye inflammation, itchy eyes or watering eyes
• Itchy ears
• Rhinitis (blocked nose, runny nose, sneezing, itchy nose, nasal discomfort), congestion of the sinuses
• 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
• Inflammation of the mouth, inflammation of the nose and throat
• Asthma, difficulty breathing
• 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):

• Swelling of the eyes, red eyes, dry eyes
• Ear infection, dizziness, ear discomfort
• Ulcers in the mouth or on the tongue, swollen palate, inflammation of the gums or lips or tongue
• Enlargement of the salivary glands, excessive saliva production
• Altered taste, belching
• Constriction of the throat, numbness of the throat, 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 lesion from scratching
• Depression, fatigue, drowsiness
• Flu-like symptoms

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

• Facial swelling, hot flushes
• Anxiety
• Increased eosinophil count.

Frequency not known (cannot be estimated from available data)
Esophageal inflammation has also been reported.
The number of side effects reported by adults who were being treated with ORALAIR in a
clinical study during 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 who received
ORALAIR compared to adults: cough, inflammation of the nose and throat, edema of the mouth (very
common), oral allergy syndrome, inflammation of the lips, sensation of a lump in the throat,
inflammation of the tongue, ear disorders (common).
In addition, the following adverse reactions have been reported in children and adolescents: bronchitis, tonsillitis
(common), chest pain (uncommon).

Further 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
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 which is stated on the carton after “Scad.” and on the
blister after “EXP”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage temperature.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 ingredient is an allergenic extract of sweet vernal grass ( Dactylis glomerataL.), sweet-scented vernal grass ( Anthoxanthum odoratumL.), perennial ryegrass ( Lolium perenneL.), meadow fescue ( Poa pratensisL.) and timothy grass ( Phleum pratenseL.) pollen. One sublingual tablet contains 300 IR. The IR (reactivity index) expresses the activity and is determined in sensitized patients via a skin test.
• The excipients are mannitol (E421), microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate and lactose monohydrate.

Description of the appearance of ORALAIR and package contents
The 300 IR tablets are slightly mottled, from white to beige in colour, with the inscription "300"
embossed on both sides.
A blister containing 30 sublingual tablets of 300 IR.
The tablets are supplied in blisters (alu/alu) consisting of a film
(polyamide/aluminium/polyvinyl chloride). The blister cells are numbered.
Packs: 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. 0033 (0) 1 55 59 20 00
Fax 0033 (0) 1 55 59 21 68

This medicinal product is authorised in the Member States of the European Economic Area with the
following designations:
Austria ORALAIR 300 IR Sublingualtabletten
Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Ireland, Italy, Latvia, Luxembourg,
Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Hungary ORALAIR 300 IR
Croatia Oralair 300 IR sublingvalne tablete
Denmark, Finland and Sweden Aitgrys
Lithuania ORALAIR 300 IR poliežuvines tabletes
Norway Oralair
Slovenia ORALAIR 300 IR podjezične tablete