Oralair 300 Ir

Leaflet accompanying the packaging: information for the user

ORALAIR 300 IR, 300 IR sublingual tablets

For use in adults, adolescents, and children over 5 years old.
Extract of allergens from pollen of the following grasses:
Cocksfoot ( Dactylis glomerataL.), Sweet vernal grass ( Anthoxanthum odoratumL.), Perennial ryegrass ( Lolium perenneL.), Meadow grass ( Poa pratensisL.) and Timothy grass ( Phleum
pratenseL.)

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

• You should keep this leaflet, so you can read it again if you need to.
• You should consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is ORALAIR and what is it used for
• 2. Important information 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 is ORALAIR and what is it used for

ORALAIR contains an allergen extract. The treatment with ORALAIR aims to increase the immune tolerance to grass pollen and thus reduce the symptoms of allergy.
ORALAIR is used to treat grass pollen allergy, which is characterized by rhinitis (sneezing, runny or itchy nose, nasal congestion) with or without conjunctivitis (itchy and watery eyes) in adults, adolescents, and children over 5 years old.
Before starting treatment, the doctor will diagnose the allergy (hypersensitivity) using a suitable skin test and/or blood test.

2. Important information before taking ORALAIR

When not to take ORALAIR

• if you are allergic to any of the other ingredients of this medicine (listed in section 6);
• if you have severe and/or unstable asthma or if you have had a severe asthma attack in the last 3 months,
• if your doctor considers that your forced expiratory volume in one second (FEV1) is below 80%,
• if you have diseases affecting the immune system, if you are taking medicines that reduce the immune system or if you have cancer,
• if you have mouth ulcers or mouth infections. Your doctor may recommend delaying the start of treatment or interrupting it until the mouth ulcers have healed. Women who are pregnant should not start treatment with ORALAIR.

Warnings and precautions

Before starting treatment with ORALAIR, you should discuss with your doctor:

• The occurrence of severe allergic symptoms, such as difficulty swallowing or breathing, changes in voice, low blood pressure or a feeling of a lump in the throat. You should stop treatment and contact your doctor immediately.
• The occurrence of a previous severe allergic reaction to a medicine containing allergen extracts.
• A significant increase in asthma symptoms. You should stop treatment and contact your doctor immediately.
• The presence of cardiovascular diseases.
• Taking beta-blockers (a class of medicines often prescribed for heart diseases and high blood pressure, but also found in some eye drops and ointments).
• Treatment of depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) or treatment of Parkinson's disease with catechol-O-methyltransferase (COMT) inhibitors.
• Patients awaiting oral surgery or tooth extraction should interrupt treatment with ORALAIR until complete healing.
• Patients with persistent heartburn or difficulty swallowing should contact their doctor.
• Patients with autoimmune diseases in remission should discuss with their doctor:
• any recent illnesses;
• the occurrence of any diseases in the patient or their family that may affect the immune system;
• if the allergy symptoms have worsened recently. If you are taking medicines to control asthma and/or medicines to relieve symptoms, you should not stop taking them without consulting your doctor, as this may lead to an increase in asthma symptoms. If you have asthma and a respiratory infection, the start of treatment with ORALAIR should be delayed until the infection has been treated. During treatment, mild or moderate local allergic reactions may occur. In case of severe allergic reactions, you should discuss with your doctor whether it is necessary to take anti-allergic medicines, such as antihistamines.

Children and adolescents

ORALAIR is used to treat grass pollen allergy, which is characterized by rhinitis with or without conjunctivitis in adults, adolescents, and children over 5 years old.
ORALAIR is not indicated for use in children under 5 years old.

Other medicines and ORALAIR

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those available without a prescription.
You should inform your doctor in particular if you are taking certain antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs)).
Patients taking other anti-allergic medicines, such as antihistamines, asthma medicines, steroids or medicines blocking the substance called immunoglobulin E (IgE) (e.g. omalizumab), should discuss with their doctor the continuation of these medicines. Stopping these anti-allergic medicines may cause further side effects during treatment with ORALAIR. During treatment with ORALAIR, symptomatic treatment (e.g. antihistamines and/or nasal corticosteroids) may be used.
You should inform your doctor or pharmacist before taking ORALAIR: if you are taking medicines blocking beta-adrenergic receptors (i.e. a group of medicines often prescribed for heart disorders and high blood pressure, as well as found in some eye drops or ointments), as they may reduce the effectiveness of adrenaline used to treat severe systemic reactions.

ORALAIR with food and drink

You should not eat or drink for 5 minutes after taking this medicine.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or think you may be pregnant, or if you plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.
There is no experience with the use of ORALAIR during pregnancy. Therefore, immunotherapy should not be started if you are pregnant. If you become pregnant during treatment with this medicine, you should discuss with your doctor whether to continue treatment.

Breastfeeding

Before taking this medicine, you should consult your doctor or pharmacist if you are breastfeeding.
Immunotherapy should not be started during breastfeeding.
There is no experience with the use of ORALAIR during breastfeeding. No effect on breastfed children is expected during treatment. If you plan to breastfeed during treatment, you should consult your doctor whether to continue treatment.

Driving and using machines

No effect of ORALAIR on the ability to drive and use machines has been observed.
ORALAIR contains lactose.
If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
ORALAIR contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be essentially sodium-free.

3. How to take ORALAIR

This medicine should always be taken exactly as prescribed by your doctor. If you are not sure, you should ask your doctor or pharmacist.
ORALAIR is prescribed by doctors with appropriate training and experience in the treatment of allergies (hypersensitivity). If the medicine is prescribed for children, it is prescribed by a doctor with appropriate experience in the treatment of children.
The first tablet should be taken under medical supervision. This will allow you to discuss with your doctor any possible side effects (adverse reactions).
Dosage
Treatment consists of an initial treatment phase (including dose increase over 3 days) and a maintenance treatment phase.
You should take 1 tablet of 300 IR once a day. ORALAIR 300 IR is intended for maintenance treatment.
Method of administration
The first tablet of ORALAIR should be taken under medical supervision. You should remain under medical supervision for at least 30 minutes after taking the first dose of the medicine. This precaution is taken to monitor the reaction to the medicine. It also allows you to discuss with your doctor any possible side effects.
The tablet should be placed under the tongue until it is completely dissolved (at least 1 minute), and then swallowed. It is recommended to take the tablet during the day on an empty stomach. For the next 5 minutes, you should not eat or drink anything.
Duration of treatment
The tablets should be taken as prescribed by your doctor until the end of the treatment period. Treatment should be started about 4 months before the expected pollen season and should be continued until the end of the pollen season.
There is no experience with the use of ORALAIR in patients over 65 years old.

Use in children and adolescents

There is no experience with the use of ORALAIR in children under 5 years old.
There is no experience with the use of ORALAIR in children for more than one pollen season.
The dosage in children and adolescents over 5 years old is the same as in adults.

Overdose of ORALAIR

In case of overdose of ORALAIR, allergic symptoms may occur, including local symptoms in the mouth and throat. If severe symptoms occur, you should contact your doctor immediately.

Missed dose of ORALAIR

You should not take a double dose to make up for a missed dose.
If treatment with ORALAIR is interrupted for less than a week, you can resume treatment with the same dose as before.
If treatment is interrupted for more than 7 days, you should consult your doctor about how to continue treatment.

Stopping treatment with ORALAIR

If you stop treatment with ORALAIR, you may not get further benefits from treatment.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ORALAIR can cause side effects, although not everybody gets them.
Patients treated with ORALAIR are exposed to the risk of local reactions at the site of administration and/or systemic reactions. Local reactions at the site of administration (such as itching in the mouth and throat irritation) are common. These reactions usually occur at the start of treatment and are temporary and generally decrease over time.

You should stop taking ORALAIR and contact your doctor or go to the hospital immediately if you experience any of the following symptoms:

• Sudden swelling of the face, lips, tongue, or throat
• Difficulty swallowing
• Difficulty breathing
• Changes in voice
• Low blood pressure (hypotension)
• Feeling of a lump in the throat
• Hives and itching of the skin

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

Other possible side effects include:

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

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

Common (affect less than 1 in 10 patients):

• Eye inflammation, itching or tearing of the eyes
• Itching of the ears
• Rhinitis (stuffy nose, runny nose, itchy nose, sneezing, discomfort in the nose), sinusitis
• Swelling or itching of the lips or tongue, tongue pain
• Mouth disorders (such as dryness, tingling, numbness, inflammation, pain, blisters or swelling)
• Throat disorders (such as dryness, discomfort, pain, blisters or swelling), hoarseness, difficulty swallowing
• Pharyngitis, tonsillitis
• Asthma, difficulty breathing
• Cough
• Chest discomfort
• Heartburn, stomach upset, abdominal pain, diarrhea, vomiting, nausea
• Persistent skin condition characterized by dryness, redness and itching, hives, itching

Uncommon (affect less than 1 in 100 patients)

• Eye swelling, eye redness, eye dryness
• Ear inflammation, dizziness, ear discomfort
• Mouth ulcers or tongue swelling, palate swelling, gum inflammation or lip or tongue inflammation
• Enlarged salivary glands, excessive saliva production
• Taste disorders, belching
• Throat tightness, throat numbness, feeling of a foreign body in the throat
• Wheezing
• Allergic reaction with face and throat swelling, hypersensitivity
• Enlarged lymph nodes
• Rash, acne, herpes, skin damage due to scratching
• Depression, fatigue, drowsiness
• Flu-like symptoms

Rare (affect less than 1 in 1000 patients)

• Face swelling, face redness
• Restlessness
• Increased eosinophil count.

Frequency not known (cannot be estimated from the available data):
Additionally, oesophagitis has been reported.
The number of side effects reported by adults who took ORALAIR during three consecutive grass pollen seasons in a clinical trial decreased in the second and third year of treatment.

Side effects in children and adolescents

In children and adolescents treated with ORALAIR, the following side effects occurred more frequently than in adults: cough, pharyngitis, mouth swelling (very common), oral allergy syndrome, lip inflammation, feeling of a lump in the throat, tongue inflammation, ear disorders (common).
Additionally, in children and adolescents, the following side effects have been reported: bronchitis, tonsillitis (common), chest pain (uncommon).

Other side effects that have occurred in adults, adolescents, and children

taking ORALAIR(post-marketing experience, frequency not known):
Asthma worsening, systemic allergic reactions.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to
Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ORALAIR

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP” and on the blister after “EXP”. The expiry date refers to the last day of that month.
No special precautions for storage of the medicinal product are necessary.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should 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 of ORALAIR is an allergen extract from the pollen of the following grasses: Cocksfoot ( Dactylis glomerataL.), Sweet vernal grass ( Anthoxanthum odoratumL.), Perennial ryegrass ( Lolium perenneL.), Meadow grass ( Poa pratensisL.) and Timothy grass ( Phleum pratenseL.). One sublingual tablet contains 300 IR.
IR (index of reactivity) is a measure of activity and is determined in allergic patients based on a skin test.
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 speckled in white to beige color, with “300” embossed on both sides.
One blister pack containing 30 sublingual tablets of 300 IR.
The tablets are provided in blisters (Alu/Alu) with foil (polyamide/aluminium/PCW). The blister cavities are numbered.
Pack sizes: 30 and 90 sublingual tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

STALLERGENES
6 rue Alexis de Tocqueville
92160 ANTONY
France
Phone: +33 (0) 1 55 59 20 00
Fax: +33 (0) 1 55 59 21 68

This medicinal product is authorized in the Member States of 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 sublingual tablets
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

Date of last revision of the leaflet: 09/2023