Prospect: information for the user

ORALAIR 300IR sublingual tablets

For use in adults, adolescents, and children over five years old

Extract of allergenic pollen from:

orchard grass (Dactylis glomerataL.), sweet vernal grass (Anthoxanthum odoratumL.), perennial ryegrass (Lolium perenneL.), meadow grass (Poa pratensisL.) and timothy grass (Phleum pratenseL.)

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

1. What isORALAIRand for what it is used

2. What you need to know before starting to takeORALAIR

3. How to takeORALAIR

4. Possible adverse effects

5. Storage ofORALAIR

6. Contents of the package and additional information

ORALAIR contains an allergenic extract. Treatment with ORALAIR is indicated to increase immunological tolerance towards grass pollen allergens, thereby reducing allergic symptoms.

ORALAIR is used for the treatment of grass pollen allergy, characterized by rhinitis (stuffy nose, sneezing, nasal itching, nasal congestion) with or without conjunctivitis (eye itching and tearing) in adults, adolescents, and children aged five years and above.

Before starting treatment, allergy must be diagnosed by appropriate skin tests or blood analyses by a specialist doctor with experience in treating allergic diseases.

Do not take ORALAIR if:

• You are allergic to any of the other components of this medication (listed in section6);
• You have severe or unstable asthma or have had severe asthma exacerbations in the last 3 months;
• Your forced expiratory volume in one second (FEV1) is less than 80% as evaluated by your doctor;
• You have a disease that affects your immune system, are taking medications that suppress your immune system, or have cancer;
• You have ulcers or oral infections. 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

Consult your doctor or pharmacist before starting ORALAIR if:

• You experience severe allergic symptoms, such as difficulty swallowing or breathing, changes in your voice, low blood pressure, or a sensation of a lump in your throat. Discontinue treatment and contact your doctor immediately.
• You have had previous severe allergic reactions to a medication with allergen extracts.
• Your asthma symptoms worsen more than usual. Discontinue treatment and contact your doctor immediately.
• You have a cardiovascular disease.
• You are taking a beta-blocker (a class of medications commonly prescribed for heart conditions and high blood pressure, but also present in some eye drops and creams).
• You are being treated for depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), or for Parkinson's disease with catechol-O-methyltransferase inhibitors (COMTs).
• You need to undergo oral surgery or dental extraction, you should discontinue ORALAIR treatment until you are fully healed.
• You experience persistent heartburn or difficulty swallowing. You should contact your doctor.
• You have an autoimmune disease in remission.

Inform your doctor about:

• Any recent illness you may have had,
• Family or personal history of any disease that may affect your immune system,
• If your allergic condition has worsened recently.

If you take medications for asthma control and/or relief, do not stop taking them without consulting your doctor, as this may worsen asthma symptoms. If you have asthma and a respiratory infection, delay starting ORALAIR treatment until the infection has resolved.

You may experience some localized allergic reactions, ranging from mild to moderate, during treatment. If these reactions are severe, talk to your doctor about whether you need an antiallergic medication such as antihistamines.

Children and adolescents

ORALAIR is used to treat grass pollen allergy 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.

Other medications and ORALAIR

Inform your doctor or pharmacist ifyou are taking, have takenrecently or may need to take any other medication, including over-the-counter medications.

Especially inform your doctor if you are taking certain antidepressants (tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs).

If you are taking other allergy medications, such as antihistamines, asthma relief medications, or steroids, or medications that block a substance called immunoglobulin E (IgE), such as omalizumab, talk to your doctorabout whether you should continue taking them. If you discontinue taking those allergy medications, you may experience more side effects during ORALAIR treatment. A symptomatic treatment (e.g. antihistamines and/or nasal corticosteroids) can be used in conjunction with ORALAIR.

Consult your doctor or pharmacist before taking Oralair: if you are taking a beta-blocker (i.e., a type of medication commonly prescribed for heart conditions and high blood pressure, and also present in some eye drops and creams), as this medication may reduce the effectiveness of adrenaline used to treat severe systemic reactions.

ORALAIR with food and beverages

No food or beverages should be consumed during the 5 minutes following the administration of this medication.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is no experience with the use of ORALAIR during pregnancy. Therefore, do not start immunotherapy if you are pregnant. If you become pregnant while taking this medication, consult your doctor about whether it is advisable to continue treatment.

Breastfeeding

If you are breastfeeding, consult your doctor or pharmacist before using this medication.

Do not initiate immunotherapy if you are breastfeeding.

There is no experience with the use of ORALAIR during breastfeeding. No effects on infants who receive breast milk during treatment are anticipated. If you wish to breastfeed while on treatment, consult your doctor to see if it is advisable for you to continue treatment.

Driving and operating machinery

No effects of ORALAIR on the ability to drive or operate machinery have been observed

ORALAIR contains lactose

If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

ORALAIR contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

ORALAIR is prescribed by doctors with adequate training and experience in the treatment of allergies. In pediatric prescriptions, the doctor has adequate experience in the treatment of children.

You are advised to take the first tablet under medical supervision. This will give you the opportunity to talk to your doctor about possible adverse reactions.

Dosage

The treatment consists of a starting phase (including a dose increase over three days) and a maintenance treatment phase. ORALAIR 300 IR is only indicated for the maintenance phase.

Take one 300 IR tablet once a day.

Administration form

The first dose of ORALAIR should be taken under medical supervision. You should remain under medical observation for at least half an hour after taking the first dose. This is a precaution to control your sensitivity to the medication. It will also give you the opportunity to talk to your doctor about possible side effects.

Keep the tablet under your tongue until it dissolves completely (at least one minute) before swallowing. It is recommended to take the tablet during the day, with an empty mouth. Do not eat or drink for at least 5 minutes.

Treatment duration

Take these tablets, as prescribed by your doctor, until the end of the treatment period. Start treatment approximately 4 months before the start of the pollen season and continue until the end of it.

There is no experience with ORALAIR in patients over 65 years old.

Use in children and adolescents

There is no experience with ORALAIR in children under 5 years old.

There is no experience of more than one pollen season in children.

The dose in adolescents and children over 5 years old is the same as in adults.

If you take more ORALAIR than you should

If you take more ORALAIR than you should, you may experience allergic symptoms, even localized symptoms in the mouth and throat. If you experience severe symptoms, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take ORALAIR

Do not take a double dose to compensate for the missed doses.

If you have interrupted treatment with ORALAIR for less than a week, you can resume treatment with the same dose.

If you interrupted treatment for more than 7 days, consult your doctor on how to resume your treatment.

If you interrupt treatment with ORALAIR

If you do not complete treatment with ORALAIR, you may not obtain continued benefit from the treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine mayproduceside effects, although not everyone will experience them.

During treatment with ORALAIR, you will be exposed to substances that may cause local reactions at the site of application and/or symptoms that may affect the entire body. Local reactions at the site of application such as mouth itching and throat irritation may be expected. These reactions usually occur at the beginning of therapy, are transient, and generally decrease over time.

Stop taking ORALAIR and immediately contact your doctor or hospital if you experience any of the following symptoms:

• Fast swelling of the face, mouth, throat, or skin.
• Difficulty swallowing
• Difficulty breathing
• Changes in voice
• Hypotension (low blood pressure)
• Sensation of fullness in the throat (like swelling)
• Urticaria or itching on the skin

The treatment should only be resumed following the instructions of a doctor.

Other possible side effects

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

• Mouth itching
• Throat irritation
• Headache

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

• Eye inflammation, eye itching, watery eyes
• Ear itching
• Rhinitis (nasal congestion, nasal discharge, nasal itching, sneezing, nasal discomfort), nasal congestion
• Swelling or itching on 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, inflammation of the mouth, nose, and throat
• Asthma, difficulty breathing
• Cough
• Chest discomfort
• Heartburn, stomach discomfort, stomach pain, diarrhea, vomiting, nausea
• Chronic skin disease characterized by dryness, redness, and itching, urticaria, itching

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

• Swelling of the eyes, eye redness, eye dryness
• Ear infection, dizziness, ear discomfort
• Mouth or tongue ulceration, palate inflammation, gum inflammation, lip or tongue inflammation
• Salivary gland enlargement, excessive saliva production
• Altered taste, belching
• Sensation of throat constriction, throat numbness, sensation of foreign body in the throat
• Wheezing
• Allergic reactions that occur with facial and throat inflammation, hypersensitivity
• Swollen lymph nodes
• Skin eruptions, acne, herpes, skin lesions after scratching
• Depression, fatigue, drowsiness
• Influenza-like illness

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

• Swelling of the face, shortness of breath
• Anxiety
• Increased eosinophil count

Frequency not known (cannot be estimated with available data):

Esophageal inflammation has also been reported.

The number of side effects reported in a clinical study in adults treated with ORALAIR for three consecutive grass pollen seasons decreased during the second and third year.

Side effects in children and adolescents

The following side effects were more frequent in children and adolescents who received ORALAIR than in adults: cough, nasal and throat inflammation, oral edema (very common), oral allergy syndrome, lip inflammation, sensation of throat constriction, tongue inflammation, ear discomfort (common).

Additionally, the following adverse reactions were reported in children and adolescents: bronchitis, tonsillitis (common), chest pain (uncommon).

Other side effects observed in adults, adolescents, and children(post-marketing experience, frequency unknown):

Worsening of asthma, systemic allergic reactions.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD” and on the blister pack after “EXP”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature..

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash.Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of ORALAIR

• The active ingredient is an allergenic extract of grass pollen from: Dáctilo (Dactylis glomerataL.), sweet vernal grass (Anthoxanthum odoratumL.), perennial ryegrass (Lolium perenneL.), meadow grass (Poa pratensisL.) and timothy grass (Phleum pratenseL.). A sublingual tablet contains 300 IR.

The IR (reactivity index) expresses the activity and is determined in sensitized patients through a skin sensitivity test.

• The other components are mannitol (E 421), microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate and lactose monohydrate.

Appearance of the product and contents of the package

The tablets are white to beige, slightly speckled, and engraved with “300” on both sides.

A blister pack containing 30 sublingual tablets of 300 IR.

The tablets are supplied in blisters (Alu/Alu) composed of a film (polyamide/aluminum/chloride of polyvinyl chloride).

Package sizes: 30 and 90 sublingual tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

STALLERGENES

6 rue Alexis de Tocqueville

92160 ANTONY

France

Tel.: 00 33 1 55 59 20 00

Fax: 00 33 1 55 59 21 68

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Stallergenes Ibérica S.A.

Llacuna, 22 – 2º 1ª

08005 BARCELONA

This medicinal product is authorized in the member states of the European Economic Area with 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, sublingual tablet

Hungary Oralair 300 IR, nyelvalatti tabletta

Lithuania ORALAIR 300 IR poliežuvines tabletes

Slovenia Oralair 300 IR podjezicne tablete

Spain ORALAIR 300 IR sublingual tablets

Last review date of this leaflet: December 2023

Detailed and updated information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/