Prospecto: information for the user

ORALAIR INITIO 100IR & 300IR sublingual tablets

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

Allergenic extract of grass pollen from:

dactylis (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, which is 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, the allergy must be diagnosed by appropriate skin tests or blood analyses by a specialist doctor experienced in the treatment of 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, voice changes, low blood pressure, or a sensation of a lump in your throat. Interrupt 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. Interrupt 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 (COMT).
• You need to undergo oral surgery or dental extraction, you should interrupt ORALAIR treatment until you are completely 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 disease has worsened recently.

If you take medications for asthma control and/or relief, do not stop asthma treatment 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 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.

Other medications and ORALAIR

Inform your doctor or pharmacist if:you are taking, have taken recently, 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 doctor about whether you should continue taking them. If you stop taking those medications for allergies, you may experience more side effects during ORALAIR treatment.You can use symptomatic treatment (e.g. antihistamines and/or nasal corticosteroids) 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

Do not ingest food or beverages 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 your baby 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 certain sugar 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 the prescription for children, 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 phase.

Starting treatment

ORALAIR treatment should be started as follows:

IR (reactivity index) expresses the activity.

ORALAIR 100 IR is only indicated for the dose increase period and not for the maintenance period.

Maintenance treatment

The dose is 300 IR (1 tablet) per day until the end of the pollen season.

Administration form

The first dose of ORALAIR must 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 the tongue until it dissolves completely (at least one minute) before swallowing. On the second day, place two 100 IR tablets simultaneously under the tongue, and swallow them after about a minute. 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

Start treatment approximately 4 months before the start of the pollen season and continue until the end of the same.

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

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 the treatment with ORALAIR, you may not obtain a 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:

• Quick 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
• Mouth, nose, and throat inflammation
• 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, fever blisters, 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):

In addition, esophageal inflammation has 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 lump, 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 side effects that do not appear in this prospectus. 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 in the 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. By doing so, you will help protect the environment.

Composition of ORALAIR

• The active principle is an allergenic extract of grass pollen from:

Creeping bent (Dactylis glomerataL.), sweet vernal grass (Anthoxanthum odoratumL.), perennial ryegrass (Lolium perenneL.), meadow grass (Poa pratensisL.) and timothy grass (Phleum pratenseL.). A sublingual tablet contains 100 IR or 300 IR.

The IR (reactivity index) expresses the activity and is determined in sensitized patients by 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 productand contents of the package

The 100 IR tablets are white to beige, slightly speckled, engraved with “100” on both sides.

The 300 IR tablets are white to beige, slightly speckled, engraved with “300” 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 blisters (Alu/Alu) composed of a film (polyamide/aluminum/chloride of polyvinyl chloride). The blister cells are numbered.

Package size: 31 sublingual tablets.

Holder of the marketing authorization and responsible for manufacturing

STALLERGENES

6 rue Alexis de Tocqueville

92160 ANTONY

France

Phone: 00 33 1 55 59 20 00

Fax: 00 33 1 55 59 21 68

For more information about this medication, please contact the local representative of the marketing authorization holder:

Stallergenes Ibérica S.A.

Llacuna, 22 – 2º 1ª

08005 BARCELONA

This medication is authorized in the member states of the European Economic Area with 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 poliežuvines tabletes

Slovenia Oralair 100 IR in 300 IR podjezicne tablete

Spain ORALAIR INICIO 100 IR/300 IR comprimidos sublinguales

Last review date of this leaflet: October 2023

For detailed and updated information about this medication, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/