Oralair 300 IR sublingual tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ORALAIR 300IR sublingual tablets

For use in adults, adolescents and children over five years of age

Allergen extract from grass pollen of:

orchard grass (Dactylis glomerata L.), sweet vernal grass (Anthoxanthum odoratum L.), perennial rye grass (Lolium perenne L.), meadow fescue (Poa pratensis L.) and timothy grass (Phleum pratense L.)

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 indicated to increase immunological tolerance to grass pollens and thereby reduce allergic symptoms.

ORALAIR is used for the treatment of grass pollen allergy, which is characterized by rhinitis (sneezing, runny nose, nasal itching, nasal congestion) with or without conjunctivitis (itchy, watery eyes) in adults, adolescents, and children from five years of age.

Before starting treatment, the allergy must be diagnosed by an allergy specialist using appropriate skin tests or blood tests.

2. What you need to know before starting 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 or unstable asthma or have experienced severe asthma exacerbations in the past 3 months;
• Your forced expiratory volume in one second (FEV1) is below 80% as assessed by your doctor;
• You have a disease affecting your immune system, are taking medicines that suppress the immune system, or have cancer;
• You have mouth ulcers or oral infections. Your doctor may advise 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 starting 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 severe allergic reactions to a medicine containing allergen extracts.
• Your asthma symptoms worsen more than usual. Stop treatment and contact your doctor immediately.
• You have a cardiovascular disease.
• You are taking a beta-blocker (a class of drugs commonly prescribed for heart conditions and high blood pressure, but also present in some eye drops and topical 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 dental extraction; you must interrupt 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,
• Personal or family history of any condition that could affect your immune system,
• If your allergic condition has recently worsened.

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

You may expect some mild to moderate localized allergic reactions during treatment. If these reactions are severe, speak with your doctor about whether you need anti-allergic medication such as antihistamines.

Children and adolescents

ORALAIR is used for the treatment of grass pollen allergy-related rhinitis with or without conjunctivitis in adolescents and children from 5 years of age. 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 need to take any other medicines, including over-the-counter medicines.

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

If you are taking other allergy medications such as antihistamines, asthma relief medications, steroids, or medicines 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 these allergy medications, you may experience more adverse effects during ORALAIR treatment. Symptomatic treatment (e.g., antihistamines and/or nasal corticosteroids) may be used alongside ORALAIR.

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

Taking ORALAIR with food and drink

Do not eat or drink anything for 5 minutes after taking this medicine.

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 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, consult your doctor about whether it is appropriate to continue treatment.

Breastfeeding

If you are breastfeeding, consult your doctor or pharmacist before using 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, consult your doctor to determine whether continuing treatment is appropriate for you.

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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

ORALAIR contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take ORALAIR

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, please consult your doctor or pharmacist again.

ORALAIR is prescribed by doctors with appropriate training and experience in the treatment of allergies. When prescribing for children, the doctor has adequate experience in treating pediatric patients.

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

Dosage

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

Take one 300 IR tablet once daily.

Method of administration

The first dose of ORALAIR must be taken under medical supervision. You must remain under medical observation for at least half an hour after taking the first dose. This precaution is to monitor your sensitivity to the medicine. It will also give you the opportunity to discuss possible side effects with your doctor.

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

Treatment duration

Take these tablets as prescribed by your doctor until the end of the treatment period. Begin treatment approximately 4 months before the start of the pollen season and continue until the end of the 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 dose in adolescents and children aged 5 years and older 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, including symptoms localized in the mouth and throat. If you experience severe symptoms, consult your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take ORALAIR

Do not take a double dose to make up for missed doses.

If you have interrupted treatment with ORALAIR for less than one week, you may resume treatment at the same dose.

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

If you stop taking ORALAIR

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 administration and/or symptoms that may affect the whole body. Local reactions at the site of administration such as itching in the mouth and throat irritation may be expected. These reactions usually occur at the beginning of therapy, are transient, and generally 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
• Difficulty breathing
• Voice changes
• Hypotension (low blood pressure)
• Sensation of throat fullness (as if swelling)
• Hives or skin itching

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

Other possible adverse effects

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

• Itching in the mouth
• Throat irritation
• Headache

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

• Eye inflammation, eye itching, watery eyes
• Itching in the ears
• Rhinitis (nasal congestion, 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, swelling, pain, blisters, or swelling)
• Throat disorders (such as dryness, discomfort, pain, blisters, or swelling), hoarseness, difficulty swallowing
• Inflammation of the mouth, nose, and throat
• Asthma, breathing difficulty
• Cough
• Chest discomfort
• Heartburn, stomach upset, stomach pain, diarrhea, vomiting, nausea
• Persistent skin condition characterized by dryness, redness, and itching, hives, itching

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

• Swelling of the eyes, eye redness, dry eyes
• Ear infection, dizziness, ear discomfort
• Ulceration of the mouth or tongue, inflammation of the palate, inflammation of the gums, lips, or tongue
• Swelling of the salivary glands, overproduction of saliva
• Altered taste, belching
• Sensation of throat tightness, throat numbness, sensation of a foreign body in the throat
• Wheezing
• Allergic reactions presenting with swelling of the face and throat, hypersensitivity
• Swollen lymph nodes
• Skin rashes, acne, herpes, skin lesions due to scratching
• Depression, fatigue, drowsiness
• Influenza-like illness

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

• Facial swelling, flushing
• Anxiety
• Increase in eosinophil count

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

Esophageal inflammation has additionally been reported.

The number of adverse reactions reported in a clinical study in adults treated with ORALAIR during three consecutive grass pollen seasons decreased during the second and third years.

Adverse effects in children and adolescents

The following adverse effects were more frequent in children and adolescents receiving ORALAIR than in adults: cough, inflammation of the nose and throat, oral edema (very common), oral allergy syndrome, lip swelling, sensation of lump in the throat, tongue swelling, ear discomfort (common).

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

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

Worsening of asthma, systemic allergic reactions.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ORALAIR

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

Do not use this medicine after the expiry date stated on the packaging after "CAD" and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of ORALAIR

• The active substance is an allergenic extract from grass pollen: of Orchard grass (Dactylis glomerata L.), Sweet vernal grass (Anthoxanthum odoratum L.), Perennial rye grass (Lolium perenne L.), Kentucky bluegrass (Poa pratensis L.) and Timothy grass (Phleum pratense L.). One sublingual tablet contains 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 monohydrate lactose.

Nature and contents of the container

The tablets are white to beige in colour, slightly mottled, and marked with "300" on both sides.

One blister contains 30 sublingual tablets of 300 IR.

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

Pack sizes: 30 and 90 sublingual tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and 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 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 poliežuvines tabletes

Slovenia Oralair 300 IR podjezicne tablete

Spain ORALAIR 300 IR comprimidos sublinguales

Date of the most recent revision of this leaflet: December 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/