ACTAIR 100 IR SUBLINGUAL TABLETS

Introduction

Package Leaflet: Information for the Patient

Actair 100IR Sublingual Tablets

For use in adolescents and adults (from 12 to 65years old)

Standardized allergen extracts from house dust mites

(Dermatophagoides pteronyssinusand Dermatophagoides farinae)

This medication is subject to additional monitoring, which will make it easier to detect new information about its safety. You can contribute by reporting any side effects you may have. The end of section 4 includes information on how to report side effects.

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

• Keep this package leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Actair and what is it used for
2. What you need to know before taking Actair
3. How to take Actair
4. Possible side effects
5. Storage of Actair
6. Package Contents and Additional Information

1. What is Actair and what is it used for

This medication contains standardized allergen extracts from house dust mites.

This medication is used to treat allergic rhinitis (inflammation of the nasal mucosa) in adolescents (12-17 years old) and adults. This medication works by increasing immune tolerance to house dust mites (i.e., the body's ability to cope with their presence). You may not notice an improvement until you have been taking the treatment for 3 months.

Actair 100 IR is indicated only for the dose escalation period and not for maintenance.

Before starting treatment, a doctor must diagnose your allergy through skin tests or appropriate blood tests.

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

This medication should be prescribed by a doctor with experience in treating allergies.

2. What you need to know before taking Actair

Do not take Actair:

• If you are allergic to any of the excipients (other components) of this medication (listed in section 6).
• If you have severe and/or unstable asthma or have had a severe asthma exacerbation in the last 3 months.
• If your doctor determines that your forced expiratory volume in one second [FEV1] is less than 80%.
• If you have a disease that affects the immune system, if you are taking immunosuppressive medications, or if you have cancer.
• If you have mouth ulcers or oral infections. Your doctor will recommend delaying the start of treatment or interrupting it until your mouth is healed.

Do not start taking this medication if you are pregnant.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have severe allergic symptoms, such as difficulty swallowing or breathing, changes in voice, hypotension (low blood pressure), or feel a lump in the throat. Stop treatment and contact your doctor immediately.
• If you have had a severe allergic reaction to a medication with allergen extracts in the past.
• If your asthma symptoms worsen more than usual. Stop treatment and contact your doctor immediately.
• If you have a cardiovascular disease.
• If you are taking a beta-adrenergic blocker (a class of medications often prescribed to treat heart diseases and high blood pressure and also present in some eye drops and ointments).
• If you are receiving treatment for depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) or for Parkinson's disease with catechol-O-methyltransferase (COMT) inhibitors.
• If you are going to undergo oral surgery or a dental extraction, temporarily interrupt treatment with this medication until it has completely healed.
• If you experience heartburn or difficulty swallowing. In that case, contact your doctor.
• If you have an autoimmune disease in remission.

Tell your doctor:

• About any disease you have had recently;
• About your personal or family history of any disease that affects the immune system;
• If your allergic disease has worsened recently.

Do not stop taking control and/or relief medications for asthma without your doctor's advice, as this may worsen asthma symptoms.

During treatment, it is expected that some localized allergic reactions of mild or moderate intensity will occur. If the reactions are severe, talk to your doctor to determine if you need any antiallergic medication, such as antihistamines.

Children and Adolescents

This medication is used to treat allergic rhinitis in adolescents (12-17 years old). This medication should not be used in children under 12 years old.

Other Medications and Actair

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including medications without a prescription. If you are taking other medications for allergies, such as antihistamines, asthma medications, or steroids, or a medication that blocks a substance called immunoglobulin E (IgE), for example, omalizumab, talk to your doctor about whether you should continue taking them. If you stop taking allergy medications, you may experience more side effects during treatment with this medication.

Using Actairwith Food and Drinks

Do not consume food or drinks in the 5 minutes after taking this medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, 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 this medication during pregnancy. Therefore, you should not start treatment with this medication if you are pregnant. If you become pregnant while taking this medication, consult your doctor about whether it is appropriate to continue treatment.

There is no experience with the use of this medication during breastfeeding. However, no effects on breastfed infants are expected. Consult your doctor to determine if it is appropriate to continue treatment with this medication during breastfeeding.

Driving and Using Machines

No effects of this medication on the ability to drive or use machines have been observed.

Actaircontains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Actair contains Sodium

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

3. How to take Actair

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Treatment with this medication should be started with 100 IR and should be gradually increased to reach the maintenance dose of 300 IR. The IR (Reactivity Index) expresses the activity.

Actair 100 IR is indicated only for the dose escalation period and not for maintenance.

The first tablet should be taken under medical supervision. Your doctor will indicate the schedule and duration of the dose escalation.

Use inAdolescents

The administration schedule in adolescents is the same as in adults.

Take this medication as follows:

1. Remove a tablet (or 2 tablets) from the package by pressing the tablet against the blister.
2. Take the tablet during the day, with an empty mouth.
3. Place the tablet under your tongue, let it dissolve completely, and then swallow.

1. Do not eat or drink for at least 5 minutes.
2. Wash your hands after handling the tablet.

If you take more Actairthan you should

If you take more medication than you should, you may experience allergic symptoms such as localized symptoms in the mouth and throat. If you experience severe symptoms, contact a doctor or hospital immediately.

If you forget to take Actair

If you have forgotten to take a tablet, take it later during the day. Do not take a double dose to make up for forgotten doses. If you have not taken this medication for more than 7 days, contact your doctor before taking this medication again.

If you stop taking Actair

If you do not take this medication as directed by your doctor, you may not get the beneficial effects of the treatment. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects can be an allergic reaction to the allergen being treated. Most side effects last from minutes to hours after taking the medication and will disappear when you have been treated for 1 to 3 months.

Stop taking this medication 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)
• Sensation of a lump in the throat (like swelling)
• Hives and itching of the skin

Other possible side effects:

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

• Swelling or itching in the mouth
• Irritation of the throat
• Itching in the ear

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

• Itching in the eyes
• Swelling or itching of the lips or tongue
• Burning or tingling in the mouth, inflammation or ulcers in the mouth, oral ulcers
• Alteration of taste
• Discomfort or pain in the mouth or throat
• Inflammation of the throat, difficulty swallowing
  • Cough
  • Difficulty breathing

• Chest pain
• Stomach pain, indigestion, nausea, diarrhea
• Itching

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

• Redness and inflammation of the eyes, swollen eyes, tearing
• Ear pain or tingling
• Dizziness, lightheadedness
  • Headache
  • General discomfort or fatigue

• Rhinitis (sneezing, runny or itchy nose, nasal congestion)
• Nasal bleeding
• Common cold
• Inflammation of the lips and tongue
• Alterations in the mouth such as burning, numbness, oral thrush, salivary problems
  • Swelling of the palate

• Swelling of the face
• Dryness of the mouth or throat, thirst
• Blisters in the mouth or throat, swelling of the mouth and throat due to fruits or vegetables
• Alterations in the throat such as burning/tingling or tightness, hoarseness, sensation of a lump in the throat, discomfort or swelling in the back of the throat
• Asthma, shortness of breath, wheezing
• Chest discomfort
• Pain in the esophagus, inflammation of the esophagus or stomach, heartburn
• Vomiting
• Gastroenteritis
• Localized swelling, subcutaneous edema
• Rash, skin irritation, hives
• Anxiety
• Sensation of tingling or pinching
• Abnormal blood test results

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

• Inflammation of the eyelids, eyelid spasms, eye irritation
• Ear blockage, tinnitus
• Nasal discomfort, sinus obstruction
• Gingivitis, bleeding in the mouth
• Halitosis, belching
• Pain when swallowing
• Irritation of the larynx
• Rapid breathing
• Numbness in the throat
• Seasonal allergy
  • Bronchitis

• Chest pain
• Palpitations, rapid heartbeat
• Inflammation of the esophagus
• Frequent defecation, irritable bowel, gas
• Irritability, attention disorder, dullness, drowsiness, speech disorders, tremors
• Blisters, skin redness, acute skin reaction, scratching lesions
• Muscle discomfort or contractions
• Urinary incontinence

If you are concerned about any side effect, consult your doctor to decide if you need to take any medication, such as antihistamines, for relief.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Actair

This medication does not require special storage conditions.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the label after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Actair

• The active ingredient is a standardized allergen extract from house dust mites Dermatophagoides pteronyssinusand Dermatophagoides farinae. One sublingual tablet contains 100 IR.

The IR (Reactivity Index) expresses the activity.

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

Appearance of the Product and Package Contents

Sublingual tablet.

The 100 IR tablets are white to beige, round, and biconvex, with brown speckles and "SAC" engraved on one side and "100" engraved on the other.

The tablets are supplied in aluminum blisters sealed with a separable aluminum foil and in a cardboard box.

Package sizes:

Package of 3 sublingual tablets

Package of 15 sublingual tablets

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Stallergenes

Rue Alexis de Tocqueville, 6

92160 Antony

France

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Stallergenes Ibérica S.A.

Llacuna, 22 – 2º 1ª

08005 – Barcelona

Spain

This medication is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Austria Actair 100 IR Sublingual Tablets

Belgium Orylmyte 100 IR Sublingual Tablets

Bulgaria ?????? 100 IR ???????????? ????????

Croatia Orylmyte 100 IR Sublingual Tablets

Czech Republic, Poland, Portugal, Romania ACTAIR

Denmark, Norway, Sweden Aitmyte

France Orylmyte 100 IR, Sublingual Tablet

Germany ORYLMYTE 100 IR

Ireland, United Kingdom (Northern Ireland) ACTAIR 100 IR Sublingual Tablets

Italy, Luxembourg ORYLMYTE

Netherlands Actair 100 IR, Tablets for Sublingual Use

Slovenia Actair 100 IR Sublingual Tablets

Slovakia ACTAIR 100 IR Sublingual Tablets

Spain Actair 100 IR Sublingual Tablets

Date of the last revision of this package leaflet: January 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/