ACTAIR 300 IR SUBLINGUAL TABLETS

Introduction

Package Leaflet: Information for the Patient

Actair 300IR 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 medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Actair and what is it used for
2. What you need to know before you take Actair
3. How to take Actair
4. Possible side effects
5. Storage of Actair
6. Contents of the pack and other information

1. What is Actair and what is it used for

This medicine contains standardized allergen extracts from house dust mites.

This medicine is used to treat allergic rhinitis (inflammation of the nasal mucosa) in adolescents (12-17 years old) and adults. This medicine 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.

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

The first dose of this medicine 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 medicine. It will also give you the opportunity to discuss any possible side effects with your doctor.

This medicine must be prescribed by a doctor with experience in the treatment of allergies.

2. What you need to know before you take Actair

Do not take Actair

• If you are allergic to any of the excipients (other components) of this medicine (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 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 medicine if you are pregnant.

Warnings and precautions

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

• 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 medicine 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-blocker (a class of medications usually prescribed to treat heart diseases and high blood pressure and which is 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 medicine until it has completely healed.
• If you have 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 your asthma control and/or relief medications without your doctor's advice, as this may worsen your 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 medicine is used to treat allergic rhinitis in adolescents (12-17 years old). This medicine should not be used in children under 12 years old.

Other medicines and Actair

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. If you are taking other medicines for allergies, such as antihistamines, asthma medications, or steroids, or a medicine 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 your allergy medications, you may experience more side effects during treatment with this medicine.

Using Actair with food and drinks

Do not consume food or drinks for at least 5 minutes after taking this medicine.

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 medicine.

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

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

Driving and using machines

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

Actair contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Actair contains sodium

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

3. How to take Actair

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

The first tablet should be taken under medical supervision. Your doctor will tell you how long you should take this medicine.

Treatment starts with an initiation phase, i.e., the dose is progressively increased until the maintenance dose of 300 IR is reached. The IR (Index of Reactivity) expresses the activity.

Maintenance treatment

The dose is 300 IR (one tablet) per day.

Use inadolescents

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

Take this medicine as follows:

1. Remove a tablet from the packaging by pressing the tablet against the blister.
2. Take the tablet during the day, with an empty mouth.
3. Place the tablet under the 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 Actair than you should

If you take more of this medicine 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 medicine for more than 7 days, contact your doctor before taking this medicine again.

If you stop taking Actair

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Stop taking this medicine 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)
• Feeling 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
• Pain in the ear or tingling
• Dizziness, dizziness
  • Headache
  • General malaise 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, feeling 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
• Feeling 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 disturbance, dullness, drowsiness, speech disorders, tremors
• Blisters, redness of the skin, acute skin reaction, scratching lesions
• Muscle discomfort or contractions
• Urinary incontinence

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

Reporting of side effects

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

5. Storage of ACTAIR

This medicine does not require any special storage conditions.

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

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. 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

Composition of Actair

• The active substance is a standardized allergen extract from house dust mites Dermatophagoides pteronyssinusand Dermatophagoides farinae. One sublingual tablet contains 300 IR.

The IR (Index of Reactivity) expresses the activity.

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

Appearance and packaging of the product

Sublingual tablet.

The 300 IR tablets are white to beige, round, and biconvex, with brown speckles and "SAC" engraved on one side and "300" 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 30 sublingual tablets

Package of 90 sublingual tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Stallergenes

Rue Alexis de Tocqueville, 6

92160 Antony

France

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Stallergenes Ibérica S.A.

Llacuna, 22 – 2º 1ª

08005 – Barcelona

Spain

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

Austria Actair 300 IR Sublingualtabletten

Belgium Orylmyte 300 IR comprimés sublinguaux

Bulgaria ?????? 300 IR ???????????? ????????

Croatia Orylmyte 300 IR sublingvalne tablete

Czech Republic, Poland, Portugal, Romania ACTAIR

Denmark, Norway, Sweden Aitmyte

France Orylmyte 300 IR comprimé sublingual

Germany ORYLMYTE 300 IR

Ireland, United Kingdom (Northern Ireland) ACTAIR 300 IR sublingual tablets

Italy, Luxembourg ORYLMYTE

Netherlands Actair 300 IR, tabletten voor sublinguaal gebruik

Slovenia Actair 300 IR podjezicne tablete

Slovakia ACTAIR 300 IR sublingválne tablety

Spain Actair 300 IR comprimidos sublinguales

Date of last revision of this leaflet: January 2023

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