ACTAIR 100 IR & 300 IR SUBLINGUAL TABLETS

The treatment includes a starting phase (progressive dose increase over a period of 3 days) and a maintenance phase.

Starting treatment

Treatment with this medication should be started as follows:

The IR (Reactivity Index) expresses the activity.

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

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 medication as follows:

1. Remove a tablet (or 2 tablets on day 2) 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 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 Actair than 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 it 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)
• 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, mouth ulcers
• Altered 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, dizziness
  • Headache
  • General discomfort or fatigue

• Rhinitis (sneezing, runny or itchy nose, nasal congestion)
• Nasal bleeding
• Common cold
• Inflammation of the lips and tongue
• Mouth disorders such as burning, numbness, oral thrush, salivary problems
  • Palate swelling

• Facial swelling
• Dryness of the mouth or throat, thirst
• Blisters in the mouth or throat, swelling of the mouth and throat due to fruits or vegetables
• Throat disorders 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
• Esophageal pain, esophageal inflammation 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, nasal sinus obstruction
• Gingivitis, bleeding in the mouth
• Halitosis, belching
• Pain when swallowing
• Laryngeal irritation
• Rapid breathing
• Numbness in the throat
• Seasonal allergy
  • Bronchitis

• Breast pain
• Palpitations, rapid heartbeat
• Esophageal inflammation
• 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 not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: 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 CAD/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 your pharmacy. If you have any questions, 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 or 300 IR.

The IR (Reactivity Index) expresses the activity.

• The other ingredients 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 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 3 sublingual tablets of 100 IR and 28 sublingual tablets of 300 IR

Marketing authorization holder and manufacturer

Stallergenes

Rue Alexis de Tocqueville, 6

92160 Antony

France

You can request more information about this medication from 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 UnitedKingdom (Northern Ireland)with the following names:

Austria Actair 100 IR + 300 IR Sublingualtabletten

Belgium Orylmyte 100 IR & 300 IR comprimés sublinguaux

Bulgaria ?????? 100 IR ? 300 IR ???????????? ????????

Croatia Orylmyte 100 IR i 300 IR sublingvalne tablete

Czech Republic, Poland, Portugal, Romania ACTAIR

Denmark, Norway, Sweden Aitmyte

France Orylmyte 100 IR, comprimé sublingual

Orylmyte 300 IR, comprimé sublingual

Germany ORYLMYTE 100 IR & 300 IR

Ireland, United Kingdom (Northern Ireland) ACTAIR 100 IR & 300 IR sublingual tablets

Italy, Luxembourg ORYLMYTE

Netherlands Actair 100 IR en 300 IR, tabletten voor sublinguaal gebruik

Slovenia Actair 100 IR in 300 IR podjezicne tablete

Slovakia ACTAIR 100 IR sublingválne tablety, ACTAIR 300 IR sublingválne tablety

Spain Actair 100 IR & 300 IR comprimidos sublinguales

Date of the last revision of this 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/