Actair

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: Patient information

ACTAIR, 100 and 300 IR, sublingual tablets

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

Standardized extracts of house dust mite allergens
Dermatophagoides pteronyssinusand Dermatophagoides farinae
This medicinal product will be subject to additional monitoring. This will allow for the quick identification of new safety information. The user of this medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

Read the leaflet carefully before taking the medicinal product, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicinal product has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is ACTAIR and what is it used for
• 2. Important information before taking ACTAIR
• 3. How to take ACTAIR
• 4. Possible adverse reactions
• 5. How to store ACTAIR
• 6. Package contents and other information

1. What is ACTAIR and what is it used for

ACTAIR contains extracts of house dust mite allergens.
ACTAIR is used to treat allergic rhinitis (inflammation of the nasal mucosa) in adolescents (from 12 to 17 years of age) and adults. ACTAIR works by increasing the patient's immunological tolerance (the body's ability to fight) to house dust mites.
It may be necessary to take the medicinal product for 3 months before an improvement is seen.
Actair 100 IR is intended for use during the dose escalation period, not for continued treatment.
Before starting treatment, the doctor will diagnose the patient's allergy by performing appropriate skin tests and/or blood tests.
The first dose of ACTAIR should be taken under medical supervision. The patient should remain under medical observation for at least half an hour after taking the first dose. This is a precautionary measure to monitor sensitivity to the medicinal product. It also allows for discussion with the doctor about any adverse reactions that may occur.
ACTAIR is prescribed by doctors with experience in treating allergies.

2. Important information before taking ACTAIR

When not to take ACTAIR:

• if the patient is allergic to any of the other ingredients of this medicinal product (listed in section 6),
• if the patient has severe and/or unstable asthma or if there has been a severe asthma exacerbation in the last 3 months,
• if, according to the doctor's assessment, the patient's forced expiratory volume in one second (FEV1) is below 80%,
• in patients with diseases affecting the immune system, patients taking immunosuppressive drugs, or patients with cancer,
• in patients with oral ulcers or infections. The doctor may recommend delaying the start of treatment or interrupting it until the oral lesions have healed. Pregnant women should not start treatment with ACTAIR.

Warnings and precautions

Before starting ACTAIR, the patient should discuss the following with their doctor:

• Severe allergic reactions, such as difficulty swallowing or breathing, changes in voice, low blood pressure, or a feeling of a lump in the throat. Treatment should be discontinued and the doctor contacted immediately.
• Prior severe allergic reactions to allergen extracts.
• Significant worsening of asthma symptoms. Treatment should be discontinued and the doctor contacted immediately.
• Cardiovascular diseases.
• Taking beta-blockers (a class of drugs often prescribed for heart disease and high blood pressure, but also found in some eye drops and ointments).
• Treatment of depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) or treatment of Parkinson's disease with catechol-O-methyltransferase (COMT) inhibitors.
• Patients awaiting oral surgery or tooth extraction should discontinue ACTAIR until complete healing.
• Patients with persistent heartburn or difficulty swallowing should contact their doctor.
• Autoimmune diseases in remission

Patients should discuss the following with their doctor:

• any recent illnesses;
• any diseases in the patient or their family that may affect the immune system;
• any recent worsening of allergy symptoms.

If the patient is taking asthma control medications and/or symptom-relieving medications, they should not stop taking them without consulting their doctor, as this may worsen asthma symptoms.
During treatment, mild or moderate local allergic reactions may occur.
In the event of severe allergic reactions, the patient should discuss with their doctor whether it is necessary to use anti-allergic medications, such as antihistamines.

Children and adolescents

ACTAIR is used to treat allergic rhinitis in adolescents (from 12 to 17 years of age). ACTAIR is not indicated for use in children under 12 years of age.

ACTAIR and other medicinal products

The patient should inform their doctor or pharmacist about all medicinal products they are taking or have recently taken, as well as any medicinal products they plan to take, including those available without a prescription. Patients taking other anti-allergic medicinal products, such as antihistamines, asthma medications, steroids, or medications that block the substance called immunoglobulin E (IgE), e.g., omalizumab, should discuss their continued use with their doctor. Discontinuing these anti-allergic medicinal products may cause further adverse reactions during treatment with ACTAIR.

ACTAIR with food and drink

The patient should not eat or drink for 5 minutes after taking this medicinal product.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicinal product.
There is no experience with the use of ACTAIR during pregnancy. Therefore, treatment with ACTAIR should not be started during pregnancy. Patients who become pregnant during treatment should discuss continuing treatment with their doctor.
There is no experience with the use of ACTAIR during breastfeeding. However, no effects on breastfed infants are expected. The patient should consult their doctor and make sure it is safe to continue taking ACTAIR while breastfeeding.

Driving and using machines

No effects of ACTAIR on the ability to drive and use machines have been observed.

ACTAIR contains lactose

Patients with intolerance to some sugars should consult their doctor before starting treatment with this medicinal product.

3. How to take ACTAIR

This medicinal product should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
It is recommended to take the first tablet under medical supervision. The doctor will inform the patient how long to take ACTAIR.
Treatment includes an initial phase (the dose is gradually increased over 3 days) and a continuation phase.

Initial treatment

Treatment with ACTAIR should be started as follows:
IR (Reactivity Index) indicates activity.
Actair 100 IR is intended for use during the dose escalation period, not for continued treatment.

Continuation treatment

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

Administration in adolescents

The dose for adolescents is the same as for adults.
ACTAIR should be taken as follows:

• 1. Remove one tablet (or 2 tablets on Day 2) from the packaging by pushing it through the foil.
• 2. At the time of administration, the patient should not have anything in their mouth.
• 3. Place the tablet under the tongue and keep it there until it dissolves, then swallow.

• 4. Do not eat or drink for at least 5 minutes.
• 5. After touching the tablet, wash your hands.

In case of overdose of ACTAIR

In case of overdose of ACTAIR, allergic reactions, including local reactions in the mouth and throat, may occur. In case of severe symptoms, the patient should contact their doctor or hospital immediately.

Missed dose of ACTAIR

A missed dose of ACTAIR can be taken later the same day. The patient should not take a double dose to make up for the missed dose. If the interruption in ACTAIR treatment was longer than 7 days, the patient should consult their doctor before re-administering the medicinal product.

Discontinuation of ACTAIR

Not taking the medicinal product as prescribed may result in a lack of beneficial treatment effects.
In case of any doubts about the use of this medicinal product, the patient should consult their doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, ACTAIR can cause adverse reactions, although not everybody gets them.
Adverse reactions may be an allergic reaction to the allergen being treated.
Most allergic adverse reactions last from a few minutes to a few hours after taking the medicinal product and most resolve after 1-3 months of treatment.
The patient should stop taking ACTAIR and contact their doctor or hospital immediately if they experience any of the following symptoms:

• Sudden swelling of the face, lips, throat, or skin
• Difficulty swallowing
• Difficulty breathing
• Changes in voice
• Low blood pressure
• Feeling of a lump in the throat
• Hives and itching of the skin

Other possible adverse reactions:
Very common (may affect more than 1 in 10 patients):

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

Common (may affect less than 1 in 10 patients):

• Itching of the eyes
• Swelling or itching of the lips or tongue
• Burning or tingling in the mouth, inflammation, and pain in the mouth, oral ulcers
• Altered taste
• Discomfort or pain in the mouth and/or throat
• Swelling of the throat, difficulty swallowing
• Cough
• Difficulty breathing
• Chest pain
• Abdominal pain, nausea, vomiting, diarrhea
• Itching

Uncommon (may affect less than 1 in 100 patients):

• Redness of the eyes and inflammation of the eyes, swelling of the eyes, tearing
• Ear pain or tingling
• Dizziness, lightheadedness
• Headache
• Malaise or fatigue
• Rhinitis (sneezing, runny nose, itching of the nose, feeling of a blocked nose)
• Nosebleeds
• Cold
• Inflammation of the lips or tongue
• Mouth conditions, such as burning, numbness of the mouth, oral thrush, problems with saliva production
• Swelling of the palate
• Swelling of the face
• Dryness in the mouth or throat, thirst
• Blisters in the mouth and/or throat, swelling of the mouth and throat caused by contact with fruits or vegetables
• Throat conditions, such as burning/tingling or feeling of pressure in the throat, hoarseness, feeling of a lump in the throat, discomfort or swelling in the back of the throat
• Asthma, shortness of breath, wheezing
• Discomfort in the chest
• Esophageal pain, inflammation of the esophagus or stomach, heartburn
• Vomiting
• Gastroenteritis
• Local swelling, subcutaneous swelling
• Rash, skin irritation, hives
• Anxiety
• Feeling of tingling or prickling
• Abnormal blood test results

Rare (may affect less than 1 in 1,000 patients):

• Inflammation of the eyelids, abnormal eyelid spasms, eye irritation
• Plugged ear, ringing in the ears
• Nasal discomfort, plugged sinuses
• Inflammation of the gums, bleeding from the mouth
• Unpleasant breath odor, belching
• Painful swallowing
• Irritation of the vocal cords
• Rapid breathing
• Numbness of the throat
• Seasonal allergy
• Bronchitis
• Chest pain
• Palpitations, rapid heartbeat
• Swelling of the esophagus
• Frequent bowel movements, irritable bowel syndrome, gas
• Irritability, concentration disorders, numbness, drowsiness, speech disorders, tremors
• Blisters, redness of the skin, acute skin reaction, scratch-like lesions
• Muscle discomfort or cramps
• Sudden need to urinate

If the patient experiences any adverse reactions that concern them, they should inform their doctor, who will decide whether to use medications, such as antihistamines, to alleviate them.

Reporting adverse reactions

If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information can be gathered on the safety of the medicinal product.

5. How to store ACTAIR

There are no special precautions for storage of this medicinal product.
Keep the medicinal product out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Medicinal products should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicinal products they no longer use. This will help protect the environment.

6. Package contents and other information

What ACTAIR contains

The active substance is a standardized extract of house dust mite allergens
Dermatophagoides pteronyssinusand Dermatophagoides farinae. One sublingual tablet contains 100 IR or 300 IR.
IR (Reactivity Index) indicates activity.
The other ingredients are: colloidal anhydrous silica, sodium croscarmellose, lactose monohydrate, magnesium stearate, mannitol (E 421), and microcrystalline cellulose.

What ACTAIR looks like and what the package contains

Sublingual tablet.
The 100 IR tablets are white to beige, round, and biconvex, with brown spots, with "SAC" embossed on one side and "100" on the other.
The 300 IR tablets are white to beige, round, and biconvex, with brown spots, with "SAC" embossed on one side and "300" on the other.
The tablets are provided in aluminum blisters with a removable aluminum foil in a cardboard box.
Package size:
Package containing 3 sublingual tablets of 100 IR and 28 sublingual tablets of 300 IR.

Marketing authorization holder and manufacturer

STALLERGENES
6 rue Alexis de Tocqueville
92160 ANTONY
France

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Actair 100 IR + 300 IR Sublingualtabletten
Belgium
Orylmyte 100 IR & 300 IR comprimés sublinguaux
Bulgaria
АКТАИР 100 IR и 300 IR сублингвални таблетки
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 podjezične tablete
Slovakia
ACTAIR 100 IR sublingválne tablety, ACTAIR 300 IR sublingválne tablety
Spain
Actair 100 IR & 300 IR comprimidos sublinguales

Date of last revision of the leaflet: 01/2023