Package leaflet: Information for the patient

ACTAIR, 100 IR, sublingual tablets
For use in adolescents and adults (aged 12 to 65 years)
Standardized allergen extracts of house dust mites
Dermatophagoides pteronyssinus and Dermatophagoides farinae
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can also help by reporting any adverse reactions that occur after taking the medicine. For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before taking 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What ACTAIR is and what it is used for
Important information before taking ACTAIR
How to take ACTAIR
Possible side effects
How to store ACTAIR
Contents of the pack and other information

1. What ACTAIR is and what it is used for

ACTAIR contains allergen extracts from house dust mites.
ACTAIR is used in the treatment of allergic rhinitis (inflammation of the nasal mucosa) in adolescents (aged 12 to 17 years) and adults. ACTAIR works by increasing immunological tolerance (the body's ability to tolerate) to house dust mites.
It may take up to 3 months of treatment before improvement becomes apparent.
Actair 100 IR is intended for use during the dose-escalation phase, not for maintenance treatment.
Before starting treatment, your doctor will diagnose your 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 30 minutes after taking the first dose. This precautionary measure allows monitoring of sensitivity to the medicine and provides an opportunity to discuss any potential adverse reactions with the doctor.
ACTAIR should be prescribed by physicians experienced in the management of allergies.

2. Important information before taking ACTAIR

When not to take ACTAIR:

if the patient is allergic to any of the other components of this medicine (listed in section 6),
if the patient suffers from severe and/or unstable asthma or if there has been a severe asthma exacerbation within the last 3 months,
if, according to the physician's assessment, the patient's forced expiratory volume in one second (FEV1) is below 80%,
in patients with diseases affecting the immune system, in patients taking medications that reduce the body's immunity, or in patients with malignancy,
in patients with oral ulcers or oral infections. The physician may recommend delaying the start of treatment or interrupting treatment until the oral lesions have healed completely. Pregnant women should not initiate treatment with ACTAIR.

Warnings and precautions
Before starting treatment with ACTAIR, discuss with your doctor if:

Severe allergic symptoms occur, such as difficulty swallowing or breathing, voice changes, hypotension (low blood pressure), or a sensation of lump in the throat. Treatment must be discontinued and medical advice sought immediately.
A previous severe allergic reaction to a medicine containing allergen extracts has occurred.
A significant worsening of asthma symptoms occurs. Treatment must be discontinued and medical advice sought immediately.
Cardiovascular diseases are present.
The patient is taking beta-blockers (a class of medicines commonly prescribed for heart conditions and high blood pressure, but also present in certain eye drops and ointments).
The patient is being treated for depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), or being treated for Parkinson's disease with catechol-O-methyltransferase (COMT) inhibitors.
The patient is scheduled for oral surgery or tooth extraction—treatment with ACTAIR should be interrupted until complete healing has occurred.
The patient suffers from persistent heartburn or difficulty swallowing and should consult a doctor.
The patient has autoimmune diseases in remission.

Patients should talk to their doctor about:

any recent illnesses;
whether the patient or their family has a history of diseases affecting the immune system;
any recent worsening of allergy symptoms.

If the patient is taking asthma control medications and/or symptom-relieving medications, do not discontinue them without consulting a doctor, as this may lead to worsening of asthma symptoms.
During treatment, mild or moderate local allergic reactions may occur.
In case of allergic reactions of significant intensity, consult a doctor to determine whether anti-allergic medications, such as antihistamines, should be used.

Children and adolescents
ACTAIR is used in the treatment of allergic rhinitis in adolescents (aged 12 to 17 years). ACTAIR is not indicated for use in children under 12 years of age.

ACTAIR with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription. Patients taking other anti-allergic medicines, such as antihistamines, asthma medications, steroids, or medicines blocking a substance called immunoglobulin E (IgE), e.g. omalizumab, should discuss continued use with their doctor. Discontinuation of these anti-allergic medications may lead to the occurrence of further adverse reactions during treatment with ACTAIR.

ACTAIR with food and drink
Do not eat or drink for 5 minutes after taking this medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is no experience with the use of ACTAIR during pregnancy. Therefore, treatment with ACTAIR should not be initiated during pregnancy. Patients who become pregnant while undergoing treatment should discuss continuation of therapy with their doctor.
There is no experience with the use of ACTAIR during breastfeeding. However, no effects on breastfed infants are expected. Medical advice should be sought to confirm whether treatment with ACTAIR should be continued during breastfeeding.

Driving and operating machinery
No influence of ACTAIR on the ability to drive or operate machinery has been observed.

ACTAIR contains lactose
Patients with intolerance to certain sugars should consult their doctor before starting treatment with this medicine.

3. How to take ACTAIR

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Treatment with ACTAIR should be initiated at a dose of 100 IR and gradually increased until
a maintenance dose of 300 IR is reached. IR (Reactivity Index) expresses the activity.
Actair 100 IR is intended for use during the dose escalation phase, not for ongoing maintenance
treatment.
It is recommended that the first tablet be taken under medical supervision. Your doctor will
provide advice on the schedule and duration of dose escalation.
Use in adolescents
The dose for adolescents is the same as for adults.
ACTAIR should be taken as follows:

Remove one tablet (or two tablets) from the packaging by pressing through the foil.
At the time of administration, the patient must not have anything in the mouth.
Place the tablet under the tongue and hold it there until it dissolves, then swallow.
Do not eat or drink for at least 5 minutes.
Wash hands after handling the tablet.

In case of an overdose of ACTAIR
If more than the recommended dose of ACTAIR is taken, allergic reactions may occur,
including local symptoms in the mouth and throat. In the event of serious symptoms,
seek immediate medical attention or go to the nearest hospital.
Missed dose of ACTAIR
A missed dose of ACTAIR may be taken later on the same day. Do not take a double dose
to make up for a missed dose. If the interruption in taking ACTAIR has been longer than 7 days,
consult your doctor before resuming treatment with ACTAIR.
Stopping ACTAIR
Failure to take the medicine as directed may result in lack of beneficial treatment effects.
In case of any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions may be an allergic response to the allergen the patient is being treated for.
Most allergic adverse reactions last from several minutes to several hours after taking the medicine,
and most resolve within 1–3 months of treatment.
You must stop using ACTAIR and contact your doctor or hospital immediately
if any of the following symptoms occur:

Sudden swelling of the face, lips, throat or skin
Difficulty swallowing
Difficulty breathing
Voice changes
Hypotension (low blood pressure)
Sensation of a tight throat (resembling swelling)
Skin rash and itching

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

Swelling or itching of the lips
Throat irritation
Itching of the ear

Common (may occur in 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 oral cavity, oral ulcers
Altered taste
Discomfort or pain in the mouth and/or throat
Swelling of the throat, difficulty swallowing
Cough
Breathing difficulties
Chest pain
Abdominal pain, indigestion, nausea, diarrhoea
Itching

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

Redness and inflammation of the eyes, eye swelling, tearing
Ear pain or tingling
Dizziness, vertigo
Headache
Malaise or fatigue
Rhinitis (sneezing, runny nose, itchy nose, sensation of blocked nose)
Nosebleeds
Common cold
Inflammation of the lips or tongue
Oral cavity disorders such as burning, numbness of the oral cavity, oral candidiasis, problems with saliva secretion
Swelling of the palate
Facial swelling
Dry mouth or dry throat, thirst
Blisters in the oral cavity and/or throat, swelling of the oral cavity and throat caused by contact with fruits or vegetables
Throat disorders such as burning/tingling or sensation of pressure in the throat, hoarseness, sensation of a lump in the throat, discomfort or swelling in the back of the throat
Asthma, shortness of breath, wheezing
Chest discomfort
Oesophageal pain, inflammation of the oesophagus or stomach, heartburn
Vomiting
Gastroenteritis
Localized swelling, subcutaneous oedema
Rash, skin irritation, urticaria
Anxiety states
Sensation of tingling or pricking
Abnormal blood test results

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

Inflammation of the eyelids, abnormal eyelid spasm, eye irritation
Blocked ear, tinnitus
Nasal discomfort, blocked sinuses
Gingivitis, bleeding from the mouth
Bad breath, belching
Painful swallowing
Vocal cord irritation
Rapid breathing
Numbness of the throat
Seasonal allergy
Bronchitis
Chest pain
Palpitations, rapid heartbeat
Oesophageal swelling
Frequent bowel movements, irritable bowel syndrome, flatulence
Irritability, concentration disturbances, numbness, drowsiness, speech disorders, tremor
Blisters, skin redness, acute skin reaction, scratch-like skin changes
Muscle discomfort or muscle cramps
Sudden urge to urinate

If any adverse reactions occur that concern the patient, the doctor should be informed. The doctor will decide whether to prescribe additional medicines such as antihistamines to help alleviate the symptoms.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store ACTAIR medicine

There are no special storage requirements for this medicine.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Actair contains

The active substance is a standardized extract of house dust mite allergens Dermatophagoides pteronyssinus and Dermatophagoides farinae. One sublingual tablet contains 100 IR.
IR (Index of Reactivity) indicates biological 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 contents of the pack
Sublingual tablet.
The 100 IR tablets are white to beige in colour, round, biconvex, with brown specks, and marked with "SAC" on one side and "100" on the other.
The tablets are supplied in aluminum blisters with a peelable aluminum foil lid, packed in a cardboard box.
Pack sizes:
Pack containing 3 sublingual tablets
Pack containing 15 sublingual tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
STALLERGENES
6 rue Alexis de Tocqueville
92160 ANTONY
France

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Actair 100 IR Sublingualtabletten
Belgium Orylmyte 100 IR comprimés sublinguaux
Bulgaria АКТАИР 100 IR сублингвални таблетки
Croatia Orylmyte 100 IR sublingvalne tablete
Czech Republic, Poland, Portugal, Romania ACTAIR
Denmark, Norway, Sweden Aitmyte
France Orylmyte 100 IR, comprimé sublingual
Germany ORYLMYTE 100 IR
Ireland, United Kingdom (Northern Ireland) ACTAIR 100 IR sublingual tablets
Italy, Luxembourg ORYLMYTE
Netherlands Actair 100 IR, tabletten voor sublinguaal gebruik
Slovenia Actair 100 IR podjezične tablete
Slovakia ACTAIR 100 IR sublingválne tablety
Spain Actair 100 IR comprimidos sublinguales