Actair

Package leaflet: Information for the user

ACTAIR, 100 and 300 IR, sublingual tablets
For use in adolescents and adults (aged 12 to 65 years)
Standardised allergen extracts from house dust mites
Dermatophagoides pteronyssinus and Dermatophagoides farinae
This medicinal product will be subject to additional monitoring. This will allow rapid identification of new safety information. You can also help by reporting any side effects that occur after taking the medicine. For information on how to report side effects – 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What ACTAIR is and what it is used for
2. Important information before taking ACTAIR
3. How to take ACTAIR
4. Possible side effects
5. How to store ACTAIR
6. 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 precaution is intended to monitor sensitivity to the medicine. It also allows for discussion with the doctor regarding any potential adverse reactions.
ACTAIR is prescribed by doctors 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 ingredients of this medicine (listed in section 6),
• if the patient suffers from severe and/or unstable asthma or if a severe asthma exacerbation has occurred 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 suppress the body's immunity, or in patients with malignant disease,
• in patients with oral ulcers or infections of the mouth. The physician may recommend delaying the start of treatment or interrupting treatment until the oral lesions have healed. Pregnant women should not start treatment with ACTAIR.

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

• occurrence of severe allergic symptoms such as difficulty swallowing or breathing, voice changes, hypotension (low blood pressure), or a sensation of a lump in the throat. Treatment must be discontinued and medical advice sought immediately.
• previous severe allergic reaction to a medicine containing allergen extracts.
• significant worsening of asthma symptoms. Treatment must be discontinued and medical advice sought immediately.
• presence of cardiovascular diseases.
• use of beta-blockers (a class of medicines commonly prescribed for heart conditions and high blood pressure, but also present in certain 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 dental procedures or tooth extraction should discontinue treatment with ACTAIR until complete healing has occurred.
• patients suffering from persistent heartburn or difficulty swallowing should consult their doctor.
• autoimmune diseases in remission.

Patients should talk to their doctor about:

• any recent illnesses;
• presence of any conditions affecting the immune system in the patient or their family;
• recent worsening of allergy symptoms.

If the patient is using asthma control medications and/or symptom-relieving medications, they should not stop using them without consulting their doctor, as this may lead to worsening of asthma symptoms.
During treatment, mild or moderate local allergic reactions may occur.
In case of severe allergic reactions, the patient should consult their 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 and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those available without a prescription. Patients taking other anti-allergic medicines such as antihistamines, asthma medications, corticosteroids, 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 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 have a baby, 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 treatment 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 ACTAIR treatment should be continued during breastfeeding.

Driving and using machines
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 this medicine.

3. How to take ACTAIR

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
It is recommended that the first tablet be taken under medical supervision. The doctor will advise
how long treatment with ACTAIR should continue.
Treatment consists of an initial treatment phase (the dose is gradually increased over a 3-day period) and a continuation phase.
Initial treatment
Treatment with ACTAIR should be started as follows:

IR (Reactivity Index) expresses activity.
Actair 100 IR is intended for use during the dose escalation period, not for continuation
of treatment.
Continuation of treatment
The dose is 300 IR (one tablet) per day.
Use in adolescents
The dose for adolescents is the same as for adults.
The medicine ACTAIR should be taken as follows:

1. Remove one tablet (or 2 tablets on day 2) from the packaging by pressing through the foil.

2. At the time of administration, the patient must not have anything in the mouth.

3. Place the tablet under the tongue and hold it there until it dissolves, then swallow.

4. Do not eat or drink for at least 5 minutes.

5. Wash hands after handling the tablet.

In case of an overdose of ACTAIR
If an overdose of ACTAIR is taken, allergic reactions may occur,
including local symptoms in the mouth and throat. In case of serious symptoms,
contact a doctor or hospital immediately.
Missed dose of ACTAIR
A missed dose of ACTAIR may be taken later the same day. Do not take a double
dose to make up for a missed dose. If the interruption in taking ACTAIR
was longer than 7 days, consult your doctor before resuming treatment with
ACTAIR.
Stopping treatment with ACTAIR
Failure to take the medicine as directed may result in lack of beneficial treatment effects.
If you have any doubts concerning 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 allergic responses to the allergen the patient is being treated for.
Most allergic adverse reactions occur within minutes to hours after taking the medicine
and usually resolve within 1–3 months of treatment.
You should 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 full throat (resembling swelling)
• Skin rash (urticaria) and itching

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

• Swelling or itching of the lips
• Sore throat
• 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
• Difficulty breathing
• 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, feeling faint
• Headache
• Malaise or fatigue
• Rhinitis (sneezing, runny nose, itchy nose, sensation of blocked nose)
• Nosebleeds
• Common cold
• Inflammation of the lips or tongue
• Oral conditions such as burning, numbness of the mouth, oral candidiasis, problems with saliva secretion
• Swelling of the palate
• Facial swelling
• Dry mouth or dry throat, thirst
• Blisters in the mouth and/or throat, swelling of the mouth 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
• Gastritis and enteritis
• Localized swelling, subcutaneous oedema
• Rash, skin irritation, urticaria
• Anxiety
• 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, ringing in the ears (tinnitus)
• Nasal discomfort, blocked sinuses
• Gum inflammation, bleeding from the mouth
• Bad breath, burping
• 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, difficulty concentrating, 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 may decide to prescribe additional medicines such as antihistamines to help relieve 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
of 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 can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store ACTAIR medicine

There are no special requirements for storing this medicine.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging 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 in use. This will help protect the environment.

6. Contents of the pack and other information

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

What Actair looks like and contents of the pack
Sublingual tablet.
100 IR tablets are white to beige in colour, round, biconvex, with brown specks, marked with "SAC" on one side and "100" on the other.
300 IR tablets are white to beige in colour, round, biconvex, with brown specks, marked with "SAC" on one side and "300" on the other.
The tablets are supplied in aluminum blisters with a peelable aluminum foil lid, packed in a cardboard box.

Pack size:
Pack containing 3 sublingual tablets of 100 IR and 28 sublingual tablets of 300 IR.

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 + 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