Actair

Package leaflet: Information for the user

ACTAIR, 300 IR, sublingual tablets
For use in adolescents and adults (aged 12 to 65 years)
Standardised extracts of house dust mite allergens
Dermatophagoides pteronyssinus and Dermatophagoides farinae
This medicine will be subject to additional monitoring. This will allow rapid identification of new safety information. Users of this medicine can also help by reporting any suspected adverse reactions that occur after using the medicine. For information on how to report adverse reactions – see section 4.
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them 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. What you need to know 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 extracts of allergens from house dust mites.
ACTAIR is used to treat 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.
Before starting treatment, your doctor will diagnose your allergy by performing appropriate skin tests and/or blood tests.
The first dose of ACTAIR must be taken under medical supervision. The patient should remain under the doctor's observation for at least 30 minutes after taking the first dose. This precaution is intended to monitor for sensitivity to the medicine and allows any adverse reactions to be discussed with the doctor.
ACTAIR is prescribed by doctors experienced in the treatment 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 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 suppress the immune system, or in patients with malignancy,
• in patients with oral ulcers or oral infections. The physician may recommend delaying the initiation of treatment or interrupting treatment until the oral lesions have healed completely. Pregnant women should not start treatment with ACTAIR.

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

• you experience severe allergic symptoms 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 you should contact your doctor immediately.
• you have previously experienced a severe allergic reaction to a medicine containing allergen extracts.
• you experience a significant worsening of asthma symptoms. Treatment must be discontinued and you should contact your doctor immediately.
• you have cardiovascular diseases.
• you are taking beta-blockers (a class of medicines commonly prescribed for heart conditions and high blood pressure, but also present in certain eye drops and topical ointments).
• you are being treated for depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), or for Parkinson's disease with catechol-O-methyltransferase (COMT) inhibitors.
• you are scheduled for dental procedures or tooth extraction—you should discontinue treatment with ACTAIR until complete healing has occurred.
• you suffer from persistent heartburn or difficulty swallowing—you should contact your doctor.
• you have autoimmune diseases in remission.

Patients should talk to their doctor about:

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

If you are taking asthma control medications and/or symptom-relieving medications, do not discontinue them without consulting your 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, talk to your 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 about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. Patients taking other anti-allergic medicines such as antihistamines, medicines used in asthma treatment, steroids, or medicines blocking a substance called immunoglobulin E (IgE), e.g. omalizumab, should discuss their continued use with their doctor. Discontinuation of these anti-allergic medicines 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your 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 during 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. Consult your doctor and make sure whether you should continue taking ACTAIR during breastfeeding.

Driving and operating machinery
No effects of ACTAIR on the ability to drive or operate machinery have 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 according to the doctor's instructions. In case of doubts, consult your doctor or pharmacist.
It is recommended that the first tablet be taken under medical supervision. Your doctor will inform you how long you should continue taking ACTAIR.
Treatment starts with an initial dose, which is gradually increased to the maintenance dose of 300 IR. IR (Reactivity Index) expresses the biological activity.

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.

ACTAIR should be taken as follows:

1. Remove one tablet 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 completely, then swallow it.
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 more than the recommended dose of ACTAIR has been taken, allergic symptoms may occur, including local symptoms in the mouth and throat. If serious symptoms occur, contact a doctor or hospital immediately.

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, contact 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 about how to use 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 a few minutes to several hours after taking the medicine,
and most 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
• Changes in voice
• Hypotension (low blood pressure)
• Sensation of a full throat (resembling swelling)
• Urticaria and skin 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, oral inflammation and pain, 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 of the eyes and eye inflammation, eye swelling, tearing
• Ear pain or tingling
• Dizziness, drowsiness
• Headache
• Nasal inflammation (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 thrush, 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 conditions 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, oesophageal or gastric inflammation, heartburn
• Vomiting
• Gastroenteritis
• Localised oedema, 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):

• Eyelid inflammation, abnormal eyelid spasm, eye irritation
• Blocked ear, tinnitus
• Nasal discomfort, blocked sinuses
• Gum inflammation, 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 oedema
• Frequent defecation, irritable bowel syndrome, flatulence
• Irritability, concentration disorders, 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, they should inform their doctor,
who will decide whether to prescribe additional medicines such as antihistamines to help relieve them.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, the patient should inform their 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 marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ACTAIR

No special storage instructions are required 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. Such measures help protect the environment.

6. Contents of the pack 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
300 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 300 IR tablets are white to beige in colour, round, biconvex, with brown specks, and 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 sizes:
Pack containing 30 sublingual tablets
Pack containing 90 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 European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria Actair 300 IR Sublingualtabletten
Belgium Orylmyte 300 IR comprimés sublinguaux
Bulgaria АКТАИР 300 IR сублингвални таблетки
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 podjezične tablete
Slovakia ACTAIR 300 IR sublingválne tablety
Spain Actair 300 IR comprimidos sublinguales