Prospect: information for the patient

Actair 100IR & 300IR sublingual tablets

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

Standardized allergenic extracts of house dust mites

(Dermatophagoides pteronyssinusandDermatophagoides farinae)

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Actair and for what it is used

2. What you need to know before starting to take Actair

3. How to take Actair

4. Possible adverse effects

5. Storage of Actair

6. Contents of the package and additional information

This medication contains allergenic extracts of house dust mites.

This medication is used to treat allergic rhinitis (inflammation of the nasal mucosa) in adolescents (12-17 years) and adults. This medication acts by increasing immune tolerance to house dust mites (i.e., the body's ability to cope with their presence). You may not notice an improvement until you have taken the treatment for 3 months.

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

Before starting treatment, a doctor must diagnose your allergy through appropriate skin tests and blood analyses.

The first dose of this medication should be taken under medical supervision. You should remain under medical observation for at least half an hour after taking the tablet. This is a precaution to observe your sensitivity to the medication. It will also give you the opportunity to discuss any possible adverse effects with your doctor.

This medication should be prescribed by a doctor with experience in treating allergies.

Do not take Actair

• If you are allergic to any of the excipients (other components) of this medication (listed in section 6).
• If you have severe and/or unstable asthma or have had a severe asthma exacerbation in the last 3 months.
• If your doctor determines that your forced expiratory volume in one second (FEV1) is less than 80%.
• If you have an immune system disorder, if you are taking immunosuppressive medications, or if you have cancer.
• If you have mouth ulcers or oral infections. Your doctor will recommend delaying the start of treatment or interrupting it until your mouth has healed.

Do not start taking this medication if you are pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have severe allergic symptoms, such as difficulty swallowing or breathing, voice changes, low blood pressure, or a lump in your throat. Stop treatment and contact your doctor immediately.
• If you have had a severe allergic reaction to a medication with allergenic extracts in the past.
• If your asthma symptoms worsen more than usual. Stop treatment and contact your doctor immediately.
• If you have a cardiovascular disease.
• If you are taking a beta-blocker (a class of medications often prescribed for heart disease and high blood pressure, and also present in some eye drops and creams).
• If you are receiving treatment for depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs) or for Parkinson's disease with catechol-O-methyltransferase inhibitors (COMTIs).
• If you are undergoing oral surgery or dental extraction, interrupt treatment with this medication until you have fully healed.
• If you have heartburn or difficulty swallowing. In this case, contact your doctor.
• If you have an autoimmune disease in remission.

Inform your doctor:

• About any recent illnesses;
• About your personal or family history of any immune system disorders;
• If your allergic condition has worsened recently.

Do not interrupt the use of asthma control and/or relief medications without consulting your doctor, as it may worsen asthma symptoms.

During treatment, it is expected that some localized allergic reactions of mild or moderate intensity will occur. If the reactions are severe, speak with your doctor to determine if you need an antiallergic medication such as antihistamines.

Children and adolescents

This medication is used to treat allergic rhinitis in adolescents (12-17 years old). This medication should not be used in children under 12 years old.

Other medications and Actair

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications. If you are taking other allergy medications, such as antihistamines, asthma medications, or steroids, or a medication that blocks a substance called immunoglobulin E (IgE), for example, omalizumab, speak with your doctor about whether you should continue taking them. If you stop taking allergy medications, you may experience more side effects during treatment with this medication.

Use of Actair with food and drinks

Do not consume food or drinks in the 5 minutes after taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is no experience with the use of this medication during pregnancy. Therefore, do not start treatment with this medication if you are pregnant. If you become pregnant while taking this medication, consult your doctor about whether it is advisable to continue treatment.

There is no experience with the use of this medication during breastfeeding. However, no effects are expected on the infant. Consult with your doctor to determine if it is advisable to continue treatment with this medication during breastfeeding.

Driving and operating machinery

No effects of this medication on the ability to drive or operate machinery have been observed.

Actair contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Actair contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is recommended to take the first tablet under medical supervision. Your doctor will inform you for how long you should take this medication.

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

Starting treatment

The treatment with this medication should be initiated as follows:

The IR (Reactivity Index) expresses the activity.

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

Maintenance treatment

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

Use inadolescents

The administration schedule in adolescents is the same as in adults.

Take this medicationas follows:

1. Remove a tablet (or 2tablets on day2) from the packaging by pressing the tablet against the foil.
2. Take the tablet during the day, with an empty mouth.
3. Place the tablet under the tongue, let it dissolve completely, and then swallow.

1. Do not eat or drink for at least 5minutes.
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 in the day. Do not take a double dose to compensate for the missed doses. If you have not taken this medicationfor more than 7days, contact your doctor before resuming this medication.

If you interrupt treatment with Actair

If you do not take this medication as indicated by your doctor, you may not obtain the beneficial effects of the treatment. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects can be an allergic reaction to the allergen you are being treated for. Most side effects last from minutes to hours after taking the medicine and most of them will disappear when you have been on treatment for 1 to 3 months.

Stop taking this medicine 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)

- Sensation of a lump in the throat (like swelling)

- Urticaria and itching on the skin

Other possible side effects:

Very common (may affect more than 1 in 10 people):

– Hives 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 in the lips or tongue

– Burning or prickling sensation in the mouth, inflammation or sores in the mouth, mouth ulcer

– Alteration of 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

– Pruritus

Uncommon (may affect up to 1 in 100 people):

– Redness and inflammation of the eyes, swollen eyes, tearing

– Ear pain or buzzing

– Dizziness, vertigo

• Headache
• General feeling of being unwell or fatigue

– Rhinitis (runny nose, nasal discharge or itching, nasal obstruction)

– Nosebleed

– Common cold

– Inflammation of the lips and tongue

– Alterations in the mouth such as burning, numbness, oral candidiasis, salivary problems

• Swelling of the palate

– Swelling of the face

– Dryness of the mouth or throat, thirst

– Blisters in the mouth or throat, swelling of the mouth and throat due to fruits or vegetables

– Alterations in the throat such as burning/hormigueo or tightness, hoarseness, sensation of a lump in the throat, discomfort or swelling in the back of the throat

– Asthma, dyspnea, wheezing

– Chest discomfort

– Esophageal pain, inflammation of the esophagus or stomach, heartburn

– Vomiting

– Gastroenteritis

– Localized swelling, subcutaneous edema

– Rash, skin irritation, urticaria

– Anxiety

– Sensation of pins and needles

– Abnormal results in blood tests

Rare (may affect up to 1 in 1,000 people):

– Inflammation of the eyelids, eyelid spasms, eye irritation

– Ear blockage, buzzing in the ears

– Nasal congestion, obstruction of the paranasal sinuses

– Gingivitis, bleeding in the mouth

– Bad breath, belching

– Difficulty swallowing

– Irritation of the larynx

– Rapid breathing

– Numbness in the throat

– Seasonal allergy

• Bronchitis

– Breast pain

– Palpitations, rapid heartbeat

– Inflammation of the esophagus

– Frequent bowel movements, irritable bowel syndrome, gas

– Irritability, alteration of attention, numbness, drowsiness, speech disorders, tremors

– Blisters, redness of the skin, acute skin reaction, skin lesions due to scratching

– Muscle discomfort or cramps

– 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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after CAD/EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Actair

• The active principle is a standardized allergenic extract of domestic dust mitesDermatophagoides pteronyssinusandDermatophagoides farinae. A sublingual tablet contains 100IR or 300IR.

The IR (reactivity index) expresses the activity.

• The other components are anhydrous colloidal silica, sodium croscarmellose, lactose monohydrate, magnesium stearate, mannitol (E-421), and microcrystalline cellulose.

Appearance of the product and contents of the package

Sublingual tablet.

The 100IR tablets are white to beige, round, and biconvex, with brown spots and "SAC" engraved on one side and "100" engraved on the other.

The 300IR tablets are white to beige, round, and biconvex, with brown spots and "SAC" engraved on one side and "300" engraved on the other.

The tablets are supplied in sealed aluminum blisters with a separable aluminum foil and inside a cardboard box.

Package sizes: package of 3 sublingual tablets of 100IR and 28sublingual tablets of 300IR

Holder of the marketing authorization and responsible for manufacturing

Stallergenes

Rue Alexis de Tocqueville, 6

92160 Antony

France

For further information about this medication, please contact 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 United Kingdom (Northern Ireland)with the following names:

Austria Actair 100 IR + 300 IR Sublingualtabletten

Bélgica Orylmyte 100 IR & 300 IR comprimés sublinguaux

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

Croacia Orylmyte 100 IR i 300 IR sublingvalne tablete

República Checa, Polonia, Portugal, Rumanía ACTAIR

Dinamarca, Noruega, Suecia Aitmyte

Francia Orylmyte 100 IR, comprimé sublingual

Orylmyte 300 IR, comprimé sublingual

Alemania ORYLMYTE 100 IR & 300 IR

Irlanda,Reino Unido (Irlanda del Norte) ACTAIR 100 IR & 300 IR sublingual tablets

Italia, Luxemburgo ORYLMYTE

Países Bajos Actair 100 IR en 300 IR,tabletten voor sublinguaal gebruik

Eslovenia Actair 100 IR in 300 IR podjezicne tablete

Eslovaquia ACTAIR 100 IR sublingválne tablety, ACTAIR 300 IR sublingválne tablety

España Actair 100 IR & 300 IR comprimidos sublinguales

Last review date of this leaflet: January 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/