Actair 100 IR & 300 IR sublingual tablets

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Actair 100IR & 300IR sublingual tablets

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

Standardized allergen extracts of house dust mites

(Dermatophagoides pteronyssinus and Dermatophagoides farinae)

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of this 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

This medicine contains allergenic extracts from house dust mites.

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

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

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

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

This medicine must be prescribed by a doctor experienced in the treatment of allergies.

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

Do not take Actair

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

Do not start taking this medicine if you are pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• If you experience severe allergic symptoms such as difficulty swallowing or breathing, voice changes, hypotension (low blood pressure), or a sensation of throat tightness. Stop treatment and contact your doctor immediately.
• If you have previously had a severe allergic reaction to a medicine containing allergen extracts.
• 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 β-adrenergic blocker (a class of medicines commonly prescribed for heart conditions and high blood pressure, and also present in some eye drops and topical ointments).
• If 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.
• If you are undergoing oral surgery or tooth extraction, temporarily interrupt treatment with this medicine until complete healing has occurred.
• If you experience heartburn or difficulty swallowing. In such cases, contact your doctor.
• If you have an autoimmune disease in remission.

Inform your doctor:

• About any illness you have recently had;
• About personal or family history of any disease affecting the immune system;
• If your allergic condition has recently worsened.

Do not stop taking asthma control and/or relief medications without consulting your doctor, as this may worsen asthma symptoms.

During treatment, mild to moderate localized allergic reactions may be expected. If reactions are severe, speak with your doctor to determine whether you need anti-allergic medication such as antihistamines.

Children and adolescents

This medicine is used to treat allergic rhinitis in adolescents (12–17 years of age). This medicine should not be used in children under 12 years of age.

Other medicines and Actair

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

Use of Actair with food and drinks

Do not consume food or drinks within 5 minutes after taking this medicine.

Pregnancy and breastfeeding

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

There is no experience regarding the use of this medicine during pregnancy. Therefore, treatment with this medicine should not be started if you are pregnant. If you become pregnant while taking this medicine, consult your doctor about whether it is appropriate to continue treatment.

There is no experience regarding the use of this medicine during breastfeeding. However, effects on breastfed infants are not expected. Consult your doctor to determine whether it is appropriate to continue treatment with this medicine during breastfeeding.

Driving and using machines

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

Actair contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Actair contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially “sodium-free”.

3. How to take Actair

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

It is recommended that the first tablet be taken under medical supervision. Your doctor will tell you how long you should take this medicine.

The treatment includes an initial phase (gradual dose increase over a period of 3 days) and a maintenance phase.

Initial treatment

Treatment with this medicine should be started as follows:

The IR (Reactivity Index) expresses activity.

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

Maintenance treatment

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

Use in adolescents

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

Take this medicine as follows:

1. Remove one tablet (or 2 tablets on day 2) from the package by pressing the tablet against the foil.
2. Take the tablet during the day, on an empty stomach.
3. Place the tablet under the tongue, allow it to dissolve completely, and then swallow.

1. Do not eat or drink for at least 5 minutes.
2. Wash your hands after handling the tablet.

If you take more Actair than you should

If you take more medicine than you should, you may experience allergic symptoms such as localized symptoms in the mouth and throat. If you develop severe symptoms, contact a doctor or hospital immediately.

If you forget to take Actair

If you forget to take a tablet, take it later during the day. Do not take a double dose to make up for forgotten doses. If you have not taken this medicine for more than 7 days, contact your doctor before restarting treatment.

If you stop taking Actair

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

4. Possible adverse effects

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

The adverse effects may be an allergic response to the allergen being treated. Most adverse effects last from minutes to hours after taking the medicine, and the majority will disappear after 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 (such as swelling)
• Hives and skin itching

Other possible adverse effects:

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

• Swelling or itching in the mouth
• Throat irritation
• Itching in the ear

Common (may affect up to 1 in 10 people):

• Itching in the eyes

• Swelling or itching of the lips or tongue

• Burning or tingling in the mouth, inflammation or sores in the mouth, oral ulcer

• Taste disturbances

• Discomfort or pain in the mouth or throat

• Throat inflammation, 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 tingling

• Dizziness, vertigo

  • Headache
  • General malaise or fatigue

• Rhinitis (sneezing, nasal discharge or itching, nasal congestion)

• Nosebleeds

• Common cold

• Swelling of the lips and tongue

• Mouth disorders such as burning, numbness, oral candidiasis, salivary problems

  • Swelling of the palate

• Facial swelling

• Dryness of the mouth or throat, thirst

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

• Throat disorders such as burning/tingling or tightness, hoarseness, sensation of a lump in the throat, discomfort or swelling in the back of the throat

• Asthma, dyspnea, wheezing

• Chest discomfort

• Pain in the esophagus, inflammation of the esophagus or stomach, heartburn

• Vomiting

• Gastroenteritis

• Localized swelling, subcutaneous edema

• Rash, skin irritation, urticaria

• Anxiety

• Tingling or pricking sensations

• Abnormal blood test results

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

• Eyelid inflammation, eyelid spasms, eye irritation

• Ear blockage, tinnitus

• Nasal discomfort, paranasal sinus obstruction

• Gum inflammation, bleeding in the mouth

• Halitosis, belching

• Pain when swallowing

• Laryngeal irritation

• Rapid breathing

• Numbness in the throat

• Seasonal allergy

  • Bronchitis

• Breast pain

• Palpitations, rapid heartbeat

• Esophagitis

• Frequent defecation, irritable bowel, flatulence

• Irritability, attention disturbances, mental fogginess, somnolence, speech disorders, tremors

• Blisters, skin redness, acute skin reaction, scratch lesions

• Muscle discomfort or contractions

• Urge incontinence

If you are concerned about any side effect, consult your doctor, who will decide whether you need to take any medication, such as antihistamines, for relief.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Actair

This medicinal product does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the label after CAD/EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Actair

• 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) expresses the biological activity.

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

Appearance of the product and package contents

Sublingual tablet.

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

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

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

Pack sizes: pack of 3 sublingual tablets of 100 IR and pack of 28 sublingual tablets of 300 IR.

Marketing Authorization Holder and Manufacturer

Stallergenes

Rue Alexis de Tocqueville, 6

92160 Antony

France

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Stallergenes Ibérica S.A.

Llacuna, 22 – 2º 1ª

08005 – Barcelona

Spain

This medicinal product is authorized in the European Economic Area Member States 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 ?????? 100 IR ? 300 IR ???????????? ????????

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 podjezicne tablete

Slovakia ACTAIR 100 IR sublingválne tablety, ACTAIR 300 IR sublingválne tablety

Spain Actair 100 IR & 300 IR comprimidos sublinguales

Date of the most recent review of this leaflet: January 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/