Orylmyte: detailed information

Package leaflet: Information for the patient

ORYLMYTE 100 IR sublingual tablets

For use in adolescents and adults (12-65 years of age)
Standardized allergen extracts from house dust mites
(Dermatophagoides pteronyssinus & Dermatophagoides farinae)
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ORYLMYTE is and what it is used for
What you need to know before taking ORYLMYTE
How to take ORYLMYTE
Possible side effects
How to store ORYLMYTE
Contents of the pack and other information

1. What ORYLMYTE is and what it is used for

ORYLMYTE contains allergen extracts from house dust mites.
ORYLMYTE is used to treat allergic rhinitis (inflammation of the nasal mucosa) in adolescents (aged 12–17 years) and adults. ORYLMYTE works by increasing immunological tolerance (your body's ability to cope) to house dust mites. Treatment may need to be continued for 3 months before improvements are observed.
ORYLMYTE 100 IR is indicated only for the dose escalation phase and not for maintenance.
Before starting treatment, your doctor will diagnose your allergy by performing appropriate skin tests/blood tests.
The first dose of ORYLMYTE must be taken under medical supervision. You must remain under medical observation for at least 30 minutes after taking the first dose. This precaution is intended to monitor your sensitivity to the medicine. You may also discuss possible side effects with your doctor.
ORYLMYTE must be prescribed by physicians experienced in the treatment of allergies.

2. What you need to know before taking ORYLMYTE

Do not take ORYLMYTE if:

You are allergic to any of the excipients (other ingredients) of this medicine (listed in section 6).
You have severe and/or unstable asthma or have experienced a severe asthma exacerbation in the past 3 months.
Your forced expiratory volume in one second (FEV1) is less than 80% as assessed by your doctor.
You have a disease affecting the immune system, are taking medicines that suppress the immune system, or have cancer.
You have mouth ulcers or mouth infections. Your doctor may advise you to delay starting treatment or to stop it until your mouth has healed. Do not start taking ORYLMYTE if you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking ORYLMYTE if:

You experience severe allergic symptoms such as difficulty swallowing or breathing, changes in your voice, hypotension (low blood pressure), or a sensation of throat tightness. Stop treatment immediately and contact your doctor without delay.
You have previously had a severe allergic reaction to a medicine containing allergen extracts.
Your asthma symptoms worsen significantly compared to normal. Stop treatment and contact your doctor immediately.
You have a cardiovascular disease.
You are taking a beta-blocker (a class of medicines often prescribed for heart conditions and high blood pressure, but also present in certain eye drops and ointments).
You are being treated for depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs), or for Parkinson’s disease with catechol-O-methyltransferase inhibitors (COMT).
You need to undergo oral surgery or tooth extraction; temporarily discontinue treatment with ORYLMYTE until complete healing has occurred.
You experience persistent heartburn or difficulty swallowing. You should contact your doctor.
You have an autoimmune disease in remission.

Inform your doctor about:

Any recent illnesses,
Personal or family history of any disease that may affect the immune system,
Whether your allergic disease has recently worsened.

If you are taking medicines to control your asthma and/or to relieve symptoms, do not stop your asthma treatment without consulting your doctor, as this could worsen your asthma symptoms.
Mild or moderate local allergic reactions may occur during treatment. If these reactions are severe, consult your doctor to determine whether anti-allergic medicines such as antihistamines are needed.

Children and adolescents
ORYLMYTE is used to treat allergic rhinitis in adolescents (12–17 years of age). ORYLMYTE is not indicated for use in children under 12 years of age.

Other medicines and ORYLMYTE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. If you are taking other anti-allergy medicines such as antihistamines, asthma medicines or steroids, or a medicine that blocks a substance called immunoglobulin E (IgE), e.g. omalizumab, ask your doctor whether you should continue taking them. If you stop taking these anti-allergy medicines, you may experience more adverse effects during treatment with ORYLMYTE.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is no experience with the use of ORYLMYTE during pregnancy. Therefore, treatment with ORYLMYTE should not be initiated during pregnancy. If you become pregnant during treatment, talk to your doctor to evaluate whether continuing treatment is appropriate for you.
There is no experience with the use of ORYLMYTE during breastfeeding. However, effects on breastfed infants are not expected. Discuss with your doctor whether you can continue taking ORYLMYTE while breastfeeding.

Driving and using machines
No effects of ORYLMYTE on the ability to drive or operate machinery have been observed.

ORYLMYTE contains lactose
If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ORYLMYTE

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Treatment with ORYLMYTE should be initiated at a dose of 100 IR, and gradually increased until reaching the maintenance dose of 300 IR. The IR (Reactivity Index) expresses the activity.
ORYLMYTE 100 IR is indicated only for the dose-increase period and not for maintenance.
It is recommended to take the first tablet under medical supervision. Your doctor will provide advice on the dose-increase schedule and duration.

Use in adolescents
The dosage in adolescents is the same as in adults.
Take ORYLMYTE as follows:

Remove one tablet (or two tablets) from the packaging by pushing the tablet through the aluminium foil.
Take the tablet during the day, on an empty stomach.
Place and keep the tablet under the tongue until it has completely dissolved, then swallow what remains.
Do not eat or drink for at least 5 minutes.
Wash your hands after handling the tablet.

If you take more ORYLMYTE than you should
If you take more ORYLMYTE than prescribed, you may experience allergic symptoms, including those affecting the mouth and throat. If you develop severe symptoms, contact your doctor or go to a hospital immediately.

If you forget to take ORYLMYTE
If you have missed a dose, take it later the same day. Do not take a double dose to make up for the missed dose. If you have not taken ORYLMYTE for more than 7 days, contact your doctor before taking ORYLMYTE again.

If you stop taking ORYLMYTE
If you do not take the medicine as prescribed, you may not achieve the beneficial effects of treatment. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects may be an allergic response to the allergen the patient is being treated for. Most of the unwanted allergic reactions last from a few minutes to several hours after taking the medicine, and most of these will diminish after 1 to 3 months of treatment.
Stop taking ORYLMYTE and contact your doctor or go to hospital immediately if you experience any of the following symptoms:

Rapid swelling of the face, mouth, throat or skin
Difficulty swallowing
Breathing difficulties
Voice changes
Hypotension (low blood pressure)
Sensation of tightness in the throat (such as swelling)
Skin tingling and itching

Other possible side effects:
Very common (may affect more than 1 in 10 people):

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

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

Itchy eyes
Swelling or itching of the lips or tongue
Burning or tingling sensation in the mouth, inflamed and painful mouth, mouth ulcer
Altered taste
Discomfort or pain in the mouth and/or throat
Swelling of the throat, difficulty swallowing
Cough
Difficulty breathing
Chest pain
Stomach pain, indigestion, nausea, diarrhoea
Itching

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

Redness and inflammation of the eyes, eye swelling, tearing
Ear pain or tingling
Dizziness, vertigo
Headache
Malaise or fatigue
Rhinitis (sneezing, runny or itchy nose, nasal congestion)
Nosebleeds
Common cold
Inflammation of the lips or tongue
Oral disorders such as mouth burning, mouth numbness, oral ulcers, salivary problems
Swelling of the palate
Facial swelling
Dry throat or mouth, thirst
Mouth and/or throat ulcers, swelling of mouth and throat due to contact with fruit or vegetables
Throat disorders such as burning/tingling or tightness in the throat, sensation of a lump in the throat, discomfort or swelling in the back of the throat
Asthma, shortness of breath, wheezing
Chest discomfort
Pain in the oesophagus, inflammation of the oesophagus or stomach, heartburn
Vomiting
Gastroenteritis
Localised swelling, subcutaneous swelling
Skin rash, skin irritation, urticaria
Anxiety
Tingling or pricking sensation
Abnormal blood test results

Rare (may affect up to 1 in 1000 people):

Inflammation of the eyelids, abnormal contraction of the eyelids, eye irritation
Muffled hearing, tinnitus
Nasal discomfort, paranasal sinus obstruction
Gingivitis, mouth bleeding
Bad breath, belching
Painful swallowing
Vocal cord irritation
Rapid breathing
Loss of throat sensitivity
Seasonal allergy
Bronchitis
Breast pain
Palpitations, rapid heartbeat
Oesophageal swelling
Frequent bowel movements, irritable bowel, presence of gas
Irritability, attention disorders, numbness, drowsiness, speech disorders, tremor
Blisters, skin redness, acute skin reaction, excoriation lesions
Muscle discomfort or contractions
Urgent need to urinate

If you are concerned about any of the side effects, contact your doctor, who will decide whether you need medication, such as antihistamines, to relieve them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ORYLMYTE

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ORYLMYTE contains

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

Description of the appearance of ORYLMYTE and the contents of the pack
Sublingual tablet.
The 100 IR tablets are white to beige in colour, round and biconvex, with brown speckles, marked with “SAC” on one side and “100” on the other.
The tablets are supplied in aluminium blisters with an aluminium foil removable lid inside the outer packaging.
Pack sizes:
Pack of 3 sublingual tablets
Pack of 15 sublingual tablets
Not all pack sizes may be marketed.

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

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

Patient Information Leaflet

ORYLMYTE 300 IR sublingual tablets

For use in adolescents and adults (12-65 years of age)
Standardized allergen extracts from 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 help by reporting any adverse reactions you experience while taking
this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ORYLMYTE is and what it is used for
What you need to know before taking ORYLMYTE
How to take ORYLMYTE
Possible side effects
How to store ORYLMYTE
Contents of the pack and other information

1. What ORYLMYTE is and what it is used for

ORYLMYTE contains allergen extracts from house dust mites.
ORYLMYTE is used to treat allergic rhinitis (inflammation of the nasal mucosa) in adolescents (12–17 years of age) and adults. ORYLMYTE works by increasing immunological tolerance (your body's ability to cope) to house dust mites. Treatment may need to be continued for 3 months before improvements are observed.
Before starting treatment, your doctor will diagnose your allergy by performing appropriate skin tests or blood tests.
The first dose of ORYLMYTE must be taken under medical supervision. You must remain under medical observation for at least 30 minutes after taking the first dose. This precaution is intended to monitor your sensitivity to the medicine. You may also discuss possible side effects with your doctor.
ORYLMYTE should only be prescribed by doctors experienced in the treatment of allergies.

2. What you need to know before taking ORYLMYTE

Do not take ORYLMYTE if:

You are allergic to any of the excipients (other ingredients) of this medicine (listed in section 6).
You have severe and/or unstable asthma or have had a severe asthma exacerbation in the last 3 months.
Your forced expiratory volume in one second (FEV1) is below 80% as assessed by your doctor.
You have a disease affecting the immune system, are taking medicines that suppress the immune system, or have cancer.
You have mouth ulcers or mouth infections. Your doctor may advise you to delay starting treatment or to stop it until your mouth has healed. Do not start taking ORYLMYTE if you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking ORYLMYTE if:

You experience severe allergic symptoms such as difficulty swallowing or breathing, changes in your voice, hypotension (low blood pressure), or a sensation of throat tightness. Stop treatment and contact your doctor immediately.
You have previously had a severe allergic reaction to a medicine containing allergen extracts.
Your asthma symptoms worsen significantly compared to normal. Stop treatment and contact your doctor immediately.
You have a cardiovascular disease.
You are taking a beta-blocker (a class of medicines often prescribed for heart conditions and high blood pressure, but also present in some eye drops and ointments).
You are being treated for depression with tricyclic antidepressants or monoamine oxidase inhibitors (MAO-I), or for Parkinson’s disease with catechol-O-methyltransferase inhibitors (COMT).
You need to undergo oral surgery or tooth extraction; temporarily stop treatment with ORYLMYTE until complete healing has occurred.
You experience persistent heartburn or difficulty swallowing. You must contact your doctor.
You have an autoimmune disease in remission.

Inform your doctor about:

Any recent illnesses.
Personal or family history of any disease that may affect the immune system.
If your allergic condition has recently worsened.

If you are taking medicines to control asthma and/or to relieve symptoms, do not stop your asthma treatment without consulting your doctor, as this could worsen your asthma symptoms.
Mild or moderate local allergic reactions may occur during treatment. If such reactions are severe, consult your doctor to evaluate whether anti-allergic medicines such as antihistamines are needed.

Children and adolescents
ORYLMYTE is used to treat allergic rhinitis in adolescents (12–17 years of age). ORYLMYTE is not indicated for use in children under 12 years of age.

Other medicines and ORYLMYTE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. If you are taking other anti-allergy medicines such as antihistamines, asthma medicines, or corticosteroids, or a medicine that blocks a substance called immunoglobulin E (IgE), e.g. omalizumab, ask your doctor whether you should continue taking them. If you stop taking these anti-allergy medicines, you may experience more adverse effects during treatment with ORYLMYTE.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There is no experience with the use of ORYLMYTE during pregnancy. Therefore, treatment with ORYLMYTE should not be started during pregnancy. If you become pregnant during treatment, talk to your doctor to evaluate whether continuing treatment is appropriate for you.
There is no experience with the use of ORYLMYTE during breastfeeding. However, effects on breastfed infants are not expected. Talk to your doctor to determine whether you can continue taking ORYLMYTE while breastfeeding.

Driving and using machines
No effects of ORYLMYTE on the ability to drive or operate machinery have been observed.

ORYLMYTE contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ORYLMYTE

Take this medicine exactly as your doctor has told you. If you have any 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 ORYLMYTE.
Treatment starts with an initial phase, during which the dose is gradually increased up to the maintenance dose of 300 IR. IR (Reactivity Index) expresses the activity of the substance.

Maintenance treatment
The dose is 300 IR (one tablet) daily.

Use in adolescents
The dosage in adolescents is the same as that in adults.

Take ORYLMYTE as follows:

Remove one tablet from the packaging by pushing the tablet through the aluminium foil.
Take the tablet during the day, on an empty stomach.
Place and hold the tablet under the tongue until it has completely dissolved, then swallow any residue.
Do not eat or drink for at least 5 minutes.
Wash your hands after handling the tablet.

If you take more ORYLMYTE than you should
If you take more ORYLMYTE than you should, you may experience allergic symptoms, including localised symptoms in the mouth and throat. If you develop severe symptoms, contact your doctor or go to a hospital immediately.

If you forget to take ORYLMYTE
If you forget to take a dose, take it later on the same day. Do not take a double dose on the same day to make up for the missed dose. If you have not taken ORYLMYTE for more than 7 days, contact your doctor before taking ORYLMYTE again.

If you stop taking ORYLMYTE
If you do not take the medicine as prescribed, you may not achieve the beneficial effects of treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects may represent an allergic reaction to the allergen you are being treated with. Most of the unwanted allergic reactions last from a few minutes to hours after taking the medicine, and most of these will subside after 1-3 months of treatment.
Stop taking ORYLMYTE 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
Breathing difficulties
Voice changes
Hypotension (low blood pressure)
Sensation of tightness in the throat (as if swelling)
Hives and skin itching

Possible other side effects:
Very common (may affect more than 1 in 10 people):

Swelling or itching of the mouth
Sore throat or throat irritation
Itching of the ear

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

Itchy eyes
Swelling or itching of the lips or tongue
Burning or tingling sensation in the mouth, inflamed and painful mouth, mouth ulcer
Altered taste
Discomfort or pain in the mouth and/or throat
Swelling of the throat, difficulty swallowing
Cough
Breathing difficulties
Chest pain
Stomach pain, indigestion, nausea, diarrhoea
Itching

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

Redness and inflammation of the eyes, eye swelling, tearing
Pain or tingling in the ear
Dizziness, vertigo
Headache
Malaise or fatigue
Rhinitis (sneezing, runny or itchy nose, nasal congestion)
Nosebleed
Common cold
Inflammation of the lips or tongue
Oral disorders such as mouth burning, mouth numbness, oral ulcers, salivary problems
Swelling of the palate
Facial swelling
Dry throat or mouth, thirst
Mouth and/or throat ulcers, swelling of the mouth and throat due to contact with fruit or vegetables
Throat disorders such as burning/stinging or tightness in the throat, sensation of a lump in the throat, discomfort or swelling in the back of the throat
Asthma, shortness of breath, wheezing
Chest discomfort
Pain in the oesophagus, inflammation of the oesophagus or stomach, heartburn
Vomiting
Gastroenteritis
Localised swelling, subcutaneous swelling
Skin rash, skin irritation, hives
Anxiety
Tingling or stinging sensation
Abnormal blood test results

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

Inflammation of the eyelids, abnormal contraction of the eyelids, eye irritation
Muffled hearing, ringing in the ears (tinnitus)
Nasal discomfort, sinus congestion
Gingivitis, bleeding from the mouth
Bad breath (halitosis), belching
Painful swallowing
Irritation of the vocal cords
Rapid breathing
Loss of throat sensitivity
Seasonal allergy
Bronchitis
Breast pain
Palpitations, rapid heartbeat
Oesophageal swelling
Frequent bowel movements, irritable bowel, presence of gas
Irritability, attention disturbances, numbness, drowsiness, speech disorders, tremor
Blisters, skin redness, acute skin reaction, scratch lesions
Muscle discomfort or contractions
Urgent need to urinate

If you are concerned about any of the side effects, contact your doctor, who will decide whether you need medication such as antihistamines to relieve them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ORYLMYTE

This medicine does not require any 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 packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

Description of the appearance of ORYLMYTE and the contents of the pack
Sublingual tablet.
The 300 IR tablets are white to beige, round and biconvex, with brown speckles, marked with "SAC" on one side and "300" on the other.
The tablets are supplied in aluminium blisters with a removable aluminium foil sheet inside the outer packaging.
Pack sizes:
Pack of 30 sublingual tablets
Pack of 90 sublingual tablets
Not all pack sizes may be marketed.

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

United Kingdom (Northern Ireland) with 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, bletten voor sublinguaal gebruik
Slovenia Actair 300 IR podjezične tablete
Slovakia ACTAIR 300 IR sublingválne tablety
Spain Actair 300 IR comprimidos sublinguales

Patient Information Leaflet

ORYLMYTE 100 IR & 300 IR sublingual tablets

For use in adolescents and adults (aged 12-65 years)
Standardized allergen extracts from house dust mites
(Dermatophagoides pteronyssinus & Dermatophagoides farinae)
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any adverse reactions you experience while taking this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ORYLMYTE is and what it is used for
What you need to know before taking ORYLMYTE
How to take ORYLMYTE
Possible side effects
How to store ORYLMYTE
Contents of the pack and other information

1. What ORYLMYTE is and what it is used for

ORYLMYTE contains allergen extracts from house dust mites.
ORYLMYTE is used to treat allergic rhinitis (inflammation of the nasal mucosa) in adolescents (12–17 years of age) and adults. ORYLMYTE works by increasing immunological tolerance (the ability of your body to cope) to house dust mites. Treatment may need to be taken for 3 months before improvements are observed.
ORYLMYTE 100 IR is indicated only for the dose escalation phase and not for maintenance.
Before starting treatment, your doctor will diagnose your allergy by performing appropriate skin tests/blood examinations.
The first dose of ORYLMYTE must be taken under medical supervision. You must remain under medical observation for at least half an hour after taking the first dose. This precaution is intended to monitor your sensitivity to the medicine. You may also discuss possible side effects with your doctor.
ORYLMYTE must be prescribed by physicians experienced in the treatment of allergies.

2. What you need to know before taking ORYLMYTE

Do not take ORYLMYTE if:

You are allergic to any of the excipients (other ingredients) of this medicine (listed in section 6).
You suffer from severe and/or unstable asthma or have had a severe asthma exacerbation in the last 3 months.
Your forced expiratory volume in one second (FEV1) is less than 80% as assessed by your doctor.
You have a disease affecting the immune system, are taking medicines that suppress the immune system, or have cancer.
You have ulcers or infections in the mouth. Your doctor may advise you to delay starting treatment or to stop treatment until your mouth has healed. Do not start taking ORYLMYTE if you are pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking ORYLMYTE if:

You experience severe allergic symptoms such as difficulty swallowing or breathing, changes in your voice, hypotension (low blood pressure), or a sensation of throat tightness. Stop treatment and contact your doctor immediately.
You have previously had a severe allergic reaction to a medicine containing allergen extracts.
Your asthma symptoms worsen significantly compared to normal. Stop treatment and contact your doctor immediately.
You have a cardiovascular disease.
You are taking a beta-blocker (a class of medicines often prescribed for heart conditions and hypertension, but also present in certain eye drops and 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 need to undergo oral surgery or tooth extraction; temporarily discontinue treatment with ORYLMYTE until complete healing has occurred.
You experience persistent heartburn or difficulty swallowing. You should contact your doctor.
You have an autoimmune disease in remission.

Inform your doctor about:

Any recent illnesses.
Personal or family history of any disease that may affect the immune system.
If your allergic disease has recently worsened.

If you are taking medicines to control asthma and/or to relieve symptoms, do not stop your asthma treatment without medical advice, as this could worsen asthma symptoms.
Mild or moderate local allergic reactions may occur during treatment. If these reactions are severe, consult your doctor to determine whether anti-allergic medicines such as antihistamines are needed.

Children and adolescents
ORYLMYTE is used to treat allergic rhinitis in adolescents (12–17 years of age). ORYLMYTE is not indicated for use in children under 12 years of age.

Other medicines and ORYLMYTE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. If you are taking other anti-allergic medicines such as antihistamines, asthma medications or steroids, or a medicine that blocks a substance called immunoglobulin E (IgE), e.g. omalizumab, ask your doctor whether you should continue taking them. If you stop taking these anti-allergic medicines, you may experience more adverse effects during treatment with ORYLMYTE.

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is no experience with the use of ORYLMYTE during pregnancy. Therefore, treatment with ORYLMYTE should not be started during pregnancy. If you become pregnant during treatment, talk to your doctor to evaluate whether continuing treatment is appropriate for you.
There is no experience with the use of ORYLMYTE during breastfeeding. However, effects on breastfed infants are not expected. Talk to your doctor to determine whether you can continue taking ORYLMYTE while breastfeeding.

Driving and using machines
No effects of ORYLMYTE on the ability to drive vehicles or operate machinery have been observed.

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

3. How to take ORYLMYTE

Take this medicine exactly as instructed by your doctor. If you have any 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 need to take ORYLMYTE.
Treatment consists of an initial phase (during which the dose is gradually increased over 3 days) and a maintenance phase.
Initial treatment
Treatment with ORYLMYTE must be started as follows:

Day 1	1 tablet of 100 IR
Day 2	2 tablets of 100 IR together
From day 3	1 tablet of 300 IR

The IR (Reactivity Index) expresses activity.
ORYLMYTE 100 IR is indicated only for the dose escalation period and not for maintenance.
Continuation of treatment
The dose is 300 IR (one tablet) daily.
Use in adolescents
The dosage in adolescents is the same as in adults.
Take ORYLMYTE as follows:

Remove one tablet (or 2 tablets per day) from the packaging by pushing the tablet through the aluminum foil.
Take the tablet during the day, on an empty stomach.
Place and keep the tablet under the tongue until it has completely dissolved, then swallow what remains.
Do not eat or drink for at least 5 minutes.
Wash your hands after handling the tablet.

If you take more ORYLMYTE than you should
If you take more ORYLMYTE than you should, you may experience allergic symptoms, including those localized in the mouth and throat. If you develop severe symptoms, contact your doctor or go to a hospital immediately.
If you forget to take ORYLMYTE
If you forget to take a dose, take it later during the day. Do not take a double dose in one day to make up for the missed dose. If you have not taken ORYLMYTE for more than 7 days, contact your doctor before taking ORYLMYTE again.
If you stop taking ORYLMYTE
If you do not take the medicine as prescribed, you may not obtain the beneficial effects of treatment. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects may be an allergic response to the allergen you are being treated with. Most unwanted allergic reactions last from a few minutes to several hours after taking the medicine, and most of these will subside after 1-3 months of treatment.

Stop taking ORYLMYTE and contact your doctor or go to hospital immediately if you experience any of the following symptoms:

Rapid swelling of the face, mouth, throat or skin
Difficulty swallowing
Breathing difficulties
Voice changes
Hypotension (low blood pressure)
Sensation of tightness in the throat (such as swelling)
Hives and skin itching

Other possible side effects:
Very common (may affect more than 1 in 10 people):

Swelling or itching in the mouth
Sore throat or throat irritation
Itching in the ears

Common (may affect less than 1 in 10 people):

Itchy eyes
Swelling or itching of the lips or tongue
Burning or tingling sensation in the mouth, inflamed and painful mouth, mouth ulcer
Taste disturbances
Discomfort or pain in the mouth and/or throat
Swelling of the throat, difficulty swallowing
Cough
Breathing difficulties
Chest pain
Stomach pain, indigestion, nausea, diarrhoea
Itching

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

Redness and inflammation of the eyes, eye swelling, tearing
Ear pain or tingling
Dizziness, vertigo
Headache
Malaise or fatigue
Rhinitis (sneezing, runny or itchy nose, nasal congestion)
Nosebleeds
Common cold
Inflammation of the lips or tongue
Oral disorders such as mouth burning, mouth numbness, oral ulcers, salivary problems
Swelling of the palate
Facial swelling
Dry throat or mouth, thirst
Mouth and/or throat ulcers, swelling of the mouth and throat due to contact with fruit or vegetables
Throat disorders such as burning, prickling, or tightness in the throat, sensation of a lump in the throat, discomfort or swelling in the back of the throat
Asthma, shortness of breath, wheezing
Chest discomfort
Pain in the oesophagus, inflammation of the oesophagus or stomach, heartburn
Vomiting
Gastroenteritis
Localised swelling, subcutaneous swelling
Skin rash, skin irritation, urticaria
Anxiety
Tingling or prickling sensation
Abnormal blood test results

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

Inflammation of the eyelids, abnormal contraction of the eyelids, eye irritation
Muffled hearing, ringing in the ears (tinnitus)
Nasal discomfort, paranasal sinus blockage
Gingivitis, bleeding from the mouth
Bad breath (halitosis), belching
Painful swallowing
Irritation of the vocal cords
Rapid breathing
Loss of throat sensitivity
Seasonal allergy
Bronchitis
Breast pain
Palpitations, rapid heartbeat
Oesophageal swelling
Frequent bowel movements, irritable bowel, gas (flatulence)
Irritability, attention disturbances, numbness, drowsiness, speech disorders, tremor
Blisters, skin redness, acute skin reaction, scratch lesions
Muscle discomfort or contractions
Urgent need to urinate

If you are concerned about any of the side effects, contact your doctor, who will decide whether you need additional medicines such as antihistamines to relieve them.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ORYLMYTE

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ORYLMYTE 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 (Reactivity Index) expresses the biological activity.
The other ingredients are anhydrous colloidal silica, sodium croscarmellose, lactose monohydrate,
magnesium stearate, mannitol (E 421), and microcrystalline cellulose.

Description of the appearance of ORYLMYTE and the contents of the pack
Sublingual tablet.
The 100 IR tablets are white to beige, round and biconvex, with brown speckles, and engraved with
"SAC" on one side and "100" on the other.
The 300 IR tablets are white to beige, round and biconvex, with brown speckles, and engraved with
"SAC" on one side and "300" on the other.
The tablets are supplied in aluminum blisters with an aluminum foil peelable lid inside the outer packaging.
Pack: pack containing 3 sublingual tablets of 100 IR and 28 sublingual tablets of 300 IR.

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

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
France Orylmyte 100 IR, comprimé sublingual
Orylmyte 300 IR, comprimé sublingual
Denmark, Norway, Sweden Aitmyte
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