ORYLMYTE 100 IR Sublingual tablet

Зміст інструкції

1. ORYLMYTE 100 IR sublingual tablets
   1. What is ORYLMYTE and what is it used for
   2. What you need to know before you take ORYLMYTE
   3. How to take ORYLMYTE
   4. Possible side effects
   5. How to store ORYLMYTE
   6. Contents of the pack and other information
2. ORYLMYTE 300 IR sublingual tablets
   1. What is ORYLMYTE and what is it used for
   2. What you need to know before you take ORYLMYTE
   3. How to take ORYLMYTE
   4. Possible side effects
   5. How to store ORYLMYTE
   6. Contents of the pack and other information
3. ORYLMYTE 100 IR & 300 IR sublingual tablets
   1. What is ORYLMYTE and what it is used for
   2. What you need to know before taking ORYLMYTE
   3. How to take ORYLMYTE
   4. Possible side effects
   5. How to store ORYLMYTE
   6. Contents of the pack and other information

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 the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ORYLMYTE is and what it is used for
• 2. What you need to know before you take ORYLMYTE
• 3. How to take ORYLMYTE
• 4. Possible side effects
• 5. How to store ORYLMYTE
• 6. Contents of the pack and other information

1. What is ORYLMYTE and what is it used for

ORYLMYTE contains allergenic 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. The
treatment may need to be taken for 3 months before improvements are observed.
ORYLMYTE 100 IR is only indicated for the dose escalation period and not for
maintenance.
Before starting treatment, a doctor will diagnose your allergy by performing skin tests/blood tests
appropriately
The first dose of ORYLMYTE must be taken under the supervision of a doctor. You will need to
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 will also be able to discuss
possible side effects with your doctor.
ORYLMYTE must be prescribed by doctors with experience in the treatment of allergies.

2. What you need to know before you take 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
• The forced expiratory volume in the first second (FEV1) is less than 80% as assessed by your doctor.
• You suffer from a condition that affects the immune system, are taking medicines that suppress the immune system or have cancer.
• You have ulcers or infections of the mouth. Your doctor may recommend delaying the start of treatment or interrupting it until your mouth is healed. Do not start taking ORYLMYTE if you are pregnant.

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

• Severe allergic symptoms occur, such as difficulty swallowing or breathing, changes in your voice, hypotension (low blood pressure) or a feeling of a lump in your throat. Stop treatment and contact your doctor immediately.
• You have previously had a severe allergic reaction to a medicine containing allergenic extracts.
• Asthma symptoms worsen significantly compared to normal. Stop treatment and contact your doctor immediately.
• You have cardiovascular disease.
• You are taking a beta-blocker (a class of drugs often prescribed for heart conditions and hypertension but also present in some 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 a tooth extraction, temporarily interrupt treatment with ORYLMYTE until complete healing.
• You experience persistent heartburn or difficulty swallowing. You need to contact your doctor.
• You have an autoimmune disease in remission.

Tell 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 treatment for asthma without your doctor's advice as this may
worsen asthma symptoms.
Mild or moderate localized allergic reactions may occur during treatment.
If such reactions are severe, consult your doctor to assess whether the use of
anti-allergic drugs such as antihistamines is necessary.

Children and adolescents
ORYLMYTE is used to treat allergic rhinitis in adolescents (12-17 years). ORYLMYTE is not
indicated for treatment 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 available without a prescription. If you are taking other
anti-allergic 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 if you should continue to
take them. If you stop taking such anti-allergic medicines, more
side effects may occur during treatment with ORYLMYTE.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, 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 assess whether it is appropriate for you to continue treatment.
There is no experience with the use of ORYLMYTE during breastfeeding. However, no effects on breastfed infants are expected.
Talk to your doctor to understand if you can continue to take
ORYLMYTE while breastfeeding your baby.

Driving and operating machinery
No effects on the ability to drive vehicles or use
machinery have been observed with ORYLMYTE.

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

3. How to take ORYLMYTE

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
Treatment with ORYLMYTE must be started with a dose of 100 IR, and increased gradually until the maintenance dose of 300 IR is reached. IR (Reactivity Index) expresses
the activity.
ORYLMYTE 100 IR is only indicated for the dose escalation period and not for maintenance.
It is recommended to take the first tablet under the supervision of a doctor. The doctor will give you
advice on the dosage regimen and the dose escalation period.

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

• 1. Remove one tablet (or 2 tablets) from the pack by pushing the tablet through the aluminum blister.
• 2. Take the tablet during the day, on an empty stomach.
• 3. Place and hold the tablet under the tongue until it has dissolved, then swallow what remains.

• 4. Do not eat or drink for at least 5 minutes.
• 5. 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 symptoms
localized to the mouth and throat. If you develop severe symptoms, contact your doctor or 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 a 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be an allergic reaction to the allergen being treated. Most allergic side effects 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
• Difficulty breathing
• Changes in voice
• Hypotension (low blood pressure)
• Feeling of fullness in the throat (as if swollen)
• Tingling and itching of the skin Possible other side effects: Very common (may affect more than 1 in 10 people):
• Swelling or itching of the mouth
• Throat irritation
• Itching in the ear

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

• Itching of the eyes
• Swelling or itching of the lips or tongue
• Burning or tingling in the mouth, inflamed and sore mouth, mouth ulcer
• Alteration of 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, diarrhea
• Itching

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

• Redness and inflammation of the eyes, eye swelling, tearing
• Ear pain or tingling
• Dizziness, lightheadedness
• Headache
• Feeling unwell or tired
• Rhinitis (sneezing, runny or itchy nose, stuffy nose)
• Nosebleed
• Common cold
• Inflammation of the lips or tongue
• Oral discomfort such as burning mouth, numbness of the mouth, mouth sores, salivary problems
• Swelling of the palate
• Swelling of the face
• Dry throat, thirst
• Mouth and/or throat sores, swelling of the mouth and throat due to contact with fruit or vegetables
• Throat discomfort such as burning/tingling or constriction of the throat, a lump in the throat, discomfort or swelling in the back of the throat
• Asthma, shortness of breath, wheezing
• Chest discomfort
• Esophageal pain, inflammation of the esophagus or stomach, heartburn
• Vomiting
• Gastroenteritis
• Localized swelling, subcutaneous swelling
• Skin rash, skin irritation, hives
• Anxiety
• Sensation of tingling or prickling
• Abnormal blood test values

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

• Inflammation of the eyelids, abnormal eyelid contractions, eye irritation
• Ear fullness, ringing in the ears
• Nasal discomfort, blockage of the sinuses
• Gum inflammation, bleeding from the mouth
• Bad breath, belching
• Painful swallowing
• Irritation of the vocal cords
• Rapid breathing
• Loss of sensation in the throat
• Seasonal allergy
• Bronchitis
• Chest pain
• Palpitations, rapid heartbeat
• Esophageal swelling
• Frequent bowel movements, irritable bowel syndrome, presence of gas
• Irritability, attention disorders, numbness, drowsiness, speech disorders, tremor
• Blisters, skin redness, acute skin reaction, scratch lesions
• Muscle discomfort or contractions
• Urgent urination

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through 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 that is reported on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredient is a standardized allergenic extract from house dust mites Dermatophagoides pteronyssinusand Dermatophagoides farinae. One sublingual tablet contains 100 IR.
• The IR (Reactivity Index) expresses the 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 contents of the pack
Sublingual tablet.
The 100 IR tablets are white to beige in color, round and biconvex, with brown speckles
and with “SAC” engraved on one side and “100” on the other.
The tablets are supplied in aluminum blisters with a removable aluminum foil 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) with the following denominations:
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 Actair100 IR comprimidos sublinguales

ORYLMYTE 300 IR sublingual tablets

For use in adolescents and adults (12-65 years of age)
Standardized allergen extracts from house dust mites

(Dermatophagoides pteronyssinusand Dermatophagoides farinae)
This medicinal product is subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ORYLMYTE is and what it is used for
• 2. What you need to know before you take ORYLMYTE
• 3. How to take ORYLMYTE
• 4. Possible side effects
• 5. How to store ORYLMYTE
• 6. Contents of the pack and other information

1. What is ORYLMYTE and what is it used for

ORYLMYTE contains allergenic 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. The
treatment may need to be taken for 3 months before improvements are observed.
Before starting treatment, a doctor will diagnose your allergy by performing skin tests/appropriate blood tests.
The first dose of ORYLMYTE must be taken under the supervision of a doctor. You will need to
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 will also be able to discuss
possible undesirable effects with your doctor.
ORYLMYTE must be prescribed by doctors with experience in the treatment of allergies.

2. What you need to know before you take 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.
• The forced expiratory volume in the first second (FEV1) is less than 80% as assessed by your doctor.
• You suffer from a condition that affects the immune system, are taking medicines that suppress the immune system, or have cancer.
• You have ulcers or infections of the mouth. Your doctor may recommend delaying the start of treatment or interrupting it until your mouth is 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 feeling of a lump in your throat. Stop treatment and contact your doctor immediately.
• You have previously had a severe allergic reaction to a medicine containing allergenic extracts.
• Your asthma symptoms worsen significantly compared to normal. Stop treatment and contact your doctor immediately.
• You have a cardiovascular condition.
• You are taking a beta-blocker (a class of drugs often prescribed for heart conditions and hypertension, but also present in some 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 interrupt treatment with ORYLMYTE until complete healing.
• You experience persistent heartburn or difficulty swallowing. You should contact your doctor.
• You have an autoimmune disease in remission.

Tell your doctor about:

• Any recent illnesses you have had.
• 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 relieve symptoms, do not
stop asthma treatment without your doctor's advice as this may
worsen your asthma symptoms.
Mild or moderate localized allergic reactions may occur during
treatment. If these reactions are severe, consult your doctor to assess whether
the use of anti-allergic drugs such as antihistamines is necessary.

Children and adolescents
ORYLMYTE is used to treat allergic rhinitis in adolescents (12-17 years). ORYLMYTE is not
indicated for treatment 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 available without a prescription. If you are taking other
anti-allergic 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 if you should continue to
take them. If you stop taking these anti-allergic medicines, more
side effects may occur during treatment with ORYLMYTE.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, 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 assess whether it is appropriate for you to continue treatment.
There is no experience with the use of ORYLMYTE during breastfeeding. However, no effects on breastfed infants are expected.
Talk to your doctor to understand if you can continue to take
ORYLMYTE while breastfeeding your baby.

Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery have been observed with ORYLMYTE.

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

3. How to take ORYLMYTE

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
It is recommended to take the first tablet under the supervision of a doctor. Your doctor will
tell you how long you will need to take ORYLMYTE.
Treatment begins with an initial phase, meaning the dose is gradually increased to the
maintenance dose of 300 IR. IR (Reactivity Index) expresses the activity.

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

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

• 1. Remove a tablet from the blister pack by pushing it through the aluminum foil.
• 2. Take the tablet during the day, on an empty stomach.
• 3. Place and hold the tablet under the tongue until it has dissolved, then swallow what remains.

• 4. Do not eat or drink for at least 5 minutes.
• 5. 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 symptoms
localized to the mouth and throat. If you develop severe symptoms, contact your doctor or a
hospital immediately.

If you forget to take ORYLMYTE
If you have forgotten to take a dose, take it later during the day. Do not
take a double dose in one day to make up for a 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be an allergic reaction to the allergen you are being treated with. Most allergic side
effects 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
• Difficulty breathing
• Changes in voice
• Hypotension (low blood pressure)
• Feeling of fullness in the throat (as if swollen)
• Hives and itchy skin

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

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

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

• Itchy eyes
• Swelling or itching of the lips or tongue
• Burning or tingling in the mouth, inflamed and sore mouth, mouth ulcer
• Change in 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, swollen eyes, tearing
• Pain or tingling in the ear
• Dizziness, lightheadedness
• Headache
• Feeling unwell or tired
• Rhinitis (sneezing, runny or itchy nose, stuffy nose)
• Nosebleed
• Common cold
• Inflammation of the lips or tongue
• Oral discomfort such as burning mouth, numbness of the mouth, mouth sores, salivary problems
• Swelling of the palate
• Swelling of the face
• Dry throat or mouth, thirst
• Mouth and/or throat sores, swelling of the mouth and throat due to contact with fruit or vegetables
• Throat discomfort such as burning/tingling or tightness in the throat, a lump in the throat, discomfort or swelling in the back of the throat
• Asthma, shortness of breath, wheezing
• Chest discomfort
• Pain in the esophagus, inflammation of the esophagus or stomach, heartburn
• Vomiting
• Gastroenteritis
• Localized swelling, swelling under the skin
• Skin rash, skin irritation, hives
• Anxiety
• Feeling of tingling or prickling
• Abnormal blood test values

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

• Inflammation of the eyelids, abnormal eyelid contractions, eye irritation
• Ear fullness, ringing in the ears
• Nasal discomfort, blocked sinuses
• Gum inflammation, bleeding mouth
• Bad breath, belching
• Painful swallowing
• Irritation of the vocal cords
• Rapid breathing
• Loss of sensation in the throat
• Seasonal allergy
• Bronchitis
• Breast pain
• Palpitations, fast heartbeat
• Swelling of the esophagus
• Frequent bowel movements, irritable bowel, gas
• Irritability, attention disorders, 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 these side effects, contact your doctor who will decide if you need
medicines such as antihistamines to relieve them.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after Scad. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredient is a standardized allergenic extract from house dust mites

Dermatophagoides pteronyssinusand Dermatophagoides farinae. One sublingual tablet contains
300 IR.
The IR (Reactivity Index) expresses the 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 contents of the pack
Sublingual tablet.
The 300 IR tablets are white to beige in colour, round and biconvex, with brown speckles
and with “SAC” inscribed on one side and “300” on the other.
The tablets are supplied in aluminium blisters with a removable aluminium foil inside
the outer packaging
Packs:
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 denominations:>
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

ORYLMYTE 100 IR & 300 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)

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What ORYLMYTE is and what it is used for
• 2. What you need to know before you take ORYLMYTE
• 3. How to take ORYLMYTE
• 4. Possible side effects
• 5. How to store ORYLMYTE
• 6. Contents of the pack and other information

1. What is ORYLMYTE and what it is used for

ORYLMYTE contains allergenic 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. The
treatment may need to be taken for 3 months before improvements are observed.
ORYLMYTE 100 IR is indicated only for the dose escalation period and not for
maintenance.
Before starting treatment, a doctor will diagnose your allergy by performing skin tests/appropriate blood tests.
The first dose of ORYLMYTE must be taken under the supervision of a doctor. You will need to
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 will also be able to discuss
possible side effects with your doctor.
ORYLMYTE must be prescribed by doctors with experience 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.
• The forced expiratory volume in the first second (FEV1) is less than 80% as assessed by your doctor.
• You suffer from a condition that affects the immune system, are taking medicines that suppress the immune system, or have cancer.
• You have ulcers or infections of the mouth. Your doctor may recommend delaying the start of treatment or interrupting 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 feeling of a lump in your throat. Stop treatment and contact your doctor immediately.
• You have previously had a severe allergic reaction to a medicine containing allergenic extracts.
• Your asthma symptoms worsen significantly compared to normal. Stop treatment and contact your doctor immediately.
• You have a cardiovascular condition.
• You are taking a beta-blocker (a class of medicines often prescribed for heart conditions and hypertension but also present in some 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 a tooth extraction, temporarily interrupt treatment with ORYLMYTE until complete healing.
• You experience persistent heartburn or difficulty swallowing. You need to contact your doctor.
• You have an autoimmune disease in remission.

Tell your doctor about:

• Any recent illnesses you have had.
• 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 relieve symptoms, do not
stop asthma treatment without your doctor's advice, as this may
worsen your asthma symptoms.
Mild or moderate localized allergic reactions may occur during
treatment. If these reactions are severe, see your doctor to assess whether
the use of anti-allergic drugs such as antihistamines is necessary.

Children and adolescents
ORYLMYTE is used to treat allergic rhinitis in adolescents (12-17 years). ORYLMYTE is not
indicated for treatment 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 available without a prescription. If you are taking other
anti-allergic 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 if you should continue to
take them. If you stop taking these anti-allergic medicines, more
side effects may occur during treatment with ORYLMYTE.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, 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 assess whether it is appropriate for you to continue treatment.
There is no experience with the use of ORYLMYTE during breastfeeding. However, no
effects on breastfed infants are expected. Talk to your doctor to find out if you can continue to
take ORYLMYTE while breastfeeding your baby.

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

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

3. How to take ORYLMYTE

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.
It is recommended to take the first tablet under the supervision of a doctor. Your doctor will
tell you how long you will need to take ORYLMYTE.
The treatment includes an initial phase (the dose is gradually increased over 3 days) and
a continuation phase.

Initial treatment
Treatment with ORYLMYTE must be started as follows:
The IR (Reactivity Index) expresses the activity.
ORYLMYTE 100 IR is only indicated for the dose escalation period and not for
maintenance.

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

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

Take ORYLMYTE as follows:

• 1. Remove one tablet (or 2 on day 2) from the blister pack by pushing the tablet through the aluminum foil.
• 2. Take the tablet during the day, on an empty stomach.
• 3. Place and hold the tablet under the tongue until it has dissolved, then swallow what remains.

• 4. Do not eat or drink for at least 5 minutes.
• 5. 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 symptoms
localized to the mouth and throat. If you develop severe symptoms, contact your doctor or a
hospital immediately.

If you forget to take ORYLMYTE
If you have forgotten to take a dose, take it later during the day. Do not
take a double dose in one day to make up for a forgotten 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 get the beneficial effects of the treatment. If you
have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects may be an allergic reaction to the allergen with which you are being treated. Most allergic
side effects 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
• Difficulty breathing
• Changes in voice
• Hypotension (low blood pressure)
• Feeling of fullness in the throat (as if swollen)
• Urticaria and itchy skin

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

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

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

• Itching of the eyes

• Swelling or itching of the lips or tongue
• Burning or tingling in the mouth, inflamed and painful mouth, mouth ulcer
• Alteration of 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, diarrhea
• 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, lightheadedness
• Headache
• Feeling unwell or tired
• Rhinitis (sneezing, runny or itchy nose, blocked nose)
• Nosebleed
• Common cold
• Inflammation of the lips or tongue
• Oral discomfort such as burning mouth, numbness of the mouth, mouth sores, salivary problems
• Swelling of the palate
• Swelling of the face
• Dry throat or mouth, thirst
• Mouth and/or throat sores, swelling of the mouth and throat due to contact with fruit or vegetables
• Throat discomfort such as burning/tingling or constriction of the throat, a lump in the throat, discomfort or swelling in the back of the throat
• Asthma, shortness of breath, wheezing
• Chest discomfort
• Pain in the esophagus, inflammation of the esophagus or stomach, heartburn
• Vomiting
• Gastroenteritis
• Localized swelling, subcutaneous swelling
• Skin rash, skin irritation, urticaria
• Anxiety
• Feeling of tingling or prickling
• Abnormal blood test values

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

• Inflammation of the eyelids, abnormal eyelid contractions, eye irritation
• Ear fullness, ringing in the ears
• Nasal discomfort, blockage of the sinuses
• Gum inflammation, bleeding from the mouth
• Bad breath, belching
• Painful swallowing
• Irritation of the vocal cords
• Rapid breathing
• Loss of sensation in the throat
• Seasonal allergy
• Bronchitis
• Breast pain
• Palpitations, rapid heartbeat
• Esophageal swelling
• Frequent bowel movements, irritable bowel, gas
• Irritability, attention disorders, numbness, drowsiness, speech disorders, tremor
• Blisters, skin redness, acute skin reaction, scratch lesions
• Muscle discomfort or contractions
• Urgent urination

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You
can also report side effects directly through 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 particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 ingredient is a standardized allergenic extract from house dust mites

Dermatophagoides pteronyssinusand Dermatophagoides farinae. One sublingual tablet contains
100 IR or 300 IR.
IR (Reactivity Index) expresses the 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 contents of the pack
Sublingual tablet.
The 100 IR tablets are white to beige in colour, round and biconvex, with brown speckles
and with “SAC” inscribed on one side and “100” on the other.
The 300 IR tablets are white to beige in colour, round and biconvex, with brown speckles
and with “SAC” inscribed on one side and “300” on the other.
The tablets are supplied in aluminium blisters with a removable aluminium foil inside
the outer packaging.
Pack size: pack of 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

United Kingdom (Northern Ireland) with the following denominations:
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 Actair100 IR & 300 IR comprimidos sublinguales