Aerolid

Package leaflet: Information for the user

AEROLID 0.1% nebulizer solution

Flunisolide
Please read this leaflet carefully before using this medicine because 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AEROLID is and what it is used for

This medicinal product contains the active substance flunisolide, which belongs to a group of medicines called corticosteroid anti-inflammatory drugs (glucocorticoids).
AEROLID is indicated for the treatment of allergic conditions affecting the respiratory tract, such as:

• bronchial asthma and chronic asthmatic bronchitis (inflammation of the bronchi causing breathing difficulty);
• chronic and seasonal rhinitis (nasal congestion).

2. What you need to know before using AEROLID

Do not use AEROLID

• if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lung infection (active or quiescent pulmonary tuberculosis);
• if you have infections caused by bacteria, viruses, or fungi;
• if you are in the first trimester of pregnancy (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using AEROLID.
Avoid using this medicine for prolonged periods and at high doses, as undesirable effects may occur, such as Cushing's syndrome (a condition caused by excessive production of a hormone, cortisol), Cushingoid appearance (characterized by localized obesity predominantly in the abdomen, face, and back), mucosal problems (atrophy), adrenal insufficiency (inability of the adrenal glands to produce sufficient cortisol), growth retardation in children and adolescents, bone fragility, eye problems (cataract and glaucoma), hyperactivity, sleep disturbances, anxiety, depression, aggression (especially in children) (see "Possible side effects").
If you use AEROLID for prolonged periods, allergic reactions (sensitization phenomena) may also occur.
Stop treatment if you experience any of these effects and do not exceed the recommended doses.
This medicine may mask symptoms of infections and may lead to new infections.
Exercise particular caution in the following cases:

• if you are switching from systemic corticosteroid therapy to treatment with flunisolide, especially if you are under stress or have recently had a severe asthma attack, as this medicine may cause adrenal insufficiency. If this occurs, discontinue treatment gradually. The replacement of systemic corticosteroid therapy with topical therapy must be carried out under close medical supervision. Your doctor will advise you on the dose and method of administration for switching from one therapy to another;
• if you have severe nasal congestion or abundant mucus (secretion). In this case, initial treatment with medicines (topical vasoconstrictors) that clear the airways may be necessary to allow the aerosol to contact the mucosa;
• if you have a lung infection (active or quiescent tuberculous infections) or an untreated infection caused by fungi, bacteria, or viruses, or an eye infection caused by the Herpes simplex virus. Consult your doctor, as in these cases it may be advisable to avoid using this medicine;
• if you have or have previously had nasal trauma, with lesions of the nasal septum or persistent nosebleeds (epistaxis), as this medicine delays wound healing (cicatrization processes);
• if during treatment you develop an alteration of the bacteria (microflora) present in the respiratory tract (dysmicrobism). Consult your doctor, as concomitant therapy may be necessary;
• if you are experiencing an asthma attack, as the medicine is not effective because its effect only becomes apparent after several days of treatment.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children
The use of AEROLID is not recommended in children under 4 years of age.
Other medicines and AEROLID

• Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
• Some medicines may increase the effects of AEROLID, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use AEROLID during the first three months of pregnancy.
Use this medicine after the first trimester of pregnancy only if necessary and under direct medical supervision.
Breastfeeding
If you are breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.
Driving and using machines
There are no data available to determine the effects of AEROLID on the ability to drive vehicles or operate machinery.

3. How to use AEROLID

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Method of administration: Use AEROLID with electric nebulizers and do not dilute it. The use of nebulizers may result in residual medication deposits adhering to the walls or bottom of the ampoule, which may therefore not be fully delivered. Please take this into account during the preparation phase of the medication.

The recommended dose in adults is 1 mg (25 drops) twice daily.

Use in children
The recommended dose is 500 micrograms (12–13 drops) twice daily.

If you take more AEROLID than you should
If you (or someone else) have taken an excessive dose of AEROLID, or if you suspect that a child may have ingested this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.

In case of overdose within a short period of time, hormonal disturbances may occur due to suppression of the connection between the brain and adrenal glands (hypothalamic-pituitary-adrenal axis suppression).

Take this leaflet, the vial, and its container with you to the hospital or doctor so that they know which medicine has been taken.

If you forget to use AEROLID
Do not use a double dose to make up for the missed dose.

If you stop using AEROLID
Do not stop treatment with this medicine abruptly. Before stopping treatment, consult your doctor, who will advise you on how to gradually reduce the dosage.

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 may cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:
Some patients have experienced cough, hoarseness, and mild, transient nasal mucosa burning.
Fungal infections (caused by fungi) in the mouth or throat have rarely been observed.
Other observed side effects include: nasal irritation, epistaxis (nosebleed), nasal congestion, rhinorrhea (runny nose), and sore throat.
The most common side effect reported has been the occurrence of nasal congestion and nasal polyps.
With prolonged treatment, systemic manifestations may occur: osteoporosis (a disease causing bone weakening), peptic ulcer (stomach lesion), hypotension (reduced blood pressure), and weight loss due to adrenal insufficiency (caused by impaired function of a type of gland).
Psychiatric disorders have also been reported, including: psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, and behavioural disorders (mainly in children).
Blurred vision and hiccup have been reported with unknown frequency.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AEROLID

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store below 25 °C. Keep the container in the original packaging to protect it from light.
Use this medicine within 30 days of first opening the bottle.
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 AEROLID contains
The active substance is flunisolide. 100 ml of solution contain 100 mg of flunisolide (1 drop contains 40 micrograms of flunisolide).
The other components are: propylene glycol, sodium chloride, purified water.
Description of the appearance of AEROLID and contents of the pack
Pack containing one 30 ml bottle.
Marketing Authorization Holder
PIAM Farmaceutici S.p.A. – Via Fieschi, 8 – 16121 Genoa
Manufacturers
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)

Package leaflet: Information for the user

AEROLID 1 mg/1 ml nebulizing solution

Flunisolide
Please read this leaflet carefully before using this medicine because 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AEROLID is and what it is used for

This medicinal product contains the active substance flunisolide, which belongs to a group of medicines called corticosteroid anti-inflammatory drugs (glucocorticoids).
AEROLID is indicated for the treatment of allergic conditions affecting the respiratory tract, such as:

• bronchial asthma and chronic asthmatic bronchitis (inflammation of the bronchi with breathing difficulty);
• chronic and seasonal rhinitis (nasal congestion).

2. What you need to know before using AEROLID

Do not use AEROLID

• if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lung infection (active or quiescent pulmonary tuberculosis);
• if you have infections caused by bacteria, viruses, or fungi;
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using AEROLID.
Avoid using this medicine for prolonged periods and at high doses, as undesirable effects may occur, such as Cushing's syndrome (a condition caused by excessive production of a hormone, cortisol), Cushingoid appearance (characterized by localized obesity mainly in the abdomen, face, and back), mucosal problems (atrophy), adrenal insufficiency (inability of the adrenal glands to produce sufficient cortisol), growth retardation in children and adolescents, bone fragility, eye problems (cataract and glaucoma), hyperactivity, sleep disturbances, anxiety, depression, aggression (especially in children) (see section “Possible side effects”).
If you use AEROLID for prolonged periods, allergic reactions (sensitization phenomena) may also occur.
Stop treatment if you experience any of these effects and do not exceed the recommended doses.
This medicine may mask symptoms of infections and may lead to new infections.
Exercise particular caution in the following cases:

• if you are switching from systemic corticosteroid therapy to flunisolide treatment, especially if you are under stress or have recently had a severe asthma attack, as this medicine may cause adrenal insufficiency. If this occurs, discontinue treatment gradually. The switch from systemic corticosteroid therapy to topical therapy must be carried out under close medical supervision. Your doctor will advise you on the dose and method of administration for transitioning from one therapy to the other;
• if you have severe nasal congestion or abundant mucus (secretion). In such cases, initial treatment with medicines (topical vasoconstrictors) that clear the airways may be necessary to allow the aerosol to reach and contact the mucosa;
• if you have a lung infection (active or quiescent tuberculous infections) or an untreated fungal, bacterial, or viral infection, or an eye infection caused by the Herpes simplex virus. Consult your doctor, as in these cases it may be advisable to avoid using this medicine;
• if you have or have previously had nasal trauma, with septal lesions or persistent nosebleeds (epistaxis), as this medicine may delay wound healing (cicatrization processes);
• if during treatment you develop an alteration in the bacteria (microflora) present in the respiratory tract (dysmicrobism). Consult your doctor, as concomitant therapy may be required;
• if you are experiencing an asthma attack, as this medicine is not effective in such cases due to its effect only becoming evident after several days of treatment.

Contact your doctor if you experience blurred vision or other visual disturbances.
Children
The use of AEROLID is not recommended in children under 4 years of age.
Other medicines and AEROLID

• Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
• Some medicines may increase the effects of AEROLID, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use AEROLID during the first three months of pregnancy.
Use this medicine after the first three months of pregnancy only if necessary and under direct medical supervision.
Breastfeeding
If you are breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.
Driving and using machines
There are no data available to determine the effects of AEROLID on the ability to drive vehicles or operate machinery.

3. How to use AEROLID

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Method of administration: Use AEROLID with electric nebulizers and do not dilute it. The use of nebulizers may result in residual medication adhering to the walls or bottom of the ampoule, and thus not being delivered. Take this into account during the preparation phase of the medication.

The recommended dose in adults is one single-dose container of AEROLID twice daily.

If you take more AEROLID than you should
If you (or someone else) have taken an excessive dose of AEROLID, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.

In case of excessive administration of this medicine within a short period of time, hormonal disturbances may occur due to suppression of the connection between the brain and the adrenal glands (suppression of hypothalamic-pituitary-adrenal function).

Take this leaflet, the vial, and its packaging with you to the hospital or doctor so they know which medicine has been taken.

If you forget to use AEROLID
Do not take a double dose to make up for the missed dose.

If you stop using AEROLID
Do not stop treatment with this medicine abruptly. Before stopping treatment, consult your doctor, who will advise you on how to gradually reduce the dosage.

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 everybody gets them.
Talk to your doctor if you experience any of the following side effects:
Some patients have developed cough, hoarseness, and mild, transient burning of the nasal mucosa.
Fungal infections (caused by fungi) in the mouth or throat have rarely been observed.
Other observed side effects include: nasal irritation, epistaxis (nosebleeds), nasal congestion, rhinorrhea (runny nose), and sore throat.
The most commonly reported side effect has been the occurrence of nasal congestion and nasal polyps.
With prolonged treatment, systemic manifestations may occur: osteoporosis (a disease causing weakening of the bones), peptic ulcer (stomach lesion), hypotension (reduced blood pressure), and weight loss due to adrenal insufficiency (caused by impaired function of a type of gland).
Psychiatric disorders have also been reported, such as: psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, and behavioural disorders (mainly in children).
Blurred vision and hiccup have been reported with unknown frequency.

Reporting of side effects
If you get any side effects, 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 www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store AEROLID

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store the product in its original packaging to protect it from light.
The shelf life after first opening of the single-dose container is 12 hours. Discard any unused medicine.
Single-dose vials kept outside the protective pouch can be stored for up to 3 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What AEROLID contains
The active substance is flunisolide. 1 ml of solution contains 1 mg of flunisolide.
The other components are: propylene glycol, sodium chloride, water for injections.
Description of the appearance of AEROLID and contents of the pack
Pack containing 30 single-dose containers of 1 mg/1 ml.
Marketing Authorization Holder
PIAM FARMACEUTICI S.p.A., Via Fieschi, 8 – 16121 Genoa
Manufacturer
GENETIC S.p.A. – Contrada Canfora - Fisciano (SA)