AEROLID 0.1% Раствор для небулайзера

Содержание инструкции

1. What is AEROLID 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. Package Contents and Other Information
7. What is AEROLID and what it is used for
8. What you need to know before using AEROLID
9. How to use AEROLID
10. Possible side effects
11. How to store AEROLID
12. Contents of the pack and other information

AEROLID 0.1% solution for nebulization
Flunisolide

Read this leaflet carefully before using 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 they have the same symptoms as you, 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 AEROLID is and what it is used for
• 2. What you need to know before you use 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 is AEROLID and what it is used for

This medicine contains the active ingredient flunisolide, which belongs to a group of medicines
called anti-inflammatory steroid 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 difficulty in breathing);
• 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 any of the other ingredients of this medicine (listed in section 6);
• if you have a lung infection (active or inactive 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
Consult your doctor or pharmacist before using AEROLID
Avoid using this medicine for prolonged periods and at high doses because adverse effects may occur
such as Cushing's syndrome (a condition caused by excessive production of a hormone, cortisol), Cushingoid
appearance (characterised by localised obesity predominantly in the abdomen, face and back), mucosal
problems (atrophy), adrenal insufficiency (inability of the adrenal glands to produce a sufficient amount of
cortisol), growth retardation in children and adolescents, bone fragility, eye problems (cataract and glaucoma),
hyperactivity, sleep disorders, anxiety, depression, aggression (especially in children) (see “Possible side
effects”).
If you use AEROLID for prolonged periods, allergic reactions (sensitisation phenomena) may also occur.
Stop treatment if you experience any of these effects and do not exceed the recommended doses.
This medicine may mask the symptoms of infections and may cause new infections to occur.
Pay particular attention in the following cases:

• if you need to switch from systemic corticosteroid therapy to treatment with flunisolide, especially if you are in a period of stress or have 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 strict medical supervision. Your doctor will indicate the dose and method of administration to switch 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 come into contact with the mucosa;
• if you have a lung infection (active or inactive tuberculosis infections) or have an infection not cured by fungi, bacteria or viruses or have an eye infection caused by the Herpes simplexvirus. Consult your doctor as, in these cases, it may be advisable to avoid using this medicine;
• if you have or have had nasal trauma in the past, with lesions of the nasal septum or continuous bleeding (epistaxis), as this medicine delays wound healing (scarring processes);
• if you develop an alteration of the bacteria (flora) present in the airways (dysmicrobism) during treatment. Consult your doctor as coverage therapy may be necessary;
• if you have an asthma attack in progress, as the medicine is not effective because its effect only manifests after a few 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

• Tell your doctor if you are taking or have recently taken any other medicines, including over-the-counter medicines.
• Some medicines may increase the effects of AEROLID and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not use AEROLID in 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 operating machinery
No data are available to establish the effects of AEROLID on the ability to drive vehicles and operate machinery.

3. How to use AEROLID

Use this medicine following the instructions of your doctor or pharmacist exactly. 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 determine the production of residues of the medicine that may adhere to the walls
of the vial or to the bottom and therefore not be delivered. Therefore, take this into consideration during the phase of
preparation of the medicine.
The recommended dose in adults is 1 mg (25 drops) 2 times a day.

Use in children
The recommended dose is 500 micrograms (12-13 drops) 2 times a day.

If you take more AEROLID than you should
If you (or someone else) have taken an excessive dose of AEROLID or if you think a child may have
taken this medicine, inform your doctor immediately or go to the Emergency Room of the nearest
hospital.
In case of an excessive administration of this medicine, in a short period of time, hormonal disorders may occur due to a block of the connection between the brain and the adrenal glands (suppression
of the hypothalamic-pituitary-adrenal function).
Bring this leaflet, the vial and its container to the hospital or doctor so they know
which medicine was taken.

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

If you stop using AEROLID
Do not abruptly stop treatment with this medicine. Before stopping treatment, consult your doctor who will tell you how to reduce the dosage gradually.
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.
Contact your doctor if you experience any of the following side effects:
Some patients have experienced mild and transient cough, hoarseness and burning of the nasal mucosa.
Rarely, fungal infections (caused by fungi) have been observed in the mouth or throat.
Other side effects observed are: nasal irritation, epistaxis (nose bleeding), nasal congestion,
rhinorrhea (runny nose) and sore throat.
The most common side effect found was the appearance of nasal congestion and nasal polyps.
In case of prolonged treatments, systemic manifestations may occur: osteoporosis (disease
that causes weakening of the bones), peptic ulcer (lesion of the stomach), hypotension (reduction
of blood pressure) and weight loss due to adrenal insufficiency (due to altered
function of a type of gland).
In addition, psychiatric disorders such as: psychomotor hyperactivity, sleep disorders, anxiety,
depression, aggression, behavioral disorders (mainly in children) have been reported.
Blurred vision and hiccups have been reported with unknown frequency.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging. The expiry date refers to
the last day of that month.
Store at a temperature not exceeding 25 °C. Keep the product in the original packaging to
protect it from light.
Use this medicine within 30 days of first opening the bottle.
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. Package Contents and Other Information

What AEROLID contains
The active ingredient is flunisolide. 100 ml of solution contains 100 mg of flunisolide (1 drop contains 40
micrograms of flunisolide).
The other ingredients are: propylene glycol, sodium chloride, purified water.

Description of the appearance of AEROLID and package contents
Package containing a 30 ml bottle.

Marketing Authorisation Holder
PIAM Farmaceutici S.p.A. – Via Fieschi, 8 – 16121 Genova

Manufacturers
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)

AEROLID 1 mg/1 ml solution for nebulisation
Flunisolide

Read this leaflet carefully before you start using 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 you get any side effects, even those not listed in this leaflet, tell 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 you use AEROLID
• 3. How to use AEROLID
• 4. Possible side effects
• 5. How to store AEROLID
• 6. Package Contents and Other Information

1. What is AEROLID and what it is used for

This medicine contains the active ingredient flunisolide, which belongs to a group of medicines
called anti-inflammatory steroid 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 difficulty in breathing);
• 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 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 “Pregnancy and breastfeeding” section).

Warnings and precautions
Talk to your doctor or pharmacist before using AEROLID.
Avoid using this medicine for prolonged periods and at high doses because undesirable effects may occur
such as Cushing's syndrome (a condition caused by excessive production of a hormone, cortisol), Cushingoid
appearance (characterised by localised obesity predominantly in the abdomen, face and back), problems with the
mucous membranes (atrophy), adrenal insufficiency (inability of the adrenal glands to produce a sufficient
amount of 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” section).
If you use AEROLID for prolonged periods, allergic reactions (sensitisation phenomena) may also occur.
Stop treatment if you experience any of these effects and do not exceed the recommended doses.
This medicine may mask the symptoms of infections and may cause new infections to occur.
Pay particular attention in the following cases:

• if you need to switch from systemic corticosteroid therapy to treatment with flunisolide, especially if you are in a
  period of stress or if you have 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 strict medical supervision. Your doctor will indicate the dose and method of administration
  to switch 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 come into contact with the
  mucosa;
• if you have a lung infection (active or quiescent tuberculosis infections) or have an infection not treated by fungi,
  bacteria or viruses or have an eye infection caused by the Herpes simplexvirus. Consult your doctor as, in these
  cases, it may be advisable to avoid using this medicine;
• if you have or have had nasal trauma in the past, with lesions of the nasal septum or continuous bleeding (epistaxis),
  as this medicine delays wound healing (cicatricial processes);
• if you experience an alteration of the bacteria (flora) present in the respiratory tract (dysmicrobism) during treatment.
  Consult your doctor as covering therapy may be necessary.
• if you are having an asthma crisis, as the medicine is not effective because its effect only manifests after a few days
  of treatment;

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

Other medicines and AEROLID

• Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a
  prescription.
• Some medicines may increase the effects of AEROLID and your doctor may want to monitor you closely if you are
  taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your
doctor or pharmacist for advice 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
No data are available to establish the effects of AEROLID on the ability to drive and operate machines.

3. How to use AEROLID

Use this medicine following the instructions of your doctor or pharmacist exactly. 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 determine the production of residue of the medicine that may adhere to the walls
of the vial or to the bottom and therefore not be delivered. Therefore, take this into consideration during the phase of
preparation of the medicine.
The recommended dose in adults is one single-dose container of AEROLID 2 times a day.

If you take more AEROLID than you should
If you (or someone else) have taken an excessive dose of AEROLID or if you think a child may have
taken this medicine, immediately inform your doctor or go to the Emergency Room of the nearest
hospital.
In case of an excessive administration of this medicine, in a short period of time, hormonal disorders may occur due to a block of the connection between the brain and the adrenal glands (suppression
of the hypothalamic-pituitary-adrenal function).
Bring this leaflet, the vial and its container with you to the hospital or to the doctor so that they know
which medicine was taken.

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

If you stop using AEROLID
Do not abruptly stop treatment with this medicine. Before stopping treatment, consult your doctor who will tell you how to reduce the dosage gradually.
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.
Contact your doctor if you experience any of the following side effects:
Some patients have experienced mild and transient cough, hoarseness and burning of the nasal mucosa.
Rarely, fungal infections (caused by fungi) have been observed in the mouth or throat.
Other side effects observed are: nasal irritation, epistaxis (nose bleeding), nasal congestion,
rhinorrhea (runny nose) and sore throat.
The most common side effect found was the appearance of nasal congestion and nasal polyps.
In case of prolonged treatments, systemic manifestations may occur: osteoporosis (disease
that causes weakening of the bones), peptic ulcer (lesion of the stomach), hypotension (reduction of
blood pressure) and weight loss due to adrenal insufficiency (due to altered function of a
type of gland).
In addition, psychiatric disorders such as: psychomotor hyperactivity, sleep disorders, anxiety,
depression, aggression, behavioral disorders (mainly in children) have been reported.
Blurred vision and hiccups have been reported with an unknown frequency.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 which is 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 the single-dose container is 12 hours. Discard any remaining medicine.
Single-dose vials outside the protective sachet should be stored for up to 3 months.
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 AEROLID contains
The active ingredient is flunisolide. 1 ml of solution contains 1 mg of flunisolide.
The other ingredients 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 Authorisation Holder
PIAM FARMACEUTICI S.p.A., Via Fieschi, 8 – 16121 Genova

Manufacturer
GENETIC S.p.A. – Contrada Canfora - Fisciano (SA)