Pulmist

Package leaflet: Information for the patient

PULMIST Jet 250 micrograms/dose inhalation suspension

Flunisolide
Generic medicine
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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PULMIST is and what it is used for

PULMIST contains the active substance flunisolide.
Flunisolide belongs to a group of medicines called anti-asthmatic glucocorticoids, which have a pronounced action against allergies and inflammatory conditions.
PULMIST is indicated for the control of the progression of asthma and conditions involving bronchial narrowing known as bronchostenosis.

2. What you need to know before taking PULMIST

Do not take PULMIST

• If you are allergic (hypersensitive) to flunisolide or to any of the other ingredients of this medicine listed in section 6.
• If you have a medical condition known as pulmonary tuberculosis, whether active or latent.
• If you have local viral infections. Do not administer PULMIST to children under six years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking PULMIST

• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are already being treated systemically with medications belonging to the class of corticosteroids. Your doctor will closely monitor your response to therapy, instructing you to initially take PULMIST concomitantly and then gradually reduce the systemic corticosteroid treatment. During periods of stress or severe asthma attack, your doctor may recommend additional systemic steroid therapy and will subject you to frequent tests to assess the function of your adrenal glands.
• If you are experiencing an acute respiratory crisis, do not use PULMIST JET, as flunisolide is a maintenance treatment (i.e. to be taken continuously and not on an as-needed basis) in asthma therapy, and therefore must be taken regularly at the prescribed doses for as long as your doctor deems necessary.

Prolonged use of PULMIST may cause:

• sensitization phenomena (i.e. administration of a given dose of the drug may produce a greater effect than that obtained after the first administration) and the classic systemic adverse effects expected with this medicine. In such cases, contact your doctor, who will advise you on the most appropriate treatment.
• when taken at high doses and by inhalation (through the upper airways), although with lower probability than with oral corticosteroids, the onset of the following adverse effects: Cushing's syndrome (a condition resulting from excess glucocorticoid hormones in the bloodstream) and Cushingoid appearance (characteristic of individuals affected by this syndrome); impaired adrenal gland function, growth retardation in children and adolescents, decreased bone mineral density, cataract, glaucoma, and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children). It is therefore important that you take the lowest possible dose of inhaled corticosteroids that is effective for adequate asthma control. See section 4 for further information.

Pay particular attention if any of the following situations occur.

• Increasing the dose of PULMIST does not improve the therapeutic efficacy of the product and increases the risk of developing adverse effects; therefore, do not take a higher dose of PULMIST than recommended.
• If you experience non-specific symptoms including loss of appetite, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, or specific symptoms such as decreased blood sugar levels with reduced consciousness and/or seizures. Inform your doctor, as these may be symptoms of a severe and intense adrenal crisis (impaired adrenal function). Very rare cases of acute adrenal crises have been reported in adolescents exposed to doses higher than recommended (approximately 1000 mcg/day) for prolonged periods (several months or years). Trauma, surgery, infections, and rapid dose reduction may be predisposing factors for such a crisis. Therefore, if you are receiving high doses of PULMIST, your doctor will keep you under close surveillance and may consider gradually reducing the dose and monitoring your adrenal gland function.
• It is important to use the inhaler correctly to allow the drug to penetrate into the bronchi and act as effectively as possible at the local level. Children Do not give PULMIST to children under 6 years of age (see "Do not take PULMIST"). For those engaged in sports activities: The use of PULMIST without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Other medicines and PULMIST
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of PULMIST, 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, planning a pregnancy, or breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.
The use of flunisolide during pregnancy and breastfeeding is not recommended. Use during pregnancy or breastfeeding should only occur under the direct guidance of your doctor, who will assess whether the potential benefits outweigh the possible risks.

Driving and using machines
PULMIST does not impair the ability to drive vehicles or operate machinery.

3. How to take PULMIST

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
2 spray-doses 2–4 times daily.
Children (6 to 14 years)
1–2 spray-doses twice daily.
For optimal results, the medication must be used regularly.
Use in children
The use of PULMIST in children under 6 years of age is not recommended.
INSTRUCTIONS FOR USE
The JET device has been designed to improve the efficiency of a standard spray inhaler and to
facilitate patient adherence to therapy (especially in elderly patients and children) who have poor
familiarity with inhalation techniques, thereby eliminating the need for precise coordination between
the actuation and inhalation phases.
When using the device, carefully follow the instructions below:

1. JET in closed position.
2. Remove the protective cap from the JET and hold as shown in the figure.
3. Shake vigorously without pressing the canister.
4. Breathe out fully, then place the mouthpiece between tightly closed lips.
5. Press with your index finger on the pressurized container and inhale deeply; continue inhaling even
   for a few seconds afterward (you may also perform several inhalations through the JET).
6. After completing inhalation, hold your breath as long as possible, then close the JET with the
   protective cap.
7. The JET must be kept clean: clean it with lukewarm water after removing the pressurized canister.

If you take more PULMIST than you should
If an excessive dose of PULMIST has been administered, immediately reduce the dosage and inform
your doctor or go to the nearest hospital.
Administration of large amounts of flunisolide within a short period of time may impair the function of
the hypothalamus, pituitary gland, and adrenal glands (the hypothalamic-pituitary-adrenal axis).
If you forget to take PULMIST
Use the product regularly. If you forget to take a dose of PULMIST, do not take a double dose to make
up for the missed dose.
If you stop taking PULMIST
Do not stop treatment with this medicine unless instructed by your doctor. For optimal results, the
medication must be used regularly.
If you have any questions 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 gets them.
The following side effects have been reported with the use of flunisolide. If you experience any of
the following side effects severely, stop treatment with PULMIST and inform your doctor immediately:

• nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhoea);
• voice changes (hoarseness), irritation of the mouth or throat.

Other side effects that may occur with PULMIST are:

• Localized fungal infections (candidiasis): these may occasionally appear in the oral cavity and resolve rapidly with local antifungal treatment without discontinuing therapy. The occurrence of such fungal infections may be minimized by regularly rinsing the mouth after each administration.
• Cough and irritation of the upper respiratory tract: particularly in particularly sensitive patients after inhalation of the aerosol.
• Nasal congestion and nasal polyps. These side effects are most commonly observed in patients receiving corticosteroid therapy and are a consequence of reduced systemic therapy. Such patients should nevertheless be kept under close monitoring during prolonged treatment in order to promptly detect any possible onset of systemic manifestations such as bone disease (osteoporosis), gastrointestinal lesions (peptic ulcer), impairment of adrenal gland function leading to low blood pressure and weight loss.

The following side effects may occur with long-term use of high doses of flunisolide:

• Impairment of adrenal function;
• growth retardation in children and adolescents;
• reduction in bone mineral density;
• eye disorders such as cataract and glaucoma.

Other side effects that may occur with flunisolide, with unknown frequency (frequency cannot be estimated from the available data):

• psychiatric adverse events including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioural disorders (particularly in children).

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 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 PULMIST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product stored in its original intact packaging and properly stored.
Do not pierce the pressurised container.
Keep the container, even when empty, away from heat sources and direct sunlight. Do not freeze. Do not store above 30°C.
Do not dispose of any medicine 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 PULMIST contains
The active substance is flunisolide.
One pressurized container contains flunisolide hemihydrate equivalent to 50 mg of flunisolide. One spray dose delivers 250 micrograms of flunisolide.
The other components are: sorbitan trioleate, trichloromonofluoromethane, dichlorodifluoromethane, peppermint flavour, soybean lecithin.

Description of the appearance of PULMIST and the contents of the pack
PULMIST JET is a pressurized suspension for inhalation with a spacer-delivery device, sufficient for 200 actuations.
PULMIST JET is available in a cardboard pack containing one aluminum monobloc pressurized container with a metering valve designed to operate in the inverted position, and a Jet spacer-delivery device made of polypropylene with a snap-on protective cap.

Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani 22
00071 Pomezia (Rome)
Italy

MANUFACTURER
CHIESI FARMACEUTICI S.p.A.
Via S. Leonardo, 96 A
43122 Parma
Italy

Patient Information Leaflet

PULMIST 250 micrograms pressurized suspension for inhalation

Flunisolide
Equivalent medicine
Please 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, 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:

1. What PULMIST is and what it is used for
2. What you need to know before using PULMIST
3. How to use PULMIST
4. Possible side effects
5. How to store PULMIST
6. Package contents and other information

1. What PULMIST is and what it is used for

PULMIST contains the active substance flunisolide.
Flunisolide belongs to a group of medicines called anti-asthmatic glucocorticoids, which have a marked action against allergies and inflammatory conditions.
PULMIST is indicated for the control of asthma progression and for conditions involving bronchial narrowing known as bronchostenosis.

2. What you need to know before taking PULMIST

Do not take PULMIST

• If you are allergic (hypersensitive) to flunisolide or to any of the other ingredients of this medicine listed in section 6.
• If you have a condition known as pulmonary tuberculosis, whether active or latent.
• If you have local viral infections. Do not administer PULMIST to children under six years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking PULMIST

• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are already receiving systemic treatment with corticosteroid medicines. Your doctor will closely monitor your response to therapy and may instruct you to initially take PULMIST concomitantly while gradually reducing your systemic corticosteroid treatment. During periods of stress or severe asthma attack, your doctor may recommend additional systemic steroid therapy and will perform frequent tests to assess the function of your adrenal glands.
• If you are experiencing a respiratory crisis, do not use PULMIST, as flunisolide is intended for maintenance treatment (i.e., taken continuously and not on an as-needed basis) in asthma therapy. Therefore, it must be taken regularly at the prescribed doses for as long as your doctor deems necessary.

Prolonged use of PULMIST may cause:

• sensitization phenomena (i.e., administration of a given dose of the drug may produce a greater effect than observed after the first dose) and the classic systemic adverse effects associated with this medicine. In such cases, contact your doctor, who will advise you on the most appropriate therapy.
• when taken at high doses and by inhalation (through the upper airways), although with lower probability compared to oral corticosteroid treatment, the following adverse effects may occur: Cushing's syndrome (a condition resulting from excess glucocorticoid hormones in the bloodstream) and Cushingoid appearance (characteristic of individuals affected by this syndrome); impaired adrenal gland function, growth retardation in children and adolescents, reduced bone mineral density, cataract, glaucoma, and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children). It is therefore important that you take the lowest possible dose of inhaled corticosteroids effective for adequate asthma control. See section 4 for further information.

Pay special attention if any of the following situations occur.

• Increasing the dose of PULMIST does not improve the therapeutic efficacy of the product and increases the risk of developing adverse effects. Therefore, do not take a higher dose of PULMIST than recommended.
• If you experience non-specific symptoms such as loss of appetite, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, or specific symptoms such as decreased blood sugar levels leading to reduced consciousness and/or seizures. Inform your doctor immediately, as these may be signs of a severe and acute adrenal crisis (impaired adrenal function). Very rare cases of acute adrenal crises have been reported in adolescents exposed to doses higher than recommended (approximately 1000 mcg/day) for prolonged periods (several months or years). Trauma, surgery, infections, and rapid dose reduction may be predisposing factors for such a crisis. Therefore, if you are receiving high doses of PULMIST, your doctor will closely monitor you and consider gradually reducing the dose and monitoring your adrenal gland function.
• It is important to use the inhaler correctly to allow the drug to reach the bronchi and act as effectively as possible at the targeted site.

Children
Do not give PULMIST to children under 6 years of age (see "Do not take PULMIST").
For those engaged in sports
The use of PULMIST without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and PULMIST
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of PULMIST, 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of flunisolide during pregnancy and breastfeeding is not recommended. Use during pregnancy or breastfeeding should only occur under the direct guidance of your doctor, who will assess whether the potential benefits outweigh the possible risks.
Driving and using machines
PULMIST does not impair the ability to drive vehicles or operate machinery.

3. How to take PULMIST

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
2 sprays 2–4 times daily.
Children (6 to 14 years of age)
1–2 sprays twice daily.
For optimal results, the medicine must be used regularly.
Use in children
The use of PULMIST is not recommended in children under 6 years of age.
INSTRUCTIONS FOR USE

1. Remove the protective cap;
2. Hold the inhaler between thumb and index finger, with the mouthpiece facing downward, as shown in
   figure;
3. Shake vigorously without pressing;
4. Place the mouthpiece between closed lips and breathe out fully;
5. Inhale slowly and deeply through the mouth only, while pressing once with the index finger.
   After completing the inhalation, hold your breath as long as possible. After finishing the inhalations,
   replace the protective cap over the mouthpiece. The mouthpiece must always be kept clean. Cleaning should
   be performed with lukewarm water, after removing the pressurized container.

If you use more PULMIST than you should
If you accidentally use too much PULMIST, immediately reduce the dosage and inform your
doctor or go to the nearest hospital.
Administration of large doses of flunisolide over a short period of time may impair the function of the hypothalamus, pituitary, and adrenal glands (the hypothalamic-pituitary-adrenal axis).
If you forget to take PULMIST
Use the product regularly. If you forget a dose, do not take a double dose to make up for the missed one.
If you stop using PULMIST
Do not stop treatment with this medicine unless instructed by your doctor. For optimal results, the medicine must be used regularly.
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 gets them.
The following side effects have been reported with the use of flunisolide. If you experience any of
the following side effects severely, stop treatment with PULMIST and contact your doctor immediately:

• nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea);
• voice changes (hoarseness), irritation of the mouth or throat. Other side effects that may occur with PULMIST are:
• Localized fungal infections (candidiasis): these may occasionally appear in the oral cavity and resolve rapidly with local antifungal therapy without discontinuing treatment. The occurrence of such fungal infections may be minimized by regularly rinsing the mouth after each administration.
• Cough and irritation of the upper respiratory tract: particularly in particularly sensitive patients after inhalation of the aerosol.
• Nasal congestion and nasal polyps. These side effects are most commonly observed in patients receiving corticosteroid therapy and are a consequence of reduced systemic therapy. Such patients should nevertheless be kept under close monitoring during prolonged treatment to promptly detect any possible systemic manifestations such as bone disease (osteoporosis), gastrointestinal lesions (peptic ulcer), impaired function of the adrenal gland leading to low blood pressure and weight loss.

The following side effects may occur with long-term use of high doses of flunisolide:

• Impairment of adrenal function;
• Growth retardation in children and adolescents;
• Reduced bone mineral density;
• Eye disorders such as cataract and glaucoma.

Other side effects that may occur with flunisolide with unknown frequency (frequency cannot be estimated from the available data):

• psychiatric adverse events including psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural disturbances (particularly in children).

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 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 PULMIST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, stored correctly.
Do not pierce the pressurised container.
Keep the container, even when empty, away from heat sources and direct sunlight. Do not freeze. Do not store above 30°C.
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 PULMIST contains
The active substance is flunisolide.
One pressurized container contains flunisolide hemihydrate equivalent to 50 mg of flunisolide.
Each actuation delivers 250 micrograms of flunisolide.
The other ingredients are: sorbitan trioleate, trichlorofluoromethane, dichlorodifluoromethane,
peppermint flavour, soybean lecithin.

Description of the appearance of PULMIST and the contents of the pack
PULMIST 250 micrograms is a pressurized suspension for inhalation, sufficient for at least 200 actuations.
PULMIST is available in a cardboard pack containing a single-piece aluminum pressurized container, equipped with a metering valve operating in inverted mode, and an actuator with a snap-on protective cap.

Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani 22
00071 Pomezia (Roma)
Italy

MANUFACTURER
CHIESI FARMACEUTICI S.p.A.
Via S. Leonardo, 96 A
43122 Parma
Italy

Patient Information Leaflet

PULMIST Adults 2mg/2ml nebulizer solution, Children 1mg/2ml nebulizer solution

Flunisolide
Generic medicine
Please read 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, 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 side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PULMIST is and what it is used for
2. What you need to know before taking PULMIST
3. How to take PULMIST
4. Possible side effects
5. How to store PULMIST
6. Package contents and other information

1. What PULMIST is and what it is used for

PULMIST contains the active substance flunisolide.
Flunisolide belongs to a group of medicines called anti-asthmatic glucocorticoids which have a pronounced action against allergies and inflammatory conditions.
PULMIST is indicated for the treatment of allergic diseases of the upper respiratory tract such as bronchial asthma, chronic bronchitis of asthmatic type, and chronic and seasonal irritations/inflammations of the nasal mucosa (rhinitis).

2. What you should know before taking PULMIST

Do not take PULMIST

• If you are allergic (hypersensitive) to flunisolide, to substances chemically closely related, or to any of the other ingredients of this medicine listed in section 6.
• If you have a condition known as pulmonary tuberculosis, whether active or quiescent.
• If you have untreated fungal, bacterial, or viral infections.

Warnings and precautions
Talk to your doctor or pharmacist before taking PULMIST

• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding");
• if you are already receiving systemic treatment with corticosteroid medicines. Your doctor will closely monitor your response to therapy, advising you to initially take PULMIST concomitantly while gradually reducing your systemic corticosteroid treatment. During periods of stress or severe asthma attack, your doctor may recommend additional systemic steroid therapy and will perform frequent tests to assess the function of your adrenal glands.

Prolonged use of PULMIST may cause:

• sensitization phenomena (i.e., administration of a given dose of the drug may produce a greater effect than that observed after the first administration) and the typical systemic side effects expected with this medicine. In such cases, contact your doctor, who will advise you on the most appropriate treatment.
• when taken at high doses and by inhalation (through the upper airways), although with lower probability compared to oral corticosteroid treatment, the onset of the following adverse effects: Cushing's syndrome (a condition resulting from excess glucocorticoid hormones in the bloodstream) and Cushingoid appearance (characteristic of individuals affected by this syndrome); impaired adrenal gland function, growth retardation in children and adolescents, decreased bone mineral density, cataract, glaucoma, and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children). It is therefore important that you take the lowest possible dose of inhaled corticosteroids effective for adequate asthma control. See information provided in section 4. Pay particular attention to the following potential situations:
• Increasing the dose does not improve the therapeutic efficacy of the product and increases the risk of developing adverse effects. Do not take a higher dose of PULMIST than the one recommended.

Children
Do not give PULMIST to children under 4 years of age, as there is insufficient experience in this population.
For those engaged in sports
The use of PULMIST without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and PULMIST
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of PULMIST, 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of flunisolide is not recommended during the first three months of pregnancy. Its use during the second and third trimesters of pregnancy and during breastfeeding should occur only under the direct guidance of your doctor, who will evaluate whether the potential benefits outweigh the possible risks.

Driving and using machines
PULMIST does not impair the ability to drive vehicles or operate machinery.

3. How to take PULMIST

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
Half the contents of a single-dose container (1 ml) of PULMIST Adults 2mg/2ml solution for
nebulization twice daily.
Children
Half the contents of a single-dose container (1 ml) of PULMIST Children 1mg/2ml solution for
nebulization twice daily.
The onset of effect is not immediate. Use the product regularly and for several days as prescribed
by your doctor.
The single-dose containers are marked at half-dose level.
Use in children
The use of PULMIST is not recommended in children under 4 years of age.
INSTRUCTIONS FOR USING THE SINGLE-DOSE CONTAINER
To use the single-dose container, perform the following steps:

1. Bend the single-dose container in both directions (see fig. A).
2. Detach the single-dose container from the strip, first at the top and then at the center (see fig. B).
3. Open the single-dose container by twisting the cap (see fig. C).
4. Apply moderate pressure on the walls of the single-dose container to dispense the prescribed
   amount of medication (see fig. D).
5. If using half the dose, the container can be reclosed by flipping and pressing the cap (see fig. E).
   The remaining solution should be used within 24 hours.

PULMIST must be used with electric nebulizers, both for outpatient and home use.
Its use with ultrasonic nebulizers is not recommended, as there is a risk of overheating.
The solution should be used undiluted. After nebulization, a small amount of solution may remain adhering to the walls or bottom of the vial and cannot be administered; this should be taken into account when evaluating the administered dose.
If you take more PULMIST than you should
In case of excessive dosing with PULMIST nebulizing solution, immediately reduce the dosage and contact your doctor or go to the nearest hospital.
Administration of large amounts of flunisolide within a short period of time may impair hypothalamic, pituitary, and adrenal function (the hypothalamic-pituitary-adrenal axis).
If you forget to take PULMIST
Use the product regularly and for several days as prescribed by your doctor. If you forget to use PULMIST, do not take a double dose to make up for the missed dose.
If you stop taking PULMIST
Do not stop treatment with this medicine unless instructed by your doctor. The onset of effect is not immediate. Use the product regularly and for several days as prescribed by your doctor.
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 everyone experiences them.
No serious adverse effects have been reported following the use of this product at the recommended doses.
The following side effects have been reported with the use of flunisolide. If you experience any of the
following side effects in a severe form, stop treatment with PULMIST and inform your doctor immediately:

• nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea);
• voice changes (hoarseness), irritation of the oral cavity or throat.

Other side effects that may occur with PULMIST include:

• Localized fungal infections (candidiasis): these may occasionally appear in the oral cavity and resolve rapidly with local antifungal treatment without discontinuing therapy. The occurrence of such fungal infections may be minimized by regularly rinsing the mouth after each administration.
• Cough and irritation of the upper respiratory tract: particularly in particularly sensitive patients following inhalation of the aerosol.
• Mild and transient burning sensation of the nasal mucosa.
• Nasal congestion and nasal polyps. These side effects are most commonly observed in patients undergoing treatment with corticosteroid drugs and are a consequence of reduced systemic therapy. Such patients should nevertheless be kept under close medical supervision during prolonged treatment in order to promptly detect any possible systemic manifestations, such as bone disease (osteoporosis), gastrointestinal lesions (peptic ulcer), impairment of adrenal gland function leading to low blood pressure and weight loss.

The following side effects may occur with long-term use of high doses of flunisolide:

• Impairment of adrenal function;
• Growth retardation in children and adolescents;
• Reduced bone mineral density;
• Eye disorders such as cataract and glaucoma.

Other side effects that may occur with flunisolide with frequency Not Known (frequency cannot be estimated from the available data):

• psychiatric adverse events including psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural disturbances (particularly in children).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may 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 PULMIST

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
The opened single-dose container should be used within 24 hours of opening.
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 PULMIST contains
The active substance is flunisolide.
100 ml of solution of PULMIST Adults 2 mg/2 ml nebulising solution contains 100 mg of
flunisolide.
100 ml of solution of PULMIST Children 1 mg/2 ml nebulising solution contains 50 mg of
flunisolide.
The other components are: propylene glycol, sodium chloride, citric acid, sodium citrate, water for
injections.

Description of the appearance of PULMIST and contents of the pack
PULMIST is a solution for nebulisation.
It is available in cardboard packs containing 15 or 20 unit-dose containers of 2 ml, graduated at half-dose and resealable.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani 22
00071 Pomezia (Rome)
Italy

MANUFACTURER
Genetic S.p.A.
Contrada Canfora, Nucleo Industriale
84084 Fisciano (SA)
Italy