PULMIST 250 МИКРОГРАММ Прессurized suspension for inhalation

Содержание инструкции

1. PULMIST Jet 250 micrograms/dose suspension for inhalation
   1. What is PULMIST and what is it used for
   2. What you need to know before you take PULMIST
   3. How to take PULMIST
   4. Possible side effects
   5. How to store PULMIST
   6. Contents of the pack and other information
2. PULMIST 250 micrograms pressurised suspension for inhalation
   1. What is PULMIST and what is it used for
   2. What you need to know before you take PULMIST
   3. How to take PULMIST
   4. Possible side effects
   5. How to store PULMIST
   6. Contents of the pack and other information
3. PULMIST Adults 2mg/2ml solution for nebulisation, Children 1mg/2ml solution for nebulisation
   1. What is PULMIST and what is it 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

PULMIST Jet 250 micrograms/dose suspension for inhalation

Flunisolide
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not 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 PULMIST is and what it is used for
• 2.What you need to know before you take 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 is PULMIST and what is it used for

PULMIST contains the active ingredient flunisolide.
Flunisolide belongs to a group of drugs called anti-asthmatic glucocorticoids which exert
a marked action against allergies and inflammatory states.
PULMIST is indicated in the control of the evolution of asthmatic disease and conditions of
narrowing of the bronchi known as bronchostenosis.

2. What you need to know before you take 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 suffer from a disease known as pulmonary tuberculosis, whether active or quiescent.
• If you have contracted 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 drugs belonging to the class of corticosteroids. Your doctor will closely monitor your response to therapy, advising you to take PULMIST initially concomitantly and then gradually reduce systemic corticosteroid treatment. During periods of stress or severe asthma attack, your doctor may advise additional therapy with systemic steroids and will subject you to frequent analysis to assess the functionality of your adrenal gland.
• If you have an ongoing respiratory crisis, do not use PULMIST JET because flunisolide constitutes a background treatment (i.e. to be taken constantly and not as needed) in asthma therapy, and therefore must be taken regularly at the prescribed doses and as long as your doctor deems appropriate.

Prolonged use of PULMIST may cause:

• phenomena of sensitization (i.e. the administration of a given dose of the drug may have a greater effect than that obtained with the first administration) and the classic systemic adverse effects expected for this medicine. In these cases, contact your doctor who will indicate the most appropriate therapy.
• if taken at high doses and by inhalation (through the upper airways), with a lower probability than treatment with oral corticosteroids, the onset of the following adverse effects: Cushing's syndrome (a condition resulting from an excess of glucocorticoid hormones in the bloodstream) and Cushingoid appearance (characteristic of those affected by this syndrome); impairment of adrenal gland activity, growth retardation in children and adolescents, reduction of bone mineral density, cataracts, glaucoma and, more rarely, a series 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 corticosteroid drugs, effective for the actual control of asthma. See section 4.

Pay particular attention in the following situations.

• Increasing the dose of PULMIST does not improve the therapeutic efficacy of the product and increases the risk of developing adverse effects, so do not take a dose of PULMIST higher than the recommended one.
• If you show non-specific symptoms including anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, or specific symptoms such as decreased blood sugar levels with reduced state of consciousness and/or convulsions. Inform your doctor because they 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 those recommended (approximately 1000 mcg/day) for prolonged periods (several months or years). Trauma, surgery, infections and a rapid reduction of the dosage may be predisposing factors for this crisis. Therefore, if you receive high doses of PULMIST, your doctor will closely monitor you and evaluate a gradual reduction of the dose and monitoring of your adrenal gland activity.
• It is important to use the inhaler correctly to allow the drug to penetrate the bronchi and act locally as effectively as possible. ChildrenDo not give PULMIST to children under 6 years of age (see “Do not take PULMIST”). For those who engage in sports The use of PULMIST without therapeutic need constitutes doping and may still result in positive 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 medicines obtained without a prescription.
Some medicines can increase the effects of PULMIST and your doctor may want to keep
you under close observation 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 or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of flunisolide during pregnancy and breastfeeding is not recommended. Use in
pregnancy or breastfeeding should only occur under direct medical supervision 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 following exactly the instructions of 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 a day.
Children (from 6 to 14 years)
1-2 spray-doses 2 times a day.
To obtain good results, the preparation 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 normal spray dispenser and to
facilitate adherence to therapy for patients (especially the elderly and children) with limited familiarity
with inhalation technique, avoiding them the mandatory synchronisation between the delivery phase and that of
inspiration.
When using, follow the following instructions carefully:

• 1) JET in the closed position.
• 2) Remove the protective cap from the JET and hold as shown in the figure.
• 3) Shake vigorously without pressing.
• 4) Perform a complete expiration and then place the mouthpiece between the lips, keeping them tightly closed.
• 5) Press with your index finger on the container under pressure and inhale deeply even after a few moments (you can also perform multiple breaths through the JET).
• 6) Once inhalation is finished, hold your breath for as long as possible and close the JET with the appropriate protective cap.
• 7) The JET must be kept clean: cleaning should be carried out with lukewarm water, after removing the container under pressure.

If you take more PULMIST than you should
In case of administration of excessive doses of PULMIST, immediately reduce the doses and inform your
doctor or go to the nearest hospital.
The administration of large quantities of flunisolide in a short period of time can determine
impairment of the function of the hypothalamus, pituitary and adrenal glands (the hypothalamus-pituitary-adrenal axis).

If you forget to take PULMIST
Use the product regularly. 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 interrupt treatment with the medicine unless your doctor tells you to. To
obtain good results, the preparation must be used regularly

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.

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 immediately inform your doctor:

• nasal irritation, nosebleed (epistaxis), nasal congestion, runny nose (rhinorrhea);
• changes in voice (hoarseness), irritation of the mouth or throat. Other side effects that may occur with PULMIST are:
• Localized fungal infections (candidiasis): can occasionally appear in the oral cavity and regress rapidly after local therapy with antifungals without stopping treatment. The occurrence of such fungal infections can be minimized by rinsing your mouth regularly after each application.
• Cough and irritation of the upper respiratory tract: particularly in patients particularly sensitive after inhalation of the aerosol.
• Nasal congestion and nasal polyps. These side effects are most commonly found in patients undergoing therapy with drugs of a corticosteroid nature, and are a consequence of the reduction of systemic therapy. Such patients should still be kept under strict control in the case of prolonged treatments, in order to promptly ascertain the possible appearance of systemic manifestations such as bone disease (osteoporosis), gastrointestinal lesions (peptic ulcer), impairment of the function of the adrenal gland with consequent lowering of blood pressure and weight loss).

The following side effects may occur in case of use of high doses of flunisolide for long periods:

• Impairment of adrenal function;
• delayed growth in children and adolescents;
• reduction in bone mineral density;
• eye diseases such as cataracts and glaucoma.

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

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

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 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 which is stated on the label after “Exp.”. The
expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not puncture the pressurized container.
Keep the container, even if empty, away from sources of heat and direct sunlight. Do not
freeze. Do not store at a temperature above 30°C.
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 PULMIST contains
The active ingredient is flunisolide.
A pressurized container contains flunisolide hemihydrate equivalent to 50 mg of flunisolide. One
spray-dose delivers 250 micrograms of flunisolide.
The other ingredients are: sorbitan trioleate, trichloromonofluoromethane, dichlorodifluoromethane,
mint flavour, soybean lecithin.

Description of the appearance of PULMIST and contents of the pack
PULMIST JET is a pressurized suspension for inhalation with a spacer device sufficient
for 200 actuations.
PULMIST JET is available in a cardboard pack containing a pressurized container made of
monobloc aluminum, with an inverted-acting metering valve, and a Jet spacer 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 (Roma)
Italy

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

PULMIST 250 micrograms pressurised suspension for inhalation

Flunisolide
Generic medicine

Read this leaflet carefully before you start to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 PULMIST is and what it is used for
• 2.What you need to know before you take 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 is PULMIST and what is it used for

PULMIST contains the active ingredient flunisolide.
Flunisolide belongs to a group of drugs called anti-asthmatic glucocorticoids which exert
a marked action against allergies and inflammatory states.
PULMIST is indicated in the control of the evolution of asthmatic disease and conditions of
narrowing of the bronchi known as bronchostenosis.

2. What you need to know before you take 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 suffer from a disease known as pulmonary tuberculosis, whether active or quiescent.
• If you have contracted 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 undergoing systemic treatment with drugs belonging to the class of corticosteroids. Your doctor will closely monitor your response to therapy, advising you to take PULMIST initially concomitantly and then gradually reduce systemic corticosteroid treatment. During periods of stress or severe asthma attack, your doctor may advise additional therapy with systemic steroids and will subject you to frequent tests to assess the functionality of your adrenal gland.
• If you have an ongoing respiratory crisis, do not use PULMIST as flunisolide constitutes a background treatment (i.e. to be taken constantly and not as needed) for asthma therapy, and therefore must be taken regularly at the prescribed doses and as long as your doctor deems appropriate.

Prolonged use of PULMIST may cause:

• phenomena of sensitization (i.e. the administration of a given dose of the drug may have a greater effect than that obtained with the first administration) and the classic systemic side effects expected for this medicine. In these cases, contact your doctor who will indicate the most appropriate therapy.
• if taken at high doses and by inhalation (through the upper airways), with a lower probability than treatment with oral corticosteroids, the onset of the following side effects: Cushing's syndrome (a condition resulting from an excess of glucocorticoid hormones in the bloodstream) and Cushingoid appearance (characteristic of those affected by this syndrome); impairment of adrenal gland activity, growth retardation in children and adolescents, reduction of bone mineral density, cataracts, glaucoma and, more rarely, a series of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (particularly in children). It is important, therefore, that you take the lowest possible dose of inhaled corticosteroid drugs, effective for the actual control of asthma. See section 4.

Pay particular attention in the following situations.

• Increasing the dose of PULMIST does not improve the therapeutic efficacy of the product and increases the risk of developing side effects, so do not take a dose of PULMIST higher than that recommended.
• If you show nonspecific symptoms including anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, or specific symptoms such as decreased blood sugar levels with reduced state of consciousness and/or convulsions. Inform your doctor as these may be symptoms of a severe and intense adrenal crisis (impairment of adrenal function). Very rare cases of acute adrenal crises have been reported in adolescents exposed to doses higher than those recommended (approximately 1000 mcg/day) for prolonged periods (several months or years). Trauma, surgery, infections and a rapid reduction of the dosage may be predisposing factors to such a crisis. Therefore, if you receive high doses of PULMIST, your doctor will closely monitor you and evaluate a gradual reduction of the dose and monitoring of your adrenal gland activity.
• It is important to use the inhaler correctly to allow the drug to penetrate the bronchi and act locally as effectively as possible.

Children
Do not give PULMIST to children under 6 years of age (see “Do not take PULMIST”).
For athletes
The use of PULMIST without therapeutic necessity constitutes doping and may still
result in positive 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 medicines obtained without a prescription.
Some medicines may increase the effects of PULMIST and your doctor may want to keep
you under close observation 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 or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The use of flunisolide during pregnancy and breastfeeding is not recommended. Use in
pregnancy or breastfeeding should only occur under direct medical supervision who
will assess whether the potential benefits outweigh the possible risks.

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

3. How to take PULMIST

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
2 inhalations 2-4 times a day.
Children (from 6 to 14 years)
1-2 inhalations 2 times a day.
To obtain good results, the preparation must be used regularly

Use in children
The use of PULMIST in children under 6 years of age is not recommended.

INSTRUCTIONS FOR USE

• 1) Remove the protective cap;
• 2) Hold the inhaler between your thumb and index finger, with the mouthpiece at the bottom, as shown in the figure;
• 3) Shake vigorously without pressing;
• 4) Place the mouthpiece between your tightly closed lips and perform a complete exhalation;
• 5) Inhale slowly and deeply through the mouth only, simultaneously press with your index finger once. After inhalation, hold your breath for as long as possible. After the inhalations, close the mouthpiece with the protective cap. The mouthpiece should always be kept clean. Cleaning should be done with warm water, after removing the pressurized container.

If you take more PULMIST than you should
In case of administration of excessive doses of PULMIST, immediately reduce the doses and inform your
doctor or go to the nearest hospital.
The administration of large quantities of flunisolide in a short period of time may determine
impairment of the function of the hypothalamus, pituitary gland and adrenal gland (the hypothalamus-
pituitary-adrenal axis).

If you forget to take PULMIST
Use the product regularly. If you forget to use PULMIST, do not take a double dose
to compensate for the missed dose.

If you stop taking PULMIST
Do not interrupt the treatment with the medicine unless your doctor tells you to. To
obtain good results, the preparation must be used regularly

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.

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 immediately inform your doctor:

• nasal irritation, nosebleed (epistaxis), nasal congestion, runny nose (rhinorrhea);
• changes in voice (hoarseness), irritation of the oral cavity or pharynx. Other side effects that may occur with PULMIST are:
• Localized fungal infections (candidiasis): they can occasionally appear in the oral cavity and rapidly regress after local therapy with antifungals without suspending treatment. The onset of such fungal infections can be minimized by regularly rinsing the mouth after each application.
• Cough and irritation of the upper respiratory tract: particularly in patients particularly sensitive after inhalation of the aerosol.
• Nasal congestion and nasal polyps. These side effects are the most commonly found in patients undergoing therapy with drugs of a corticosteroid nature, and are a consequence of the reduction of systemic therapy. Such patients should still be kept under strict control in case of prolonged treatments, in order to promptly ascertain the possible appearance of systemic manifestations such as bone disease (osteoporosis), gastrointestinal lesions (peptic ulcer), impairment of the function of the adrenal gland with consequent lowering of blood pressure and weight loss.

The following side effects may occur in case of use of high doses of flunisolide for long periods:

• Impairment of adrenal function;
• delayed growth in children and adolescents;
• reduction in bone mineral density;
• eye diseases such as cataracts and glaucoma.

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

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

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 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 which is stated on the label after “Exp.”. The
expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Do not puncture the pressurized container.
Keep the container, even if empty, away from sources of heat and direct sunlight. Do not
freeze. Do not store at a temperature above 30°C.
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 PULMIST contains
The active ingredient is flunisolide.
A pressurised container contains flunisolide hemihydrate equivalent to 50 mg of flunisolide.
One actuation delivers 250 micrograms of flunisolide.
The other ingredients are: sorbitan trioleate, trichlorofluoromethane, dichlorodifluoromethane, mint flavour, soybean lecithin.

Description of the appearance of PULMIST and contents of the pack
PULMIST 250 micrograms is a pressurised suspension for inhalation sufficient for at least
200 actuations.
PULMIST is available in a cardboard pack containing a pressurised aluminium monobloc container, with an inverted-acting metering valve, and an actuator button with a snap-on protective cap.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION 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

PULMIST Adults 2mg/2ml solution for nebulisation, Children 1mg/2ml solution for nebulisation

Flunisolide
Generic medicine

Read this leaflet carefully before you start to take 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 PULMIST is and what it is used for
• 2.What you need to know before you take 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 is PULMIST and what is it used for

PULMIST contains the active ingredient flunisolide.
Flunisolide belongs to a group of drugs called antiasthmatic glucocorticoids which exert
a marked action against allergies and inflammatory states.
PULMIST is indicated in the treatment of allergic conditions of the upper respiratory tract such as bronchial asthma, chronic bronchitis of the asthmatic type and irritations/inflammations of the nasal mucosa
(rhinitis) chronic and seasonal.

2. What you need to know before taking PULMIST

Do not take PULMIST

• If you are allergic (hypersensitive) to flunisolide, to substances closely related chemically, or to any of the other ingredients of this medicine listed in section 6.
• If you suffer from a disease known as pulmonary tuberculosis, whether active or quiescent.
• If you have contracted infections not treated by fungi, bacteria or viruses.

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 drugs belonging to the class of corticosteroids. Your doctor will closely monitor your response to therapy, advising you to take PULMIST initially concomitantly and then gradually reduce systemic corticosteroid treatment. During periods of stress or severe asthma attacks, your doctor may advise additional therapy with systemic steroids and will subject you to frequent tests to assess the functionality of your adrenal gland.

Prolonged use of PULMIST may cause:

• phenomena of sensitization (i.e. the administration of a given dose of the drug may have a greater effect than that obtained with the first administration) and the classic systemic side effects expected for this medicine. In these cases, contact your doctor who will indicate the most appropriate therapy.
• if taken at high doses and by inhalation (through the upper airways), with a lower probability than treatment with oral corticosteroids, the onset of the following side effects: Cushing's syndrome (a condition resulting from an excess of glucocorticoid hormones in the bloodstream) and Cushingoid appearance (characteristic of those affected by this syndrome); impairment of adrenal gland activity, growth retardation in children and adolescents, reduction of bone mineral density, cataracts, glaucoma and, more rarely, a series 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 corticosteroid drugs, effective for effective asthma control. See section 4. Pay particular attention to these possible situations:
• Increasing the dose does not improve the therapeutic efficacy of the product and involves an increased risk of developing side effects. Do not take a higher dose of PULMIST than recommended.

Children
Do not give PULMIST to children under 4 years of age, as there is insufficient experience in this
population.
For athletes
The use of PULMIST without therapeutic necessity constitutes doping and may in any case
result in positive anti-doping tests.

Other medicines and PULMIST
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine, including over-the-counter medicines.
Some medicines may increase the effects of PULMIST and your doctor may want to keep you
under close observation if you are taking these medicines (including some medicines for the
treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The use of flunisolide is not recommended during the first three months of pregnancy. Use in the
second and third trimesters of pregnancy and during breastfeeding should only occur under direct
instruction from 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is:
Adults
Half the contents of a single-dose container (1 ml) of PULMIST Adulti 2mg/2ml solution for

nebulisationtwice a day.
Children
Half the contents of a single-dose container (1 ml) of PULMIST Bambini 1mg/2ml solution for

nebulisationtwice a day.
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 graduated to half the dose.

Use in children
The use of PULMIST in children under 4 years of age is not recommended.

INSTRUCTIONS FOR USE OF THE SINGLE-DOSE CONTAINER
To use the single-dose container, perform the following operations:

• 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 in the middle (see fig. B).
• 3) Open the single-dose container by rotating the flap (see fig. C).
• 4) By exerting moderate pressure on the walls of the single-dose container, release the medicine in the prescribed quantity (see fig. D).
• 5) If using half a dose, the container can be closed by inverting and pressing the cap (see fig. E). The remaining quantity must be used within 24 hours.

PULMIST must be used with electric nebulisers, both for outpatient and home use.
The use with ultrasonic nebulisers is not recommended because there is a risk of overheating.
The solution should be used as is without dilution. At the end of nebulisation, a small part of the
solution adheres to the walls or bottom of the ampoule and cannot be delivered; this should be
taken into account when assessing the administered dose.

If you take more PULMIST than you should
In the event of administering excessive doses of PULMIST solution for nebulisation, reduce
the doses immediately and inform your doctor or go to the nearest hospital.
The administration of large quantities of flunisolide in a short period of time may determine
the impairment of the function of the hypothalamus, pituitary gland and adrenal gland (the hypothalamus-
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 interrupt treatment with the medicine unless your doctor tells you to. The onset of
effect is not immediate. Use the product regularly and for several days as prescribed by your
doctor.

If you have any further questions on 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.
No serious side effects have been reported following use of the 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 severely, stop treatment with PULMIST and immediately inform your doctor:

• nasal irritation, nosebleed (epistaxis), nasal congestion, runny nose (rhinorrhea);
• changes in voice (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 mouth and rapidly resolve after local therapy with antifungals without discontinuing treatment. The occurrence of such fungal infections can be minimized by regularly rinsing the mouth after each application.
• Cough and irritation of the upper respiratory tract: particularly in patients particularly sensitive after inhalation of the aerosol.
• Mild and transient burning sensation of the nasal mucosa.
• Nasal congestion and nasal polyps. These side effects are most commonly found in patients undergoing therapy with drugs of a corticosteroid nature, and are a consequence of the reduction of systemic therapy. Such patients should nevertheless be kept under strict control in the case of prolonged treatments, in order to promptly ascertain the possible appearance of systemic manifestations such as bone disease (osteoporosis), gastrointestinal lesions (peptic ulcer), impairment of the function of the adrenal gland with consequent lowering of blood pressure and weight loss)

The following side effects may occur in case of use of high doses of flunisolide for
long periods:

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

Other side effects that may occur withflunisolide with frequency Not Known (the
frequency cannot be estimated on the basis of available data):

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

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 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 which is stated on the label after “Scad.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
The opened single-dose container must be used within 24 hours of opening.
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 PULMIST contains
The active ingredient is flunisolide.
100 ml of solution of PULMISTAdults 2mg/2ml solution for nebulisationcontains 100 mg of
flunisolide.
100 ml of solution of PULMISTChildren 1mg/2ml solution for nebulisationcontains 50 mg of
flunisolide.
The other ingredients 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 single-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, Industrial Area
84084 Fisciano (SA)
Italy