Citiflux

Package leaflet: Information for the patient

Citiflux 2 mg/2ml nebulising solution, 1 mg/2ml nebulising solution

Flunisolide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Citiflux is and what it is used for

The active substance of Citiflux is flunisolide, a substance belonging to a group of medicines called glucocorticoids.
This medicine is used in the treatment of certain allergic respiratory diseases such as:
bronchial asthma (airway obstruction and breathing attacks)
chronic asthmatic bronchitis (asthma arising from inflammation of the bronchi)
chronic and seasonal rhinitis (inflammation of the nasal mucosa)

2. What you need to know before using Citiflux

Do not use Citiflux

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

Warnings and precautions
Talk to your doctor or pharmacist before using Citiflux.
Exercise particular caution with Citiflux:

• If you have an untreated respiratory infection, such as tuberculosis, caused by viruses, bacteria, or fungi, or an eye infection caused by the herpes simplex virus. In these cases, you should not use this medicine.
• If you currently have or have recently had nasal trauma with a wound (ulcer) on the nasal septum or recurrent nosebleeds (epistaxis), as this medicine may slow wound healing.
• If you use Citiflux for a long time, as this medicine may alter the natural microbial flora of the airways. In such cases, concomitant therapy may be required. Prolonged use of the medicine may also lead to sensitization phenomena and, occasionally, adverse effects (see section “Possible side effects”). If this occurs, stop treatment and consult your doctor to establish appropriate therapy.
• If you use Citiflux for prolonged periods and at high doses (higher than recommended), as it may cause reduced activity of the gland regulating the stress response (adrenal gland) and reduced natural mucosal growth.
• If you are using medicines for respiratory diseases administered by inhalation (inhaled corticosteroids such as Citiflux), as these medicines may cause general adverse effects due to hormonal imbalance. Some of these effects include Cushing's syndrome (excess hormones in the bloodstream), Cushingoid appearance (facial or trunk swelling), adrenal suppression (reduced function of the gland regulating the stress response), growth retardation in children and adolescents, reduced bone mineral density, cataract (loss of transparency of the lens), and glaucoma (damage to the optic nerve). Rarely, a range of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity (restlessness), sleep disturbances, anxiety, depression, aggression, and behavioral disorders (particularly in children).
• If you are switching from systemic steroid therapy, for example oral, to treatment with Citiflux, as alterations in the gland regulating the stress response (adrenal gland) may be present. Generally, systemic treatment should not be stopped abruptly. If you are receiving systemic treatment, you require medical supervision and special precautions, as adrenal function recovery is slow. In this case, your respiratory condition should also be relatively "stabilized" through systemic therapy. Initially, your doctor will instruct you to use Citiflux while continuing systemic treatment, gradually reducing the latter while monitoring adrenal function and adjusting the Citiflux dose according to results. During periods of stress or severe asthma attack, if you have switched from systemic treatment to Citiflux, you will need additional systemic steroid treatment. Furthermore, you should undergo periodic checks of cortico-adrenal function (the gland regulating the stress response), including early morning measurements of cortisol levels (a hormone) under resting conditions.
• If you are on continuous treatment with steroid medicines, as a gradual and controlled transition from oral (by mouth) to topical endobronchial (directly into the bronchi) therapy is advisable.

The effect of Citiflux is not immediate; therefore, it is not effective during acute asthma attacks. Use this medicine regularly for several days.
If your nose is severely congested (blocked) or if you have abundant secretions, your doctor may advise you to first take medicines that resolve these conditions (blocked nose or excessive secretions), so that Citiflux can come into direct contact with the mucous membranes.
The use of Citiflux may mask certain symptoms of infection and may also lead to new infections.
Take the dose as indicated in the package leaflet or as prescribed by your doctor. Do not increase or decrease the dose without first consulting your doctor. Exceeding the recommended doses will not improve the therapeutic efficacy of Citiflux and may result in systemic side effects due to absorption (general adverse effects).
For athletes: Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Children
Exercise caution when using medicines for respiratory diseases administered via inhalation (inhaled corticosteroids such as Citiflux) in children, as these medicines may cause general adverse effects due to hormonal imbalance. Some of these effects include growth retardation in children and adolescents.
Rarely, a range of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity (restlessness), sleep disturbances, anxiety, depression, aggression, and behavioral disorders (see “Possible side effects”).
Citiflux is not recommended for children under 4 years of age.
Other medicines and Citiflux
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Citiflux, 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, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Citiflux is not recommended during the first three months of pregnancy. In the subsequent period and during breastfeeding, use this medicine only when strictly necessary and under direct medical supervision.
Driving and use of machines
No effects on the ability to drive or use machinery are known.
Citiflux contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.

3. How to use Citiflux

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose in adults is: half the contents of one Citiflux 2 mg/2 ml container (equivalent to 1 mg), twice daily.
Use in children: half the contents of one Citiflux 1 mg/2 ml container (equivalent to 0.5 mg), twice daily.
The use of this medicine is not recommended in children under 4 years of age.
Method of administration
Citiflux must be used with electric nebulizers and must not be diluted.
When administering medicinal solutions via electric nebulizers, some residual solution remains, adhering to the vial walls or at the bottom, and is not delivered. Take this into account when preparing the nebulization, and add to the initial dose the amount that remains at the bottom or on the sides of the vial.
If you use more Citiflux than you should
In case of accidental ingestion/overdose of Citiflux, contact your doctor immediately or go to the nearest hospital.
Administration of large amounts of the medicine within a short period of time may lead to suppression of an endocrine gland system that regulates various body functions, including sleep, stress response, appetite, body temperature, and growth. In such a case, return immediately to the recommended dose.
If you forget to use Citiflux
Do not use a double dose to make up for the missed dose.
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.
Common (may affect up to 1 in 10 people)

• Nasal obstruction* (nasal congestion) and nasal polyps* (nodules forming inside the nose). These effects occurred in patients requiring continuous treatment with steroid medicines and are due precisely to the reduction in systemic (continuous) therapy use.
  Rare (may affect up to 1 in 1,000 people)

• Fungal infections of the mouth and throat. These effects resolve rapidly with locally acting medicines and can be completely avoided by thoroughly rinsing the mouth after using Citiflux.

Frequency not known (frequency cannot be estimated from the available data)

• Cough (in patients with highly sensitive airways);
• Mild and transient burning sensation of the nasal mucosa;
• Hiccups;
• Cushing's syndrome (swelling of the face or trunk caused by hormonal imbalance);
• Adrenal suppression/acute hypoadrenalism (suppression of the gland regulating the stress response);
• Growth retardation in children and adolescents;
• Reduced bone mineral density;
• Cataract (blurred vision);
• Blurred vision;
• Glaucoma (damage to the optic nerve caused by increased intraocular pressure);
• Nasal irritation**, nosebleeds** (epistaxis), blocked nose**, nasal discharge** (rhinorrhea);
• Sore throat**, hoarseness** (low, raspy voice), irritation of the mouth and throat**;
• Osteoporosis (loss of bone mass and strength);
• Psychomotor hyperactivity (restlessness, agitation);
• Sleep disorders;
• Anxiety, depression, aggression, behavioural disturbances (mainly in children);
• Peptic ulcer (lesion of the stomach mucosa);
• Signs of secondary cortico-adrenal insufficiency (hormonal imbalance) such as reduced blood pressure (hypotension) and weight loss.

* These adverse effects, typical of corticosteroids administered systemically, occurred only when Citiflux was used improperly.
** If these adverse effects become severe, treatment with Citiflux may need to be discontinued.
Following the instructions provided in this leaflet reduces the occurrence of adverse effects.
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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citiflux

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle after "Exp.".
The expiry date refers to the last day of that month. This date applies to the product in its original, unopened packaging, properly stored.
Store the medicine in its original packaging to protect it from light.
Use the medicine within 12 hours after first opening the container. Discard any remaining medicine.
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 Citiflux contains

• The active substance is flunisolide. One container of Citiflux 2 mg/2 ml nebulising solution contains 2 mg of flunisolide. One container of Citiflux 1 mg/2 ml nebulising solution contains 1 mg of flunisolide.
• The other components are: propylene glycol, sodium chloride, water for injections.

Description of the appearance of Citiflux and contents of the pack
Citiflux is a solution for nebulisation.
Pack: 15 single-dose containers of 2 ml of 2 mg/2 ml solution
Pack: 15 single-dose containers of 2 ml of 1 mg/2 ml solution

Marketing Authorization Holder
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri, 71 – Sanremo (IM)
Manufacturer
Genetic S.p.A. - Contrada Canfora - Fisciano (SA)

Patient information leaflet

Citiflux 100 mg/100 ml nebulizer solution

Flunisolide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Citiflux is and what it is used for

The active substance of Citiflux is flunisolide, a substance belonging to a group of medicines called glucocorticoids.
This medicine is used in the treatment of certain allergic respiratory diseases such as:
bronchial asthma (airway obstruction and breathing attacks)
chronic asthmatic bronchitis (asthma arising from inflammation of the bronchi)
chronic and seasonal rhinitis (inflammation of the nasal mucosa)

2. What you should know before using Citiflux

Do not use Citiflux

• if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6);
• if you have active or quiescent pulmonary tuberculosis (a lung infection caused by active or inactive mycobacteria);
• if you have a bacterial, viral, or fungal infection;
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using Citiflux.
Exercise particular caution with Citiflux:

• If you have an untreated respiratory tract infection, such as tuberculosis, caused by viruses, bacteria, or fungi, or an eye infection caused by the herpes simplex virus. In these cases, you should not use this medicine.
• If you have or have recently had nasal trauma with a wound (ulcer) in the nasal septum or recurrent nosebleeds (epistaxis), as this medicine may slow down wound healing.
• If you use Citiflux for a long period of time, because this medicine may alter the natural microbial flora of the airways. In such cases, additional therapy may be required. Prolonged use of the medicine may also lead to sensitization phenomena and, occasionally, to adverse effects (see section “Possible side effects”). If this occurs, discontinue treatment and consult your doctor to establish appropriate therapy.
• If you use Citiflux for prolonged periods and at high doses (higher than recommended), as it may cause reduced activity of the gland regulating the stress response (adrenal gland) and reduced natural mucosal growth.
• If you are using medicines for respiratory diseases administered by inhalation (inhaled corticosteroids such as Citiflux), because these medicines may cause systemic adverse effects due to hormonal imbalance. Some of these effects include Cushing's syndrome (excess hormones in the bloodstream), cushingoid appearance (swelling of the face or trunk), adrenal suppression (reduced function of the gland regulating the stress response), growth retardation in children and adolescents, decreased bone mineral density, cataract (loss of transparency of the lens), and glaucoma (damage to the optic nerve). Rarely, a range of psychological and behavioral side effects may occur, including psychomotor hyperactivity (restlessness), sleep disorders, anxiety, depression, aggression, behavioral disturbances (particularly in children).
• If you are switching from systemic steroid therapy, for example oral, to treatment with Citiflux, because alterations in the gland regulating the stress response (adrenal gland) may already be present. Generally, systemic treatment should not be stopped abruptly. If you are receiving systemic treatment, you require medical supervision and special precautions, as recovery of adrenal function is slow. In this case, your respiratory disease should also be relatively "stabilized" through systemic therapy. Initially, your doctor will instruct you to start using Citiflux while continuing systemic treatment, gradually reducing the latter while monitoring adrenal function and adjusting the dose of Citiflux according to the results obtained. During periods of stress or severe asthma attack, if you have switched from systemic treatment to Citiflux, you will need additional systemic steroid therapy. Furthermore, you should undergo periodic checks of cortico-adrenal function (the gland regulating the stress response), including early morning measurements of cortisol levels (a hormone) under resting conditions.
• If you are on continuous treatment with steroid medicines, because in this case a gradual and controlled transition from oral (by mouth) to topical endobronchial (administered directly into the bronchi) therapy is advisable.

The effect of Citiflux is not immediate; therefore, it is not effective during acute asthma attacks. Use this medicine regularly for several days as directed.
If you have severe nasal congestion (obstruction) or excessive secretions, your doctor may advise you to first take medicines that resolve these conditions (nasal obstruction or excessive secretions) so that Citiflux can come into direct contact with the mucous membranes.
The use of Citiflux may mask certain symptoms of infection and may also lead to new infections.
Take the dose as indicated in the package leaflet or as prescribed by your doctor. Do not increase or decrease the dose without first consulting your doctor. Exceeding the recommended doses will not improve the therapeutic efficacy of Citiflux and increases the risk of systemic effects due to absorption (general adverse effects).
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
Exercise caution when using medicines for respiratory diseases administered via the airways (inhaled corticosteroids such as Citiflux) in children, because these medicines may cause systemic adverse effects due to hormonal imbalance. Some of these effects include growth retardation in children and adolescents.
Rarely, a range of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity (restlessness), sleep disorders, anxiety, depression, aggression, and behavioral disturbances (see “Possible side effects”).
Citiflux is not recommended for children under 4 years of age.
Other medicines and Citiflux
Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Citiflux, 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 are breastfeeding, consult your doctor or pharmacist before using this medicine.
Citiflux is not recommended during the first three months of pregnancy. In the subsequent period and during breastfeeding, use this medicine only when clearly needed and under direct medical supervision.
Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery are known.
Citiflux contains propylene glycol
This medicine contains propylene glycol, which may cause skin irritation.

3. How to use Citiflux

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose in adults is: 25 drops (equivalent to 1 mg), twice daily.
Use in children
12–13 drops (equivalent to 0.5 mg), twice daily.
The use of this medicine is not recommended in children under 4 years of age.
Method of administration
Citiflux must be used with electric nebulizers and must not be diluted.
When administering medicinal solutions via electric nebulizers, some solution residue remains, adhering to the vial walls or at the bottom, and is not delivered. Take this into account when preparing the nebulization, and add to the initial dose the amount that remains at the bottom or on the sides of the vial.
If you use more Citiflux than you should
In case of accidental ingestion/overdose of Citiflux, contact your doctor immediately or go to the nearest hospital.
Administration of large amounts of the medicine within a short period of time may lead to suppression of an endocrine system regulating various body functions, including sleep, stress response, appetite, body temperature, and growth. In such case, return immediately to the recommended dose.
If you forget to use Citiflux
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Common (may affect up to 1 in 10 people)

• Nasal obstruction* (nasal congestion) and nasal polyps* (nodules forming inside the nose). These effects occurred in patients requiring continuous treatment with steroid medicines and are due to the reduction in systemic (ongoing) therapy use.

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

• Fungal infections of the mouth and throat. These effects resolve rapidly with locally acting medicines and can be completely avoided by thoroughly rinsing the mouth after using Citiflux.

Frequency not known (frequency cannot be estimated from the available data)

• Cough (in patients with highly sensitive airways);
• Mild and transient burning sensation of the nasal mucosa;
• Hiccups;
• Cushing's syndrome (swelling of the face or trunk caused by hormonal imbalance);
• Adrenal suppression/acute hypoadrenalism (suppression of the gland regulating the stress response);
• Growth retardation in children and adolescents;
• Reduced bone mineral density;
• Cataract (blurred vision); Blurred vision
• Glaucoma (damage to the optic nerve caused by increased intraocular pressure);
• Nasal irritation**, nosebleeds** (epistaxis), blocked nose**, runny nose** (rhinorrhea);
• Sore throat**, hoarseness** (low, rough voice), irritation of mouth and throat**;
• Osteoporosis (loss of bone mass and strength);
• Psychomotor hyperactivity (restlessness, agitation);
• Sleep disorders;
• Anxiety, depression, aggression, behavioural disturbances (mainly in children);
• Peptic ulcer (lesion of the stomach mucosa);
• Signs of secondary adrenal insufficiency (hormonal imbalance) such as reduced blood pressure (hypotension) and weight loss.

* These side effects, typical of corticosteroids administered systemically, occurred only when Citiflux was used improperly.
** If these side effects become severe, treatment with Citiflux may need to be discontinued.
Following the instructions in this leaflet reduces the occurrence of side effects.
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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citiflux

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 pack and on the bottle after "Exp.". The expiry date refers to the last day of that month. This date applies to the product in its original, unopened packaging and correctly stored.
Store the medicine in its original packaging to protect it from light.
Use the medicine within 30 days of first opening the bottle. Dispose of any remaining medicine.
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 Citiflux contains

• The active substance is flunisolide. 100 ml of solution contain 100 mg of flunisolide. One drop contains 0.04 mg of flunisolide.
• The other ingredients are: propylene glycol, sodium chloride, purified water.

Description of the appearance of Citiflux and contents of the pack
Citiflux is a solution for nebulization.
30 ml bottle of solution.
Marketing Authorization Holder
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri, 71 – Sanremo (IM)
Manufacturer
Farmila – Thea Farmaceutici S.p.A. – Via E. Fermi, 50 – Settimo Milanese (MI)