Patient information leaflet

NEBULCORT

1 mg/ml solution for nebuliser
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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Nebulcort is and what it is used for
What you need to know before using Nebulcort
How to use Nebulcort
Possible side effects
How to store Nebulcort
Contents of the pack and other information

1. What Nebulcort is and what it is used for

Nebulcort contains the active substance flunisolide.
Nebulcort belongs to a group of medicines called glucocorticosteroids, which have a strong action against allergies and inflammatory conditions.
Nebulcort is indicated for the treatment of certain allergic diseases of the respiratory tract, such as:

bronchial asthma, an inflammatory disease characterized by obstruction of the bronchi;
chronic asthmatic bronchitis, a persistent inflammatory disease of the bronchi, accompanied by breathing difficulties;
rhinitis, chronic and seasonal inflammations of the nasal mucosa.

2. What you should know before using Nebulcort

Do not use Nebulcort

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have an infectious disease called active or quiescent pulmonary tuberculosis;
if you have a bacterial, viral, or fungal infection;
if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using Nebulcort.
Take special care with NEBULCORT:

If you have a respiratory tract infection, such as tuberculosis or an untreated infection caused by viruses, bacteria, or fungi, or an eye infection caused by the herpes simplex virus. In these cases, you must not use this medicine.
If you currently have or have recently had nasal trauma with ulceration of the nasal septum or recurrent nosebleeds (epistaxis), as this medicine may slow wound healing.
If you use NEBULCORT for a prolonged period, because this medicine may alter the natural microbial flora of the airways. In such cases, concomitant therapy to restore the natural microbial flora may be necessary. Long-term use of the medicine may also lead to sensitization 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 NEBULCORT for prolonged periods and at high doses, because it may reduce the activity of the gland regulating the stress response (adrenal gland) and impair the natural growth of mucosal tissues.
Inhaled corticosteroids such as NEBULCORT may cause systemic adverse effects due to hormonal imbalance, especially when prescribed at high doses over prolonged periods. 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, cataracts, and glaucoma. Rarely, a range of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression (particularly in children).
If switching from systemic steroid therapy (e.g., oral) to NEBULCORT therapy, because adrenal gland function (the gland regulating the stress response) may already be impaired. 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 (the gland regulating the stress response) is slow. In this case, your respiratory condition should also be relatively "stabilized" through systemic therapy. Initially, your doctor will instruct you to start using NEBULCORT while continuing systemic treatment, gradually reducing the latter while monitoring adrenal function and adjusting the NEBULCORT dose according to results. During periods of stress or severe asthma attack, if you have switched from systemic therapy to NEBULCORT, you may require supplementary systemic steroid treatment. Additionally, you should undergo periodic checks of hypothalamic-pituitary-adrenal (HPA) axis function, including early morning measurements of cortisol levels (a hormone) under resting conditions.
If you are on long-term treatment with steroid medicines, because a gradual and controlled transition from oral therapy to topical endobronchial therapy (administered directly into the bronchi) is recommended.

The effect of NEBULCORT is not immediate; therefore, this medicine is not effective during ongoing asthma attacks. Use this medicine regularly for several days as directed.
The use of NEBULCORT 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 NEBULCORT but increases the risk of systemic absorption effects (general adverse effects).
Contact your doctor if you experience blurred vision or other visual disturbances.
For those engaged in sports: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Nebulcort is not recommended for children under four years of age.
Be cautious when using this medicine in children, as general adverse effects such as growth retardation in children and adolescents may occur. Rarely, a range of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, and behavioral disturbances.
Other medicines and Nebulcort
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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.
This medicine is not recommended during the first three months of pregnancy. During the remainder of pregnancy and while breastfeeding, the medicine should be used only when clearly needed and under direct medical supervision.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
NEBULCORT contains propylene glycol
This medicine contains 1036 mg of propylene glycol per maximum daily dose in adults (equivalent to 50 drops) and 528 mg of propylene glycol per maximum daily dose in children (equivalent to 25 drops).

3. How to take Nebulcort

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

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

Use in children and adolescents
The recommended dose is: 500 micrograms (12–13 drops) twice daily.
It is not recommended to administer this medicine to children under four years of age.
One drop contains 40 micrograms of flunisolide.
NEBULCORT must be used with electric nebulizers.
The solution should be used undiluted.
At the end of nebulization, a small portion of the solution adheres to the walls or bottom of the ampoule and cannot be delivered.
Taking this into account, during preparation, it is necessary to consider adding extra volume to compensate for the amount that cannot be delivered.

If you use more Nebulcort than you should
In case of accidental ingestion/overdose of NEBULCORT, contact your doctor immediately or go to the nearest hospital.
Administration of large amounts of flunisolide over a short period of time may lead to suppression of certain important hormonal functions (the hypothalamic-pituitary-adrenal axis). In such a case, return immediately to the recommended dose.

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

If you stop treatment with Asmaflu
If you have any doubts about using 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.
If you experience any of the following side effects severely, inform your doctor immediately,
as treatment may need to be stopped:

Nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea);
Voice changes (hoarseness), sore throat, irritation of the oral cavity or pharynx.

Contact your doctor if you experience any of the following side effects:
Frequency not known (frequency cannot be estimated from the available data):

Fungal infections of the mouth or throat. These side effects disappeared rapidly following appropriate local treatment. These infections can be prevented or minimized by thoroughly rinsing the mouth after each administration.
Cough and hoarseness: particularly in especially sensitive patients after inhalation of the aerosol.
Mild and transient sensation of burning in the nasal mucosa.
Nasal congestion and nasal polyps. These side effects are most commonly observed in patients receiving corticosteroid medications and are a consequence of reduced systemic therapy. However, such patients should be closely monitored during prolonged treatment 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.
Cushing's syndrome (excess hormones in the bloodstream), Cushingoid appearance (swelling of the face or trunk),
Impairment of adrenal function,
Growth retardation in children and adolescents,
Reduced bone mineral density;
Eye disorders such as cataract and glaucoma.
Psychological and behavioral events including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (particularly in children).
Blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 Nebulcort

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 carton after “Exp.”. The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect the medicine from light.
Use the medicine within 30 days of first opening the bottle. Any remaining medicine should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Nebulcort contains

The active substance is flunisolide. 1 ml of solution contains 1 mg of flunisolide. One drop of NEBULCORT contains 40 micrograms of flunisolide.
The other components are propylene glycol, sodium chloride, purified water.

Description of the appearance of Nebulcort and contents of the pack
Solution for nebuliser.
Box containing one 30 ml bottle of solution for nebuliser.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ITC FARMA S.r.l.
Viale Pier Luigi Nervi, 164
04100 Latina
Manufacturer
Genetic S.P.A. - Contrada Canfora – Nucleo Industriale - 84084 Fisciano (SA)