Patient Information Leaflet

PLAUDIT adults 2mg/2ml nebulizer solution, children 1mg/2ml nebulizer solution

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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PLAUDIT is and what it is used for
What you need to know before taking PLAUDIT
How to take PLAUDIT
Possible side effects
How to store PLAUDIT
Contents of the pack and other information

1. What PLAUDIT is and what it is used for

PLAUDIT 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.
PLAUDIT is indicated for the treatment of allergic disorders 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 need to know before taking PLAUDIT

Do not take PLAUDIT

If you are allergic (hypersensitive) to flunisolide, to substances closely related from a chemical point of view, or to any of the other components 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.
If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

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

if you are already being treated systemically with medicines belonging to the corticosteroid class. Your doctor will closely monitor your response to therapy, advising you to initially take PLAUDIT 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 perform frequent tests to assess the function of your adrenal gland. A gradual transition from systemic treatment to localized bronchial inhalation therapy is recommended.
If you have impaired adrenal function, switching from systemic steroid therapy to flunisolide therapy must be done with great caution. Abrupt discontinuation of systemic treatment should generally be avoided.
If you have active or quiescent tuberculous infections of the respiratory tract, or untreated fungal, bacterial, or viral infections, or ocular herpes simplex.
If you have had previous or recent nasal trauma, if you suffer from lesions (ulcers) of the nasal septum, or if you frequently experience nosebleeds (epistaxis). The use of flunisolide may inhibit healing processes.
If you are experiencing an acute respiratory (asthmatic) crisis, do not use PLAUDIT, as the effect of flunisolide is not immediate; to exert its function, it must be taken regularly at the prescribed doses for several days, as long as your doctor deems appropriate.

Contact your doctor if you experience blurred vision or other visual disturbances.
Prolonged use of PLAUDIT may cause:

sensitization phenomena (i.e., administration of a given dose of the drug may produce a greater effect than that obtained with the first administration) and the classic systemic adverse effects expected with this medicine. In such a case, contact your doctor, who will indicate 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 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, 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 the actual control of asthma. See section 4 for further information.
possible inhibition of adrenal activity and deterioration of internal layers. This effect, resulting from localized and high-dose use, has not yet been demonstrated in clinical experience.
rarely, alteration of intestinal bacterial flora. In such a case, your doctor may advise monitoring for possible alterations in microbial flora of the upper airways and, if necessary, starting a covering therapy.

Pay particular attention to these possible situations:

The use of medicines belonging to the same family as PLAUDIT (corticosteroids) may mask certain symptoms of a possible infection, and new infections may arise during their use.
Increasing the dose of PLAUDIT does not improve the therapeutic efficacy of the product and increases the risk of developing adverse effects. Do not take a higher dose of PLAUDIT than the one recommended.
If you experience non-specific symptoms such as anorexia, 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 could be symptoms of a severe and intense adrenal crisis (impaired adrenal function). Very rare cases of acute adrenal crises have occurred 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 PLAUDIT, your doctor will keep you under close surveillance and may consider gradually reducing the dose and monitoring your adrenal gland function.

Children
Use of PLAUDIT is not recommended in children under 4 years of age.
For those engaged in sports activities
Using PLAUDIT without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and PLAUDIT
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 PLAUDIT, 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.
Flunisolide is not recommended during the first three months of pregnancy. Its use during the remainder of pregnancy and during 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
PLAUDIT does not impair the ability to drive vehicles or operate machinery.

3. How to take PLAUDIT

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 one adult vial twice daily.
Children
Half the contents of one children's vial twice daily.
Use in children
The use of PLAUDIT in children under 4 years of age is not recommended.
INSTRUCTIONS FOR USE
To use the single-dose vial, follow these steps:
a) open the vial by applying slight pressure on the neck,
b) withdraw the prescribed amount from the vial using a syringe, or by inverting the opened vial and
tapping gently on the bottom with a finger.
To withdraw exactly 1 ml, empty the vial up to the mark indicated on it.
PLAUDIT must be used with electric nebulizers, both for clinical 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 PLAUDIT than you should
In case of accidental overdose with PLAUDIT nebulizing solution, immediately reduce the dosage and
inform your doctor or go to the nearest hospital.
Administration of large amounts of flunisolide over 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 PLAUDIT
Use the product as prescribed by your doctor. If you forget to take a dose of PLAUDIT, do not take a
double dose to make up for the missed dose.
If you stop using PLAUDIT
Consult your doctor or pharmacist before stopping treatment.
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 will experience them.
No serious adverse effects have been reported following the use of this product at the recommended doses.

The following adverse reactions have been reported with the use of flunisolide. If you experience any of the
following side effects severely, stop treatment with PLAUDIT and inform your doctor immediately:

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

Other side effects that may occur with PLAUDIT include:

Localized fungal infections (candidiasis): oral candidiasis has been rarely observed, which resolves rapidly with local antifungal therapy without discontinuation of 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 patients with highly sensitive airways.
Mild and transient sensation of burning 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 be kept under close medical supervision during prolonged treatment to promptly detect any possible systemic manifestations, such as bone disease (osteoporosis), gastrointestinal lesions (peptic ulcer), or impaired adrenal gland function leading to low blood pressure and weight loss.

Typical side effects associated with systemically administered corticosteroid medicines may occur,
although to a lesser extent, in case of inappropriate use (at high doses and for prolonged periods) (see
“Warnings and precautions”).
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).
blurred vision.

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 PLAUDIT

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.
Store in the original packaging to protect the medicine from light.
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 PLAUDIT contains
The active substance is flunisolide.
1 vial of PLAUDIT adults nebulizing solution contains 2 mg of flunisolide.
1 vial of PLAUDIT children nebulizing solution contains 1 mg of flunisolide.
The other components are: Propylene glycol, sodium chloride, citric acid, sodium citrate, water for
injections.

Description of the appearance of PLAUDIT and contents of the pack
PLAUDIT is a nebulizing solution.
It is available in cardboard packs containing 15 glass vials of 2 ml.

Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
S.F. Group Srl
Via Tiburtina, 1143
00156 Rome
MANUFACTURER
ESSETI Farmaceutici S.r.l.
Via Campobello, 15
00071 Pomezia (RM)
Italy