PLAUDIT 2 mg /2 Ml Solution For Nebulization

Зміст інструкції

1. PLAUDIT adults 2mg/2ml solution for nebulisation, children 1mg/2ml solution for nebulisation
   1. What is PLAUDIT and what is it used for
   2. What you need to know before taking PLAUDIT
   3. How to take PLAUDIT
   4. Possible side effects
   5. How to store PLAUDIT
   6. Contents of the pack and other information

PLAUDIT adults 2mg/2ml solution for nebulisation, children 1mg/2ml solution for nebulisation

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

1. What is PLAUDIT and what is it used for

PLAUDIT 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.
PLAUDIT 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 PLAUDIT

Do not take PLAUDIT

• 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.
• If you are pregnant or if you are breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking PLAUDIT

• 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 PLAUDIT initially concomitantly and then gradually reduce systemic treatment with corticosteroids. 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. A gradual transition from systemic treatment to localized inhalational therapy at the bronchial level is recommended.

Pag. 1to 5

• If you suffer from impaired adrenal function, the transfer from systemic steroid therapy to therapy with flunisolide must be carried out with great caution. Abrupt discontinuation of systemic treatment is generally to be avoided.
• If you have contracted active or quiescent tuberculosis infections of the respiratory tract or infections not treated by fungi, bacteria or viruses, or with herpes simplex in the eyes.
• If you have suffered previous or recent nasal trauma, if you suffer from lesions (ulcers) of the nasal septum or if you have frequent episodes of nosebleeds (epistaxis). The use of flunisolide inhibits the healing process.
• If you have an ongoing respiratory crisis (asthmatic), do not use PLAUDIT because the effect of flunisolide is not immediate but to exert its function it must be taken regularly at the prescribed doses and for several days until the doctor deems it appropriate.

Contact your doctor if you experience blurred vision or other visual disturbances.
Prolonged use of PLAUDIT 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 this case, 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 (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 effective asthma control. See section 4.
• the possible inhibition of adrenal activity and deterioration of the inner layers. This effect, resulting from localized and high-dose use, has not yet been demonstrated by clinical experience.
• rarely, alteration of the intestinal bacterial flora. In this case, your doctor will advise you to check for any changes in the microbial flora of the upper airways and, if necessary, to start a covering therapy.

Pay particular attention to these possible situations:

• The use of drugs belonging to the same family as PLAUDIT (corticosteroids) can mask some symptoms of a possible infection, and new infections may occur 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 dose of PLAUDIT higher than that recommended.
• If you show non-specific symptoms that include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, or specific symptoms such as decreased blood sugar levels with reduced consciousness and/or convulsions. Inform your doctor because they 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 this crisis. Therefore, if you receive high doses of PLAUDIT, your doctor will keep you under close surveillance and assess a gradual reduction of the dose and monitoring of your adrenal gland activity.

Children
The use of PLAUDIT is not recommended in children under 4 years of age.
Pag. 2to 5
For those who play sports
The use of PLAUDIT without therapeutic necessity constitutes doping and may still result in positivity to
anti-doping tests.

Other medicines and PLAUDIT
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of PLAUDIT 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 during
the further period of pregnancy and during breastfeeding should only occur under direct indication of your
doctor who will assess whether the potential benefits outweigh the possible risks.

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

3. How to take PLAUDIT

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
Half the content of an adult vial 2 times a day.
Children
Half the content of a children's vial 2 times a day.

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, perform the following operations:
a) open the vial by applying slight pressure to the cap,
b) withdraw the contents of the vial in the prescribed amount using a syringe or by inverting the
open vial and tapping on the bottom with a finger.
To withdraw only 1 ml, empty it up to the mark indicated on the vial.
PLAUDIT must be used with electric nebulizers, both in outpatient and home settings. The use with ultrasonic nebulizers is not
advisable because there is a risk of overheating. The solution
should be used as is without dilution. At the end of nebulization, a small part of the solution adheres
to the walls or bottom of the ampoule and cannot be delivered; this must be taken into account when evaluating
the administered dose.

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

If you forget to take PLAUDIT
Use the product as prescribed by your doctor. If you forget to use PLAUDIT
do not take a double dose to compensate for the missed dose.

If you stop taking PLAUDIT
Ask your doctor or pharmacist for advice before stopping treatment.

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.
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 PLAUDIT and inform
your doctor immediately:

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

Other side effects that may occur with PLAUDIT are:

• Localized fungal infections (candidiasis): these have been rarely observed in the oral cavity and resolve rapidly after local therapy with antifungals without discontinuing treatment. The occurrence of these fungal infections can be minimized by rinsing the mouth regularly after each application.
• Cough and irritation of the upper respiratory tract: particularly in patients with very sensitive airways.
• 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 corticosteroids, and are a consequence of reduced systemic therapy. However, these patients should still be closely monitored 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 adrenal gland function with consequent lowering of blood pressure and weight loss.

Typical side effects of corticosteroids administered systemically may occur,
even if to a reduced extent, in case ofinappropriateuse (athigh doses and for long periods) (see
“Warnings and precautions”).
Other side effects that may occur with flunisolide with unknown frequency(frequency cannot
be defined based on available data):

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system reported at the address 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 which is stated on the label after “Scad.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
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 PLAUDIT contains
The active ingredient is flunisolide.
1 vial of PLAUDIT adults nebulizer solution contains 2mg of flunisolide.
1 vial of PLAUDIT children nebulizer solutioncontains 1mg of flunisolide.
The other ingredients 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 nebulizer solution.
It is available in cardboard packs containing 15 glass vials of 2 ml.

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