Eliosid

PACKAGE LEAFLET

ELIOSID 2 mg/2 ml nebulizer solution, 1 mg/2 ml nebulizer solution, 2 ml vials

Flunisolide
Equivalent medicine
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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ELIOSID is and what it is used for

ELIOSID contains the active substance flunisolide.
Flunisolide belongs to a group of medicines called anti-asthmatic glucocorticoids, which
exert a marked action against allergies and inflammatory conditions. ELIOSID is indicated for
the treatment of allergic disorders of the upper respiratory tract: bronchial asthma, chronic
asthmatic bronchitis, and chronic or seasonal nasal mucosal irritations/inflammations (rhinitis).

2. What you need to know before taking ELIOSID

Do not take ELIOSID

• If you are allergic (hypersensitive) to flunisolide or to any of the other ingredients of this medicine listed in section 6.
• If you have a medical condition known as pulmonary tuberculosis, whether active or latent.
• If you have 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 ELIOSID

• If you are already being treated systemically with corticosteroid drugs. Your doctor will closely monitor your response to therapy and may instruct you to initially take ELIOSID concomitantly while gradually reducing systemic corticosteroid treatment.
• During periods of stress or severe asthma attack, your doctor might recommend additional systemic steroid therapy and will perform frequent tests to assess the function of your adrenal cortex. A gradual transition from systemic treatment to inhaled therapy localized in the bronchial tree is recommended.
• If you have impaired adrenal function, switching from systemic steroid therapy to flunisolide treatment must be done with great caution. Abrupt discontinuation of systemic treatment should generally be avoided.
• If you have active or latent tuberculous respiratory tract infections, or untreated fungal, bacterial, or viral infections, or ocular herpes simplex of tubercular origin, either active or latent.
• If you have had previous or recent nasal trauma, nasal septum lesions (ulcers), or frequent episodes of nosebleeds (epistaxis). The use of flunisolide may impair healing processes.
• If you are experiencing an acute respiratory (asthmatic) crisis, since the effect of flunisolide is not immediate. It is advisable to follow a regular use of ELIOSID at the prescribed doses for several days, until your doctor determines it is no longer necessary.

Prolonged use of ELIOSID may cause:

• Sensitization phenomena (i.e., administration of a given dose of the drug may produce a greater effect than observed with the first administration) and classic systemic adverse effects associated with this medicine. In such cases, contact your doctor, who will advise on the most appropriate treatment.
• The following adverse effects when administered at high inhaled doses (through the upper airways): possible suppression of adrenal gland function, mucosal atrophy, growth retardation in children and adolescents, reduced bone mineral density, cataract, glaucoma. It is therefore important that you use the lowest possible inhaled corticosteroid dose that is effective in controlling asthma (see section 4).
• Alterations in bacterial flora, although these have been reported only rarely. In such cases, your doctor may recommend monitoring for changes in microbial flora of the upper airways and, if necessary, initiating concomitant antimicrobial therapy. Pay particular attention to these possible situations:
• Increasing the dose does not improve the therapeutic efficacy of the product and increases the risk of adverse effects. Do not take a higher dose of ELIOSID than recommended.

The effect of ELIOSID, as with all inhaled corticosteroids, is not immediate.
Therefore, keep in mind that ELIOSID is not effective for acute asthma attacks, and
regular use of the product over several days is recommended.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
Do not give ELIOSID to children under 4 years of age, as there is insufficient experience in this population.
For those engaged in sports
The use of ELIOSID without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and ELIOSID
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. No interactions with other drugs have been reported.

• 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 ELIOSID, 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 pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of flunisolide is not recommended during the first three months of pregnancy. Its use during the second and third trimesters of pregnancy and during breastfeeding should occur only under direct medical supervision, with the physician evaluating whether potential benefits outweigh possible risks.
Driving and using machines
ELIOSID does not impair the ability to drive vehicles or operate machinery.

3. How to take ELIOSID

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
This medicine must not be diluted.

Adults
Half the contents of a 2 mg/2 ml vial twice daily

Children
Half the contents of a 1 mg/2 ml vial twice daily

ELIOSID is not recommended for children under four years of age.

If you take more ELIOSID than you should
In case of excessive doses of ELIOSID nebulizing solution, immediately reduce the dosage and contact your doctor or go to the nearest hospital.
Administration of large amounts of flunisolide within 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 ELIOSID
Use the product regularly and for several days as prescribed by your doctor. If you forget to take a dose, do not take a double dose to make up for the missed dose.

If you stop using ELIOSID
Do not stop treatment with this medicine unless instructed by your doctor. The therapeutic effect is not immediate. Use the product regularly and for several days as prescribed by your doctor.

4. Possible side effects
Like all medicines, ELIOSID can cause side effects, although not everybody experiences them.
The side effects are listed below, categorized by organ, system, and frequency. Frequencies are defined as follows: very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 1/10,000, < 1/1000), and very rare (< 1/10,000).

Common side effects:

• Nasal irritation, nasal burning, nasal congestion, nasal polyps, runny nose (rhinorrhea), epistaxis, sore throat, oropharyngeal irritation, cough, voice changes (hoarseness). If severe, these side effects may require discontinuation of therapy.

Rare side effects:

• Fungal infections of the mouth or throat.
• Fungal infections of the mouth or throat that resolved rapidly with appropriate local therapy. These infections can be prevented or minimized if patients thoroughly rinse their mouth after each administration.

Very rare side effects:

• Secondary adrenal insufficiency, adrenal crisis
• Osteoporosis, growth retardation in children and adolescents
• Cataract, glaucoma
• Gastrointestinal lesions (peptic ulcer)

Only in cases of inappropriate use, and even then only to a limited extent, may the typical effects of systemically administered corticosteroids occur.

The following side effects may occur with high doses of flunisolide used over long periods:

• Impairment of adrenal function.
• Growth retardation in children and adolescents.
• Reduced bone mineral density.
• Eye disorders such as cataract and glaucoma.

Other side effects that may occur with flunisolide at an unknown frequency (frequency cannot be estimated from the available data):

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

Other side effects that may occur with uncommon frequency (may affect up to 1 in 100 people):

• 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 through the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ELIOSID

Keep this medicine out of the sight and reach of children.
Store the containers in the original packaging to protect the medicine from light.
Use the product within 12 hours after the first opening of the vial. Any remaining
product must be discarded.
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.
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

ELIOSID 2 ml solution for nebuliser
One 2 ml vial contains:
Active substance: Flunisolide 2 mg
Other components: Propylene glycol, sodium chloride, citric acid, sodium citrate, water for
injections

ELIOSID 2 ml solution for nebuliser
One 2 ml vial contains:
Active substance: Flunisolide 1 mg
Other components: Propylene glycol, sodium chloride, citric acid, sodium citrate, water for
injections

Description of the appearance of ELIOSID and contents of the pack
Solution for nebuliser
Pack of 15 vials of 2 ml solution at 2 mg/2 ml
Pack of 15 vials of 2 ml solution at 1 mg/2 ml

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
DYMALIFE PHARMACEUTICAL S.R.L.
Via Bagnulo, 95 – 80063 – Piano di Sorrento (NA)
MANUFACTURER
ESSETI FARMACEUTICI S.r.l.
Via Campobello n. 15, 00040 Pomezia (RM)

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: