Astian

Package leaflet: Information for the user

ASTIAN 2 mg/2 ml nebulizer solution ASTIAN 1 mg/1 ml nebulizer solution, 0.5 mg/1 ml nebulizer solution Flunisolide

Equivalent medicine
Please read all of this leaflet carefully before you start 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ASTIAN is and what it is used for

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

2. What you should know before taking ASTIAN

Do not take ASTIAN
If you are allergic (hypersensitive) to Flunisolide or to any of the other ingredients of this
medicinal product listed in section 6.
If you have a condition known as pulmonary tuberculosis, whether active or quiescent.
If you have fungal, bacterial, or viral infections.
Generally contraindicated if you are pregnant or breastfeeding (see
"Pregnancy and breastfeeding").

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

• If you are already undergoing systemic treatment with corticosteroid drugs. Your doctor will closely monitor your response to therapy, advising you to initially take ASTIAN concomitantly while gradually reducing 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 treatment 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 of tuberculous nature, either active or quiescent.

• 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 ongoing respiratory (asthmatic) crisis, since the effect of Flunisolide is not immediate. It is advisable to use ASTIAN regularly at the prescribed doses for several days until your doctor determines otherwise.

Prolonged use of ASTIAN may cause:

• Sensitization phenomena (i.e., administration of a given dose of the drug may produce a greater effect than that obtained after the first administration) and classic systemic adverse effects expected with this medicine. In such a case, contact your doctor, who will advise you on the most appropriate therapy.
• The occurrence of the following adverse effects when administered at high doses via inhalation (through the upper airways): possible suppression of adrenal gland activity, mucosal atrophy, growth retardation in children and adolescents, decreased bone mineral density, cataract, glaucoma. It is therefore important that you use the lowest possible dose of inhaled corticosteroids effective for actual asthma control. (See section 4).
• Alteration of bacterial flora, although rarely reported. In such a case, your doctor may advise monitoring for possible changes in microbial flora of the upper airways and, if necessary, starting a covering therapy.

Pay special attention to the following possible situations:

• Increasing the dose does not improve the therapeutic efficacy of the product and increases the risk of developing adverse effects. Do not take a higher dose of ASTIAN than recommended.
• If you experience non-specific symptoms including loss of appetite, 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 may be signs of a severe and intense adrenal crisis (impaired adrenal function).

Very rare cases of acute adrenal crises have been reported in adolescents exposed to higher-than-recommended doses (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 ASTIAN, your doctor will keep you under close surveillance and may consider gradually reducing the dose and monitoring your adrenal gland function.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Do not give ASTIAN to children under 4 years of age, as there is insufficient experience in this population.

For those engaged in sports
The use of ASTIAN without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and ASTIAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular:

• Inform your doctor if you are taking or have recently taken other medicines, including those obtained without a prescription.
• Some medicines may increase the effects of ASTIAN, 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, consult your doctor or pharmacist before taking this medicine.
The use of ASTIAN is not recommended during the first three months of pregnancy. Its use during the second and third trimesters of pregnancy and during breastfeeding should only occur under strict medical supervision, with your doctor evaluating whether potential benefits outweigh possible risks.

Driving and using machines
ASTIAN does not impair the ability to drive vehicles or operate machinery.

3. How to take ASTIAN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Adults
Half the contents of one single-dose container of ASTIAN 2 mg/2 ml twice daily, or
The contents of one single-dose container of ASTIAN 1 mg/1 ml twice daily.
Children
The contents of one single-dose container of ASTIAN 0.5 mg/1 ml twice daily. Administration to children under four years of age is not recommended.

ASTIAN must be used with electric nebulizers. The solution should be used undiluted. At the end of nebulization, a small amount of the solution may remain adhering to the walls or bottom of the container and cannot be delivered.
Taking this into account, during preparation, allowance should be made for this non-deliverable portion.

If you take more ASTIAN than you should
In case of accidental overdose with ASTIAN nebulizing solution, contact your doctor or go immediately to the nearest hospital. They will advise you on what to do.
Administration of large amounts of flunisolide within a short period of time may impair the function of the hypothalamus, pituitary, and adrenal glands (the hypothalamic-pituitary-adrenal axis).

If you forget to take ASTIAN
Use the product exactly as directed 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 ASTIAN
Do not stop treatment with ASTIAN unless instructed by your doctor. Use the product regularly as prescribed by your doctor.

If you have any questions about the use of ASTIAN, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ASTIAN can cause side effects, although not everybody gets them.
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 ASTIAN and inform your doctor immediately:

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

Other side effects that may occur with ASTIAN include:

• Localized fungal infections (candidiasis): these may rarely appear in the oral cavity and resolve rapidly with local antifungal treatment without discontinuing therapy. The occurrence of such fungal infections may be minimized by regularly rinsing the mouth after each application.
• Cough and irritation of the upper respiratory tract: particularly in especially sensitive patients following aerosol inhalation.
• Mild and transient burning sensation of the nasal mucosa.
• Nasal congestion and nasal polyps. These side effects are most commonly observed in patients receiving corticosteroid therapy and are a consequence of reduced systemic treatment. However, such patients should be kept under close monitoring during prolonged treatment to promptly detect any possible systemic manifestations such as bone disease (osteoporosis), gastrointestinal lesions (peptic ulcer), impaired adrenal gland function leading to low blood pressure and weight loss.

The following side effects may occur with long-term use of high doses of Flunisolide:

• Impaired adrenal function
• Growth retardation in children and adolescents
• Reduced bone mineral density;
• Eye disorders such as cataracts and glaucoma.

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 disturbances, anxiety, depression, aggression, behavioural disorders (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 may also report side effects directly via the national reporting system at 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 ASTIAN

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 the containers in the original packaging to protect the medicine from light.
A single-dose container, once opened, should be used within 12 hours of opening.
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 ASTIAN contains
The active substance is Flunisolide.
ASTIAN 2 ml nebulizing solution
One single-dose container of 2 ml contains:
Flunisolide 2 mg
Other components: Propylene glycol, Sodium chloride, Water for injections.
ASTIAN 1 ml nebulizing solution
One single-dose container of 1 ml contains:
Flunisolide 1 mg
Other components: Propylene glycol, Sodium chloride, Water for injections.
ASTIAN 1 ml nebulizing solution
One single-dose container of 1 ml contains:
Flunisolide 0.5 mg
Other components: Propylene glycol, Sodium chloride, Water for injections.

Description of the appearance of ASTIAN and package contents
ASTIAN is a solution for nebulization. It is available in the following pack sizes:
2 ml solution 2 mg / 2 ml
Box containing 15 single-dose containers
1 ml solution 1 mg / 1 ml
Box containing 30 single-dose containers
1 ml solution 0.5 mg / 1 ml
Box containing 30 single-dose containers

Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
S.F Group S.r.l.
Via Tiburtina, 1143 – 00156 Rome, Italy

MANUFACTURER
GENETIC S.p.A.
Contrada Canfora – 84084 Fisciano (SA), Italy

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY