Nebulgen

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

NEBULGEN ADULTS 2 mg/2 ml nebulising solution, ADULTS 1 mg/1 ml nebulising solution, CHILDREN 1 mg/2 ml nebulising solution, CHILDREN 0.5 mg/1 ml nebulising solution

Flunisolide
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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, because it could 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 NEBULGEN is and what it is used for
2. What you need to know before taking NEBULGEN
3. How to take NEBULGEN
4. Possible side effects
5. How to store NEBULGEN
6. Contents of the pack and other information

1. What NEBULGEN is and what it is used for

NEBULGEN contains the active substance Flunisolide, which belongs to a group of medicines called glucocorticoid drugs, anti-asthmatic agents that have an anti-inflammatory action capable of reducing swelling and irritation in the airway walls, thereby alleviating respiratory problems.
NEBULGEN is indicated for the treatment of allergic conditions affecting the respiratory tract, such as:

• inflammation of the bronchi with breathing difficulty (bronchial asthma and asthmatic chronic bronchitis);
• inflammation of the nasal mucosa (chronic and seasonal rhinitis).

2. What you should know before taking NEBULGEN

Do not take NEBULGEN:

• if you are allergic (hypersensitive) to the active substance or to any of the other components of NEBULGEN (listed in section 6);
• if you have a pulmonary infection caused by mycobacteria (active or quiescent pulmonary tuberculosis);
• if you have infections caused by bacteria, viruses, or fungi.

If you are pregnant or breastfeeding, see the section “Pregnancy and breastfeeding”.

Warnings and precautions

Talk to your doctor or pharmacist before taking NEBULGEN.

Take particular care:

• If you have a lung infection (active or quiescent tuberculosis), respiratory tract infections, or untreated fungal, bacterial, or viral infections, or if you have herpes simplex (virus) affecting the eyes, as some symptoms of infection may be masked and new infectious processes may develop during treatment.
• If you have had previous or recent nasal trauma, nasal septum ulceration, or recurrent nosebleeds (epistaxis).
• If you suffer from marked nasal congestion or abundant secretions, your doctor may consider prior treatment with topical vasoconstrictors to allow the aerosol to reach and contact the mucosa effectively.
• If you use NEBULGEN for a long period of time, as this medicine may cause dysbiosis (alteration of bacterial flora). In such cases, your doctor will monitor possible changes in the microbial flora of the upper respiratory tract and, if necessary, initiate appropriate concomitant therapy.
• If you use NEBULGEN for prolonged periods, allergic reactions may occur, and exceptionally, systemic adverse effects typical of this medicine may arise (see section “Possible side effects”). In such cases, inform your doctor, who will advise you on how to discontinue treatment and initiate appropriate therapy.
• If you use this medicine for prolonged periods and at high doses, inform your doctor, who will consider the possibility of adrenal suppression (inability of the adrenal glands to produce sufficient cortisol) and mucosal atrophy. Symptoms may include eating disorders (anorexia), abdominal pain, weight loss, fatigue, headache, nausea, vomiting; low blood sugar levels (hypoglycemia) with reduced consciousness and/or seizures. Situations that could potentially lead to an adrenal crisis include trauma, surgery, infections, or rapid dose reduction. Possible systemic effects include:
  • Cushing's syndrome, Cushingoid appearance (facial or trunk swelling),
  • hormonal disorders due to suppression of the hypothalamic-pituitary-adrenal axis (adrenal suppression),
  • growth retardation in children and adolescents,
  • reduced bone mineral density (osteoporosis),
  • eye problems (cataract, glaucoma),
  • a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (particularly in children). If high doses are required, your doctor will closely monitor the dose and advise you on how to taper it gradually. If switching from systemic corticosteroid therapy (tablets, drops, injections) to NEBULGEN, or if you are currently receiving systemic treatment, medical supervision is necessary. During periods of stress or severe asthma attack, when switching from systemic therapy to NEBULGEN, you may require additional treatment. Your doctor will monitor your corticosteroid levels and provide guidance on supplementary therapy, gradual transition, and dosing.

Contact your doctor if you experience blurred vision or other visual disturbances.

The effect of NEBULGEN, like all inhaled corticosteroids, is not immediate. Therefore, it is not effective during acute asthma attacks, and regular use over several days is recommended.

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.

Children and adolescents

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

Inhaled corticosteroid medicines such as NEBULGEN may cause general adverse effects due to hormonal imbalance and behavioral effects (see sections “Warnings and precautions” and “Possible side effects”).

Other medicines and NEBULGEN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

NEBULGEN contains 518 mg of propylene glycol per single-dose container of 1 ml and 1036 mg of propylene glycol per single-dose container of 2 ml, equivalent to 518 mg per ml.

This medicine contains less than 1 mmol (23 mg) of sodium per drop, i.e., essentially 'sodium-free'.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine is not recommended during the first three months of pregnancy. During the remainder of pregnancy and while breastfeeding, the product should be administered only if clearly necessary and under direct medical supervision.

Breastfeeding
If you are breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
There are no data available to determine the effects of NEBULGEN on the ability to drive vehicles or operate machinery.

3. How to take NEBULGEN

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

Recommended dose:
Adults
Use half the contents of a single-dose container of NEBULGEN ADULTS 2 mg/2 ml twice daily
Or
Use the entire contents of a single-dose container of NEBULGEN ADULTS 1 mg/1 ml twice daily

Children
Use half the contents of a single-dose container of NEBULGEN CHILDREN 1 mg/2 ml twice daily
Or
Use the entire contents of a single-dose container of NEBULGEN CHILDREN 0.5 mg/1 ml twice daily

Administration to children under four years of age is not recommended.
Do not dilute NEBULGEN.

Method of administration
NEBULGEN must be used exclusively by inhalation. Do not inject intravenously or administer orally.
NEBULGEN should be administered via inhalation using a suitable device (nebulizer), according to your doctor's instructions.

It is known that administration of drug solutions via electric nebulizers results in residual solution remaining adherent to the vial walls or at the bottom, which is not delivered. Therefore, during preparation, consider the need to compensate for this undelivered portion.

In cases of asthma, the duration of treatment will be determined by the doctor. The dose will be regularly assessed and reviewed by the doctor and adjusted to the lowest effective dose required to control asthma symptoms.
Do not increase or decrease the dose without first consulting your doctor. Increasing the recommended doses will not improve NEBULGEN’s therapeutic efficacy and may increase the risk of systemic effects due to absorption (see section “Warnings and precautions”).

If you take more NEBULGEN than you should
If an excessive dose of NEBULGEN is accidentally ingested or administered, inform your doctor immediately or go to the nearest hospital.
Administration of large amounts of this medicine within a short period of time may cause hormonal disturbances due to suppression of the connection between the brain and adrenal glands (hypothalamic-pituitary-adrenal axis suppression) (see section “Warnings and precautions”). In such cases, immediately return to the recommended dose.

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

If you stop using NEBULGEN
Do not stop treatment with this medicine abruptly. Before stopping treatment, consult your doctor, who will advise you on how to gradually reduce the dosage.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NEBULGEN may cause side effects, although not everyone experiences them.
Contact your doctor if you experience any of the following side effects:

• cough, hoarseness or voice changes (dysphonia), mild and transient burning of the nasal mucosa;
• fungal infections of the mouth or throat. These infections can be prevented or reduced by thoroughly rinsing the mouth after administration of this medicine by aerosol.
• nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea), sore throat, irritation of mouth and throat. If these effects are severe, stop treatment and contact your doctor immediately.
• nasal congestion, development of benign nodules in the nose (nasal polyps),
• bone problems (osteoporosis),
• stomach and intestinal disorders (peptic ulcer),
• symptoms due to adrenal insufficiency such as low blood pressure and weight loss. At high doses used over long periods, symptoms of adrenal suppression (inability of the adrenal glands to produce sufficient cortisol) may occur:
• growth retardation in children and adolescents,
• reduced bone mineral density,
• eye problems (cataract and glaucoma) (see section “Warnings and precautions”).

Side effects that may occur with unknown frequency (frequency cannot be estimated from available data):

• psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural disturbances (mainly in children),
• blurred vision (see section “Warnings and precautions”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following 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 NEBULGEN

Keep this medicine out of the sight and reach of children.
Do not use NEBULGEN after the expiry date stated on the packaging “Exp.”. The expiry date refers to the last day of that month.
Store the product in its original packaging to protect it from light.
Use the product within 12 hours after the first opening of the single-dose container. Any remaining product 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

NEBULGEN ADULTS 2 ml nebulizing solution
One single-dose container of 2 ml contains:

• The active substance is: Flunisolide 2 mg;
• The other components are: Propylene glycol, sodium chloride, water for injections.

NEBULGEN ADULTS 1 ml nebulizing solution
One single-dose container of 1 ml contains:

• The active substance is: Flunisolide 1 mg;
• The other components are: Propylene glycol, sodium chloride, water for injections.

NEBULGEN CHILDREN 2 ml nebulizing solution
One single-dose container of 2 ml contains:

• The active substance is: Flunisolide 1 mg;
• The other components are: Propylene glycol, sodium chloride, water for injections.

NEBULGEN CHILDREN 1 ml nebulizing solution
One single-dose container of 1 ml contains:

• The active substance is: Flunisolide 0.5 mg;
• The other components are: Propylene glycol, sodium chloride, water for injections.

Description of the appearance of NEBULGEN and package contents
Nebulizing solution.
Pack: 15 single-dose containers of 2 ml solution 2 mg/2 ml
Pack: 30 single-dose containers of 1 ml solution 1 mg/1 ml
Pack: 15 single-dose containers of 2 ml solution 1 mg/2 ml
Pack: 30 single-dose containers of 1 ml solution 0.5 mg/1 ml

Marketing Authorization Holder
I.B.N. Savio S.r.l., Via del Mare, 36 Pomezia (RM)

Manufacturer
Pharma Stulln GmbH - c/o Frau Mark - Weksstrasse 3 – 92551 Stulln – Germany
Genetic SpA - Contrada Canfora - 84084 Fisciano (SA)

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