NEBULGEN 1 mg /2 Ml Solution For Nebulization

Зміст інструкції

1. NEBULGEN ADULTI 2 mg/2 ml solution for nebulisation, ADULTI 1 mg/1 ml solution for nebulisation, BAMBINI 1 mg/2 ml solution for nebulisation, BAMBINI 0,5 mg/1 ml solution for nebulisation
   1. What is NEBULGEN and what is it 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

NEBULGEN ADULTI 2 mg/2 ml solution for nebulisation, ADULTI 1 mg/1 ml solution for nebulisation, BAMBINI 1 mg/2 ml solution for nebulisation, BAMBINI 0,5 mg/1 ml solution for nebulisation

Flunisolide

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 could 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 NEBULGEN is and what it is used for
• 2. What you need to know before you take 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 is NEBULGEN and what is it used for

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

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

2. What you need to know before taking NEBULGEN

Do not take NEBULGEN:

• if you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of NEBULGEN (listed in section 6);
• if you have a lung 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 section “Pregnancy and
breastfeeding”.

Warnings and precautions
Talk to your doctor or pharmacist before taking NEBULGEN.
Pay particular attention:

• If you have a lung infection (active or quiescent tuberculosis), of the respiratory tract or untreated infections from fungi, bacteria or viruses or with herpes simplex(virus) in the eyes as they may mask some symptoms of infection and new infectious processes may develop during treatment.
• If you have had previous or recent nasal trauma, with an ulcer in the nasal septum or with recurrent nosebleeds (epistaxis).
• If you suffer from marked nasal congestion or with abundant secretions, the doctor will assess a preliminary treatment with topical vasoconstrictors to allow the aerosol to come into contact with the mucosa.
• If you use NEBULGEN for a long period of time because this medicine can cause dysbiosis (alterations of the bacterial flora). In these cases, the doctor will check the possible change in the microbial flora of the upper airways, instituting, if necessary, a covering therapy.
• If you use NEBULGEN for prolonged periods, it may lead to allergic reactions and, exceptionally, to the classic systemic side effects of the medicine (see section “Possible side effects ”). In this case, you must inform your doctor who will tell you how to stop treatment and establish suitable therapy.
• If you use this medicine for a prolonged period and at high doses, it is good to inform your doctor who will consider the possibility of inhibition of the adrenal activity (inability of the adrenal glands to produce a sufficient amount of cortisol) and problems (atrophy) of the mucous membranes. Symptoms may manifest as eating disorders (anorexia), abdominal pain, weight loss, fatigue, headache, nausea, vomiting; a low level of sugar in the blood (hypoglycemia) with reduced state of consciousness and/or convulsions. Situations that could potentially determine an adrenal crisis are: trauma, surgery, infections and rapid reduction of the dosage. Possible systemic effects include:
• Cushing's syndrome, Cushingoid appearance (swelling of the face or trunk),
• hormonal disorders due to a block of the connection between the brain and the adrenal glands (adrenal suppression),
• growth retardation in children and adolescents,
• reduction of bone mineral density (osteoporosis),
• eye problems (cataract, glaucoma)
• a series of psychological or behavioral effects that include psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (especially in children). If you have to take high doses, the doctor will strictly evaluate the dose and give you advice on how to reduce it gradually. If you switch from a therapy with corticosteroids in other forms (tablets, drops, vials) to NEBULGEN or if you are receiving systemic treatment, you need medical supervision. During periods of stress or severe asthma attack if you switch from systemic treatment to NEBULGEN you will need additional treatment. The doctor will also check the levels of corticosteroids in your body and give you advice on supplementary therapy, gradual transition and dosages.

Contact your doctor if you experience blurred vision or other visual disturbances.
The effect of NEBULGEN, as with all corticosteroids administered by inhalation, is not immediate.
For this reason, it is not effective in ongoing asthma crises and it is advisable to adhere to a regular use of the
product for several days.
do not decrease the dose without first consulting your doctor.

Children and adolescents
It is not advisable to administer to children under four years of age.
Inhaled corticosteroid medicines such as NEBULGEN can cause general side effects
caused by hormonal imbalance and behavioral type (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 medicine.
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 or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

PregnancyThis medicine is not recommended in the first three months of pregnancy. In the further period
and during breastfeeding, the product should only be administered in cases of actual need and under direct
medical control.

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

Driving and operating machinery
No data are available to establish the effects of NEBULGEN on the ability to drive vehicles and operate
machinery.

3. How to take NEBULGEN

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The recommended dose is:

Adults
Use half the contents of a single-dose container of NEBULGEN ADULTI 2 mg/2 ml twice a day
Or
Use the contents of a single-dose container of NEBULGEN ADULTI 1 mg/1 ml twice a day

Children
Use half the contents of a single-dose container of NEBULGEN BAMBINI 1 mg/2 ml twice a day
Or
Use the contents of a single-dose container of NEBULGEN BAMBINI 0,5 mg/1 ml twice a day
It is not advisable to administer to children under four years of age.
Do not dilute NEBULGEN.

Method of administration
NEBULGEN must be used exclusively via inhalation. Do not inject intravenously or use orally.
NEBULGEN must be administered by inhalation with a suitable device (nebulizer) according to the
doctor's instructions.
As is known, the administration of drugs in solution using electric nebulizers involves a residue
of solution which, adhering to the walls of the vial or to the bottom, is not delivered. Taking this into
account, it is necessary, during preparation, to consider the need to supplement the non-deliverable part.
In case of asthma, the doctor will decide the duration of treatment. The dose will be evaluated and regularly
reviewed by the doctor and brought to the minimum effective dose for asthma control.
Do not increase or decrease the doses without first consulting your doctor. Increasing the recommended doses
in addition to not improving the therapeutic efficacy of NEBULGEN involves the risk of systemic effects from
absorption (see paragraph “Warnings and precautions”).

If you take more NEBULGEN than you should
In case of ingestion/accidental intake of an excessive dose of NEBULGEN, immediately inform
your doctor or go to the nearest hospital.
In case of administration of large quantities of this medicine, in a short period of time, you may experience
hormonal disorders due to a block of the connection between the brain and the adrenal glands
(suppression of the hypothalamic-pituitary-adrenal function) (see paragraph “Warnings and
precautions”). In this case, reduce and return immediately to the recommended dose.

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

If you stop taking NEBULGEN
Do not abruptly stop treatment with this medicine. Before stopping treatment, consult your doctor who will
tell you how to reduce the dosage gradually.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, NEBULGEN can cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:

• cough, lowering and alteration of the voice (hoarseness), mild and temporary burning of the nasal mucosa;
• fungal infections in the mouth or throat. These infections can be prevented or reduced if, after administering this medicine by aerosol, the mouth is rinsed thoroughly.
• irritation of the nose, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea), sore throat, irritation of the mouth and throat. If these effects are severe, stop treatment and consult your doctor immediately.
• nasal congestion, appearance 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 for long periods, symptoms of adrenal suppression may occur (inability of the adrenal glands to produce enough cortisol):
• delayed growth in children and adolescents,
• reduction in bone mineral density,
• eye problems (cataract and glaucoma), (see section “Warnings and precautions”).

Side effects that may occur with unknown frequency (frequency cannot be defined on the basis of available data):

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at: 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 which is reported on the packaging “Exp.”. The expiry date
refers to the last day of that month.
Store the product in the original packaging to protect it from light.
Use the product within 12 hours of first opening the single-dose container. Any excess product should
be discarded.
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

NEBULGEN ADULTI 2 ml solution for nebulisation
One single-dose container of 2 ml contains:

• the active ingredient is: Flunisolide 2 mg;
• the other ingredients are: Propylene glycol, sodium chloride, water for injections. NEBULGEN ADULTI 1 ml solution for nebulisation One single-dose container of 1 ml contains:
• the active ingredient is: Flunisolide 1 mg;
• the other ingredients are: Propylene glycol, sodium chloride, water for injections. NEBULGEN BAMBINI 2 ml solution for nebulisation One single-dose container of 2 ml contains:
• the active ingredient is: Flunisolide 1 mg;
• the other ingredients are: propylene glycol, sodium chloride, water for injections. NEBULGEN BAMBINI 1 ml solution for nebulisation One single-dose container of 1 ml contains:
• the active ingredient is: Flunisolide 0.5 mg;
• the other ingredients are: propylene glycol, sodium chloride, water for injections.

Description of the appearance of NEBULGEN and contents of the pack
Solution for nebulisation.
Pack of 15 single-dose containers of 2 ml of 2 mg/2 ml solution
Pack of 30 single-dose containers of 1 ml of 1 mg/1 ml solution
Pack of 15 single-dose containers of 2 ml of 1 mg/2 ml solution
Pack of 30 single-dose containers of 1 ml of 0.5 mg/1 ml solution

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

Manufacturer
Pharma Stulln GmbH - z. Hd Frau Mark - Weksstrasse 3 – 92551 Stulln – Germany
Genetic SpA - Contrada Canfora- 84084 Fisciano (SA)

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