NEBULCORT 1 mg /Ml Roztwór Do Nebulizacji
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Treść ulotki
NEBULCORT
1mg/ml solution for nebulizer
Flunisolide
Equivalent medicinal product
Read this leaflet carefully before taking this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any doubts, 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 could be dangerous.
- If any undesirable effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Nebulcort is and what it is used for
- 2. What you need to know before you use Nebulcort
- 3. How to use Nebulcort
- 4. Possible side effects
- 5. How to store Nebulcort
- 6. Contents of the pack and other information
1. What is Nebulcort and what is it used for
Nebulcort contains the active substance flunisolide.
Nebulcort belongs to a group of medicines called glucocorticosteroids which exert a
marked action against allergies and inflammatory states.
Nebulcort is indicated in the treatment of some allergic diseases of the respiratory tract such as:
- bronchial asthma, an inflammatory disease characterized by an obstruction of the bronchi;
- chronic asthmatic bronchitis, a persistent inflammatory disease of the bronchi, accompanied by breathing difficulties;
- rhinitis, inflammation of the nasal mucosa, chronic and seasonal.
2. What you need to know before using Nebulcort
Do not use Nebulcort
- if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
- if you have an infectious disease called pulmonary tuberculosis, active or quiescent;
- if you have a bacterial, viral or fungal infection;
- if you are pregnant and breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Consult your doctor or pharmacist before using Nebulcort.
Pay particular attention with NEBULCORT:
- If you have a respiratory infection, such as tuberculosis or an untreated infection caused by viruses, bacteria or fungi, or an eye infection caused by herpes simplex virus. In these cases, you should not use this medicine.
- If you have had or recently had nasal trauma with a wound (ulcer) to the nasal septum or with recurrent bleeding (epistaxis), as this medicine slows down wound healing.
- If you use NEBULCORT for a long period of time, as this medicine can alter the natural microbial flora of the airways. In this case, covering therapy (restoration of the natural microbial flora) may be necessary. Prolonged use of the medicine can also lead to sensitization phenomena and, sometimes, to undesirable effects (see section “Possible side effects”). In this case, discontinue treatment and consult your doctor to establish appropriate therapy.
- If you use NEBULCORT for prolonged periods and at high doses, as it can cause a reduction in the activity of the gland that regulates the stress response (adrenal gland) and a reduction in the natural growth of the mucous membranes.
- Inhaled corticosteroids such as NEBULCORT can cause general undesirable effects due to hormonal imbalance, especially when prescribed at high doses for prolonged periods. Some of these effects include Cushing's syndrome (excess hormones in the bloodstream), cushingoid appearance (swelling of the face or trunk), adrenal suppression (suppression of the function of the gland that regulates the stress response), growth retardation in children and adolescents, reduced bone mineral density, cataracts and glaucoma. Rarely, a series of psychological and behavioral undesirable effects can occur, including psychomotor hyperactivity, sleep disturbances, anxiety,depression, aggression, (especially in children).
- If you are switching from systemic steroid therapy, for example by mouth, to therapy with NEBULCORT, as alterations of the gland that regulates the stress response (adrenal gland) may be in progress. Generally, systemic treatment should not be stopped abruptly. If you are receiving systemic treatment, you need medical supervision and special precautions, because the recovery of adrenal function (the gland that regulates the stress response) is slow. In this case, your disease (respiratory) must also be relatively "stabilized" by systemic therapy. Initially, your doctor will advise you to use NEBULCORT while continuing systemic treatment, gradually reducing the latter, monitoring adrenal function and modifying the dose of NEBULCORT according to the results obtained. During periods of stress or severe asthma attack, if you have switched from systemic treatment to NEBULCORT, you will need supplementary systemic steroid treatment. You should also undergo periodic checks of cortico-adrenal function (the gland that regulates the stress response), including measurements of cortisol levels (a hormone) in the morning in a resting state.
- If you are undergoing continuous treatment with steroid medications, as in this case a gradual and controlled transition from oral (by mouth) to topical endobronchial therapy (administered directly into the bronchi) is recommended.
The effect of NEBULCORT is not immediate, so this medicine is not effective during ongoing asthma crises.
Follow a regular use of this medicine for several days.
The use of NEBULCORT can mask some symptoms of infection and can also lead to new
infections.
decrease the dose without first consulting your doctor. Exceeding the recommended doses, in addition to
not improving the therapeutic efficacy of NEBULCORT, carries the risk of systemic effects from
absorption (general undesirable effects).
Contact your doctor if you experience blurred vision or other visual disturbances.
For athletes: the use of the drug without therapeutic need constitutes doping and
may still result in positive anti-doping tests.
Children and adolescents
Nebulcort is not recommended in children under four years of age.
Be careful when using this medicine in children, as general undesirable effects such as growth retardation in children and adolescents may occur. Rarely, a series of psychological and behavioral undesirable effects can occur, including
psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders
Other medicines and Nebulcort
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
The medicine is not recommended during the first three months of pregnancy. In the further period of
pregnancy and during breastfeeding, the medicine should only be administered in cases of actual need
and under the direct control of the doctor.
Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery are known.
NEBULCORT contains propylene glycol
This medicine contains 1036 mg of propylene glycol per maximum daily dose in adults
(equivalent to 50 drops) and 528 mg of propylene glycol per maximum daily dose in children (equivalent to 25
drops).
3. How to take Nebulcort
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Use in adults
The recommended dose is: 1 mg (25 drops) 2 times a day.
Use in children and adolescents
The recommended dose is: 500 micrograms (12-13 drops) 2 times a day.
It is not advisable to administer to children under four years of age.
One drop contains 40 micrograms of flunisolide.
NEBULCORT must be used with electric nebulizers.
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.
Taking this into account, it is necessary to consider, during preparation, the need to supplement the
non-deliverable part.
If you use more Nebulcort than you should
In case of ingestion/accidental intake of an excessive dose of NEBULCORT, immediately inform
your doctor or go to the nearest hospital.
Administration of large quantities of flunisolide in a short period of time may determine
the suppression of some important hormonal functions (the hypothalamus-pituitary-adrenal axis). In this
case, immediately return to the recommended dose.
If you forget to take Nebulcort
Do not use a double dose to make up for a missed dose.
If you stop taking Asmaflu
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects in a severe form, inform your doctor immediately as it may be necessary to stop the therapy:
- nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea);
- changes in voice (hoarseness), sore throat, irritation of the oral cavity or pharynx.
See a doctor if you experience any of the following side effects:
Frequency not known(frequency cannot be estimated based on available data):
- Fungal infections in the mouth or throat. These side effects disappeared quickly after appropriate local therapy. These infections can be prevented or minimized by rinsing the mouth thoroughly after each administration.
- Cough and hoarseness: especially in particularly sensitive patients after inhalation of the aerosol.
- 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 drugs of a corticosteroid nature, and are a consequence of reducing systemic therapy. These patients should still be kept under strict control 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 the function of the adrenal gland with consequent lowering of blood pressure and weight loss)
- Cushing's syndrome (excess hormones in the bloodstream), Cushingoid appearance (swelling of the face or trunk),
- Impairment of adrenal function
- Growth retardation in children and adolescents
- Reduction in bone mineral density;
- Eye diseases such as cataracts and glaucoma.
- Psychological and behavioral events including psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral disorders (particularly in children).
- Blurred vision
Reporting of side effects
If you experience any side effect, including 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 Nebulcort
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 pack after “Scad.”. The
expiry date refers to the last day of that month.
Store at a temperature below 25°C
Store in the original packaging to protect the medicine from light.
Use the medicine within 30 days of first opening the bottle. Any unused medicine must
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
What Nebulcort contains
- The active ingredient is flunisolide. 1 ml of solution contains 1 mg of flunisolide. One drop of NEBULCORT contains 40 micrograms of flunisolide.
- The other ingredients are propylene glycol ,sodium chloride, purified water.
Description of the appearance of Nebulcort and contents of the pack
Solution for nebulizer.
Box with a 30 ml bottle of solution for nebulizer.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
ITC FARMA S.r.l.
Viale Pier Luigi Nervi, 164
04100 Latina
Manufacturer
Genetic S.P.A. - Contrada Canfora – Industrial Area - 84084 Fisciano (SA)
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- Kraj rejestracji
- Postać farmaceutycznaSolution for nebulization, 1 MG/ML
- Kod ATCR03BA03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki NEBULKORTPostać farmaceutyczna: Solution for nebulization, 0.1%Substancja czynna: flunisolideProducent: S.F. GROUP S.R.L.Wymaga receptyPostać farmaceutyczna: Solution for nebulization, 0.1%Substancja czynna: flunisolideProducent: PIAM FARMACEUTICI S.P.A.Wymaga receptyPostać farmaceutyczna: Solution for nebulization, 0.1%Substancja czynna: flunisolideProducent: GENETIC S.P.A.Wymaga recepty
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NEBULKORT wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w NEBULKORT jest flunisolide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
NEBULKORT jest produkowany przez ITC FARMA S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie NEBULKORT jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić NEBULKORT w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (flunisolide) to m.in. AERFLU, AEROLID, ASMAFLU. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
