ELIOSID 2 mg /2 Ml Roztwór Do Nebulizacji
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Jak stosować ELIOSID
Treść ulotki
ELIOSID 2 mg/2 ml solution for nebulizer vials of 2 ml, 1 mg/2 ml solution for nebulizer vials of 2 ml
Flunisolide
Equivalent medicine
Read this leaflet carefully before you take 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
- If any side effect occurs, including those not listed in this leaflet, tell 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 you take ELIOSID
- 3.How to take ELIOSID
- 4.Possible side effects
- 5.How to store ELIOSID
- 6.Contents of the pack and other information
1. What is ELIOSID and what is it used for
ELIOSID contains the active ingredient flunisolide.
Flunisolide belongs to a group of drugs called antiasthmatic glucocorticoids which
exert a marked action against allergies and inflammatory states. ELIOSID is indicated in the
treatment of allergic conditions of the upper respiratory tract: bronchial asthma, chronic bronchitis
of the asthmatic type and chronic and seasonal irritations/inflammations of the nasal mucosa (rhinitis).
2. What you need to know before you take 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 suffer from a disease known as pulmonary tuberculosis, whether active or quiescent.
- If you have contracted 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 drugs belonging to the class of corticosteroids. Your doctor will closely monitor your response to therapy, advising you to take ELIOSID initially concurrently and then gradually reduce systemic corticosteroid treatment.
- During periods of stress or severe asthma attack, your doctor may advise additional therapy with systemic steroids and will subject you to frequent tests to assess the functionality of your adrenal gland. A gradual transition from systemic to localized inhalation therapy at the bronchial level is recommended.
- If you suffer from impaired adrenal function, the transfer from systemic steroid therapy to therapy with Flunisolide must be carried out with great caution. Abrupt discontinuation of systemic treatment is generally to be avoided.
- If you have contracted active or quiescent tuberculosis infections of the respiratory tract or untreated infections from fungi, bacteria or viruses, or with herpes simplex in the eyes, of a tuberculous nature whether active or quiescent.
- If you have suffered previous or recent nasal trauma, if you suffer from lesions (ulcers) of the nasal septum or if you have frequent episodes of nosebleeds (epistaxis). The use of flunisolide inhibits the healing process.
- If you have an asthma crisis in progress, as the effect of flunisolide is not immediate, it is advisable to adhere to regular use of ELIOSID at the prescribed doses and for several days until your doctor deems it appropriate.
Prolonged use of ELIOSID may cause:
- phenomena of sensitization (i.e. administration of a given dose of the drug may have a greater effect than that obtained with the first administration) and the classic systemic adverse effects expected for this medicine. In these cases, contact your doctor who will indicate the most suitable therapy.
- the onset of the following adverse effects, if taken at high doses by inhalation (through the upper airways): possibility of inhibition of adrenal gland activity, atrophy of the mucous membranes, growth retardation in children and adolescents, reduction of bone mineral density, cataracts, glaucoma. It is therefore important that you take the lowest possible dose of inhaled corticosteroid drugs, effective for effective asthma control. (See section 4).
- alteration of the bacterial flora, although rarely reported. In this case, your doctor will advise you to check for any changes in the microbial flora of the upper airways and, if necessary, start covering therapy. Pay particular attention to these possible situations:
- Increasing the dose does not improve the therapeutic efficacy of the product and involves an increased risk of developing adverse effects. Do not take a dose of ELIOSID higher than the recommended one.
The effect of ELIOSID, as with all corticosteroids administered by inhalation, is not immediate.
Therefore, it is important to remember that ELIOSID is not effective in acute asthma crises and
that it is advisable to adhere to regular use of the product for several days
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 athletes
The use of ELIOSID without therapeutic necessity constitutes doping and may still result in
positive anti-doping tests.
Other medicines and ELIOSID
Tell 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.
- Tell your doctor if you are taking or have recently taken other medicines, including over-the-counter medicines.
- Some medicines may increase the effects of ELIOSID and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
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 taking this medicine.
The use of Flunisolide is not recommended during the first three months of pregnancy. Use in the
second and third trimesters of pregnancy and during breastfeeding should only occur under direct
guidance of your doctor who will assess whether the potential benefits outweigh the possible risks.
Driving and operating machinery
ELIOSID does not impair the ability to drive vehicles or operate machinery
3. How to take ELIOSID
Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask your doctor or pharmacist.
The medicine should not be diluted.
Adults
Half the contents of a vial 2 mg/2 ml twice a day
Children
Half the contents of a vial 1 mg/2 ml twice a day
It is not advisable to administer to children under four years of age.
If you take more ELIOSID than you should
In the event of administering excessive doses of ELIOSID nasal spray solution, immediately reduce the doses and inform your doctor or go to the nearest hospital.
Administering large amounts of flunisolide in a short period of time can determine the impairment of the hypothalamus, pituitary gland and adrenal gland (the hypothalamus-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 use ELIOSID, do not take a double dose to make up for the missed dose.
If you stop taking ELIOSID
Do not stop treatment with the medicine unless your doctor tells you to. The onset of the effect is not immediate. Use the product regularly and for several days as prescribed by your doctor.
I4. Possible side effects
Like all medicines, ELIOSID can cause side effects, although not everyone gets them.
The side effects are listed below, subdivided by organ, apparatus/system and frequency. The frequencies are defined as: very common (> 1/10), common (> 1/100, <1>1/1000, <1>1/10000, <1>
Common side effects:
- nasal irritation, nasal burning, nasal congestion, nasal polyps, runny nose (rhinorrhea), epistaxis, sore throat, oro-pharyngeal irritation, cough, changes in voice (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 have disappeared rapidly after appropriate local therapy. These infections can be prevented or minimized if patients rinse their mouth thoroughly 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 case of inappropriate use, even if to a limited extent, can the typical effects of corticosteroids administered systemically occur.
The following side effects may occur in case of use of high doses of flunisolide for long periods:
- Impairment of adrenal function.
- Growth retardation in children and adolescents.
- Reduction of bone mineral density.
- Eye diseases such as cataract and glaucoma.
Other side effects that may occur with flunisolide with unknown frequency(the frequency cannot be estimated based on available data):
- Psychiatric adverse events including psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral disorders (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 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
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 of first opening the vial. Any excess product
must be discarded.
Do not use this medicine after the expiry date which is stated on the label after “Exp.”. The
expiry date refers to the last day of that month.
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
ELIOSID2 ml solution for nebulizer
One 2 ml vial contains:
Active ingredient: Flunisolide mg 2
Other components: Propylene glycol, sodium chloride, citric acid, sodium citrate, water for
injections
ELIOSID2 ml solution for nebulizer
One 2 ml vial contains:
Active ingredient: Flunisolide mg 1
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 nebulizer
Pack of 15 vials of 2 ml solution 2 mg/2 ml
Pack of 15 vials of 2 ml solution 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)
CO:
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- Kraj rejestracji
- Postać farmaceutycznaSolution for nebulization, 2 MG/2 ML
- Kod ATCR03BA03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ELIOSIDPostać 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
Odpowiedniki ELIOSID w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik ELIOSID w Hiszpania
Lekarze online w sprawie ELIOSID
Omów stosowanie ELIOSID, bezpieczeństwo i ocenę zasadności recepty zgodnie z obowiązującymi przepisami.
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Często zadawane pytania
ELIOSID wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ELIOSID jest flunisolide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ELIOSID jest produkowany przez DYMALIFE PHARMACEUTICAL 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 ELIOSID 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 ELIOSID 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.
