FLUNIGAR 1 mg /Ml Roztwór Do Nebulizacji
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Treść ulotki
- What is FLUNIGAR and what is it used for
- What you need to know before using FLUNIGAR
- How to use FLUNIGAR
- Possible side effects
- How to store FLUNIGAR
- Contents of the pack and other information
FLUNIGAR 1mg/ml solution for nebulisation
Flunisolide
Generic medicine
Read this leaflet carefully before you start using 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 they have the same symptoms as you, as it may 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 FLUNIGAR is and what it is used for
- 2. What you need to know before you use FLUNIGAR
- 3. How to use FLUNIGAR
- 4. Possible side effects
- 5. How to store FLUNIGAR
- 6. Contents of the pack and other information
1. What is FLUNIGAR and what is it used for
This medicine contains the active ingredient flunisolide, which belongs to a group of medicines
called anti-inflammatory steroid drugs (“FAS”, glucocorticoids).
FLUNIGAR is indicated for the treatment of allergic conditions affecting the respiratory tract, such as:
- inflammation of the bronchi with difficulty breathing (bronchial asthma and chronic asthmatic bronchitis);
- chronic and seasonal rhinitis.
2. What you need to know before using FLUNIGAR
Do not use FLUNIGAR
- if you are allergic to flunisolide or any of the other ingredients of this medicine (listed in section 6);
- if you have a lung infection (active or quiescent pulmonary tuberculosis);
- if you have infections caused by bacteria, viruses or fungi;
- if you are pregnant or breastfeeding, unless after careful evaluation by your doctor (see the “Pregnancy and breastfeeding” section).
Warnings and precautions
Consult your doctor or pharmacist before using FLUNIGAR.
Avoid using this medicine for prolonged periods and at high doses because adverse effects such as delayed growth in children and adolescents, bone fragility, eye problems (cataract and glaucoma), mucosal problems (atrophy), hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (especially in children) may occur
(see the “Possible side effects” section).
If you use FLUNIGAR for prolonged periods, allergic reactions (sensitization phenomena) may also occur.
Stop treatment if you experience any of these effects and do not exceed the recommended doses.
Contact your doctor if you experience blurred vision or other visual disturbances.
This medicine can mask the symptoms of infections and can cause new infections to occur.
Pay particular attention in the following cases:
- if you need to switch from systemic corticosteroid therapy to treatment with flunisolide, especially if you are in a period of stress or have had a severe asthma attack, as this medicine may cause adrenal insufficiency. If this occurs, discontinue treatment gradually. The replacement of systemic corticosteroid therapy with topical therapy must be carried out under strict medical supervision. Your doctor will indicate the dose and method of administration to switch from one therapy to another.
- if you have severe nasal congestion or abundant mucus (secretion). In this case, initial treatment with medicines (topical vasoconstrictors) that clear the airways may be necessary to allow the aerosol to come into contact with the mucosa.
- if you have a lung infection (active or quiescent tuberculosis infections) or have an untreated infection caused by fungi, bacteria or viruses or have an eye infection caused by the Herpes simplexvirus. Consult your doctor as, in these cases, it may be appropriate to avoid using this medicine.
- if you have or have had nasal trauma in the past, with lesions of the nasal septum or continuous bleeding (epistaxis), as this medicine delays wound healing (scarring processes);
- if you develop an alteration of the bacteria (flora) present in the respiratory tract (dysmicrobism) during treatment. Consult your doctor as coverage therapy may be necessary.
- if you are having an asthma attack, as the medicine is not effective because its effect only manifests after a few days of treatment.
Children
The use of FLUNIGAR is not recommended in children under 4 years of age.
Other medicines and FLUNIGAR
Tell your doctor if you are taking or have recently taken any other medicines, including over-the-counter medicines.
Some medicines may increase the effects of Flunigar 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, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
FLUNIGAR is not recommended in the first three months of pregnancy.
Use this medicine after the first three months of pregnancy only if necessary and under the direct supervision of your doctor.
Breastfeeding
If you are breastfeeding, use this medicine only if strictly necessary and under the direct supervision of your doctor.
Driving and operating machinery
No data are available to establish the effects of FLUNIGAR on the ability to drive vehicles and operate machinery.
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3. How to use FLUNIGAR
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
Method of administration:Use FLUNIGAR with electric nebulizers and do not dilute it. The use of
nebulizers may determine the production of residues of the medicine that may adhere to the
walls of the vial or to the bottom and therefore not be delivered. Take this into account
during the preparation phase of the medicine.
The recommended dose in adults is 1 mg (25 drops) 2 times a day.
Use in children
The recommended dose is 500 micrograms (12-13 drops) 2 times a day.
If you take more FLUNIGAR than you should
If you (or someone else) have taken an excessive dose of FLUNIGAR or if you think a child
may have taken this medicine, inform your doctor immediately or go to the Emergency
Room of the nearest hospital.
In case of an excessive administration of this medicine, in a short period of time, hormonal
disorders may occur due to a block of the connection between the brain and the adrenal glands
(suppression of the hypothalamic-pituitary-adrenal function). If you experience these effects, reduce
the dose immediately.
Bring this leaflet, the bottle and its container with you to the hospital or to the doctor so that
they know which medicine was taken.
If you forget to use FLUNIGAR
Do not use a double dose to make up for a missed dose.
If you stop using FLUNIGAR
Do not abruptly stop treatment with this medicine. Before stopping the
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, this medicine can cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:
Uncommon(may affect up to 1 in 100 people):
- blurred vision.
Frequency not known(the frequency cannot be estimated from the available data):
- psychomotor hyperactivity;
- sleep disturbances;
- anxiety and depression;
- aggression;
- behavioural disorders (mainly in children).
Only some patients with very sensitive airways have experienced cough and alteration of the voice
(hoarseness). Occasionally, mild and transient burning of the nasal mucosa may occur. Rarely
oral or throat fungal infections have been observed, which have disappeared quickly after
appropriate local therapy.
These infections can be prevented or minimised if patients carefully rinse their mouths after each
administration.
Other side effects observed are: nasal irritation, nosebleeds (epistaxis),
nasal congestion, runny nose (rhinorrhea), sore throat, hoarseness and irritation of the oral cavity and
mouth. If severe, these side effects may require discontinuation of therapy.
The most common side effect found in corticosteroid-dependent patients was the appearance of
nasal congestion and benign nodules in the nose (nasal polyps), due to the reduction of
systemic corticosteroids. Patients should nevertheless be kept under strict control in case of
prolonged treatments, in order to promptly ascertain the possible appearance of systemic
manifestations (problems with the bones (osteoporosis), disorders of the stomach and intestines (peptic ulcer),
signs of secondary adrenal insufficiency, such as low blood pressure
(hypotension) and weight loss) in order to avoid in the latter event serious incidents
caused by reduced and/or insufficient adrenal function (acute adrenal insufficiency).
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 http://www.aifa.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
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5. How to store FLUNIGAR
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 packaging after Exp. The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
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 FLUNIGAR contains
The active ingredient is flunisolide. 1 ml of solution contains 1 mg of flunisolide (1 drop contains 40
micrograms of flunisolide).
The other ingredients are: propylene glycol, sodium chloride, water for injections.
Description of the appearance of FLUNIGAR and contents of the pack
Pack containing a 30 ml bottle.
Marketing Authorisation Holder
ABC FARMACEUTICI SPA – Corso Vittorio Emanuele II, 72 - Turin
Manufacturers
Farmila- Thea Farmaceutici S.p.A. - Via E. Fermi, 50 20019 - Settimo Milanese (MI)
C.O.C Farmaceutici S.r.l. Via Modena, 15 40019 - Sant’Agata Bolognese (BO)
GENETIC S.p.A. Contrada Canfora 84084 – Fisciano (Sa)
- 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 FLUNIGARPostać 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 FLUNIGAR w innych krajach
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Odpowiednik FLUNIGAR w Hiszpania
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FLUNIGAR wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w FLUNIGAR jest flunisolide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
FLUNIGAR jest produkowany przez ABC FARMACEUTICI S.P.A.. 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 FLUNIGAR 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 FLUNIGAR 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.
