LEVONIS 0.5 mg/ml Roztwór do nebulizacji
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Jak stosować LEVONIS
Treść ulotki
Levonis 0.1 % solution for nebulisation
Levonis adults solution for nebulisation
Levonis children 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 may be harmful.
- If you get any side effects, see your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Levonis is and what it is used for
- 2. What you need to know before you take Levonis
- 3. How to take Levonis
- 4. Possible side effects
- 5. How to store Levonis
- 6. Contents of the pack and other information
1. What is Levonis and what is it used for
Levonis contains the active ingredient flunisolide, a corticosteroid, with anti-inflammatory activity..
Levonis is indicated in allergic conditions of the respiratory tract:
- bronchial asthma, a disease characterized by inflammation and airway obstruction;
- chronic asthmatic bronchitis, a persistent inflammatory disease of the bronchi, accompanied by breathing difficulties;
- rhinitis, inflammation of the inner part of the nose, persistent (chronic) and seasonal.
2. What you need to know before taking Levonis
Do not take Levonis
- if you are allergic to flunisonide or any of the other ingredients of this medicine (listed in section 6);
- if you have an active or quiescent infectious disease called pulmonary tuberculosis;
- if you have infections caused by microorganisms such as bacteria, viruses or fungi;
- if you are pregnant and if you are breastfeeding (see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Levonis if:
- you have herpes simplex infections of the eyes;
- you have previous or recent nasal trauma, with lesions of the nasal septum that do not tend to heal (ulcers) or with recurrent nosebleeds (epistaxis);
- if you have a change in the microorganisms (microbial flora) present in the nose and throat (upper airways) which manifests especially during prolonged treatments, contact your doctor who will prescribe a covering therapy. Rarely, a series of psychological and behavioral effects may occur, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (especially in children).
The use, especially if prolonged, of the medicine can lead to sensitization phenomena and
exceptionally, undesirable effects involving the whole organism
(systemic) such as loss of appetite (anorexia), abdominal pain, weight loss, fatigue, headache, nausea, vomiting; specific symptoms in case of treatment with inhaled corticosteroids
include hypoglycemia with reduced consciousness and/or convulsions. In such cases, your doctor will
interrupt the treatment and institute appropriate therapy.
Contact your doctor if you experience blurred vision or other visual disturbances.
For those who practice sports: the use of the drug without therapeutic need constitutes doping and may
anyway determine positivity to anti-doping tests.
Children and adolescents
Levonis is not recommended for children under four years of age.
Other medicines and Levonis
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
Some medicines can increase the effects of Levonis and your doctor may want to keep you under
close observation 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
ask your doctor or pharmacist for advice before taking this medicine.
The medicine is not recommended in 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 using machines
No effects on the ability to drive and operate machines are known.
3. How to take Levonis
Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
Adults
Levonis 0.1 % solution for nebulisation
The recommended dose is: 1 mg (25 drops) 2 times a day.
Each drop contains 40 micrograms of flunisolide.
Levonis adults solution for nebulisation
The recommended dose is: half the contents of one container of Levonis adults 2 times a day.
Children
Levonis 0.1 % solution for nebulisation
The recommended dose is: 500 micrograms (12-13 drops) 2 times a day.
Each drop contains 40 micrograms of flunisolide.
It is not advisable to administer to children under four years of age.
Levonis children solution for nebulisation
The recommended dose is: half the contents of one container of Levonis children 2 times a day.
It is not advisable to administer to children under four years of age.
Instructions for use
Levonis must be used with electric nebulisers and must not be diluted.
As is known, the administration of medicines in solution by means of electric nebulisers results in 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.
If you take more Levonis than you should
The administration of large quantities of flunisolide in a short period of time can determine the suppression of some important hormonal functions (hypothalamic-pituitary-adrenal function).
If you forget to take Levonis
Do not take a double dose to make up for a missed dose.
If you stop taking Levonis
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.
The following side effects have been observed:
- cough and hoarseness in patients with very sensitive airways;
- sometimes mild and transient burning inside (mucosa) of the nose;
- rarely fungal infections in the mouth or throat that disappear quickly after appropriate local therapy. These infections can be prevented or minimized by rinsing the mouth thoroughly after each administration;
- nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea), sore throat, hoarseness and irritation of the mouth (oral cavity) and throat. If severe, these side effects may require discontinuation of therapy;
- only in case of excessive use of the medicine, even if to a limited extent, you can experience the typical effects of glucocorticosteroids administered systemically. Commonly, these have been observed in patients who take glucocorticosteroids for a long time (corticosteroid-dependent) as nasal congestion and nasal polyps. In the case of prolonged treatments, patients should be kept under strict medical supervision in order to promptly ascertain the possible appearance of manifestations involving the whole organism (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency such as hypotension and weight loss). At high doses used for long periods, suppression of the activity of the glands called adrenal glands, growth retardation in children and adolescents, reduction of bone mineral density, clouding of the eye (cataract) and prolonged damage to the optic nerve (glaucoma) can occur. Side effects that can occur with unknown frequency are:
- psychomotor hyperactivity;
- sleep disturbances;
- anxiety;
- depression;
- aggression;
- behavioral disorders (especially in children);
- blurred vision (with unknown frequency).
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.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 Levonis
Levonis 0.1 % solution for nebulisation
Store at a temperature not exceeding 25°C in the original package to protect the medicine
from light.
Use the medicine within 30 days of first opening the bottle. Any excess medicine must
be discarded.
Levonis adults solution for nebulisation
Levonis children solution for nebulisation
Store in the original package to protect the medicine from light.
Use the medicine within 12 hours of first opening the container. Any excess medicine must
be discarded.
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 the inscription
“Expiry”.
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
What Levonis contains
Levonis 0.1%solution for nebulisation
- The active ingredient is flunisolide. 100 ml of solution contains 100 mg of flunisolide.
- The other ingredients are propylene glycol, sodium chloride, water for injections.
Levonis adults solution for nebulisation
- The active ingredient is flunisolide. One 2 ml container of solution contains 2 mg of flunisolide.
- The other ingredients are propylene glycol, sodium chloride, water for injections.
Levonis children solution for nebulisation
- The active ingredient is flunisolide. One 2 ml container of solution contains 1 mg of flunisolide
- The other ingredients are propylene glycol, sodium chloride, water for injections.
Description of the appearance of Levonis and contents of the pack
Levonis 0.1%solution for nebulisation
Solution for nebulisation. 30 ml bottle of 0.1% solution.
One drop contains 40 micrograms of flunisolide.
Levonis adults solution for nebulisation
Solution for nebulisation.
Pack of 15 containers of 2 ml solution 2 mg/2 ml
Levonis children solution for nebulisation
Solution for nebulisation.
Pack of 15 containers of 2 ml solution 1 mg/2 ml
Marketing Authorisation Holder
Farto S.r.l., Viale Guidoni 97, 50127 Florence
Manufacturer
Levonis 0.1%solution for nebulisation
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)
Levonis adults solution for nebulisation
Levonis children solution for nebulisation
Genetic S.p.A. – Contrada Canfora – Fisciano (SA )
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- Kraj rejestracji
- Postać farmaceutycznaSolution for nebulization, 0.5MG/ML
- Kod ATCR03BA03
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki LEVONISPostać 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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LEVONIS wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w LEVONIS jest flunisolide. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
LEVONIS jest produkowany przez FARTO S.R.L. - FARMACO BIOCHIMICO TOSCANO. 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 LEVONIS 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 LEVONIS 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.
