Flunigar

Italy
Brand name Flunigar
Form solution for nebulizer
Active substance / Dosage
FLUNISOLIDE
Prescription type Prescription only
ATC code
R03BA03
Registration number 034968
Manufacturer ABC FARMACEUTICI S.P.A.

Table of Contents

Package leaflet: Information for the user

FLUNIGAR 1mg/ml nebulising solution

Flunisolide
Generic medicine
Please read all of 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including any 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 using 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 FLUNIGAR is and what it is used for

This medicinal product contains the active substance flunisolide, which belongs to a group of medicines called corticosteroid anti-inflammatory drugs ("CSD", glucocorticoids).
FLUNIGAR is indicated for the treatment of allergic conditions affecting the respiratory tract, such as:

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

2. What you should know before using FLUNIGAR

Do not use FLUNIGAR

  • if you are allergic to flunisolide or to 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 section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using FLUNIGAR.
Avoid using this medicine for prolonged periods and at high doses, as undesirable effects may occur, such as growth retardation in children and adolescents, bone fragility, eye problems (cataract and glaucoma), mucosal problems (atrophy), hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioural disorders (especially in children) (see section “Possible side effects”).
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 may mask symptoms of infections and may lead to new infections.
Pay special attention in the following cases:

  • if you are switching from systemic corticosteroid therapy to treatment with flunisolide, especially if you are under physical stress or have recently had a severe asthma attack, since 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 close medical supervision. Your doctor will advise you on the appropriate dose and method of administration for switching 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 reach and contact the mucosa.
  • if you have a lung infection (active or quiescent tuberculous infections) or an untreated fungal, bacterial, or viral infection, or an eye infection caused by the Herpes simplex virus. Consult your doctor, as in these cases it may be advisable to avoid using this medicine.
  • if you have or have previously had nasal trauma, septal lesions, or persistent nosebleeds (epistaxis), since this medicine may delay wound healing (cicatrization processes);
  • if during treatment you develop an alteration of the bacteria (microflora) present in the respiratory tract (dysmicrobism). Consult your doctor, as concomitant therapy may be required.
  • if you are experiencing an asthma attack, since the medicine is not effective in this case, as its effect becomes evident only after several days of treatment.

Children
The use of FLUNIGAR is not recommended in children under 4 years of age.
Other medicines and FLUNIGAR
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of FLUNIGAR, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
FLUNIGAR is not recommended during the first three months of pregnancy.
Use this medicine after the first three months of pregnancy only if necessary and under direct medical supervision.
Breastfeeding
If you are breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.
Driving and using machines
There are no data available to assess the effects of FLUNIGAR on the ability to drive vehicles or operate machinery.

3. How to use FLUNIGAR

Use this medicine exactly as directed by your doctor or pharmacist. 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 result in residual medicine adhering to the walls of the ampoule or settling at the bottom, thus not being fully delivered. Please take this into account during the preparation phase of the medicine.
The recommended dose in adults is 1 mg (25 drops) twice daily.
Use in children
The recommended dose is 500 micrograms (12–13 drops) twice daily.
If you take more FLUNIGAR than you should
If you (or someone else) have taken an excessive dose of FLUNIGAR, or if you suspect that a child may have ingested this medicine, inform your doctor immediately or go to the nearest hospital emergency department.
In case of overdose within a short period of time, hormonal disturbances may occur due to suppression of the connection between the brain and adrenal glands (hypothalamic-pituitary-adrenal axis suppression). If you experience these effects, reduce the dose immediately.
Take this leaflet, the bottle, and its container with you to the hospital or doctor so that they know which medicine has been taken.
If you forget to use FLUNIGAR
Do not take a double dose to make up for the forgotten dose.
If you stop using FLUNIGAR
Do not stop treatment with this medicine abruptly. Before stopping treatment, consult your doctor, who will advise you on how to gradually reduce the dosage.
If you have any questions 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.
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 (frequency cannot be estimated from the available data):

  • psychomotor hyperactivity;
  • sleep disorders;
  • anxiety and depression;
  • aggression;
  • behavioural disorders (mainly in children).

Only some patients, with particularly sensitive airways, have experienced cough and voice changes (hoarseness). Occasionally, a mild and transient burning sensation of the nasal mucosa may occur. Rarely, fungal infections in the mouth or throat have been observed, which disappeared rapidly following appropriate local treatment.
These infections can be prevented or minimized if patients thoroughly rinse their mouth after each administration.
Other observed side effects include: 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 treatment.
The most common adverse effect observed in corticosteroid-dependent patients has been the onset of nasal congestion and benign nasal growths (nasal polyps), due to the reduction of systemic corticosteroid therapy. Patients should nevertheless be kept under close medical supervision during prolonged treatment, in order to promptly detect any possible systemic manifestations (bone problems (osteoporosis), stomach and intestinal disorders (peptic ulcer), signs of secondary adrenocortical insufficiency, such as low blood pressure (hypotension) and weight loss), thus avoiding, in the latter case, serious complications caused by reduced and/or insufficient adrenal function (acute hypocortisolism).
Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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.

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 stated on the pack 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 via 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 substance is flunisolide. 1 ml of solution contains 1 mg of flunisolide (1 drop contains 40 micrograms of flunisolide).
The other components are: propylene glycol, sodium chloride, water for injections.

Description of the appearance of FLUNIGAR and contents of the pack
Pack containing one 30 ml bottle.

Marketing Authorization 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)