FLUNISOLIDE MYLAN GENERICS

Package leaflet: Information for the user

Flunisolide Mylan Generics 0.1% solution for nebuliser

flunisolide
Generic medicine
Read this entire leaflet carefully before using 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 for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Flunisolide Mylan Generics is and what it is used for
2. What you need to know before using Flunisolide Mylan Generics
3. How to use Flunisolide Mylan Generics
4. Possible side effects
5. How to store Flunisolide Mylan Generics
6. Contents of the pack and other information

1. What Flunisolide Mylan Generics is and what it is used for

This medicine contains the active substance flunisolide, which belongs to a group of medicines called corticosteroid anti-inflammatory drugs (“CSD”, glucocorticoids).
Flunisolide Mylan Generics is indicated for the treatment of allergic conditions affecting the respiratory tract, such as:

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

2. What you need to know before using Flunisolide Mylan Generics

Do not use Flunisolide Mylan Generics

• 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 disease (active or quiescent pulmonary tuberculosis);
• if you have infections caused by bacteria, viruses, or fungi;
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before using Flunisolide Mylan Generics.
Avoid using this medicine for prolonged periods and at high doses, as undesirable effects may occur, such as
Cushing's syndrome (a condition caused by excessive production of a hormone, cortisol), Cushingoid appearance
(characterized by localized obesity mainly in the abdomen, face, and back), mucosal problems (atrophy), adrenal
insufficiency (inability of the adrenal glands to produce sufficient cortisol), bone fragility, eye problems
(cataract and glaucoma), growth retardation in children and adolescents, sleep disturbances, hyperactivity,
anxiety, depression, aggression, behavioral disorders (especially in children) (see section “Possible
side effects”).
If you use Flunisolide Mylan Generics 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.
Consult your doctor if you have blurred vision or other visual disturbances.
This medicine may mask symptoms of infections and may lead to new infections.
Pay particular attention in the following cases:

• if you are switching from systemic corticosteroid therapy to flunisolide treatment, especially during periods of stress or after 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 advise you on the appropriate dose and administration method for transitioning between therapies.
• if you have severe nasal congestion or excessive 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), untreated fungal, bacterial, or viral infections, 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), as this medicine may delay wound healing (scar formation);
• if during treatment you develop an alteration of the bacteria (microflora) present in the respiratory tract (dysbiosis). Consult your doctor, as concomitant therapy may be required.
• if you are experiencing an asthma attack, as this medicine is not effective since its effect only becomes apparent after several days of treatment;
• if you experience symptoms of adrenal insufficiency such as loss of appetite (anorexia), abdominal pain, weight loss, fatigue, headache, nausea, vomiting, low blood glucose (hypoglycemia) with reduced consciousness and/or seizures. These effects may occur following trauma, surgery, infections, or rapid dose reduction.

For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Children and adolescents
Avoid using this medicine for prolonged periods and at high doses, as undesirable effects such as growth retardation, hyperactivity, sleep disturbances, anxiety, depression, aggression, and behavioral disorders (especially in children) may occur (see section 4).
Other medicines and Flunisolide Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may increase the effect of Flunisolide Mylan Generics, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Flunisolide Mylan Generics may be used during treatment with bronchodilators, chemotherapeutic agents, and in the replacement phase of oral corticosteroid therapy.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Flunisolide Mylan Generics 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.
This medicine contains 518 mg of propylene glycol per dose (1 mg), equivalent to 20.72 mg/kg/day.
Driving and using machines
There are no data available to determine the effects of Flunisolide Mylan Generics on the ability to drive vehicles or operate machinery.

3. How to use Flunisolide Mylan Generics

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 Flunisolide Mylan Generics with electric nebulizers, including ultrasonic nebulizers, and it may be diluted with physiological saline solution. The use of nebulizers may result in the formation of residual medication that may adhere to the walls of the vial or settle at the bottom, thus not being fully delivered. Please take this into account during the preparation phase of the medication.
The recommended dose in adults is 1 mg (25 drops) twice daily.
Use in children
The recommended dose is 20 micrograms/kg (equivalent to half a drop/kg) twice daily.
To determine the dose according to body weight, refer to the following table:

Instructions for use

1. To open the bottle, simultaneously press and turn the dropper cap counterclockwise.
2. After use, close the bottle by screwing the cap clockwise.
   Flunisolide Mylan Generics should be used with electric nebulizers, including ultrasonic ones, and may be diluted with physiological saline solution.
   Flunisolide Mylan Generics may be used during concomitant therapy with bronchodilators, chemotherapeutic agents, and corticosteroids in the replacement phase of oral corticosteroid therapy.

If you use more Flunisolide Mylan Generics than you should
If you (or someone else) have used an excessive dose of Flunisolide Mylan Generics, or if you think a child may have accidentally taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
Take this leaflet, the bottle, and its packaging with you to the hospital or doctor so they know which medicine has been taken.
If this medicine is used excessively over a short period of time, hormonal disturbances may occur due to suppression of the connection between the brain and the adrenal glands (hypothalamic-pituitary-adrenal axis suppression). If you experience these effects, reduce the dose immediately.

If you forget to use Flunisolide Mylan Generics
Do not use a double dose to make up for the forgotten dose.

If you stop using Flunisolide Mylan Generics
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 everybody gets them.
Contact your doctor if you experience any of the following side effects:

• cough, lowered voice or hoarseness, mild and temporary burning sensation of the nasal mucosa;
• fungal infections in the mouth or throat. These infections can be prevented or reduced by thoroughly rinsing the mouth after administration of this medicine by aerosol;
• nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhoea), sore throat, irritation of the mouth and throat. If these effects are severe, discontinue treatment.
• nasal congestion, development of benign nasal growths (nasal polyps), bone problems (osteoporosis), stomach and intestinal disorders (peptic ulcer), symptoms due to adrenal insufficiency such as reduced blood pressure and weight loss.

During prolonged treatment and with high doses, the following additional side effects may also occur: Cushing's syndrome (a condition caused by excessive production of a hormone, cortisol), Cushingoid appearance (characterized by localized obesity predominantly in the abdomen, face and back), adrenal insufficiency (inability of the adrenal glands to produce sufficient cortisol), growth retardation in children and adolescents, bone fragility, eye problems (cataract and glaucoma) and blurred vision, hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioural disorders (especially in children) (see section “Warnings and precautions”).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via 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 Flunisolide Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the product in the original packaging to protect it from light.
Use this medicine within 30 days of first opening the bottle. Dispose of any remaining medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Flunisolide Mylan Generics contains
The active substance is flunisolide. 100 ml of solution contain 100 mg of flunisolide (1 drop contains 40
micrograms of flunisolide).
The other components are: propylene glycol, sodium chloride, purified water.
Description of the appearance of Flunisolide Mylan Generics and package contents
Pack containing one 30 ml bottle.
Marketing Authorization Holder and Manufacturer
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)