Package leaflet: Information for the patient

Lunis 5 mg/14 ml nasal spray, 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lunis is and what it is used for
What you need to know before using Lunis
How to use Lunis
Possible side effects
How to store Lunis
Contents of the pack and other information

1. What Lunis is and what it is used for

The active substance of Lunis is flunisolide, a substance belonging to a group of
medicines called corticosteroids. Lunis is a topical (local) nasal medicine that
acts against inflammation by reducing or eliminating swelling of the nasal mucosa.
This medicine is used for the prevention and treatment of inflammatory conditions of the
nasal mucosa (rhinitis), including allergic, chronic and seasonal rhinitis, such as hay fever.

2. What you need to know before using Lunis

Do not use Lunis

if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6);
if you have a bacterial, viral, or fungal infection affecting the nasal area;
if you have tuberculosis.

Warnings and precautions
Talk to your doctor or pharmacist before using Lunis.
Contact your doctor if you experience blurred vision or any other visual disturbances.
Exercise particular caution with Lunis:

If signs of hypersensitivity occur. The use of topical products, especially if prolonged, may lead to such reactions. If this happens, stop treatment and consult your doctor to establish appropriate therapy.
If you need to use Lunis for a prolonged period. Although clinical studies have not shown sufficient systemic absorption to produce effects on the body, there remains a possibility of reduced cortisol production (adrenal suppression), which should be considered if the medicine is used for too long.
Talk to your doctor or pharmacist if, after prolonged use and at high doses of intranasal corticosteroids, any of the following conditions occur:
Cushing's syndrome (excess hormones in the bloodstream),
Cushingoid appearance (swelling of the face or trunk),
Adrenal suppression (reduced function of the gland regulating the stress response),
Growth retardation in children and adolescents,
Reduced bone mineral density,
Cataract (loss of lens transparency) and glaucoma (damage to the optic nerve),
Psychological and behavioral changes including psychomotor hyperactivity (restlessness), sleep disorders, anxiety, depression, or aggression (particularly in children).

If you are switching from systemic steroid therapy, for example oral, to treatment with Lunis,
be aware that alterations in the gland regulating the stress response (adrenal gland) may still be present.
Glucocorticoids (anti-inflammatory medicines such as Lunis) may mask certain signs of infection, and new infections may arise during treatment.
Take the dose of medicine as indicated in the package leaflet or as prescribed by your doctor. Using doses higher than recommended may worsen symptoms.
The effect, as with all intranasal corticosteroids, is not immediate; therefore, follow a regular dosing schedule for several days.

Children and adolescents
Lunis nasal spray can be used in children aged 5 years and older.
Be cautious when using Lunis in children and adolescents, as these medicines may cause general adverse effects due to hormonal imbalance. Some of these effects include growth retardation in children and adolescents. Regularly monitor the height of children receiving prolonged treatment with Lunis (see "Possible side effects").
Rarely, a range of psychological and behavioral adverse effects may occur, including psychomotor hyperactivity (restlessness), sleep disorders, anxiety, depression, or aggression.

Other medicines and Lunis
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 Lunis, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: Ritonavir, Cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Lunis is not recommended during the first three months of pregnancy.
During later stages of pregnancy and while breastfeeding, use this medicine only if clearly necessary and under direct medical supervision.

Driving and using machines
No effects on the ability to drive or operate machinery are known.

Lunis contains propylene glycol
This medicine contains 29 mg of propylene glycol per dose (1 spray) of Lunis, equivalent to 0.42 mg/kg in an adult (70 kg) and 0.73 mg/kg in a child (40 kg).
This amount corresponds (for maximum daily dose) to 4.98 mg/kg/day in an adult (70 kg) and 2.18 mg/kg/day in a child over 5 years of age (40 kg) (see section 3, "How to use Lunis").

3. How to use Lunis

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
Adults : 2 metered sprays per nostril, two to three times daily.
For prolonged treatment, the dose may be reduced to 1 metered spray per nostril, two to three times daily.
The maximum daily dose is 6 sprays in each nostril.
Use in children over 5 years of age : 1 metered spray per nostril, three times daily.
The maximum daily dose is 3 sprays in each nostril.

Instructions for use
When using the spray for the first time, prime the pump by releasing 4 sprays into the air.

Shake well.
Remove the safety clip.
Remove the protective cap.
Firmly press down with your index and middle finger from top to bottom.
Replace the cap.
Reapply the safety clip.

If the nasal nozzle becomes blocked, clean it with lukewarm water.
If you use more Lunis than you should
If you accidentally ingest or use an excessive amount of Lunis, inform your doctor immediately or go to the nearest hospital.
Administration of large quantities of the medicine within a short period of time may lead to suppression of an endocrine system that regulates various body functions, including sleep, stress response, appetite, body temperature, and growth. Return immediately to the recommended dose.
If you forget to use Lunis
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects with unknown frequency (frequency cannot be estimated from the available data):

blurred vision
mild transient burning sensation
itching
nasal irritation
nosebleeds (epistaxis)
nasal congestion
runny nose (rhinorrhea)
sore throat
hoarseness
throat irritation. If severe, these side effects may require discontinuation of treatment.

Systemic effects may occur with intranasal corticosteroids, particularly when prescribed at high doses over prolonged periods. These may include growth retardation in children and adolescents.
Following the instructions provided 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, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
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 Lunis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following
"Exp:". The expiry date refers to the last day of that month. The stated expiry date applies to the product in its original, unopened packaging, correctly stored.
Do not use this medicine 120 days after first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lunis contains
The active substance is flunisolide. One bottle contains 5 mg of flunisolide. Each spray delivers
0.025 mg of flunisolide.
The other ingredients are: edetate disodium, citric acid, trisodium citrate, propylene glycol,
hydrochloric acid 1N, purified water.
Description of the appearance of Lunis and contents of the pack
Lunis is a nasal spray, solution.
Bottle for 200 sprays.
Marketing Authorization Holder and Manufacturer
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan, Italy