LUNIS 5 mg /14 Ml Nasal Spray, Solution

Зміст інструкції

1. Lunis 5 mg/14 ml nasal spray, solution
   1. What is Lunis and what is it used for
   2. What you need to know before using Lunis
   3. How to use Lunis
   4. Possible side effects
   5. How to store Lunis
   6. Contents of the pack and other information

Lunis 5 mg/14 ml nasal spray, solution

Flunisolide
Generic Medicine

Read this leaflet carefully before 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 Lunis is and what it is used for
• 2. What you need to know before you use Lunis
• 3. How to use Lunis
• 4. Possible side effects
• 5. How to store Lunis
• 6. Contents of the pack and other information

1. What is Lunis and what is it used for

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

2. What you need to know before using Lunis

Do not use Lunis

• if you are allergic to flunisolide or any of the other ingredients of this medicine (listed in section 6);
• if you have a bacterial, viral or fungal infection in 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 other visual disturbances
Take special care with Lunis:

• If sensitization phenomena occur. The use, especially if prolonged, of topical products can also give rise to these phenomena. In such a case, discontinue 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 absorption to determine effects on the body (systemic), there is a possibility of a decrease in cortisol production (adrenal suppression), which must be considered if the medicine is used for too long.
• Talk to your doctor or pharmacist if, after prolonged use and high doses of intranasal corticosteroids, you experience the following conditions:
• Cushing's syndrome (excess hormones in the bloodstream),
• cushingoid appearance (swelling of the face or trunk),
• adrenal suppression (suppression of the function of the gland that regulates the stress response),
• growth retardation in children and adolescents,
• reduction of bone mineral density,
• cataract (loss of transparency of vision) and glaucoma (damage to the optic nerve),
• psychological and behavioral changes including psychomotor hyperactivity (mania), sleep disturbances, anxiety, depression or aggression (particularly in children).

If you switch from systemic steroid therapy, for example by mouth, to therapy with Lunis,
because alterations of the gland that regulates the stress response
(adrenal gland) may be in progress.
Glucocorticoids (anti-inflammatory drugs such as Lunis) can mask some signs of
infection and new infections may appear during their use.
doctor. The use of doses higher than those recommended can worsen the
symptoms.
The effect, as with all nasal corticosteroids, is not immediate; therefore, adhere to
regular use of the medicine for several days.

Children and adolescents
Lunis nasal spray can be used in children from 5 years of age.
Take care when using Lunis in children and adolescents, as this type of medicine
can cause general adverse effects caused by 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 number of psychological and behavioral side effects may occur
including psychomotor hyperactivity (mania), sleep disturbances,
anxiety, depression or aggression.

Other medicines and Lunis
Tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines can increase the effects of Lunis 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 using this medicine.
Lunis is not recommended during the first three months of pregnancy.
In the subsequent period and during breastfeeding, use this medicine only
if absolutely necessary and under the direct control of your doctor.

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

Lunis containspropylene glycol
This medicine contains 29 mg of propylene glycol per dose (1 spray) of Lunis
equivalent to 0.42 mg/kg in adults (70 kg) and to 0.73 mg/kg in children (40 Kg).
This amount is equivalent (for maximum daily dose) to 4.98 mg/kg/day in adults
(70 kg) and to 2.18 mg/kg/day in children over 5 years of age (40kg) (see section 3.
“How to use Lunis”).

3. How to use Lunis

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dosesare:

Adults: 2 metered sprays per nostril, two - three times a day.
For very prolonged therapies, the dose may be reduced to 1 metered spray per nostril, two -
three times a day.
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 a day.
The maximum daily dose is 3 sprays in each nostril.

Instructions for use
When the spray is used for the first time, it is advisable to precede the
administration with 4 empty sprays.

• 1. Shake.
• 2. Remove the safety clip.
• 3. Remove the protective cap.
• 4. Press firmly and decisively, with the index and middle fingers from top to bottom.
• 5. Replace the cap.
• 6. Reapply the safety clip.

If the nasal applicator becomes blocked, wash it with lukewarm water.

If you use more Lunis than you should
In case of ingestion/accidental intake of an excessive dose of Lunis, immediately inform
your doctor or go to the nearest hospital.
Administration of large quantities of the medicine in a short period of time may
determine the suppression of a system of hormonal glands that regulate various
functions of the body including sleep, response to stress, appetite, body temperature
and growth. Immediately return to the recommended dose.

If you forget to use Lunis
Do not use a double dose to make up for a missed dose.
If you have any doubts 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.

Side effects with unknown frequency(frequency cannot be estimated based on available data):

• blurred vision
• mild transient burning
• stinging
• nasal irritation
• nosebleed (epistaxis)
• stuffy nose
• runny nose (rhinorrhea)
• sore throat
• hoarseness
• throat irritation. If severe, these side effects may require discontinuation of therapy.

Effects on the body (systemic) can occur with intranasal corticosteroids, particularly if prescribed at high doses for prolonged periods. These may include delayed growth in children and adolescents.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please 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 Lunis

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
“Expires on.”. The expiry date refers to the last day of that month. The expiry date
indicated refers to the product in intact packaging, correctly stored.
Do not use this medicine after 120 days from the first opening of the bottle.
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 Lunis contains
The active ingredient is flunisolide. One bottle contains 5 mg of flunisolide. Each spray delivers
0.025 mg of flunisolide.
The other ingredients are: sodium edetate, citric acid, trisodium citrate, propylene
glycol, 1N hydrochloric acid, purified water.

Description of the appearance of Lunis and contents of the pack
Lunis is presented as a nasal spray, solution.
Bottle for 200 sprays.

Marketing authorisation holder and manufacturer
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milano