ELTAIR 50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

1. Eltair 50 micrograms/spray nasal suspension, 100 micrograms/spray nasal suspension
   1. What Eltair is and what it is used for
   2. What you need to know before using/giving Eltair to the child
   3. How to use/give Eltair to the child
   4. Possible side effects
   5. How to store Eltair
   6. Contents of the pack and other information

Eltair 50 micrograms/spray nasal suspension, 100 micrograms/spray nasal suspension

Budesonide

Read this leaflet carefully before using/giving this medicine to the child
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 only for you or your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Eltair is and what it is used for
• 2. What you need to know before using/giving Eltair to the child
• 3. How to use/give Eltair to the child
• 4. Possible side effects
• 5. How to store Eltair
• 6. Contents of the pack and other information

1. What Eltair is and what it is used for

Eltair is a medicine containing the active substance budesonide.
Budesonide belongs to a group of medicines called “corticosteroids” and works by
reducing inflammation of the nasal mucosa.
Eltair is indicated in adultsand children over 6 years of agein the treatment of:

• irritations and inflammation of the nose (rhinitis) or allergic (such as hay fever) and non-allergic (vasomotor) or seasonal or perennial
• nasal polyps or treatment or prevention after surgery to remove them (polypectomy)

What are hay fever and perennial rhinitis?
Hay fever, which occurs at certain times of the year, is an allergic reaction
caused by breathing in pollen from some plants, grasses and weeds, but also molds and
fungal spores.
Perennial rhinitis occurs throughout the year and its symptoms may be due to a
sensitivity to a wide range of elements such as dust mites, animal hair (or dander),
feathers, certain foods.
Non-allergic (vasomotor) rhinitis presents symptoms similar to a cold, but without an apparent cause.
The symptoms of non-allergic rhinitis are similar to those of hay fever, but
there is actually no allergen causing the discomfort.
These allergies cause a runny nose and sneezing and cause swelling of the inner lining
of the nose, which then gives the sensation of having a stuffy nose.

What are nasal polyps?
Nasal polyps are small growths that grow on the inner lining of the nose and
usually affect both nostrils. The main symptom is the sensation of having a
stuffy nose.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using/giving Eltair to the child

Do not use/give Eltair to the child

• if you and/or the child are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using/giving Eltair to the child.
Intranasal administration of corticosteroids may have effects even after a period of
time, of a systemic type, particularly when prescribed at high doses for prolonged periods. These effects
are less likely to occur than with oral corticosteroid treatment and may
vary in individual patients and between different corticosteroid preparations. Possible systemic effects include Cushing's Syndrome, characterized by sudden weight gain,
excessive hair growth, excess fat on the face and neck (moon face or Cushingoid appearance), stretch marks on the abdomen, possible menstrual irregularities in girls, flushing of the
face, reduced activity of the adrenal glands, growth retardation in children and
adolescents, reduced bone mineral density, eye diseases such as cataracts
(clouding of the lens of the eye) and glaucoma (increased pressure inside the
eye) and, more rarely, a number of psychological or behavioral effects including
psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression
(particularly in children).
In particular, inform your doctor if you/the child:

• suffer from infections of the respiratory tract caused by fungi or viruses
• have tuberculosis (a lung infectious disease)
• have had recent ulcers or perforations of the nasal septum
• have recently undergone surgery or trauma to the nose, as you should not be treated with nasal corticosteroids until complete healing
• have reduced liver function
• experience blurred vision or other visual disturbances

Switching from oral corticosteroid therapy to Eltair therapy:
If you/the child need to switch from treatment with corticosteroids (anti-inflammatory drugs) by
mouth to treatment with Eltair nasal spray, the doctor will gradually reduce the dosage of
the oral corticosteroid.

Children and adolescents
Long-term treatments with this medicine are not recommended in children, as the long-term effects of intranasal corticosteroid administration in children
are not fully known.

Influence on growth
The use of corticosteroids can affect the growth of children and adolescents (see
section "Additional undesirable effects in children and adolescents"). Therefore, it is recommended
that the height of children undergoing prolonged treatment with corticosteroids is periodically
monitored by the doctor. The doctor will carefully assess the benefits of corticosteroid therapy and the possible risk of growth inhibition.

Other medicines and Eltair
Tell your doctor or pharmacist if you/the child are taking, have recently
taken or might take any other medicines, including those available without a prescription.
Some medicines can increase the effects of ELTAIR and your doctor may
want to monitor you closely if you are taking these medicines
(including some medicines for the treatment of HIV: ritonavir, cobicistat).
No interactions with budesonide have been observed with any other drug used in the
treatment of nasal irritation and inflammation (rhinitis).
In particular, inform your doctor or pharmacist if you are taking:

• ketoconazole and itraconazole (medicines used to treat fungal infections), your doctor may adjust the dose or timing of Eltair;
• medicines containing hormones (estrogens) or oral contraceptives (the pill).

Laboratory tests and Eltair
Tell your doctor if you/the child need to undergo blood tests to assess the
functionality of certain glands (ACTH stimulation test) as, during the use of
corticosteroids, the test may give false results.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before using this
medicine.

Pregnancy
There are currently no known risks to the health of the fetus/newborn with the use
of this medicine during pregnancy.
Before taking this medicine, consult your doctor, who will assess the expected benefits for the mother on a case-by-case basis against the risks to the fetus

Breastfeeding
Although budesonide passes into breast milk, no effects on the infant are expected with this medicine used at the recommended doses.

Driving and using machines
Eltair does not affect the ability to drive vehicles and operate machinery.

Eltair contains potassium sorbate
It may cause local skin reactions (e.g. contact dermatitis).

3. How to use/give Eltair to the child

Use/give this medicine to the child always following exactly the instructions of the doctor or
pharmacist. If you have doubts consult the doctor or the pharmacist.
The doctor will establish the most suitable dose for her/the child.
Treatment of rhinitis
Recommended dose for adults and children over 6 years:

• two administrations of 50 micrograms per each nostril (100 micrograms/nostril) twice a day, morning and evening, or,
• two administrations of 100 micrograms per each nostril (200 micrograms/nostril) once a day, in the morning. Treatment/prevention of nasal polyposis
• 200 micrograms (100 micrograms/nostril) twice a day.

Duration of treatment
The full therapeutic effect of Eltair nasal spray is achieved only after a few days of
treatment (in rare cases not before two weeks).
The treatment of irritations and inflammation of the nose of allergic nature of a seasonal type,
should be started before exposure to allergens.
The doctor may in some cases associate Eltair with other medicines for allergy to
control the effects of allergy on the eyes or to vasoconstrictor medicines (medicines
decongestants that relieve nasal congestion, obstruction) to free the nasal passages.

Instructions for the correct use of Eltair

• 1. Shake the bottle well (figure 1)
• 2. Remove the protective cap from the nasal applicator with

delicate rotary movement

• 3. Holding the bottle upright and away from your face, activate the metering valve by pressing the bottle between your fingers firmly, until a fine mist is formed. Subsequently, the valve remains activated unless the bottle is disassembled or used very sporadically
• 4. Gently blow your nose before administering Eltair nasal spray to clear the nostrils well.
• 5. Keep your head slightly bent, close one nostril with a

finger, and gently insert the nasal applicator into the other
nostril (figure 2)

• 6. Press upwards on the bottom of the bottle to produce a fine mist(figure 2)
• 7. Move the bottle away from your nose and keep your head turned backwards to allow the medication to spread to the back of your nose.
• 8. Repeat the procedure in the other nostril
• 9. Reapply the protective cap.

WARNING:
Use within 3 months of opening the bottle.
In case of clogging, remove the nasal applicator from the bottle and rinse it in
lukewarm water for a few minutes (figure 3).
Do not use any sharp object to try to clear the obstruction .
If you use/give the child more Eltair than you should
Accidental intake of an excessive dose of Eltair should not cause discomfort.
In case of accidental intake of an excessive dose of Eltair, immediately inform
the doctor or go to the nearest hospital.

If you forget to use/give Eltair to the child
Do not use/give the child a double dose to compensate for the missed dose.

If you stop the treatment with Eltair
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.
Systemic effects of nasal corticosteroids can occur, especially at
high doses when used for prolonged periods.
The side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

• nasal irritation
• mucus discharge with blood and nosebleeds

Uncommon (may affect up to 1 in 100 people)

• immediate or delayed allergic reactions, including urticaria (skin redness accompanied by itching), irritation, skin inflammation, angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat) and itching
• sudden and involuntary muscle contraction (muscle spasm)

Rare (may affect up to 1 in 1,000 people)

• signs and symptoms of systemic corticosteroids (i.e. taken orally, intramuscularly or intravenously), including adrenal suppression (severe impairment of the activity of the adrenal glands) and growth retardation
• severe, rapidly appearing allergic reaction, which can lead to collapse (anaphylactic reaction)
• alteration of voice (dysphonia)
• bruising
• perforation of the nasal septum, lesions of the nasal mucosa (nasal ulcer)
• blurred vision

Not known (frequency cannot be estimated based on available data)

• glaucoma (eye disease caused by increased pressure of the fluid contained within the eye) ,
• cataract (clouding of the lens, the lens of the eye used to focus images)

A
nd growth retardation has been reported in children treated with intranasal steroids.
Given the risk of growth slowing in the pediatric patient population,
growth should be monitored as described in the “Children and
adolescents” section.

Reporting of side effects
If you/the child experience any side effects, including those not listed in
this leaflet, please inform 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 Eltair

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after SCAD.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Store in the original container.
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

Eltair 50 micrograms/spray nasal spray, suspension

• the active ingredient is: budesonide (1 ml of suspension contains 1 mg of budesonide).
• the other ingredients are :Microcrystalline cellulose/sodium carboxymethylcellulose, hydroxypropylmethylcellulose, sodium lauryl sulfate, macrogol 400, butylated hydroxyanisole, sodium citrate, citric acid monohydrate, potassium sorbate, disodium edetate, purified water. Eltair 100 micrograms/spray nasal spray, suspension
• the active ingredient is: budesonide (1 ml of suspension contains 2 mg of budesonide).
• the other ingredients are :Microcrystalline cellulose/sodium carboxymethylcellulose, hydroxypropylmethylcellulose, sodium lauryl sulfate, macrogol 400, butylated hydroxyanisole, sodium citrate, citric acid monohydrate, potassium sorbate,disodium edetate, purified water.

Description of the appearance of Eltair and contents of the pack
Eltair is presented as a suspension for nebulization in a glass bottle equipped with a dosing valve.
Eltair 50 micrograms/spray nasal spray contains 200 sprays.
Eltair 100 micrograms/spray nasal spray contains 200 sprays.

Marketing Authorisation Holder
SCHARPER S.p.A.
Viale Ortles, 12
20139 Milano

Manufacturer
Mipharm S.p.A.
Via B. Quaranta, 12 – 20141 Milano