Active ingredients: Budesonide
Eltair 50 micrograms / actuation nasal spray, suspension
Eltair 100 micrograms / actuation nasal spray, suspension
Indications Why is Eltair used? What is it for?
Eltair is a medicine that contains the active substance budesonide.
Budesonide belongs to a group of medicines called 'corticosteroids' and works by reducing inflammation of the lining of the nose.
Eltair is indicated in adults and children over 6 years of age in the treatment of:
- irritation and inflammation of the nose (rhinitis)
- allergic (such as hay fever) and non-allergic (vasomotor)
- seasonal or perennial
- polyps in the nose
- treatment
- prevention after surgery by removal (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 certain plants, grasses and weeds, as well as molds and fungal spores.
Perennial rhinitis occurs throughout the year and its symptoms may be due to sensitivity to a wide range of elements such as dust mites, animal hair (or dandruff), feathers, certain foods.
Non-allergic (vasomotor) rhinitis has cold-like symptoms, but with no apparent cause. The symptoms of non-allergic rhinitis are similar to those of hay fever, but there is actually no allergen that causes the discomfort.
These allergies cause the nose to run and sneeze and cause the inner lining of the nose to swell, which then causes the nose to feel clogged.
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 blocked nose.
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Eltair should not be used
Do not use / give your child Eltair
- if you and / or the child are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Eltair
Talk to your doctor or pharmacist before using / giving your child Eltair.
Intranasal administration of corticosteroids can also present distant systemic effects, 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, excess hair, excess fat on the face and neck (full moon face or Cushingoid aspect), stretch marks on the abdomen, possible menstrual disorders in girls, redness to the face, decreased activity of the adrenal glands, growth retardation in children and adolescents, decreased bone mineral density, eye diseases such as cataracts (clouding of the lens of the lens) and glaucoma (increased pressure inside the "eye) and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (particularly in children).
In particular, tell your doctor if you / your child:
- suffer from respiratory tract infections caused by fungi or viruses
- you have tuberculosis (an infectious disease of the lungs)
- you have had recent nasal septal ulcers or perforations
- you have recently undergone surgery or trauma to the nose, as you should not be treated with nasal corticosteroids until completely healed
- you have reduced liver function
Switching from oral corticosteroid therapy to Eltair therapy:
If you / your child need to switch from oral corticosteroid (anti-inflammatory) treatment to treatment with Eltair nasal spray, your doctor will gradually reduce the dose of the corticosteroid by mouth.
Children and adolescents
Long-term treatment with this medicine is not recommended in children, as the long-term effects of nasal administration of corticosteroids in children are not fully understood.
Influence on growth
The use of corticosteroids may affect the growth of children and adolescents (see section "Additional side effects in children and adolescents"). Therefore, it is recommended that the height of children on prolonged corticosteroid treatment is periodically monitored by their physician. Your doctor will carefully evaluate the benefits of corticosteroid therapy and the possible risk of growth block.
Interactions Which drugs or foods may change the effect of Eltair
Tell your doctor or pharmacist if you / your child are taking, have recently taken or might take any other medicines, even those 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 of budesonide have been observed with any other drug used in the treatment of irritation and inflammation of the nose (rhinitis).
In particular, tell your doctor or pharmacist if you are taking:
- ketoconazole and itraconazole (medicines used to treat fungal infections), your doctor may change the dose or timing of taking Eltair;
- medicines that contain hormones (estrogen) or oral contraceptives (pill).
Laboratory analysis and Eltair
Tell your doctor if you / your child need to have blood tests to evaluate the function of some glands (ACTH stimulation test) as the test may give false results when using corticosteroids.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There is currently no known risk of malformation on the health of the fetus / newborn from the use of this medicine during pregnancy. Before taking this medicine, consult your doctor, who will evaluate the expected benefits for the mother on a case-by-case basis against the risks for the mother. the fetus.
Feeding time
Although budesonide passes into breast milk, no effects on the suckling child are to be expected for this medicinal product used at recommended doses.
Driving and using machines
Eltair does not affect the ability to drive and use machines.
Eltair contains potassium sorbate
May cause local skin reactions (e.g. contact dermatitis).
Dosage and method of use How to use Eltair: Dosage
Always use / give your child this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Your doctor will work out which dose is best for you / your child.
Treatment of rhinitis
Recommended dose for adults and children over 6 years:
- two doses of 50 micrograms in each nostril (100 micrograms / nostril) twice a day, morning and evening,
or,
- two doses of 100 micrograms in 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 earlier than two weeks).
Treatment of seasonal allergic nose irritations and inflammations should be started prior to exposure to allergens.
Your doctor may in some cases combine Eltair with other allergy medicines to control the effects of the allergy on the eyes or with vasoconstrictor medicines (decongestant medicines that relieve nasal congestion, obstruction) to clear the nasal passages.
Instructions for the correct use of Eltair
- Shake the vial well
- Remove the protective cap from the nasal applicator with a gentle twisting motion
- Holding the bottle upright and away from your face, activate the metering valve by squeezing the bottle firmly between your fingers, until a fine mist is formed. Subsequently, the valve remains activated unless the bottle is disassembled or used very occasionally
- Gently blow your nose before administering Eltair Nasal Spray in order to clear your nostrils well.
- Keep the head slightly bent, close one nostril with a finger, and gently insert the nasal applicator into the other nostril
- Press the bottom of the vial upwards to produce a fine mist
- Remove the bottle from your nose and keep your head pointing back to allow the dressing to spread to the bottom of the nose
- Repeat the procedure in the other nostril
- Re-apply the protective cap.
CAUTION: Use within 3 months of opening the vial. In case of obstruction, remove the nasal applicator from the vial and rinse it in warm water for a few minutes. Do not use any pointed object to try to clear the obstruction.
If you forget to use / give your child Eltair
Do not use / give your child a double dose to make up for a forgotten dose.
If you stop taking Eltair
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Eltair
Accidentally taking an overdose of Eltair should not cause any discomfort. If you accidentally take an overdose of Eltair, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Eltair
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.
Undesirable effects are listed below according to the following frequency:
Common (may affect up to 1 in 10 people)
- irritation of the nose
- mucus discharge with blood and nosebleed
Uncommon (may affect up to 1 in 100 people)
- immediate or delayed allergic reactions, including hives (redness of the skin accompanied by itching), irritation, inflammation of the skin, angioedema (swelling of the 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 (ie taken orally, intramuscular, or intravenous) corticosteroid effects, including adrenal suppression (severe impairment of adrenal gland activity) and growth retardation
- severe rapid allergic reaction which can lead to collapse (anaphylactic reaction)
- voice changes (dysphonia)
- bruise
- perforation of the septum of the nose, injury to the nasal mucosa (nasal ulcer)
Not known (frequency cannot be estimated from the available data)
- glaucoma (eye disease caused by increased pressure of the fluid inside the eye),
- cataract (clouding of the lens, the lens of the eye that is used to focus images)
ADDITIONAL UNDESIRABLE EFFECTS IN CHILDREN AND ADOLESCENTS
Growth retardation has been reported in children treated with intranasal steroids. Given the risk of growth retardation in the pediatric patient population, growth should be monitored as described in the section "Children and adolescents".
Reporting of side effects
If you / your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Store in the original container.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
Composition
Eltair 50 micrograms / actuation 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 laurilsulfate, polyethylene glycol 400, butylhydroxyanisole, sodium citrate, citric acid monohydrate, potassium sorbate, disodium edetate, purified water.
Eltair 100 micrograms / actuation 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 laurilsulfate, polyethylene glycol 400, butylhydroxyanisole, sodium citrate, citric acid monohydrate, potassium sorbate, disodium edetate, purified water.
What Eltair looks like and contents of the pack
Eltair is presented as a suspension to be sprayed in a glass vial with a metering valve.
Eltair 50 micrograms / puff nasal spray contains 200 puffs.
Eltair 100 micrograms / puff nasal spray contains 200 puffs.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ELTAIR - NASAL SPRAY, SUSPENSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
ELTAIR 50 mcg nasal spray, suspension
1 ml of suspension contains:
Active ingredient: budesonide 1 mg
ELTAIR 100 mcg nasal spray, suspension
1 ml of suspension contains:
Active ingredient: budesonide 2 mg
03.0 PHARMACEUTICAL FORM
Nasal spray, suspension
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Seasonal allergic rhinitis, allergic and non-allergic perennial rhinitis.
Treatment of nasal polyposis.
Prophylaxis of recurrence of nasal polyposis after polypectomy.
04.2 Posology and method of administration
Doses should be set individually.
Treatment of rhinitis
Recommended dose for adults and children over 6 years: two doses of 50 mcg for each nostril (100 mcg / nostril) twice a day, morning and evening, or, two doses of 100 mcg for each nostril (200 mcg / nostril) once a day, in the morning.
Treatment / prevention of nasal polyposis
200 mcg (100 mcg / nostril) twice a day.
Patients should be advised that the full therapeutic effect of ELTAIR Nasal Spray is only achieved after a few days of treatment (in rare cases not earlier than two weeks).
Treatment of seasonal allergic rhinitis should be started before exposure to allergens. Concomitant therapy, for example with antihistamines, may sometimes be necessary to control allergic ocular symptoms. In case the nasal passages are blocked, in the former. two days of therapy, the application of ELTAIR nasal spray can be preceded by the administration of a nasal vasoconstrictor.
04.3 Contraindications
Known individual hypersensitivity to budesonide and to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Systemic effects may occur with intranasal corticosteroids, particularly when prescribed in 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 Cusching's syndrome, Cushingoid appearance, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, disturbances sleep, anxiety, depression or aggression (particularly in children).
Reduced hepatic function may affect the elimination of corticosteroids resulting in reduced elimination and consequently increased systemic exposure. These patients should be monitored for the risk of potential systemic effects.
Particular attention is needed in patients with active or quiescent pulmonary tuberculosis and in patients with fungal or viral respiratory tract infections. In patients suffering from tuberculosis, the use of corticosteroids must follow a careful evaluation of the therapeutic advantages in comparison with the possible undesirable effects. Due to the inhibitory effect of corticosteroids on the healing of skin lesions, patients with recent nasal septal ulcers, surgery or nasal trauma should not be treated with nasal corticosteroids until healing is complete. In patients receiving oral corticosteroids the switching to the use of ELTAIR nasal spray alone must be done in a controlled manner to prevent imbalances of the hypothalamus-hypophysis-adrenal axis. Combine ELTAIR nasal spray by progressively reducing the dose of the oral corticosteroid.
Pediatric population
The long-term effects of nasal administration of glucocorticoids in children are not fully understood. Physicians should regularly monitor the growth of children receiving prolonged corticosteroid treatment by any route of administration (see section 4.8) and carefully weigh the benefits of glucocorticosteroid therapy against the possibility of stunting (the benefit / risk ratio). ).
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
04.5 Interactions with other medicinal products and other forms of interaction
Budesonide does not appear to interact with any of the drugs used for the treatment of rhinitis.
CYP3A4 is the major enzyme involved in the metabolism of budesonide. Inhibitors of this enzyme such as eg. ketoconazole and itraconazole may therefore increase systemic exposure to budesonide several times. Since there are no data to support a recommended dosage, their combination should be avoided. If this is not possible, the period between the two treatments should be as long as possible, and a reduction in the dose of budesonide may be considered.
An increase in plasma concentrations resulting from an increased effect of corticosteroids was observed in women also treated with estrogen and steroid contraceptives, but no effect was seen with budesonide and the concomitant intake of low doses of oral contraceptives.
Because adrenal function can be suppressed, the ACTH stimulation test for the diagnosis of pituitary insufficiency may give false (low values) results.
04.6 Pregnancy and breastfeeding
Results from prospective epidemiological studies and international post marketing experience indicate that administration of inhaled or intranasal budesonide does not overall increase the risk of congenital malformations when administered in early pregnancy.
As with other drugs, the administration of budesonide during pregnancy requires a careful evaluation of the balance of benefit to the mother and risk to the fetus.
Budesonide is excreted in breast milk. In any case, at the therapeutic doses of budesonide used by the nasal route, no effects on the infant are to be expected and therefore it can be used during lactation.
Maintenance treatment with inhaled budesonide (200 or 400 mcg / 2 times daily) in asthmatic women results in negligible systemic exposure of the infant to budesonide.
In a pharmacokinetic study, the daily dose of the infant estimated to be 0.3% of the maternal daily dose for both doses and the mean plasma concentration in the neonates, assuming complete oral bioavailability of the child, was estimated to be 1/600 of the mean concentrations observed in maternal plasma.
The concentrations of budesonide in the neonatal plasma samples were all below the limit of determination. Based on the data of inhaled budesonide and the fact that it exhibits linear pharmacokinetics in the therapeutic dose ranges after nasal, inhalation, oral and rectal administration, it can be expected that at the therapeutic doses used the exposure for the infant may be low.
04.7 Effects on ability to drive and use machines
ELTAIR Nasal Spray does not affect the ability to drive or use machines.
04.8 Undesirable effects
Frequency classes are defined as follows: very common (≥ 1/10); common (≥ 1/100, a
Systemic effects of nasal corticosteroids may occur, especially at high doses when used for prolonged periods (see section 4.4).
Pediatric population
Growth retardation has been reported in children treated with intranasal steroids. Due to the risk of growth retardation in the pediatric population, growth should be monitored as described in section 4.4.
04.9 Overdose
An acute overdose with ELTAIR Nasal Spray, even in excessive doses, does not lead to clinical problems.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Budesonide is a glucorticosteroid with high local anti-inflammatory activity. Budesonide exhibits a high first pass metabolism (90%) in the liver with the formation of metabolites with reduced glucocorticoid activity. The mechanism of action of budesonide in the treatment of rhinitis depends on the anti-inflammatory action which is expressed with the inhibition of the synthesis and release of inflammatory mediators and with the inhibition of the immune response mediated by cytokines.
A clinical study in seasonal rhinitis, with budesonide administered both nasally and orally compared to placebo, showed that the therapeutic effect of budesonide is fully attributable to the local action of the drug. In prophylaxis, budesonide has also shown protective effects towards the immediate allergic response. Controlled clinical studies have shown that budesonide gives a good therapeutic response with few and mild undesirable effects.
Even in the case of long-term treatments in adults and children with perennial rhinitis, budesonide has been shown to be well tolerated.
05.2 Pharmacokinetic properties
The systemic bioavailability of nasally administered aqueous suspension budesonide is 33%.
The maximum plasma concentration after nasal administration of 400 mcg of budesonide in aqueous suspension is 1.0 mcmol / L within 42 minutes. Budesonide is 90% transformed during the first hepatic passage into metabolites with low glucocorticosteroid activity, such as 6-beta-hydroxybudesonide and 16-alpha-hydroxyprednisolone, whose activity is less than 1% of that of budesonide.
05.3 Preclinical safety data
Single dose administration by the oral route showed LD50 values greater than 800 mg / kg in mice and 400 mg / kg in rats. Toxicity tests conducted on the dog for repeated administration up to 12 months of 200 mcg / day by inhalation, did not show any toxic effects.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Microcrystalline cellulose / sodium carboxymethylcellulose, hydroxypropylmethylcellulose, sodiolaurylsulfate, polyethylene glycol 400, butylhydroxyanisole, sodium citrate, citric acid monohydrate, potassium sorbate, disodium edetate, purified water.
06.2 Incompatibility
None known.
06.3 Period of validity
ELTAIR 50 nasal spray: 24 months, in intact and correctly stored packaging.
ELTAIR 100 nasal spray: 36 months, in intact and correctly stored packaging.
06.4 Special precautions for storage
Store below 25 ° C.
Store in the original container.
06.5 Nature of the immediate packaging and contents of the package
Nebulizer bottle of 200 sprays.
Amber glass vials of 12 ml of nominal volume, equipped with a 50 microliter dosing valve.
06.6 Instructions for use and handling
Before each administration:
1) SHAKE THE VIAL WELL
2) Remove the protective capsule from the nasal applicator with a gentle twisting motion
3) Keeping the bottle vertical and away from your face, activate the dosing valve by squeezing the bottle firmly between your fingers, until a fine mist is formed. Subsequently, the valve remains activated unless the bottle is disassembled or used very occasionally
4) Gently blow your nose before administering ELTAIR nasal spray in order to clear the nostrils well
5) Keep the head slightly bent, close one nostril with a finger, gently insert the nasal applicator in the other nostril and press the bottom of the vial upwards in order to produce a fine nebulization
6) Remove the bottle from the nose and keep the head pointing backwards to allow the dressing to spread to the back of the nose. Repeat the procedure in the other nostril
7) Reattach the protective cap.
ATTENTION:
Use within 3 months of opening the vial.
In case of obstruction, remove the nasal applicator from the vial and rinse it in warm water for a few minutes.
Do not use any pointed object to attempt to clear the obstruction.
07.0 MARKETING AUTHORIZATION HOLDER
SCHARPER S.p.A. Via Manzoni, 45 - 20121 MILAN
08.0 MARKETING AUTHORIZATION NUMBER
ELTAIR 50 nasal spray - AIC n. 033916014
ELTAIR 100 nasal spray - AIC n. 033916026
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
28 January 2000/28 March 2010
10.0 DATE OF REVISION OF THE TEXT
November 2012
