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AERIUS 0.5 mg/ml ORAL SOLUTION

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About the medicine

How to use AERIUS 0.5 mg/ml ORAL SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Aerius 0.5mg/ml Oral Solution

desloratadine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What Aerius Oral Solution is and what it is used for
  2. What you need to know before you take Aerius Oral Solution
  3. How to take Aerius Oral Solution
  4. Possible side effects
  5. Storage of Aerius Oral Solution
  6. Contents of the pack and other information

1. What Aerius Oral Solution is and what it is used for

What is Aerius

Aerius contains desloratadine, which is an antihistamine.

How Aerius works

Aerius Oral Solution is a non-drowsy antiallergic medicine that helps control allergic reactions and their symptoms.

When to use Aerius

Aerius Oral Solution relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or house dust mite allergy) in adults, adolescents, and children from 1 year of age. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

Aerius Oral Solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rashes.

Relief from these symptoms lasts a full day and helps you to carry out your daily activities and have normal sleep periods.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Aerius Oral Solution

Do not take Aerius Oral Solution

  • if you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6) or to loratadine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Aerius:

  • if you have impaired kidney function.
  • if you have a history of seizures.

Children and adolescents

Do not give this medicine to children under 1 year of age.

Other medicines and Aerius

There are no known interactions between Aerius and other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Aerius Oral Solution with food, drinks, and alcohol

Aerius can be taken with or without food.

Be careful when taking Aerius with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Aerius Oral Solution is not recommended if you are pregnant or breastfeeding.

No data are available on male and female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.

Aerius Oral Solution contains sorbitol(E420)

This medicine contains 150 mg of sorbitol per ml of oral solution.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Aerius Oral Solution contains propylene glycol (E1520)

This medicine contains 100.19 mg of propylene glycol per ml of oral solution.

Aerius Oral Solution contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

Aerius Oral Solution contains benzyl alcohol

This medicine contains 0.375 mg of benzyl alcohol per ml of oral solution.

Benzyl alcohol may cause allergic reactions.

This product should not be used for more than one week in children under 3 years of age unless advised by your doctor or pharmacist.

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

3. How to take Aerius Oral Solution

Follow exactly the administration instructions given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Use inchildren

Children from 1 to 5 years of age:

The recommended dose is 2.5 ml (½ of a 5 ml spoon) of oral solution once a day.

Children from 6 to 11 years of age:

The recommended dose is 5 ml (one 5 ml spoon) of oral solution once a day.

Use inadults and adolescents from 12years of age

The recommended dose is 10 ml (two 5 ml spoons) of oral solution once a day.

If the pack containing the bottle of oral solution includes a dosing syringe, you can use it as an alternative to take the correct amount of oral solution.

This medicine is for oral use.

Swallow the dose of oral solution, and then drink a little water. You can take this medicine with or without food.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Aerius Oral Solution.

If your allergic rhinitis is intermittent (symptoms present for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule based on the evaluation of your disease history.

If your allergic rhinitis is persistent (symptoms present for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from patient to patient, and you should follow your doctor's instructions.

If you take more Aerius Oral Solution than you should

Take Aerius Oral Solution only as your doctor has told you. An accidental overdose is not expected to cause serious problems. However, if you take more Aerius Oral Solution than you should, tell your doctor, pharmacist, or nurse immediately.

If you forget to take AeriusOral Solution

If you forget to take your dose at the scheduled time, take it as soon as possible and then continue with your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Aerius

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of Aerius, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, rash, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medicine and seek medical attention immediately.

In clinical trials in most children and adults, the side effects with Aerius were approximately the same as with a solution or tablet that does not contain the active ingredient. However, the common side effects in children under 2 years of age were diarrhea, fever, and insomnia, while in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet that does not contain the active ingredient.

The following side effects have been reported in clinical trials with Aerius:

Common: may affect up to 1 in 10 people

  • fatigue
  • dry mouth
  • headache

Children

Common in children under 2 years of age: may affect up to 1 in 10 children

  • diarrhea
  • fever
  • insomnia

The following side effects have been reported during the marketing of Aerius:

Very rare: may affect up to 1 in 10,000 people

  • severe allergic reactions
  • skin rash
  • strong or irregular heartbeat
  • fast heartbeat
  • stomach pain
  • nausea
  • vomiting
  • upset stomach
  • diarrhea
  • dizziness
  • drowsiness
  • difficulty sleeping
  • muscle pain
  • hallucinations
  • seizures
  • agitation with increased body movement
  • liver inflammation
  • abnormal liver function tests

Frequency not known: frequency cannot be estimated from the available data

  • unusual weakness
  • yellowing of the skin and/or eyes
  • increased sensitivity of the skin to sun, even on cloudy days, and to ultraviolet light, for example, from a sunbed
  • changes in heart rhythm
  • abnormal behavior
  • aggression
  • weight gain, increased appetite
  • depressed mood
  • dry eyes

Children

Frequency not known: frequency cannot be estimated from the available data

  • slow heartbeat
  • changes in heart rhythm
  • abnormal behavior
  • aggression

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aerius Oral Solution

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 is the last day of the month shown.

Do not freeze. Store in the original package.

Do not use this medicine if you notice any change in the appearance of the oral solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Aerius Oral Solution

  • The active substance is desloratadine 0.5 mg/ml
  • The other ingredients of the oral solution are: sorbitol (E-420), propylene glycol (E-1520) (see section 2 "Aerius Oral Solution contains sorbitol (E-420) and propylene glycol (E-1520)"), sucralose (E-955), hypromellose 2910, sodium citrate dihydrate, natural and artificial flavor (gum, which contains propylene glycol (E-1520) and benzyl alcohol (see section 2 "Aerius Oral Solution contains benzyl alcohol")), anhydrous citric acid, disodium edetate, and purified water.

Appearance of the product and pack contents

Aerius Oral Solution is a clear, colorless solution.

Aerius Oral Solution is available in bottles of 30, 50, 60, 100, 120, 150, 225, and 300 ml, with a child-resistant cap. All presentations, except the 150 ml bottle, include a measuring spoon, with markings for 2.5 ml and 5 ml doses. The 150 ml presentation includes a measuring spoon or an oral dosing syringe, with markings for 2.5 ml and 5 ml doses.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

Manufacturer:

Organon Heist bv, Industriepark 30, 2220 Heist-op-den-Berg, Belgium.

For further information about this medicine, please contact the local representative of the marketing authorization holder:

België/Belgique/Belgien

Organon Belgium

Tél/Tel: 0080066550123 (+32 2 2418100)

[email protected]

Lietuva

Organon Pharma B.V. Lithuania atstovybe

Tel.: +370 52041693

[email protected]

Text in Bulgarian language with contact information of Organon Bulgaria including phone number and email address

Luxembourg/Luxemburg

Organon Belgium

Tél/Tel: 0080066550123 (+32 2 2418100)

[email protected]

Ceská republika

Organon Czech Republic s.r.o.

Tel.: +420 233 010 300

[email protected]

Magyarország

Organon Hungary Kft.

Tel.: +36 1 766 1963

[email protected]

Danmark

Organon Denmark ApS

Tlf: +45 4484 6800

[email protected]

Malta

Organon Pharma B.V., Cyprus branch

Tel: +356 2277 8116

[email protected]

Deutschland

Organon Healthcare GmbH

Tel: 0800 3384 726 (+49 (0) 89 2040022 10)

[email protected]

Nederland

N.V. Organon

Tel.: 00800 66550123

(+32 2 2418100)

[email protected]

Eesti

Organon Pharma B.V. Estonian RO

Tel: +372 66 61 300

[email protected]

Norge

Organon Norway AS

Tlf: +47 24 14 56 60

[email protected]

Ελλάδα

ΒΙΑΝΕΞ Α.Ε.

Τηλ: +30 210 80091 11

[email protected]

Österreich

Organon Healthcare GmbH

Tel: +49 (0) 89 2040022 10

[email protected]

España

Organon Salud, S.L.

Tel: +34 91 591 12 79

[email protected]

Polska

Organon Polska Sp. z o.o.

Tel.: +48 22 105 50 01

[email protected]

France

Organon France

Tél: +33 (0) 1 57 77 32 00

Portugal

Organon Portugal, Sociedade Unipessoal Lda.

Tel: +351 218705500

[email protected]

Hrvatska

Organon Pharma d.o.o.

Tel: +385 1 638 4530

[email protected]

România

Organon Biosciences S.R.L.

Tel: +40 21 527 29 90

[email protected]

Ireland

Organon Pharma (Ireland) Limited

Tel: +353 15828260

[email protected]

Slovenija

Organon Pharma B.V., Oss, podružnica Ljubljana

Tel: +386 1 300 10 80

[email protected]

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Organon Slovakia s. r. o.

Tel: +421 2 44 88 98 88

[email protected]

Italia

Organon Italia S.r.l.

Tel: +39 06 90259059

[email protected]

Suomi/Finland

Organon Finland Oy

Puh/Tel: +358 (0) 29 170 3520

[email protected]

Κύπρος

Organon Pharma B.V., Cyprus branch

Τηλ: +357 22866730

[email protected]

Sverige

Organon Sweden AB

Tel: +46 8 502 597 00

[email protected]

Latvija

Arvalsts komersanta “Organon Pharma B.V.” parstavnieciba

Tel: +371 66968876

[email protected]

United Kingdom (Northern Ireland)

Organon Pharma (UK) Limited

Tel: +44 (0) 208 159 3593

[email protected]

Date of last revision of this leaflet:06/2024.

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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Family medicine 7 years exp.

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Tomasz Grzelewski

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Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Yevgen Yakovenko

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Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

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Frequently Asked Questions

Is a prescription required for AERIUS 0.5 mg/ml ORAL SOLUTION?
AERIUS 0.5 mg/ml ORAL SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in AERIUS 0.5 mg/ml ORAL SOLUTION?
The active ingredient in AERIUS 0.5 mg/ml ORAL SOLUTION is desloratadine. This information helps identify medicines with the same composition but different brand names.
How much does AERIUS 0.5 mg/ml ORAL SOLUTION cost in pharmacies?
The average pharmacy price for AERIUS 0.5 mg/ml ORAL SOLUTION is around 3.98 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures AERIUS 0.5 mg/ml ORAL SOLUTION?
AERIUS 0.5 mg/ml ORAL SOLUTION is manufactured by Organon N.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of AERIUS 0.5 mg/ml ORAL SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether AERIUS 0.5 mg/ml ORAL SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to AERIUS 0.5 mg/ml ORAL SOLUTION?
Other medicines with the same active substance (desloratadine) include AERIUS 5 mg ORALLY DISINTEGRATING TABLETS, AERIUS 5 mg FILM-COATED TABLETS, DASERGIN 5 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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