Package Leaflet: Information for the Patient

Aerius 0.5mg/ml Oral Solution

desloratadina

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking 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 additional information

What is Aerius

Aerius contains desloratadine, which is an antihistamine.

How Aerius works

Aerius oral solution is an antiallergic medication that does not cause drowsiness. It helps to control the allergic reaction and its symptoms.

When to use Aerius

Aerius oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy) in adults, adolescents, and children aged 1 year and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Aerius oral solution is also used to relieve symptoms associated with urticaria (skin disease caused by an allergy). These symptoms include itching and skin hives.

The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

Do not take Aerius oral solution

-if you are allergic to desloratadine or any of the other components of this medication (listed in section6) or to loratadine.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Aerius:

-if you have impaired renal function.

-if you have a personal or family history of seizures.

Children and adolescents

Do not administer this medication to children under 1year of age.

Other medications and Aerius

No known interactions have been reported between Aerius and other medications.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Aerius oral solution with food, drinks, and alcohol

Aerius can be taken regardless of meals.

Be cautious when taking Aerius with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is not recommended to take Aerius oral solution if you are pregnant or breastfeeding.

No data is available on male and female fertility.

Driving and operating machinery

At the recommended dose, this medication is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities that require mental alertness, such as driving a car or operating machinery, until you have determined your own response to the medication.

Aerius oral solution contains sorbitol(E‑420)

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

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

Aerius oral solution contains propylene glycol (E‑1520)

This medication contains 101.9mg of propylene glycol per ml of oral solution.

Aerius oral solution contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; essentially “sodium-free”.

Aerius oral solution contains benzyl alcohol

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

Benzyl alcohol can cause allergic reactions.

This product should not be used for more than one week in children under 3years of age unless instructed 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 adverse 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 adverse effects (metabolic acidosis).

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use in children

Children from1to5years of age:

The recommended dose is2.5ml (½ of a 5ml spoonful) of oral solution once a day.

Children from6to11years of age:

The recommended dose is5ml (a 5ml spoonful) of oral solution once a day.

Use in adults and adolescents from 12years of age

The recommended dose is10ml (two 5ml spoonfuls) of oral solution once a day.

If the package containing the oral solution bottle includes a dosing syringe, you can use it alternatively to take the correct amount of oral solution.

This medication is for oral use.

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

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

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

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

For urticaria, the duration of treatment may vary from one patient to another, and therefore 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 indicated. An accidental overdose is not expected to cause serious problems. However, if you take more Aerius oral solution than you have been told, 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 you remember and then continue with your usual dosing schedule. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Aerius

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

In clinical trials in most children and adults, the side effects of Aerius were approximately the same as those of a solution or a tablet without active ingredient. However, frequent 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 without active ingredient.

During clinical trials with Aerius, the following side effects were reported:

Frequent: the following may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Children

Frequent in children under 2 years of age: the following may affect up to 1 in 10 children

• diarrhea
• fever
• insomnia

During the marketing of Aerius, the following side effects were reported as:

Rare: the following may affect up to 1 in 10,000 people

• severe allergic reactions
• skin rash
• strong or irregular heartbeats
• rapid heartbeats
• stomach pain
• nausea (gag reflex)
• vomiting
• stomach upset
• diarrhea
• dizziness
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• convulsions
• agitation with increased body movement
• inflammation of the liver
• alteration in liver function tests

Unknown frequency: the frequency cannot be estimated from the available data

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

Children

Unknown frequency: the frequency cannot be estimated from the available data

• slow heart rate
• change in heart rhythm
• abnormal behavior
• aggression

Reporting of side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Do not freeze. Store in the original packaging.

Do not use this medication if you observe any change in the appearance of the oral solution.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Aerius oral solution

• The active ingredient is desloratadine0.5mg/ml

• The other components of the oral solution are: sorbitol(E‑420), propylene glycol(E‑1520) (see section2 “Aerius oral solution contains sorbitol (E‑420) and propylene glycol (E‑1520)”), sucralose (E‑955), hypromellose 2910, sodium citrate dihydrate, natural and artificial flavor (chewing gum, which contains propylene glycol (E‑1520) and benzyl alcohol (see section2 “Aerius oral solution contains benzyl alcohol”)), anhydrous citric acid, disodium edetate, and purified water.

Appearance of the product and contents of the container

Aerius oral solution is a transparent and colorless solution.

Aerius oral solution is available in bottles of30,50,60,100,120,150,225and300ml, with a child-resistant cap. All presentations, except the 150ml bottle, include a measuring spoon, with markings for2.5mland5ml. The 150ml bottle includes a measuring spoon or an oral dosing syringe, with markings for2.5mland5ml.

Only some container 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, 2220Heist-op-den-Berg, Belgium.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:06/2024.

For more detailed information about this medicinal product, please visit the website of the European Medicines Agency: https://www.ema.europa.eu.