AERIUS 0.5 mg/ml ORAL SOLUTION

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.

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(E‑420)

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 (E‑1520)

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.

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:

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.