Package Leaflet: Information for the Patient

Aerius5Film-Coated Tablets

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 pass it on 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. See section 4.

1. What is Aerius and what it is used for

2. What you need to know before you start taking Aerius

3. How to take Aerius

4. Possible side effects

5. Storage of Aerius

6. Contents of the pack and additional information

What is Aerius

Aerius contains desloratadine, which is an antihistamine.

How Aerius works

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

When to use Aerius

Aerius 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 and adolescents 12 years of age and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Aerius 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

-if you are allergic to desloratadine or to any of the other ingredients of this medication (including those 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 12years of age.

Other medications and Aerius

No known interactions of Aerius with other medications.

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

Taking Aerius with food, drinks and alcohol

Aerius can be taken regardless of meals.

Be careful when taking Aerius with alcohol.

Pregnancy, breastfeeding and fertility

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

Do not recommend taking Aerius if you are pregnant or breastfeeding a baby.

No data 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 a state of mental alertness, such as driving a car or operating machinery, until you have determined your own response to the medication.

Aeriustabletscontains lactose

If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medication.

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

Use in adults and adolescents 12 years of age and older

The recommended dose is one tablet once a day with water, with or without food.

This medication is for oral use.

Swallow the tablet whole.

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

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

If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and 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 than you should

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

If you forget to take Aerius

If you forget to take your dose at the usual time, take it as soon as you remember and 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 questions 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 adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet.In adolescents, headache was the most frequently reported adverse reaction.

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

Frequent: The following may affect up to 1 in 10 peoplepeople

• fatigue
• dry mouth
• headache

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

Rare: The following may affect up to 1 in 10,000 peoplepeople

• severe allergic reactions
• skin rash
• strong or irregular heartbeats
• rapid heartbeats
• stomach pain
• nausea (urge to vomit)
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• 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 ultraviolet light from 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

• aggression
• change in heart rhythm
• abnormal behavior

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 and blister after EXP.The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C. Store in the original packaging.

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

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. In this way, you will help protect the environment.

Composition of Aerius

• The active principle is desloratadine5mg
• The other components of the tablet are: calcium dihydrogen phosphate, microcrystalline cellulose, cornstarch, talc. The tablet coating contains a pellicular coating (containing lactose monohydrate(see section2 “Aerius tablets contain lactose”), hypromellose, titanium dioxide, macrogol400, indigotin (E‑132)), a transparent coating (containing hypromellose, macrogol400), carnauba wax, white wax.

Appearance of the product and contents of the pack

Aerius5mg film-coated tablets are blue in colour, round, engraved with “C5” on one side and smooth on the other.

Aerius5mg film-coated tablets are available in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90or100tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorisation and manufacturer responsible

Holder of the marketing authorisation:

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

Manufacturer responsible:

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

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

Last update of the summary of product characteristics:02/2025.

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu.