DESLORATADINE VIATRIS 0.5 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the Patient

Desloratadine Viatris 0.5 mg/ml Oral Solution EFG

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

• Keep this package 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 is Desloratadine Viatris and what is it used for
2. What you need to know before you take Desloratadine Viatris
3. How to take Desloratadine Viatris
4. Possible side effects
5. Storage of Desloratadine Viatris
6. Contents of the pack and further information

1. What is Desloratadine Viatris and what is it used for

How it worksDesloratadine Viatris

Desloratadine Viatris oral solution is a non-drowsy antiallergic medicine that helps control allergic reactions and their symptoms. Desloratadine is an antihistamine.

When to use Desloratadine Viatris

Desloratadine Viatris oral solution relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, 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.

Desloratadine Viatris oral solution is also used to relieve the symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin rash.

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

2. What you need to know before you take Desloratadine Viatris

Do not take Desloratadine Viatris

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

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Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Desloratadine Viatris:

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

Children and adolescents

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

Others

Other medicines and Desloratadine Viatris

There are no known interactions of desloratadine with other medicines.

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

Taking Desloratadine Viatris with food, drinks, and alcohol

Desloratadine Viatris can be taken with or without food. Be careful when taking this medicine 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.

It is not recommended to take desloratadine if you are pregnant or breastfeeding. There is no data 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.

Desloratadine Viatris contains sorbitol (E-420)

This medicine contains 147.15 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 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.

Desloratadine Viatris contains propylene glycol (E 1520)

This medicine contains 102.30 mg of propylene glycol per ml of oral solution.

Desloratadine Viatris contains sodium

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

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

3. How to take Desloratadine Viatris

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

Use in children

Children from 1 to 5 years:

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:

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

Use in adults and adolescents (from 12 years of age)

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

In the case that the packaging containing the bottle of oral solution includes a dosing syringe, you can use it alternatively to take the appropriate 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 for how long you should take desloratadine Viatris oral solution.

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

If your allergic rhinitis is persistent (presence of symptoms 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 one patient to another, and therefore, you should follow your doctor's instructions.

If you take more Desloratadine Viatris than you should

Take this medicine only as your doctor has told you. An accidental overdose is not expected to cause serious problems.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Desloratadine Viatris

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

If you stop taking Desloratadine Viatris

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 desloratadine Viatris oral solution, very rare cases of serious 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 desloratadine Viatris oral solution 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.

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

Common: may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

Children

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

• diarrhea
• fever
• insomnia

During the marketing of desloratadine, the following side effects have been reported:

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

• serious allergic reactions
• skin rash
• strong or irregular heartbeats
• fast heartbeats
• stomach pain
• nausea
• vomiting
• upset stomach
• diarrhea
• dizziness
• drowsiness
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• agitation with increased body movement
• liver inflammation
• changes in 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 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

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, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance 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 Desloratadine Viatris

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

Once opened, it should be used within 2 months.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

If you notice any change in the appearance of the oral solution, inform your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Desloratadine Viatris

• The active substance is desloratadine 0.5 mg/ml.

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The other ingredients of the oral solution are:

liquid sorbitol (E-420)

(non-crystallizing)

propylene glycol (E 1520)

citric acid monohydrate

sodium citrate

hypromellose 2910

sucralose

disodium edetate

tutti-frutti flavor

Appearance of the product and pack contents

Desloratadine Viatris oral solution is presented as a clear, colorless solution, free from foreign particles.

Desloratadine Viatris oral solution 0.5 mg/ml is supplied in six different volumes: 50, 60, 115, 120, 150, and 300 ml, and packaged in 60, 100, 125, 150 ml, and 300 ml sizes.

Ambber glass bottles type III, closed with a child-resistant screw cap (C/R). This screw cap has a coated face and is composed of multiple layers of polyethylene. 50 and 60 ml of the solution are packaged in 60 ml bottles. 100 ml is packaged in 100 ml bottles. 120 ml is packaged in 125 ml bottles. 150 ml is packaged in 150 ml bottles. 300 ml is packaged in 300 ml bottles. The bottles are then packaged in cardboard boxes.

All packs are supplied with a measuring spoon of 2.5 ml and 5 ml or an oral dosing syringe of a final volume of 5 ml, with 0.5 ml graduations.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Balkanpharma - Troyan AD

1 Krayrechna Str.

Troyan 5600

Bulgaria

Or

H2 Pharma

21 Rue Jacques Tati

78390 Bois d'Arcy

France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/