Desloratadine Viatris 0.5 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Desloratadine Viatris 0.5 mg/ml oral solution EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Desloratadine Viatris is and what it is used for
2. What you need to know before taking Desloratadine Viatris
3. How to take Desloratadine Viatris
4. Possible side effects
5. How to store Desloratadine Viatris
6. Contents of the pack and other information

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

How Desloratadine Viatris works

Desloratadine Viatris oral solution is a non-drowsy antiallergic medicine. It helps control the allergic reaction and its symptoms. Desloratadine is an antihistamine.

When Desloratadine Viatris should be used

Desloratadine Viatris 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 from 1 year of age. These symptoms include sneezing, runny or itchy nose, itching of the palate, and eye itching, redness, or watering.

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

Relief from these symptoms lasts for a full day, helping you continue your daily activities and maintain normal sleep periods.

2. What you need to know before taking Desloratadine Viatris

Do not take Desloratadine Viatris

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

.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take 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.

Other

Other medicines and Desloratadine Viatris

There are no known interactions between desloratadine and other medicines.

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

Taking Desloratadine Viatris with food, drinks, and alcohol

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Desloratadine is not recommended if you are pregnant or breast-feeding. There are no available data regarding male or female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery.

Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery, until you have determined how this medicine affects you.

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 informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) 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; therefore, it is essentially “sodium-free”.

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

3. How to take Desloratadine Viatris

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in children

Children aged 1 to 5 years:

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

Children aged 6 to 11 years:

The recommended dose is 5 ml (one 5 ml spoonful) of oral solution once daily.

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

The recommended dose is 10 ml (two 5 ml spoonfuls) of oral solution once daily.

If the packaging containing the bottle of oral solution includes an oral dosing syringe, you may alternatively use it to measure 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 may 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 desloratadine Viatris oral solution.

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

If your allergic rhinitis is persistent (symptoms present for 4 or more days per 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 therefore you should follow your doctor's instructions.

If you take more Desloratadine Viatris than you should

Take this medicine only as directed by your doctor. Accidental overdose is not expected to cause serious problems.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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 your usual dosing schedule. Do not take a double dose to make up for missed doses.

If you stop treatment with Desloratadine Viatris

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

During the marketing of desloratadine Viatris oral solution, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and contact your doctor without delay.

In clinical trials involving most children and adults, adverse effects with desloratadine Viatris oral solution were approximately the same as those with a solution or tablet containing no active ingredient. However, in children under 2 years of age, the frequent adverse effects were diarrhoea, fever, and insomnia, whereas in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient.

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

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

• diarrhoea
• fever
• insomnia

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

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

• severe allergic reactions
• skin rash
• strong or irregular heartbeat
• rapid heartbeat
• stomach pain
• nausea
• vomiting
• upset stomach
• diarrhoea
• dizziness
• somnolence
• difficulty sleeping
• muscle pain
• hallucinations
• seizures
• agitation with increased body movement
• liver inflammation
• abnormalities 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 sunlight, even on cloudy days, and to ultraviolet light, for example, ultraviolet light from a sunbed
• changes in heart rhythm
• abnormal behaviour
• aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Children

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

• slow heartbeat
• change in heart rhythm
• abnormal behaviour
• aggression

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 must be used within 2 months.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Viatris

• The active substance is desloratadine 0.5 mg/ml.

The other components 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 flavour

Appearance of the product and contents of the pack

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

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

Amber glass bottles of type III, closed with child-resistant screw caps (C/R). These screw caps have a coated surface and are composed of multiple layers of polyethylene. 50 and 60 ml of solution are packaged in 60 ml bottles. 100 ml are packaged in 100 ml bottles. 120 ml are packaged in 125 ml bottles. 150 ml are packaged in 150 ml bottles. 300 ml are packaged in 300 ml bottles. The bottles are subsequently packed in cardboard boxes.

All packs are supplied with a dosing spoon of 2.5 ml and 5 ml or an oral dosing syringe with a final volume of 5 ml marked in 0.5 ml increments.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information on this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/