Prospecto: information for the patient

Desloratadina Viatris 0.5 mg/ml oral solution EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.

• This medicine has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or nurse, even if they do not appear in this prospect. See section 4.

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

2.What you need to know before starting to take Desloratadina Viatris

3.How to take Desloratadina Viatris

4.Possible adverse effects

5.Storage of Desloratadina Viatris

6.Contents of the package and additional information

How it worksDesloratadina Viatris

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

When to use Desloratadina Viatris

Desloratadina 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 aged 1 year and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina Viatris 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 Desloratadina Viatris

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

.

Warnings and precautions

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

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

Children and adolescents

Do not administer this medicine to children under 1 year.

Others

Other medicines and Desloratadina Viatris

No known interactions of desloratadine with other medicines have been reported.

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

Taking Desloratadina Viatris with food, drinks and alcohol

Desloratadina 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 become pregnant,consult your doctor or pharmacist before using this medicine.

Desloratadina Viatris is not recommended for use during pregnancy or breastfeeding. No data are available on male and female fertility..

Driving and operating machinery

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 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 medicine.

Desloratadina 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) suffer from an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medicine.

Desloratadina Viatris contains propylene glycol (E 1520)

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

Desloratadina Viatris contains sodium

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

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

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 1 to 5 years old:

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

Children 6 to 11 years old:

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

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

The recommended dose is 10 ml (two 5 ml 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 desloratadine Viatris oral solution.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 will depend on the evaluation of your disease history.

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 patient to patient, and therefore you should follow your doctor's instructions.

If you take more Desloratadina Viatris than you should

Take this medication only as your doctor has indicated. No accidental overdose is expected to cause serious problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desloratadina Viatris

If you forgot 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 compensate for the missed doses.

If you interrupt treatment with Desloratadina Viatris

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

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

During the marketing of desloratadine Viatris oral solution, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. 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 desloratadine Viatris oral solution were approximately the same as those of a solution or tablet without active ingredient. However, frequent side effects in children under 2 years old were diarrhea, fever, and insomnia, while in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet without active ingredient.

In clinical trials with desloratadine, 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 old: the following may affect up to 1 in 10 children

• diarrhea
• fever
• insomnia

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

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
• vomiting
• stomach upset
• 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 available data

• abnormal 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 tanning bed
• changes in heart rhythm.
• abnormal behavior
• aggression
• weight gain, increased appetite.
• depressed mood.
• dry eyes.

Children

Unknown frequency: the frequency cannot be estimated from available data

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es/ww.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.

Once opened, it must be used before 2 months.

No special storage conditions are required.

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

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Desloratadina Viatris

- The active ingredient is desloratadine 0.5 mg/ml.

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The other components of the oral solution are:

sorbitol liquid (E-420)

(non-crystallizing)

propylene glycol (E 1520)

monohydrate citric acid

sodium citrate

hypromellose 2910

sucralose

sodium edetate

tutti frutti flavor

Appearance of the product and contents of the package

Desloratadina Viatris oral solution is presented as a transparent and colorless solution, free of foreign particles.

Desloratadina 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 60, 100, 125, 150 ml, and 300 ml sizes.

Amber glass type III bottles closed with child-resistant screw caps (C/R). This screw cap has a coating 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 subsequently packaged in cardboard boxes.

All packages are delivered with a measuring spoon for doses of 2.5 ml and 5 ml or an oral dosing syringe with a final volume of 5 ml in increments of 0.5 ml.

Only some sizes of packaging may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Balkanpharma - Troyan AD

1 Krayrechna Str.

Troyan 5600

Bulgaria

O

H2 Pharma

21 Rue Jacques Tati

78390 Bois d'Arcy

France

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet:February 2025

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/