DESLORATADINE VIR 0.5 mg/ml ORAL SOLUTION

Introduction

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Patient Information Leaflet

Desloratadine Vir 0.5 mg/ml oral solution EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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This medicine contains desloratadine, which is an antihistamine.

Desloratadine Vir oral solution is an anti-allergic medicine that does not cause drowsiness. It helps to control the allergic reaction and symptoms.

This medicine relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

This medicine is also used to relieve the symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin rashes.

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2. What you need to know before taking Desloratadine Vir

Do not take Desloratadine Vir:

• 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 or pharmacist before taking desloratadine VIR

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

Use in children and adolescents

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

This medicine is indicated for children from 1 to 11 years of age, adolescents (12 years of age and older), and adults, including the elderly.

Using desloratadine Vir with other medicines

No interactions with other medicines are known for this medicine.

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

Using desloratadine Vir with food and drink

This medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

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.

If you are pregnant or breastfeeding, it is not recommended to take this medicine.

Fertility

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 perform activities that require a state of alertness, such as driving a car or using machines, until you have established your own response to the medicine.

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Desloratadine Vir

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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 1-5 years of age:

The recommended dose is 2.5 ml (half a 5 ml spoon) of oral solution once a day

Children from 6-11 years of age:

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

Adults and adolescents

Adults and adolescents (12 years of age and older):

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

If the bottle comes with a dosing syringe, you can use it 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 how long you should take this medicine.

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 plan based on the assessment 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 one patient to another, and therefore, you should follow your doctor's instructions.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) have been reported. If you experience any of these serious side effects, stop taking this medicine and consult your doctor immediately.

In most children and adults, the side effects 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 desloratadine:

Children:

Common in children under 2 years of age: the following may affect up to 1 in 10 children:

• Diarrhea
• Fever
• Insomnia

Adults:

Common: the following may affect up to 1 in 10 people

• Fatigue
• Dry mouth
• Headache

The following adverse reactions have been reported during the marketing of desloratadine:

Adults:

Very rare, affects up to 1 in 10,000 people:

Severe allergic reactions, skin rash, irregular heartbeats

Rapid heartbeats, stomach pain, nausea

Vomiting, upset stomach, diarrhea

Dizziness, drowsiness, difficulty sleeping

Muscle pain, hallucinations, seizures

Agitation with increased movement, liver inflammation, changes in liver function tests

Frequency not known: the 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, from a sunlamp

Change in heart rhythm

• Abnormal behavior
• Aggression

• Weight gain, increased appetite
• Depressed mood
• Dry eyes

Children

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

• Slow heartbeat
• Change in heart rhythm
• Abnormal behavior
• Aggression

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Vir

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Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions. Keep 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. Dispose of the packaging and any unused medicine in the SIGRE collection pointConverted with the trial version of Word Cleaner Server Version, it will only convert 75% of a document.To remove this message click here to buy the full version now.

6. Package contents and further information

Composition of Desloratadine Vir

• The active ingredient is desloratadine 0.5 mg/ml.
• The other ingredients are: sodium citrate, sorbitol, sucralose, anhydrous citric acid, propylene glycol, hypromellose, tuti fruit flavor, and purified water.

Appearance of Desloratadine Vir and package contents

Desloratadine Vir oral solution is presented in 120 ml bottles with a child-resistant closure.

The presentation includes a dosing syringe

Marketing authorization holder and manufacturer

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

Famar A.V.E- Avlon Plant

49 km National Road

Athens-Lamia

19011, Greece

or

Genepharm SA

18 km Marathonos Ave

Pallini Attiki

15351, Greece

Date of last revision of this leaflet: May 2022

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