Desloratadine Vir 0.5 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

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Package leaflet: Information for the user

Desloratadine Vir 0.5 mg/ml oral solution EFG

Read all of 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 or pharmacist.
• 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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1. What Desloratadine Vir Is and What It Is Used For

This medicine contains desloratadine, which is an antihistamine.

Desloratadine Vir oral solution is an antiallergic medicine that does not cause drowsiness. It helps control allergic reactions and symptoms.

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

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

2. What you need to know before starting to take Desloratadine Vir

Do not take Desloratadine Vir:

• 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

Consult your doctor or pharmacist before starting to take 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 administer this medicine to children under 1 year of age.

This medicine is indicated for use in children aged 1 to 11 years, adolescents (12 years of age and older), and adults, including elderly people.

Taking Desloratadine Vir with other medicines

No interactions of this medicine with other medicines are known.

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

Taking Desloratadine Vir with food and drink

This medicine may be taken regardless of meals.

Pregnancy, breast-feeding and fertility

Pregnancy

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.

If you are pregnant or breastfeeding a baby, it is not recommended that you take this medicine.

Fertility

There are no data available regarding male and 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 perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined your individual response to the medicine.

This medicine contains sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Desloratadine Vir

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

Use in children

Children aged 1–5 years:

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

Children aged 6–11 years:

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

Adults and adolescents

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

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

If the bottle is supplied with a dosing syringe, you may 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 this medicine.

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 regimen 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.

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4. Possible adverse effects

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

During the post-marketing period of desloratadine, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and seek medical attention right away.

In most children and adults, adverse effects were approximately the same as with a solution or tablet containing no active ingredient. However, the frequent adverse effects in children under 2 years of age were diarrhea, 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:

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

During the post-marketing period of desloratadine, the following adverse reactions have been reported:

Adults:

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

? severe allergic reactions ? skin rash ? strong or irregular heartbeat

? rapid heartbeat ? stomach pain ? nausea

? vomiting ? upset stomach ? diarrhea

? dizziness ? drowsiness ? difficulty sleeping

? muscle pain ? hallucinations ? seizures

? agitation with increased ? liver inflammation ? abnormal liver body movement 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

? change in heartbeat 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 heartbeat rhythm
• abnormal behaviour
• aggression

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Vir

Keep out of sight and reach of children.

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

This medicine does not require any special storage conditions. Keep in the original packaging.

Do not use this medicine if you notice any changes in the appearance of the oral solution.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point.

6. Contents of the pack and other information

Composition of Desloratadina Vir

• The active substance is desloratadine 0.5 mg/ml.
• The other components are: sodium citrate, sorbitol, sucralose, anhydrous citric acid, propylene glycol, hypromellose, tutti fruit flavour, and purified water.

Appearance of Desloratadina Vir and contents of the container

Desloratadina Vir oral solution is supplied in 120 ml bottles with child-resistant closure.

The package includes an oral dosing syringe.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70. 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 S.A.

18th Km Marathonos Avenue.

Pallini

Attica

153 51

Greece

Or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the most recent revision of this leaflet: May 2022

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): http://www.aemps.es/