DESLORATADINE VIR 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Desloratadina Vir 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

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

1. What you need to know before taking Desloratadina Vir
2. How to take Desloratadina Vir

1. Possible side effects
2. Storage of Desloratadina Vir
3. Package Contents and Additional Information

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

Desloratadina Vir is a non-sedating antihistamine medication that helps control allergic reactions and their symptoms.

Desloratadina Vir relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

Desloratadina Vir is also used to relieve symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin hives.

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

2. What you need to know before taking Desloratadina Vir

Do not take Desloratadina Vir:

• If you are allergic to desloratadine, loratadine, or any of the other components of this medication (listed in section 6).

Desloratadina Vir is indicated for adults and adolescents (12 years of age and older).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Desloratadina Vir:

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

Taking Desloratadina Vir with other medications

There are no known interactions between Desloratadina Vir and other medications.

Taking Desloratadina Vir with food and drinks

Desloratadina Vir can be taken with or without food.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using any medication during pregnancy or breastfeeding.

If you are pregnant or breastfeeding, it is not recommended that you take Desloratadina Vir.

Driving and Using Machines

At the recommended dose, it is not expected that Desloratadina Vir will cause drowsiness or affect your attention. However, very rarely, some people may experience drowsiness, which may affect their ability to drive or use machines.

Desloratadina Vir contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Desloratadina Vir

Follow the exact instructions for administration of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults and adolescents (12 years of age and older): take one tablet once a day. Swallow the tablet whole with water, 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 Desloratadina Vir.

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 based on the evaluation of your medical 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 one patient to another, and therefore, you should follow your doctor's instructions.

If you take more Desloratadina Vir than you should

Take Desloratadina Vir only as your doctor has indicated. An accidental overdose is not expected to cause serious problems.

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

If you forget to take Desloratadina Vir

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 missed doses.

4. Possible side effects

Like all medications, Desloratadina Vir can cause side effects, although not everyone will experience them.

In adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet. In adolescents, headache was the most commonly reported adverse reaction.

During the marketing of Desloratadina Vir, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin hives, and swelling) and skin rash have been reported. Palpitations, rapid heart rate, stomach pain, nausea (vomiting), vomiting, upset stomach, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and changes in liver function tests have also been reported very rarely.

Frequency not known: abnormal behavior and aggression, weight gain, increased appetite, depressed mood, and dry eyes.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Desloratadina Vir

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package, after EXP. The expiration date is the last day of the month indicated.

Store below 30°C. Store in the original packaging.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Desloratadina VIR

• The active ingredient is desloratadine 5 mg.

• The other components of the tablet are anhydrous lactose, microcrystalline cellulose, cornstarch, magnesium stearate, and magnesium oxide. The tablet coating contains a film coating (containing hypromellose, titanium dioxide, polyethylene glycol/macrogol, indigo carmine (E132)).

Appearance of the Product and Package Contents

The tablets are packaged in PVC/Aclar/aluminum blisters and in monodose paper-based pouches.

Packages containing 100 tablets in PVC/Aclar/aluminum blisters.

Packages containing monodose paper-based pouches that contain 10, 20, 30, 50, or 90 tablets.

Monodose paper-based pouch.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid) - Spain

Date of the Last Revision of this Package Leaflet:May 2022

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