Desloratadine Vir 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Desloratadine Vir 5 mg film-coated tablets EFG

Read the entire 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 could harm them.

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

Contents of the leaflet

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

2. What you need to know before taking Desloratadine Vir

3. How to take Desloratadine Vir

4. Possible side effects

5. How to store Desloratadine Vir

6. Contents of the pack and other information

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

Desloratadine Vir is a non-sedating antihistamine medicine. It helps control allergic reactions and their symptoms.

Desloratadine 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, itching of the palate, and itchy, red, or watery eyes.

Desloratadine Vir 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 Vir

Do not take Desloratadina Vir:

• If you are allergic to desloratadine, loratadine, or to any of the other ingredients of this medicine (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 medicines

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

Taking Desloratadina Vir with food and drink

Desloratadina Vir can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine 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, Desloratadina Vir is not expected to cause drowsiness or reduce your attention span. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Desloratadina Vir contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Desloratadine Vir

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

Adults and adolescents (12 years of age and older): take one tablet once daily. 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 Desloratadine Vir.

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

If you have persistent allergic rhinitis (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 Vir than you should

Take Desloratadine Vir only as your doctor has instructed. 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desloratadine Vir

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.

4. Possible adverse effects

Like all medicines, Desloratadina Vir may cause adverse effects, although not everyone experiences them.

In adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient. In adolescents, headache was the most frequently reported adverse reaction.

During the marketing of Desloratadina Vir, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) and skin rash have been reported. Very rare cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhoea, dizziness, somnolence, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and abnormalities in liver function tests have also been reported.

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

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

5. Storage of Desloratadine Vir

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine VIR

• The active substance is desloratadine 5 mg.

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

Appearance of the product and contents of the pack

The tablets are packed in PVC/Aclar/aluminum blisters and in single-dose sachets made of coated paper composite.

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

Packs containing 10, 20, 30, 50 or 90 tablets in single-dose sachets made of coated paper composite.

Single-dose sachets made of coated paper composite.

Only certain pack 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 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.gob.es/