DESLORATADINE VIATRIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Desloratadine Viatris 5 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Desloratadine Viatris and what is it used for
2. What you need to know before you take Desloratadine Viatris
3. How to take Desloratadine Viatris
4. Possible side effects
5. Storage of Desloratadine Viatris
6. Contents of the pack and further information

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

Desloratadine Viatris is a non-drowsy antihistamine medicine that helps to control allergic reactions and their symptoms.

Desloratadine is indicated in adults and adolescents (12 years of age and older) to relieve the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or house dust mite allergy). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

Desloratadine is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to carry out your daily activities and sleep.

You should consult a doctor if your symptoms worsen or do not improve.

2. What you need to know before you take Desloratadine Viatris

Do not take Desloratadine Viatris

• If you are allergic to desloratadine, 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 taking Desloratadine Viatris if:

• You have a history of, or have had, seizures.
• You have kidney problems.

If you are not sure if any of these apply to you, ask your doctor or pharmacist.

Children

Desloratadine tablets are not suitable for children under 12 years of age.

Other medicines and Desloratadine Viatris

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

Taking Desloratadine Viatris with alcohol

Be careful when taking desloratadine with alcohol.

Pregnancy and breastfeeding

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.

Desloratadine Viatris is not recommended if you are pregnant or breastfeeding.

Driving and using machines

At the recommended dose, desloratadine is not expected to cause drowsiness or affect your ability to drive or use machines. However, in rare cases, some people may experience drowsiness, which may affect their ability to drive or use machines.

Desloratadine Viatris contains sunset yellow FCF (E110) and sodium

Sunset yellow FCF (E 110) may cause allergic reactions.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".

3. How to take Desloratadine Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose for adults and adolescents (12 years of age and older) is one tablet once a day.

Swallow the tablet whole with a glass of 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.

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 evaluation of your medical 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 you should follow your doctor's instructions.

If you take more Desloratadine Viatris than you should

Take desloratadine only as your doctor has told you. 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 medicine and the amount taken.

If you forget to take Desloratadine Viatris

If you forget to take your dose at the scheduled time, take it as soon as possible and then continue with your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently with desloratadine than with the placebo tablet. In adolescents, headache was the most frequently reported side effect.

If you experience any of the following side effects, stop taking this medicine and contact your doctor or go to the emergency department of your nearest hospital immediately:

Very rare (may affect up to 1 in 10,000 people):

• Severe allergic reactions such as difficulty breathing, shortness of breath, wheezing, itching, rash, and swelling of the face, lips, tongue, or other parts of the body, and skin rash.
• Seizures (convulsions).
• Liver disease (nausea, vomiting, loss of appetite, feeling unwell, fever, itching, yellowing of the skin and eyes, pale stools, dark urine).

Frequency not known (cannot be estimated from the available data):

• Changes in heart rhythm, which may cause dizziness or weakness. This can be detected in tests to check the electrical activity of the heart (electrocardiogram or ECG).

In clinical trials with desloratadine, the following side effects were reported as:

Frequent (may affect up to 1 in 10 people):

• Fatigue.
• Dry mouth.
• Headache.

During the marketing of desloratadine, the following side effects were reported in adults as:

Very rare (may affect up to 1 in 10,000 people):

• Fast heart rate.
• Nausea (feeling sick).
• Dizziness.
• Muscle pain.
• Agitation with increased body movement.
• Stomach pain.
• Upset stomach.
• Drowsiness.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Strong or irregular heartbeats.
• Feeling sick (nausea).
• Diarrhea.
• Difficulty sleeping.
• Abnormal liver function tests.

Frequency not known (cannot be estimated from the available data):

• Abnormal behavior.
• Aggression.
• Unusual weakness.
• Increased sensitivity of the skin to the sun, even on cloudy days, and to ultraviolet light, such as that from a sunlamp.
• Weight gain, increased appetite.
• Depressed mood.
• Dry eyes.

Other side effects in children and adolescents

Frequency not known (cannot be estimated from the available data):

• Slow heart rate.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine Viatris

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Desloratadine Viatris

The active substance is desloratadine. Each tablet contains 5 mg of desloratadine.

The other ingredients are: magnesium stearate (E 572), sodium lauryl sulfate (E 487), anhydrous colloidal silica (E 551), microcrystalline cellulose (E 460i), and pregelatinized corn starch.

The tablet coating contains: polyvinyl alcohol (E 1203), carmine indigo aluminum lake (E 132), sunset yellow FCF aluminum lake (E 110), macrogol, talc (E 553b), and titanium dioxide (E 171).

See section 2, "Desloratadine Viatris contains sunset yellow FCF (E110) and sodium".

Appearance of the product and pack contents

Desloratadine Viatris are blue, round, curved-sided tablets marked with "DE 5" on one side and an "M" on the other.

Desloratadine Viatris 5 mg film-coated tablets are packaged in blisters containing 10, 15, 20, 30, 50, 60, 90, 100 tablets or in bottles containing 30 and 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories Limited t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

or

VIATRIS SANTE

360 Avenue Henri Schneider

69300 Meyzieu

France

or

Mylan Hungary Kft. / Mylan Hungary Ltd.

Mylan utca 1

Komárom, 2900

Hungary

You can request more information about this medicine from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

SpainDesloratadine Viatris 5 mg film-coated tablets EFG

FranceDesloratadine Viatris 5 mg, film-coated tablet

ItalyDesloratadine Mylan Generics

NetherlandsDesloratadine Viatris 5 mg, film-coated tablets

United Kingdom (Northern Ireland)Desloratadine Mylan 5mg Film-coated Tablets

Czech RepublicDesloratadine Viatris 5mg, film-coated tablets

SwedenDesloratadine Viatris 5 mg film-coated tablet

Date of last revision of this leaflet:July 2025

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