Desloratadine Viatris 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Viatris 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Desloratadine is indicated in adults and adolescents (12 years of age and older) for the relief of 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 eye itching, redness, or watering.

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

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

You should consult a doctor if your condition worsens or does not improve.

2. What you need to know before starting to 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

Talk to your doctor or pharmacist before taking Desloratadine Viatris if:

• You have a personal or family history of seizures.
• You have renal impairment.

If you are unsure whether this applies to you, please consult your doctor or pharmacist.

Children

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

Other medicines and Desloratadine Viatris

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

Taking Desloratadine Viatris with alcohol

Be cautious when taking desloratadine with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of 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 reduced alertness. However, rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Desloratadine Viatris contains Sunset Yellow aluminium lake (E110) and sodium

Sunset Yellow aluminium lake (E110) may cause allergic-type reactions.

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

3. How to take Desloratadine Viatris

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

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

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 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 an 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 Viatris than you should

Take desloratadine only as directed by your doctor. 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 Viatris

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.

If you have any further questions about 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 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 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 immediately or go straight to the nearest hospital emergency department:

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

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

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

• Changes in heartbeat, which may cause dizziness or weakness. These can be detected during tests to monitor 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 post-marketing experience with desloratadine, the following side effects have been reported in adults:

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

• Fast heartbeat.
• Malaise (vomiting).
• Dizziness.
• Muscle pain.
• Restlessness with increased body movement.
• Stomach pain.
• Upset stomach.
• Drowsiness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Strong or irregular heartbeats.
• Feeling sick (nausea).
• Diarrhea.
• Difficulty sleeping.
• Abnormal liver function test results.

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

• Abnormal behaviour.
• Aggression.
• Unusual weakness.
• Increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, for example, ultraviolet light from a sunbed.
• Weight gain, increased appetite.
• Depressed mood.
• Dry eyes.

Other side effects in children and adolescents

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

• Slow heartbeat.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly via the Spanish System for Pharmacovigilance of Human 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 Viatris

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

Blister pack: Store below 30°C.

Bottle: This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Viatris

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

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

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

See section 2, “Desloratadine Viatris contains orange yellow S aluminium lake (E110) and sodium”.

Nature of the product and pack size

Desloratadine Viatris are blue, round, biconvex 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.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Further information on this medicine is available from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Spain Desloratadina Viatris 5 mg comprimidos recubiertos con película EFG
France Desloratadine Viatris 5 mg, comprimé pelliculé
Italy Desloratadina Mylan Generics
Netherlands Desloratadine Viatris 5 mg, filmomhulde tabletten
United Kingdom (Northern Ireland) Desloratadine Mylan 5mg Film-coated Tablets
Czech Republic Desloratadin Viatris 5mg, potahované tablety
Sweden Desloratadin Viatris 5 mg film-coated tablet

Date of the most recent review of this leaflet: July 2025

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