Prospect: information for the patient

Desloratadina Viatris 5 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

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

-This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section4.

1.What is Desloratadina Viatris and how it is used

2.What you need to know before starting to take Desloratadina Viatris

3.How to take Desloratadina Viatris

4.Possible adverse effects

5.Storage of Desloratadina Viatris

6.Contents of the package and additional information

Desloratadina Viatris is an antihistamine medication that does not causedrowsiness. It helps to control allergic reactions and their symptoms.

Desloratadina Viatris is indicated for adults and adolescents (12years of age or older) to relieve 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 nose or nasal itching, palate itching, eye redness or tearing.

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

The relief of these symptoms lasts a full day and helps you to continue your daily activities and sleep.

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

Do not take Desloratadina Viatris

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina Viatris if:

• You have a history, personal or family, of seizures.
• You have kidney insufficiency.

If you are unsure if this applies to you, ask your doctor or pharmacist.

Children

Desloratadina Viatris tablets are not suitable for children under 12 years old.

Other medications and Desloratadina Viatris

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

Taking Desloratadina Viatris with alcohol

Be careful when taking Desloratadina Viatris with alcohol.

Pregnancy and breastfeeding

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

Desloratadina Viatris is not recommended for use during pregnancy or breastfeeding.

Driving and operating machines

At the recommended dose, desloratadine is not expected to make you drowsy or less alert. However, in rare cases, some people may experience drowsiness, which may affect your ability to drive and operate machines.

Desloratadina Viatris contains yellow-orange aluminium lake S (E110) and sodium

This medication may cause allergic reactions because it contains yellow-orange aluminium lake S (E110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet, which is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults and adolescents (12 years 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 for how long you should take Desloratadina Viatris.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or less than 4 weeks), your doctor will recommend a treatment plan based on the evaluation of your disease history.

If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from patient to patient, and you should follow your doctor's instructions.

If you take more Desloratadina Viatris than you should

Take Desloratadina Viatris only as your doctor has instructed. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desloratadina Viatris

If you forgot to take your dose at the usual time, take it as soon as possible and continue with your usual dosing schedule. Do not take a double dose to make up for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may 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 headachewere reportedmore frequently with desloratadina than with the placebo tablet. In adolescents,headachewas the side effect reported most frequently.

If you experience any of the following side effects, stop taking this medicine and contact your doctor or go immediately 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, hives, and inflammation of the face, lips, tongue, or other parts of the body, and skin rash.
• Seizures (convulsions).
• Hepatopathy (nausea, vomiting, loss of appetite, general feeling of discomfort, fever, itching, yellowing of the skin and eyes, light-colored stools, dark urine).

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

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

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

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

• Fatigue.
• Dry mouth.
• Headache.

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

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

• Fast heartbeats.
• Discomfort (vomiting).
• Dizziness.
• Muscle pain.
• Restlessness with increased body movement.
• Stomach pain.
• Upset stomach.
• Drowsiness.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Strong or irregular heartbeats.
• Nausea (gagging).
• Diarrhea.
• Difficulty sleeping.
• Alteration in liver function tests.

Frequency not known (the frequency 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, for example, to the ultraviolet light of a tanning bed.
• Weight gain, increased appetite.
• Depressed mood.
• Dry eyes.

Other side effects in children and adolescents

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

• Slow heart rate.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box, blister pack, and bottle after CAD or EXP. The expiration date is the last day of the month indicated.

For bottle containers, discard after 30 days from the first opening.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Desloratadine Viatris

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

The other components are: magnesium stearate (E-572), sodium lauryl sulfate (E487), anhydrous colloidal silica (E-551), microcrystalline cellulose (E-460i), and pregelatinized cornstarch.

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

See section2, “Desloratadine Viatris contains yellow-orange S aluminum lake (E110) and sodium”.

Appearance of the product and contents of the package

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

Desloratadine Viatris 5 mg film-coated tablets are packaged in blisters containing 2, 3, 5, 7, 10, 15, 20, 30, 50, 60, 90, 100 tablets or in a bottle containing 30 tablets.

Only some package 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 SANTÉ

360 Avenue Henri Schneider

693000 Meyzieu

France

or

Mylan Hungary Kft. ./Mylan Hungary Ltd.

Mylan utca 1

Komárom, 2900

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the European Economic Area member states with the following names:

SpainDesloratadine Viatris 5 mg film-coated tablets EFG

FinlandDesloratidin Mylan 5 mg film-coated tablet

FranceDesloratadine Viatris 5 mg, coated tablet

ItalyDesloratadina Mylan Generics

NetherlandsDesloratadine Mylan 5 mg, film-coated tablets

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

Czech RepublicDesloratadin Mylan 5mg, coated tablets

SwedenDesloratadin Mylan 5 mg film-coated tablet

Last review date of this leaflet:August 2024

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/