DESLORATADINE ARISTO 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Desloratadina Aristo 5 mg orodispersible tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains

important information for you.

-Keep this 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 only 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 leaflet.

Contents of the leaflet:

1. What is Desloratadina Aristo and what is it used for
2. What you need to know before taking Desloratadina Aristo
3. How to take Desloratadina Aristo
4. Possible side effects
5. Storage of Desloratadina Aristo
6. Package contents and additional information

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

Desloratadina Aristo orodispersible tablets are a non-sedating antihistamine medication that helps control allergic reactions and their symptoms.

Desloratadina Aristo orodispersible tablets relieve 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 Aristo orodispersible tablets are also used to relieve symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin rashes.

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 Aristo

Do not take Desloratadina Aristo

• if you are allergic to desloratadine or any other component of this medication (listed in section 6) or to loratadine.

Desloratadina Aristo 5 mg orodispersible tablets are indicated for adults and adolescents (from 12 years of age).

Warnings and precautions

Consult your doctor or pharmacist before taking Desloratadina Aristo :

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

Using Desloratadina Aristo with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take

any other medication.

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

Taking Desloratadina Aristo with food and drinks

It is not necessary to take Desloratadina Aristo orodispersible tablets with food and drinks.

Additionally, Desloratadina Aristo orodispersible tablets can be taken independently of meals.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, it is not recommended to take Desloratadina Aristo.

Driving and using machines

At the recommended dose, Desloratadina Aristo is not expected to 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 Aristo contains aspartame.

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Desloratadina Aristo

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

Before use, carefully remove the blister pack, open it, and remove the orodispersible tablet without breaking it.

Place it in your mouth and it will dissolve immediately. No water or other liquid is needed to swallow the dose.

Adults and adolescents (from 12 years of age): take one 5 mg dose of Desloratadina Aristo orodispersible tablets once a day. Take the dose immediately after removing it from the blister pack.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Desloratadina Aristo orodispersible tablets. 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 patient to patient, and you should follow your doctor's instructions.

If you take more Desloratadina Aristo orodispersible tablets than you should

Take Desloratadina Aristo orodispersible tablets 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 Aristo orodispersible tablets

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 individual doses.

4. Possible side effects

Like all medications, Desloratadina Aristo can cause side effects, although not everyone experiences 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, very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin rash have been reported.

Very rare cases of palpitations, rapid heartbeat, 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.

Abnormal behavior, aggression, depressed mood, changes in heart rhythm, dry eyes, weight gain, and increased appetite have also been reported with an unknown frequency (frequency cannot be estimated from available data).

.

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

5. Storage of Desloratadina Aristo

Keep this medication out of sight and reach of children.

Do not use Desloratadina Aristo orodispersible tablets after the expiration date stated on the packaging and blister pack. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Desloratadina Aristo orodispersible tablets

-The active ingredient is desloratadine 5 mg

-The other ingredients are mannitol, microcrystalline cellulose, sodium croscarmellose, potassium polacrilin, aspartame, magnesium stearate, Tutti-Frutti flavor (contains cornstarch), red iron oxide, citric acid, purified water.

Appearance of the product and package contents

Desloratadina Aristo 5 mg orodispersible tablets are reddish-brown, beveled, and marked with a "5" on one side.

Desloratadina Aristo orodispersible tablets are available in blister packs, in packages of 20 and 30 orodispersible tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid – Spain

Manufacturer:

Genepharm S.A., 18 km

Marathonos Avenue, 1

5351 Pallini

Greece.

O

Pharmapath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

Date of the last revision of this leaflet: October 2023

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.