Desloratadine Aristo 5 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Aristo 5 mg orodispersible 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

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

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

Desloratadine Aristo orodispersible tablets are an antiallergic medicine that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

Desloratadine 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, itching of the palate, and eye itching, redness, or watering.

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

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

2. What you need to know before starting to take Desloratadine Aristo

Do not take Desloratadine Aristo

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadine Aristo:

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

Taking Desloratadine Aristo with other medicines

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

There are no known interactions between Desloratadine Aristo and other medicines.

Taking Desloratadine Aristo with food and drinks

It is not necessary to take Desloratadine Aristo orodispersible tablets with food or drinks.

Moreover, Desloratadine Aristo orodispersible tablets can be taken regardless of meals.

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.

If you are pregnant or breastfeeding a baby, it is not recommended that you take Desloratadine Aristo.

Driving and using machines

At the recommended dose, Desloratadine Aristo is not expected to cause drowsiness or reduce your attention capacity. However, very rarely, some individuals may experience drowsiness, which could affect their ability to drive or operate machinery.

Desloratadine Aristo contains aspartame.

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

3. How to take Desloratadina Aristo

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

Before use, carefully peel back 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 daily. Take the dose immediately after removing it from the blister.

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 per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If your allergic rhinitis is persistent (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 Desloratadina Aristo orodispersible tablets than you should

Take Desloratadina Aristo orodispersible tablets only as directed by your doctor.

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 at telephone number 91 562 04 20, indicating the medicine 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, then continue with your usual dosing schedule.

Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Desloratadine Aristo 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 Desloratadine, 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 of wanting to vomit), vomiting, upset stomach, diarrhoea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, restlessness with increased body movement, liver inflammation and changes in liver function tests have also been reported.

Additionally, with unknown frequency (frequency cannot be estimated from the available data), abnormal behaviour, aggression, depressed mood, changes in heart rhythm, dry eyes, weight gain and increased appetite have been reported.

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 Desloratadina Aristo

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

Do not use Desloratadina Aristo orodispersible tablets after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers 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. Package contents and other information

Composition of Desloratadine Aristo orodispersible tablets

• The active substance is desloratadine 5 mg.

• The other components are mannitol, microcrystalline cellulose, sodium croscarmellose, polacriline potassium, aspartame, magnesium stearate, Tutti-Frutti flavour (contains maize starch), red iron oxide, citric acid, purified water.

Appearance of the medicinal product and contents of the container

Desloratadine Aristo 5 mg orodispersible tablets are reddish-brown in colour, bevelled edge, and marked with a "5" on one side.

Desloratadine Aristo orodispersible tablets are supplied in blisters, in pack sizes of 20 and 30 orodispersible tablets. Only certain 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
15351 Pallini
Greece.

Or

Pharmapath S.A.
28is Oktovriou 1,
Agia Varvara, 123 51,
Greece

Date of the most recent revision of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es.