Patient Information Leaflet: Desloratadina Aristo 5 mg Buccodispersable Tablets

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this 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. Contents of the pack and additional information

Desloratadina Aristo buccal tablets is an antihistamine medication that does not cause drowsiness. It helps control allergic reactions and their symptoms.

Desloratadina Aristo buccal tablets relieves 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 Aristo buccal tablets is also used to relieve symptoms associated with urticaria (skin disease caused by an allergy). These symptoms include itching and skin hives.

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

periods

of normal sleep.

Do not take Desloratadina Aristo

- if you are allergic to desloratadine or to any of the other ingredients of this medication (including those listed in section 6) or to loratadine.

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

Warnings and precautions

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

- if you have impaired renal function.

- if you have a personal or family history of seizures.

Use of Desloratadina Aristo with other medications

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

any other medication.

No known interactions of Desloratadina Aristo with other medications.

Taking Desloratadina Aristo with food and drinks

No need to take Desloratadina Aristo chewable tablets with food and drinks.

Additionally, Desloratadina Aristo chewable tablets can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 operating machines

At the recommended dose, it is not expected that Desloratadina Aristo will cause drowsiness or impair your ability to pay attention. However, very rarely some people may experience drowsiness, which may affect your ability to drive or operate machines.

Desloratadina Aristo contains aspartame.

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

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

Before use, carefully remove the blister, open it, and take out the orally disintegrating 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 (12 years of age and older): take one 5 mg dose of Desloratadina Aristo orally disintegrating tablets once a day. 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 for how long you should take Desloratadina Aristo orally disintegrating tablets. If you have intermittent allergic rhinitis (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 you have persistent allergic rhinitis (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 Aristo orally disintegrating tablets than you should

Take Desloratadina Aristo orally disintegrating tablets only as your doctor has instructed.

No serious problems are expected from accidental overdose.

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 Aristo orally disintegrating tablets

If you forgot to take your dose at the usual 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 the missed doses.

Like all medications, Desloratadina Aristo may produce adverse effects, although not all people experience them. In adults, adverse 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 frequently 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 eruption have been reported.

Very rare cases of palpitations, rapid heartbeats, stomach pain, nausea (urge to vomit), vomiting, stomach upset, diarrhea, dizziness, somnolence, difficulty sleeping, muscle pain, hallucinations, convulsions, agitation with increased body movement, liver inflammation, and alteration in liver function tests have also been reported.

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

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If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

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

Do not use Desloratadina Aristo chewable tablets after the expiration date that appears on the packaging and blister. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown into the drains or trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Desloratadina Aristo chewable tablets

-The active ingredient is desloratadine 5 mg

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

Appearance of the product and content of the packaging

Desloratadina Aristo 5 mg chewable tablets are red-brown in color, have a beveled edge and

are marked on one side with a “5”.

Desloratadina Aristo chewable tablets are presented in blisters, in packs of 20 and 30

chewable tablets. Some pack sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid – Spain

Responsible for manufacturing:

Genepharm S.A., 18 km

Marathonos Avenue, 1

5351 Pallini

Greece.

Or

Pharmapath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

Last review date of this leaflet: October 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es.