DESLORATADINE COMBIX 5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Desloratadine Flas Combix 5 mg orodispersible tablets EFG

Desloratadine

Read this leaflet carefully before starting to take this medicine, as 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 to you 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. See section 4.

Contents of the leaflet

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

1. What is Desloratadine Flas Combix and what is it used for

Desloratadine Flas Combix 5 mg orodispersible tablets is a non-sedating antihistamine that helps control allergic reactions and their symptoms.

Desloratadine relieves 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.

This medicine is 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 Desloratadine Flas Combix

Do not take Desloratadine Flas Combix

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

Desloratadine Flas Combix is indicated for adults and adolescents (from 12 years of age)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadine Flas Combix:

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

Taking Desloratadine Flas Combix with other medicines

There are no known interactions between desloratadine and other medicines.

Taking Desloratadine Flas Combix with food and drinks

It is not necessary to take Desloratadine Flas Combix with food and drinks. Additionally, this medicine can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine during pregnancy or breastfeeding.

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

Driving and using machines

At the recommended dose, it is not expected that Desloratadine Flas Combix will cause drowsiness or reduce your attention. However, very rarely, some people may experience drowsiness, which may affect their ability to drive or use machines.

Desloratadine Flas Combix contains aspartame and lactose

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

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Desloratadine Flas Combix

Before use, carefully open the blister pack 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 tablet 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 Desloratadine Flas Combix.

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 schedule 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 Desloratadine Flas Combix than you should

Take Desloratadine Flas Combix 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 medicine and the amount ingested.

If you forget to take Desloratadine Flas Combix

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 medicines, Desloratadine Flas Combix can cause side effects, although not everyone gets them.

During the marketing of desloratadine, 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 altered liver function tests have also been reported.

In adults, the 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 frequently reported adverse reaction.

Adults

Frequency not known: frequency cannot be estimated from available data

• abnormal behavior
• aggression
• weight gain
• increased appetite
• depressed mood
• dry eyes

Children

Frequency not known: frequency cannot be estimated from available data

• slow heartbeat
• change in heartbeat
• abnormal behavior
• aggression
• weight gain
• increased appetite
• depressed mood
• dry eyes

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use 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 Combix

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Desloratadine Flas Combix 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 Desloratadine Flas Combix, inform your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Desloratadine Flas Combix

• The active ingredient is desloratadine 5 mg.
• The other ingredients are: polacrilin potassium, anhydrous citric acid (E330), gelatin, microcrystalline cellulose, crospovidone, red iron oxide (E172), anhydrous colloidal silica, aspartame (E951), Tutti-Frutti flavor, mannitol (E421), lactose monohydrate, magnesium stearate, and sodium stearyl fumarate.

Appearance of the product and package contents

Light pink to light brown, speckled, round, flat, smooth tablets on both sides.

Aluminum-Aluminum blister packs with desiccant and OPA/Aluminum/PVC/Aluminum blister packs.

Packaging of 20 tablets.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

25, parc d’activités des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of last revision of this leaflet: July 2022

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