DESLORATADINE FLAS COMBIX 5 MG ORODISPERSIBLE TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadine Flas Combix 5 mg orodispersible tablets EFG

Desloratadine

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, 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. See section 4.

Contents of the leaflet

1. What Desloratadine Flas Combix is and what it is 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. How to store Desloratadine Flas Combix
6. Contents of the pack and other information

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

Desloratadine Flas Combix 5 mg orodispersible tablets is an antihistamine medicine that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

Desloratadine 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 or itchy nose, itching of the palate, and itchy, red or watery eyes.

This medicine is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rashes.

Relief from these symptoms lasts for a full day, helping you carry on with your daily activities and normal sleep periods.

2. What you need to know before starting to take Desloratadine Flas Combix

Do not take Desloratadine Flas Combix

• if you are allergic to desloratadine or to any of the other components 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 renal 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 or drinks. This medicine may be taken regardless 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, it is not recommended that you take Desloratadine Flas Combix.

Driving and using machines

At the recommended dose, Desloratadine Flas Combix 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 Flas Combix contains aspartame and lactose

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

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

3. How to take Desloratadina Flas Combix

Before use, carefully open the blister and remove the orodispersible tablet without breaking it. Place it in your mouth, where it will disintegrate immediately. No water or other liquid is needed to swallow the dose.

Adults and adolescents (from 12 years of age): take one tablet 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 Flas Combix.

If you have intermittent allergic rhinitis (symptoms present for fewer than 4 days per week or for fewer than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.

If you have persistent allergic rhinitis (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, so you should follow your doctor's instructions.

If you take more Desloratadina Flas Combix than you should

Take Desloratadina Flas Combix only as directed by your doctor. 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 medication and the amount ingested.

If you forget to take Desloratadina Flas Combix

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 Flas Combix can cause adverse effects, although not everyone will experience them.

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 vomiting), vomiting, upset stomach, diarrhoea, dizziness, somnolence, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and changes in liver function tests have also been reported.

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.

Adults

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

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

Children

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

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 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 Desloratadine Flas Combix, inform your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. In case of doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadine Flas Combix

• The active substance is desloratadine 5 mg.
• The other components are: polacriline potassium, anhydrous citric acid (E330), gelatin,

microcrystalline cellulose, crospovidone, iron oxide red (E172), anhydrous colloidal silica,

aspartame (E951), tutti-frutti flavour, mannitol (E421), lactose monohydrate, magnesium stearate and sodium stearyl fumarate.

Appearance of the medicine and contents of the pack

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

Aluminum-Aluminum blisters with desiccant and OPA/Aluminum/PVC/Aluminum blisters.

Pack sizes 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 the most recent revision of this leaflet: July 2022

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