DESLORATADINE COMBIX 5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Desloratadine Combix 5 mg film-coated tablets EFG

Read this 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Desloratadine Combix is a non-drowsy antihistamine medicine that helps control allergic reactions and their symptoms.

Desloratadine Combix relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or house dust mite allergy). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red, or watery eyes.

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

Relief from these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.

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

Do not take Desloratadine Combix

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Desloratadine Combix:

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

Taking Desloratadine Combix with other medicines

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

No known interactions with other medicines have been reported for desloratadine.

Taking Desloratadine Combix with food and drink

Desloratadine Combix can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are pregnant or breastfeeding, it is not recommended to take Desloratadine Combix.

Driving and using machines

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

Desloratadine Combix contains lactose

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

3. How to take Desloratadine Combix

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents (12 years of age and older): take one tablet once a day. Swallow the tablet whole with water, with or without food.

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Desloratadine 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 assessment 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 one patient to another, and you should follow your doctor's instructions.

If you take more Desloratadine Combix than you should

Take Desloratadine Combix only as your doctor has told you. An accidental overdose is not expected to cause serious problems.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Desloratadine Combix

If you forget to take your dose at the right time, take it as soon as possible, and then continue with your normal dosing schedule. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Desloratadine Combix

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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. Also, very rare cases of palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), 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 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, the most commonly reported adverse reaction was headache.

Adults

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

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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. Storing Desloratadine Combix

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

If you notice any change in the appearance of Desloratadine Combix, contact your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Desloratadine Combix

• The active substance is desloratadine 5 mg.

The other ingredients are polacrilin potassium, anhydrous citric acid (E330), gelatin, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, mannitol (E421), lactose monohydrate, magnesium stearate, sodium stearyl fumarate, hypromellose (E464), talc (E553b), triacetin (E1518), potassium sorbate (E202), titanium dioxide (E171), and carmine indigo lake.

Appearance and packaging

Light blue, round, film-coated tablets marked with "5" on one side and smooth on the other.

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

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