Desloratadine Combix 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Desloratadina Combix 5 mg film-coated tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

Desloratadina Combix 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, itching of the palate, and itchy, red or watery eyes.

Desloratadina Combix is 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, helping you continue your daily activities and maintain normal sleep patterns.

2. What you need to know before starting Desloratadine Combix

Do not take Desloratadine 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 Combix is indicated for adults and adolescents (12 years of age and older).

Warnings and precautions

Consult your doctor or pharmacist before starting Desloratadine Combix:

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

Taking Desloratadine Combix 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 and other medicines.

Taking Desloratadine Combix with food and drinks

Desloratadine Combix can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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

Driving and using machines

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

Desloratadine Combix contains lactose

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

3. How to take Desloratadine Combix

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

The recommended dose is:

Adults and adolescents (12 years of age and older): take one tablet once daily. 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 you have intermittent allergic rhinitis (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 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, and therefore you should follow your doctor's instructions.

If you take more Desloratadine Combix than you should

Take Desloratadine 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 medicine and the amount ingested.

If you forget to take Desloratadine Combix

If you forget to take your dose at the scheduled 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 a missed dose.

If you stop taking Desloratadine Combix

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

4. Possible adverse effects

Like all medicines, this medicine 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 reports have also included palpitations, rapid heartbeat, stomach pain, nausea (feeling sick), vomiting, upset stomach, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, restlessness with increased body movements, liver inflammation, and changes in liver function tests.

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 heart 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 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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

If you notice any changes in the appearance of Desloratadine Combix, inform your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you have any doubts, 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 Combix

• The active substance is desloratadine 5 mg.

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

Appearance of the product and contents of the pack

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

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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/