Patient Information Leaflet

Desloratadine Flas Combix 5 mg Buccal Tablets EFG

Desloratadine

Read this leaflet carefully before you start taking 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 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. See section 4.

1. What isDesloratadine Flas Combixand 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. Storage of Desloratadine Flas Combix

6. Contents of the pack and additional information

Desloratadina Flas Combix 5 mg chewable tablets is an antihistamine medication that does not cause drowsiness. It helps to control allergic reactions and their symptoms.

Desloratadina 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.

This medication is also used to relieve symptoms associated with urticaria (a 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 to continue your daily activities and normal sleep periods.

Do not take Desloratadina Flas Combix

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

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

Warnings and precautions

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

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

Taking Desloratadina Flas Combix with other medications

No known interactions of desloratadine with other medications.

Taking Desloratadina Flas Combix with food and drinks

No need to take Desloratadina Flas Combix with food and drinks. This medication can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machinery

At the recommended dose, Desloratadina Flas Combix is not expected to cause drowsiness or impair your ability to pay attention. However, very rarely, some people may experience drowsiness, which can affect your ability to drive or operate machinery.

Desloratadina Flas Combix contains aspartame and lactose

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

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

Before use, carefully open the blister pack and remove the buccal dispersible 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 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 for how long you should take Desloratadina Flas Combix.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment plan based on the evaluation of your disease history.

If your allergic rhinitis is persistent (presence of symptoms 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 Desloratadina Flas Combix than you should

Take Desloratadina Flas Combix only as your doctor has instructed. 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desloratadina Flas Combix

If you forgot to take your dose at the scheduled time, take it as soon as possible and continue with your usual dosing schedule. Do not take a double dose to compensate for the missed doses.

Like all medications, Desloratadina Flas Combix may cause adverse effects, although not everyone will experience them.

During the marketing of desloratadina, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) and skin eruptions have been communicated. Very rarely, palpitations, rapid heartbeats, stomach pain, nausea (urge to vomit), vomiting, stomach upset, diarrhea, dizziness, drowsiness, difficulty sleeping, muscle pain, hallucinations, seizures, agitation with increased body movement, liver inflammation, and liver function test alterations have also been reported.

In adults, the adverse effects were approximately the same as those 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

Unknown frequency: the frequency cannot be estimated from the available data

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

Children

Unknown frequency:the frequency cannot be estimated from the available data

• slow heart rate
• change in heart rhythm
• abnormal behavior
• aggression
• weight gain
• increased appetite
• depressed mood
• dry eyes

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

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

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

Composition ofDesloratadina Flas Combix

- The active ingredient is desloratadine 5 mg.

- The other components are: polacrilina 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 stearate fumarate.

Appearance of the product and content of the packaging

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

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

Packages of 20 tablets.

Holder of the marketing authorization

Combix, S.L.U. Laboratories

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: July 2022

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